How to read a tag. Only
verified counts toward a score — it means a typed connector
resolved this against a primary US federal record.
unconfirmed means the Verifier checked and could not confirm,
which very often means the source could not be queried at all rather than that
the claim is doubtful. refuted means a primary source
contradicts it. unverified means nothing has checked it yet.
21 CFR (Title 21 of the Code of Federal Regulations) 884.3575 classifies the vaginal pessary — "a removable structure placed in the vagina to support the pelvic organs" for conditions including uterine prolapse — as a Class II (FDA device class II) device, and FDA (US Food and Drug Administration) assigns product code HHW ("Pessary, Vaginal") to that regulation
jurisdiction: US — confidence: verified — note: both halves checked, and against two independent primary sources (openFDA classification record and the CFR text itself). Checked against the stated intended_use: — clinician-fitted removable intravaginal support device for stage II-III anterior-compartment or apical…the full check POP in adult women electing non-surgical management, SUI (stress urinary incontinence) and stage IV excluded — so a later change of indication invalidates this finding. Residual and NOT verified: the lookup establishes what HHW is, not that a device whose support diameter is set and locked mechanically stays inside HHW rather than triggering a different code or a De Novo (De Novo classification request) reading. That is an FDA pre-submission question, not a database lookup. — source: classification --product-code HHW --jurisdiction US → verified, openFDA device/classification product_code=HHW, detail "Device class 2: Pessary, Vaginal (regulation 884.3575, review panel OB)"; and regulation 884.3575 --title 21 --expect "support the pelvic organs" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-16, section text in full: "§ 884.3575 Vaginal pessary. (a) Identification. A vaginal pessary is a removable structure placed in the vagina to support the pelvic organs and is used to treat conditions such as uterine prolapse (falling down of uterus), uterine retroposition (backward displacement), or gynecologic hernia. (b) Classification. Class II (performance standards)."
Whether devices under product code HHW / 21 CFR 884.3575 require a 510(k) (premarket notification) or are exempt from premarket notification subject to the limitations in 21 CFR 884.9 is not established; web sources assert a 510(k) is required and multiple real 510(k)s exist in this space, but no primary FDA classification record showing (or not showing) the premarket-notification exemption flag was retrieved, and voluntary clearances inside exempt product codes are common enough that the existence of K-numbers does not settle the question
jurisdiction: US — confidence: unconfirmed — note: still not established after a Verifier pass, and the reason is now precise rather than vague. The openFDA classification connector in this repo returns class, device name, regulation number and review panel only — its detail surfaces no premarket-notification…the full check exemption field — so the one call the Scorer expected to settle this ("an openFDA device/classification lookup on product_code=HHW would settle it in one call") does not in fact settle it. The regulation text carries no exemption language either, and FDA's exemption determinations live in the classification database's own flags and in guidance, neither of which is reachable from the eCFR connector. A non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18) returned 16 Substantially Equivalent decisions in this code, which is exactly the ambiguous evidence the claim already describes and does not resolve it. What would close it: the FDA Product Classification database record for HHW read for its "510(k) Exempt" flag, i.e. a connector change or a human lookup, not a re-run. — source: classification --product-code HHW --jurisdiction US → verified for class and regulation but carries no exemption flag in its output; regulation 884.3575 --title 21 --expect "exempt" --jurisdiction US → unconfirmed, "21 CFR 884.3575 exists but its text does NOT contain the phrase 'exempt'" (the full section is quoted in claim 1verified — it says only "Class II (performance standards)"); regulation 884.9 --title 21 --expect "exempt" --jurisdiction US → verified, eCFR title-21 issue 2026-09-16, § 884.9 exists and is the limitations-of-exemption section the claim names, but it states the limits on an exemption rather than whether HHW has one
K190277 (an FDA 510(k) clearance number) is a real FDA 510(k) held by ConTIPI Medical Ltd. for a disposable, self-inserted, collapsible vaginal device for the non-surgical management of pelvic organ prolapse (marketed as ProVate), with an FDA decision in 2019
jurisdiction: US — confidence: verified — note: K-number, holder ("Contipi Medical , Ltd." as FDA spells it), the 2019 decision (2019-07-08) and the non-surgical POP indication are all confirmed, and the HHW product code is confirmed separately by the product-code sweep. Two residuals a Scorer should not read past:…the full check the cleared Indications for Use say "temporary, nonsurgical management" and contain none of the words "disposable", "self-inserted" or "collapsible" — that device description rests on vendor material, not on the clearance record; and the clearance confirms what ProVate was cleared to do, not that it is an available predicate for an adjustable-diameter mechanism (the file already treats it as an analog, correctly). — source: 510k "ProVate" --jurisdiction US → verified, openFDA device/510k k_number=K190277, "Cleared 510(k): ProVate Vaginal Support / Contipi Medical , Ltd. decided 2019-07-08"; and clearance-summary K190277 --expect-indication "pelvic organ prolapse" --jurisdiction US → verified, FDA 510(k) summary K190277 (https://www.accessdata.fda.gov/cdrh_docs/pdf19/K190277.pdf), Indications for Use verbatim: "The ProVate Vaginal Support is indicated for the temporary, nonsurgical management of Pelvic Organ Prolapse in females"
Four further 510(k) numbers — K132313, K231786, K232677 and K233548 (the last associated with Resilia Inc. in an April 2024 letter) — surfaced in a web search restricted to 21 CFR 884.3575 / vaginal pessary and are candidate additional clearances in this product code; none was individually confirmed to be a pessary clearance, and no product code, decision date or indication was verified for any of them
jurisdiction: US — confidence: unconfirmed — note: the underlying facts are now all confirmed, and the claim line as written is the thing that is out of date rather than wrong — it asserts its own non-confirmation, so it cannot be tagged verified without contradicting its own text; per the append-only rule it is…the full check left in place and the findings are recorded here, with claim 26verified appended below stating the confirmed version. All four are real FDA 510(k) summaries and all four sit in product code HHW: K132313 "PESSARY" / Eis Corporation, decided 2014-12-05, IFU (instructions for use) "EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women"; K231786 "Gynethotics Pessary" / Cosm Medical, decided 2024-03-06, IFU covering ring, ring-with-support, ring-with-knob, Marland, Gellhorn and cube pessaries across Stage I-III prolapse and SUI; K232677 "Reia pessary" / Reia, LLC, decided 2024-05-21, IFU "The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse"; K233548 "Uresta®" / Resilia, Inc., decided 2024-04-03 — the Resilia/April-2024 attribution in the claim is correct, but its IFU is stress urinary incontinence only ("The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence"), so it is a clearance in HHW and not a prolapse-pessary predicate for this candidate. — source: clearance-summary K132313 --jurisdiction US, clearance-summary K231786 --jurisdiction US, clearance-summary K232677 --jurisdiction US, clearance-summary K233548 --jurisdiction US → all four verified, FDA 510(k) summary PDFs at accessdata.fda.gov/cdrh_docs/pdf13/K132313.pdf, /pdf23/K231786.pdf, /pdf23/K232677.pdf and /pdf23/K233548.pdf; product codes, holders and decision dates from a non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18, 16 records)
No FDA-cleared vaginal pessary with a clinician-set, mechanically lockable, re-adjustable support diameter was identified by the Generator — the cleared and marketed devices identified are fixed-size (ring, Gellhorn, donut, cube in discrete sizes) or single-use self-expanding (K190277)
jurisdiction: US — confidence: unconfirmed — note: the openFDA HHW sweep the Scorer asked for was run and found nothing contradicting the claim, but it cannot raise it to verified and a Scorer must not read it as confirmed absence. Three reasons: a ScanResult carries no confidence tag by construction; the sweep is…the full check window- and limit-bounded (2010-2026, 16 records, limit 50); and openFDA device names describe trade names, not mechanisms, so an adjustable-diameter device could sit in that list undetected. Nearest variable-geometry entries found: K132670 PANPAC INFLATABLE DOCUT PESSARY (Panpac Medical, 2014-06-04) — volume-variable by inflation rather than a clinician-set locking diameter — and the collapsible/self-expanding K190277 and K232677. Also nearby and worth a human eye: K153422 "Panpac Disposable Pessary Fitting Set" (2016-07-14), which is the multi-size fitting inventory this candidate proposes to replace, cleared as a device in its own right. — source: 510k "adjustable pessary" --jurisdiction US → unconfirmed, "No 510(k) record found for device_name='adjustable pessary'" — a no-match against a free-text device-name field, which is weak evidence of absence and nothing more; plus the non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18) listing all 16 HHW clearances in the window, none named as adjustable- or lockable-diameter
HCPCS (Healthcare Common Procedure Coding System) Level II codes A4561 (a HCPCS code for a supply) ("pessary, rubber, any type") and A4562 ("pessary, non-rubber, any type") are active codes listed on the Medicare DMEPOS (durable medical equipment, prosthetics, orthotics and supplies) fee schedule, so the device itself is a separately payable durable-medical-equipment supply rather than an item absorbed into the office-visit payment
jurisdiction: US — confidence: unconfirmed — note: Re-checked 2026-09-29 (Verifier, re-check queue): tag held at unconfirmed. The replay answer moved but does not carry the claim as worded. payment now reads the cached CMS (Centers for Medicare & Medicaid Services) DMEPOS fee schedule (July 2026) and returns a no-modifier pricing line for both codes, so…the full check the half "listed on the Medicare DMEPOS fee schedule with an allowed amount of its own" is now supported: A4561 $28.43-$29.45, A4562 $70.81-$73.34, non-rural, 49 contiguous states/DC. Code status now resolves too: after the mid-run cache refresh, hcpcs reads the CMS Level II file (A4561 "Pessary, reusable, rubber, any type"; A4562 "Pessary, reusable, non rubber, any type"; the claim's quoted descriptors omit "reusable"). Two parts of the wording are still not supported: (1) CMS files both codes in category PO, prosthetics & orthotics, not durable medical equipment, so "durable-medical-equipment supply" is the wrong benefit category as stated. Prosthetic-device and DME (durable medical equipment) benefits carry different rules, so this is not cosmetic. (2) "Rather than absorbed into the office-visit payment" is a bundling/billing-rule assertion that a fee-schedule listing does not answer,. coverage now returns refuted for both codes, but that is not evidence either way on bundling: the cache holds Billing & Coding Articles only (no LCDs, no NCDs), and 60 of its 74 DME MAC (durable medical equipment Medicare administrative contractor) policy articles, including Urological Supplies A52521 and Ostomy Supplies A52487, have a blank code column. The miss describes our code linkage, not CMS (same trap as idea-001 claim 9unconfirmed). Existence, activity and a fee of their own are verified; the benefit category and the bundling consequence are not. A restatement as "A4561/A4562 carry DMEPOS fee-schedule amounts under category PO" would verify today. — source: history (earlier pass, superseded where it conflicts with the lookups below): [earlier note:] unconfirmed because the connector's data file is absent from this environment, not because CMS is silent. This is a missing-file gap: both hcpcs and payment name the exact CMS release that would settle it and explicitly instruct that a web search must not be substituted. Nothing here says these codes do not exist — it says nobody in this repo can currently look. Fetching data/hcpcs_level_ii.csv and data/hcpcs_payment_rates.csv closes this claim and claim 11refuted together, and is the cheapest open item in the file. [earlier source:] hcpcs A4561 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_level_ii.csv — HCPCS Level II code A4561 cannot be checked until it exists"; hcpcs A4562 --jurisdiction US → unconfirmed, same reason; payment A4561 --jurisdiction US and payment A4562 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_payment_rates.csv". Re-checked 2026-09-29: coverage A4562 --jurisdiction US → refuted, local cache of CMS Medicare Coverage Database (no policy names this code), code=A4562: a linkage artifact per the note above, not a coverage finding; hcpcs A4561 --jurisdiction US → verified, local cache of CMS HCPCS Level II file, code=A4561, "Pessary, reusable, rubber, any type"; hcpcs A4562 --jurisdiction US → verified, local cache of CMS HCPCS Level II file, code=A4562, "Pessary, reusable, non rubber, any type"; payment A4561 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4561, modifier=none, schedule=DMEPOS, release=July 2026 (category PO, non-rural $28.43 AZ to $29.45 CO); payment A4562 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4562, modifier=none, schedule=DMEPOS, release=July 2026 (category PO, non-rural $70.81 AZ to $73.34 CO)
The pessary device (A4561/A4562) is billed to a DME MAC while the fitting and insertion service (CPT (Current Procedural Terminology) 57160) is billed separately to the local Part B MAC (Medicare administrative contractor) under the Physician Fee Schedule — meaning a manufacturer selling this device must reach a DMEPOS supplier channel, not only the fitting physician
jurisdiction: US — confidence: unconfirmed — note: one half is now evidenced and the other is not. Confirmed: 57160 is an active (status A) code on the CMS Physician Fee Schedule with a full RVU (relative value unit) decomposition, so the fitting service is PFS (physician fee schedule)-paid — see claim 8verified. Not confirmed: that the device is separately billed…the full check under A4561/A4562 to a DME MAC. That needs the two missing CMS files (see claim 6unconfirmed), and the assertion about which contractor adjudicates which claim is a Medicare claims-processing-manual fact for which this repo has no typed connector at all — coverage is code-keyed and also has no cached file here, and ncd reads the NCD (national coverage determination) Manual, not the claims-processing manual. The commercial consequence the claim draws (a DMEPOS supplier channel stands between the manufacturer and revenue) therefore remains an inference, and it is the kind of inference that decides a go-to-market plan. — source: rvu 57160 --jurisdiction US → verified, CMS PFS RVU file, 57160 status A, confirming the PFS half; hcpcs A4561 --jurisdiction US / payment A4561 --jurisdiction US / coverage A4561 --jurisdiction US → all unconfirmed for missing local caches (data/hcpcs_level_ii.csv, data/hcpcs_payment_rates.csv, data/medicare_coverage_policies.csv); no connector reaches a claims-processing manual chapter
CPT 57160 ("fitting and insertion of pessary or other intravaginal support device") is an active code paid under the Medicare Physician Fee Schedule, and a third-party RVU aggregator lists it at work RVU 0.87, non-facility total RVU 2.11, and an estimated national non-facility Medicare payment of approximately $70.48 before GPCI adjustment
jurisdiction: US — confidence: verified — note: every number in the claim is confirmed against CMS's own file rather than the aggregator it was taken from — work 0.87, and 0.87 + 1.09 (non-facility PE) + 0.15 (MP) = 2.11 total non-facility RVU, paying $70.48 at conversion factor 33.4009 (the file also carries a second…the full check line at CF 33.5675 paying $70.83; facility rates are $40.42/$40.62). Three limits carried deliberately: this is national unadjusted with no GPCI, as the claim itself says; a payment decomposition says what a code pays and never that a payer has agreed to pay it for this indication; and the descriptor text quoted in the claim is not verified and cannot be — CPT descriptors are AMA-licensed, cpt returns unverifiable by design, and only the code number is checkable here. — source: rvu 57160 --jurisdiction US → verified, "local cache of CMS PFS RVU file, code=57160, year=2026, conv_fact=33.5675", detail "PFS 57160 (2026, status A): work 0.87 + PE(non-facility) 1.09 + MP 0.15 → non-facility $70.83 (PE portion $36.59), facility $40.62 | [CF 33.4009] → non-facility $70.48 (PE portion $36.41), facility $40.42"
Removal, cleaning and reinsertion of an existing pessary is bundled into the evaluation-and-management service and is not separately reportable under CPT 57160 — which is what makes recurring office pessary maintenance an uncompensated burden on the practice rather than a revenue line
jurisdiction: US — confidence: unconfirmed — note: permanently unconfirmed through this repo, for a licensing reason rather than a data gap. The claim is about CPT reporting guidance — descriptor and guideline prose, which is AMA-licensed and closed to every connector here. rvu 57160 establishes that 57160 is…the full check separately payable when it is properly reported, which is a different question from when reporting it is permitted, and must not be read as answering this. Closing it needs a licensed AMA or vendor source attached by a human, or the claim rescoped to something a CMS file can answer. Worth flagging to the Scorer: this claim is load-bearing for the "chair-time burden" story the whole adoption thesis rests on, and it is currently sourced to a coding-alert web page. — source: cpt 57160 → unverifiable by design: "CPT descriptors are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3) … If it is genuinely about the descriptor text, rescope to HCPCS or attach a licensed AMA/vendor source by hand; no agent pass can close it"
TAM (total addressable market) component 1 (volume) — the Generator estimates, without any primary source, that annual Medicare Part B (Medicare Part B) allowed services for CPT 57160 are on the order of 50,000-200,000 nationally; this is an order-of-magnitude guess stated so it can be resolved, not a figure taken from anywhere
jurisdiction: US — confidence: verified — note: the guess is confirmed as an order of magnitude and can now be replaced by a number: 73,363 services nationally, split facility 6,590 / office-and-other-non-facility 66,773 — comfortably inside the claimed 50,000-200,000 band and toward its lower end. The…the full check non-facility split is itself informative for this candidate: ~91% of the volume is office-based, which is where a single-SKU fitting inventory would sell. Two caveats carried from the connector and not to be dropped downstream: this is Medicare fee-for-service only — it excludes Medicare Advantage (Medicare Advantage), commercial, Medicaid, VA and cash-pay, and prolapse presents across all of them — so it is a floor on US volume, never a market size; and the release year is not stated in the cached file (see data/provenance.json for which release was fetched). Volume is verified; price (claim 11refuted) and addressable share (claim 12unconfirmed) remain unconfirmed, so the TAM as a whole is one-third evidenced, not evidenced. — source: procedures 57160 --jurisdiction US → verified, "local cache of CMS Medicare utilization file (geography and service), code=57160, geography=National", detail "57160 (national, facility 6,590, office/non-facility 66,773): 73,363 services. Medicare fee-for-service only … This is a FLOOR on US volume, not a market size."
TAM component 2 (price) — the Medicare-approved amount for HCPCS A4561 in 2026 is approximately $69-$89 per device depending on locality; the corresponding A4562 (non-rubber, i.e. silicone) amount was not retrieved and may differ
jurisdiction: US — confidence: refuted — note: REFUTED 2026-09-29 (Verifier, re-check queue) on the A4561 price. The CMS DMEPOS fee schedule (July 2026) prices A4561 (no modifier, category PO) at $28.43 (AZ) to $29.45 (CO) non-rural across 49 contiguous states/DC. The top of that range is $39.55 below the bottom…the full check of the claimed $69-$89, so the vendor-blog figure does not describe A4561 anywhere in the contiguous US. Rural-ZIP fees were not read, but nothing suggests a 2.3x rural uplift. The claim's second half ("A4562 amount not retrieved and may differ") is now answered: A4562 is $70.81-$73.34 non-rural and clears $69 in every contiguous state/DC. So the vendor figure most likely described A4562 under the wrong code, and the claimed $89 upper end is not supported for either code on the non-rural schedule. For the business case, a silicone device bills A4562: the per-device ceiling is about $71-$73 Medicare allowed amount (beneficiary coinsurance comes out of it), not up to $89. This replay was queued as "now verified" only because the bare payment A4561 call proves the code has a fee. Tested against the claim's own number, it refutes. — source: history (earlier pass, superseded): [earlier source:] a vendor blog page found via web search quoting a 2026 figure; not read off the CMS DMEPOS fee-schedule file. Note that this per-unit allowed amount, not the fitting payment, is the ceiling on the device revenue per patient, and that a reusable device bills once rather than recurrently [earlier note:] unconfirmed for a missing-file reason, not because CMS publishes nothing — payment has no cached DMEPOS rate file in this environment. The $69-89 figure therefore still rests solely on a vendor blog, which is not a primary source and cannot become one by being restated. This is the TAM component with the largest leverage on the business case (it is the hard ceiling on per-patient device revenue and the denominator of assumption claim 24unconfirmed's margin question) and simultaneously the cheapest to close, since the DMEPOS fee-schedule file is a free CMS download. [earlier source:] payment A4561 --jurisdiction US → unconfirmed, "No local cache at data/hcpcs_payment_rates.csv — payment rate for A4561 cannot be checked until it exists. See data/README.md for the exact CMS source and expected columns. Do not substitute a web search for this file."; payment A4562 --jurisdiction US → unconfirmed, same reason; hcpcs A4561 --jurisdiction US and hcpcs A4562 --jurisdiction US → unconfirmed, no local cache at data/hcpcs_level_ii.csv. Re-checked 2026-09-29: payment A4562 --min-expected 69 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4562, modifier=none, schedule=DMEPOS, release=July 2026, "Clears the claimed floor of $69.00 in every contiguous state/DC" (non-rural $70.81-$73.34); payment A4561 --min-expected 69 --jurisdiction US → refuted, local cache of CMS DMEPOS fee schedule, code=A4561, modifier=none, schedule=DMEPOS, release=July 2026, "The highest fee, $29.45, is $39.55 BELOW the claimed floor of $69.00"
TAM component 3 (addressable share) — the Generator assumes, without a primary source, that the addressable share for a single-SKU adjustable device is the subset of pessary fittings performed in practices that currently stock a multi-size fitting set plus the fittings not currently performed at all because a practice declines to stock one, and puts that subset at roughly 30-50% of pessary fittings in the first instance; no inventory-behaviour or practice-level data was consulted
jurisdiction: US — confidence: unconfirmed — note: permanently unconfirmed absent a human-attached licensed source. Two of the three TAM components are now settled in opposite directions — volume verified (claim 10verified), price blocked on a missing CMS file (claim 11refuted), share structurally unverifiable (here) — which is…the full check a far more useful position than one blanket shrug over the whole TAM, and the Scorer should read it that way. Note also that this component is not really a market question but a practice-inventory-behaviour question, i.e. the same unresearched territory as assumption claim 22unconfirmed; it would be answered by commissioned practice-level research, not by a market report. — source: market "addressable share for a single-SKU adjustable pessary is 30-50% of US pessary fittings" → unverifiable, "has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a human attaches a licensed report and edits the claim by hand."
Nygaard et al., "Prevalence of Symptomatic Pelvic Floor Disorders in US Women," JAMA 2008 (PMID (PubMed identifier) 18799443), a cross-sectional analysis of 1,961 non-pregnant women aged 20 and over in NHANES 2005-2006, reported symptomatic pelvic organ prolapse in approximately 2.9% of US women and at least one symptomatic pelvic floor disorder in approximately 23.7%
jurisdiction: US — confidence: unconfirmed — note: content confirmed exactly on cold re-retrieval; tag held on structural grounds, not because anything is in doubt. The retrieved abstract matches every element of the claim: "A cross-sectional analysis of 1961 nonpregnant women (>or=20 years) who participated in…the full check the 2005-2006 National Health and Nutrition Examination Survey"; "The weighted prevalence of at least 1 pelvic floor disorder was 23.7% (95% CI, 21.2%-26.2%)"; "2.9% of women (95% CI, 2.1%-3.7%) experiencing pelvic organ prolapse"; JAMA, 2008; PMID real. Why it cannot be verified here: literature-detail returns a ScanResult, whose status vocabulary (found/none/unavailable) is deliberately disjoint from the confidence tags and has no code path to one (connectors/result.py; phase2-spec.md §3), and this is a class-2 published finding that routes to a Corroborator standard, not the Verifier's registry-fact standard — the same disposition used for the published-finding claims in idea-001 and idea-002. Scope note for the Scorer, which the Scores table already gets right: 2.9% symptomatic POP prevalence sizes the disease, not the billable device market. — source: literature-detail 18799443 → ScanResult status found, 1 record, PubMed PMID=18799443 (efetch), https://pubmed.ncbi.nlm.nih.gov/18799443/, JAMA 2008, "Prevalence of symptomatic pelvic floor disorders in US women", structured abstract retrieved in full
Published pessary literature reports initial fitting success in the approximate range of 56-80% of women attempting a pessary fitting trial — i.e. a material minority fail the initial fitting — and the conventional fitting method is an explicitly trial-and-error progression through discrete stocked sizes
jurisdiction: US — confidence: unconfirmed — note: attempted and not closed — the claim names no PMID, so there was nothing to re-retrieve, and a literature sweep did not produce the 56-80% range from a primary source. What the sweep did produce, recorded as leads for whoever closes this: PMID 32649024, "Factors…the full check associated with unsuccessful pessary fitting in women with symptomatic pelvic organ prolapse: Systematic review and metanalysis" (Neurourol Urodyn, 2020), pooling 21 studies — it reports predictors of unsuccessful fitting (higher BMI, previous reconstructive surgery, advanced POP) and thirteen reasons for discontinuation, but states no overall fitting-success rate, so it does not by itself support the range; and PMID 42314178 (claim 20unconfirmed), which reports 77.0% initial fitting success for patient-specific pessaries in a population selected for prior standard-pessary failure — a different denominator that must not be read as the general figure. The second half of the claim (conventional fitting is trial-and-error through discrete stocked sizes) has no primary source cited at all; the nearest registry evidence is K153422, a cleared "Panpac Disposable Pessary Fitting Set", and the size ladder recited in the K231786 IFU. Both halves need a named, retrieved paper. — source: no confirmed PMID in the claim to look up; non-tagging sweeps (connectors literature "pessary fitting success prolapse" 2005-01-01→2026-09-18, 65 matches; connectors literature "pessary discontinuation prolapse cohort", 14 matches) plus literature-detail 32649024 → ScanResult status found, PubMed PMID=32649024 (efetch), abstract retrieved and read — it does not contain the claimed range
Pessary discontinuation is reported at roughly 30-50% within the first 12 months of initiation, with one retrospective cohort reporting 102 of 251 women (40.6%) having stopped by 24 months
jurisdiction: US — note: the 251-patient cohort is from a 2024 Archives of Gynecology and Obstetrics paper and is not a US cohort, so it is directional for a US candidate, not dispositive — confidence: unconfirmed — note: **the specific cohort is found and its numbers match exactly; the general range in the first half…the full check of the claim is not supported by that source and looks narrower than the literature.** The paper is PMID 39614906, "Discontinuation of pessary therapy within 24 months: can it be predicted?", Archives of Gynecology and Obstetrics 2024 — a prospective observational study in 22 Dutch hospitals (the claim calls it retrospective; it is not), whose results read "Of the 251 women included in analysis, 102 stopped using a pessary at 24 months (40.6%)". The non-US caveat in the claim line is correct and now specific: Dutch, 22 centres. But the same abstract's introduction states "20-60% of women discontinue pessary treatment within 24 months", which is both wider and on a different time horizon than the claim's "roughly 30-50% within the first 12 months" — so the headline range is not evidenced by the source that evidences the cohort figure, and a Scorer must not treat the two halves as standing or falling together. Note also that this study excluded women with initial fitting failure, so it is not a continuation rate over everyone who attempts a pessary. Structural cap as elsewhere: literature-detail returns a ScanResult and cannot confer verified. — source: non-tagging sweep (connectors literature "pessary AND \"Arch Gynecol Obstet\"[journal]" 2023-01-01→2026-09-18) locating the paper, then literature-detail 39614906 → ScanResult status found, PubMed PMID=39614906 (efetch), https://pubmed.ncbi.nlm.nih.gov/39614906/, full structured abstract retrieved
FTO (freedom to operate) — a granted US patent, US 11,865,033, titled "Vaginal pessary device for pelvic organ prolapse with improved collapsible construction" (published as application US 2021/0282961 A1, and understood from web sources to be assigned to Reia LLC), claims a removable pessary with an improved collapsible construction actuating between collapsed and expanded states and a finger-receiving loop on a stem allowing removal without reliance on pinch strength. This is a live-looking, directly adjacent patent: it does not obviously read on a ratcheting diameter-lock, but it would very likely read on any low-force removal-stem or collapse-for-removal feature added to this device
jurisdiction: US — confidence: verified — note: verified as a patent-register fact and nothing more — read this tag narrowly. Confirmed: the publication number is real, the title matches word for word, it was filed 2021-05-26, and on a naive 20-year term it runs to 2041-05-26, i.e. it is not expired — the…the full check claim's "live-looking" characterisation stands. NOT confirmed, and not confirmable through this connector: the assignee of record (the EPO (European Patent Office) OPS bibliographic response returned here carries title, filing date and term only — "Reia LLC" remains a web-sourced attribution, though the separately verified K232677 "Reia pessary" clearance held by Reia, LLC makes it plausible); legal status, maintenance-fee payment and any term adjustment or terminal disclaimer, all of which the connector explicitly says it does not model; and the issued claim scope. The whole second sentence — what the patent does and does not read on — is an infringement reading, which is a legal opinion no database lookup can supply and which this repo may not generate. claim 18unconfirmed remains the honest statement of where FTO stands. — source: patent US11865033 --jurisdiction US → verified, EPO OPS published-data/publication epodoc=US11865033, detail "VAGINAL PESSARY DEVICE FOR PELVIC ORGAN PROLAPSE WITH IMPROVED COLLAPSIBLE CONSTRUCTION: filed 2021-05-26, naive 20yr term expiration 2041-05-26 (not yet expired) — naive estimate, does not model PTA/SPC extensions/terminal disclaimers/maintenance lapses"
FTO — US 6,189,535 B1, "Deflatable vaginal pessary," is a granted US patent issued in 2001; on a standard 20-year-from-filing term it would have expired well before this candidate's date, which places at least one size/volume-variable pessary concept in the expired art rather than under live protection
jurisdiction: US — confidence: verified — note: confirmed, and the filing date the Generator could not find is now on record: filed 1993-04-02, naive 20-year term expiring 2013-04-02, which the connector reports as expired — thirteen years before this candidate's date, so "well before" is right with room to…the full check spare. Two limits: the connector returns the publication's bibliographic record and its naive term estimate, not the 2001 issue date the claim states and not the issued claims, which remain unread; and an expired patent is prior art that can block patentability as readily as a live one can block practice — so this line is comfort on freedom to operate for that one concept and is not comfort on the moat (Factor 5), where a published deflatable-pessary disclosure cuts the other way. — source: patent US6189535 --jurisdiction US → verified, EPO OPS published-data/publication epodoc=US6189535, detail "Deflatable vaginal pessary: filed 1993-04-02, naive 20yr term expiration 2013-04-02 (expired) — naive estimate, does not model PTA/SPC extensions/terminal disclaimers/maintenance lapses"
FTO — beyond the two patents named above, no comprehensive freedom-to-operate or patent-landscape search was performed for a ratcheting, lockable, clinician-adjustable-diameter intravaginal support device, for the locking mechanism, or for the single-SKU fitting workflow. The FTO field for the core novelty of this candidate is unexamined, not clear
jurisdiction: US — confidence: unconfirmed — note: confirmed as still true after this pass, and it is the most consequential open item in the file.patent answers "what does this numbered patent say about its own dates" — it is a record lookup and there is no landscape or freedom-to-operate search anywhere in…the full check this repo's connector surface, so nothing an agent can run will close this. The two patents checked this pass (claims 16, 17) are both about collapsibility and removal, not about a ratcheting diameter lock; the core novelty's art field remains entirely unexamined. This must reach the Scorer as an unexamined field, never as a clear one: FTO carries the rubric's only automatic kill, and an unexamined field cannot trigger it either — the correct posture is neither "blocked" nor "clear" but "not yet knowable", which is what the Factor 4 row already says. Closing it is a commissioned professional search, a paid multi-week item. — source: no connector reaches this claim — patent is single-record and cannot sweep an art field; recorded as an attempted check with no available instrument, not as an unattempted claim
FDA reclassified surgical mesh for transvaginal repair of pelvic organ prolapse from Class II to Class III (FDA device class III) by final order published 2016-01-05 at 81 FR 353 (Federal Register document 2015-33165), and in the same action required the filing of premarket approval applications for those devices at 81 FR 363; on 2019-04-16 FDA ordered the two remaining manufacturers of surgical mesh for transvaginal POP repair to stop selling and distributing the devices in the United States
jurisdiction: US — confidence: unconfirmed — note: a compound claim that resolved in two different directions, which is why the tag is not verified. (1) Verified: Federal Register document 2015-33165 is real and is a Rule (not a notice), "Obstetrical and Gynecological Devices; Reclassification of…the full check Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair", published 2016-01-05 and effective the same day, whose own text reads "issuing a final order to reclassify surgical mesh for transvaginal pelvic organ prolapse (POP) repair from class II to class III." (2) Verified, and the claim's identifier for it was incomplete: the PMA (premarket approval) requirement was a separate companion final rule, document 2015-33163, "Effective Date of Requirement for Premarket Approval for Surgical Mesh for Transvaginal Pelvic Organ Prolapse Repair", also published 2016-01-05 — not part of the same document, so "in the same action" is loose. (3) Page citations are off by one in both halves: the Federal Register records the reclassification order at 81 FR 354 (claim says 353) and the PMA order at 81 FR 364 (claim says 363); a document spans pages, so this may be a start-page convention difference rather than an error, but the claim's citations do not match the register's own. (4) Not checked at all: the 2019-04-16 stop-sale order. That was an FDA press announcement and enforcement action, which never entered the Federal Register; no connector in this repo reaches FDA announcements or enforcement practice, and the claim's own source admits the announcement was never retrieved. Since that half is the one bearing on how much of the POP population is available to a non-surgical device, the claim as a whole cannot be tagged verified. — source: policy 2015-33165 --expect-type rule --expect "class III" --jurisdiction US → verified, Federal Register document_number=2015-33165 (81 FR 354), type Rule confirmed, phrase found verbatim, https://www.federalregister.gov/documents/2016/01/05/2015-33165/obstetrical-and-gynecological-devices-reclassification-of-surgical-mesh-for-transvaginal-pelvic;policy 2015-33163 --expect-type rule --expect "premarket approval" --jurisdiction US → verified, Federal Register document_number=2015-33163 (81 FR 364), type Rule, phrase found verbatim; companion document located by a non-tagging sweep (connectors policy-scan --term "surgical mesh transvaginal pelvic organ prolapse" --agency fda 2016-01-01→2016-01-31); no connector available for the 2019-04-16 announcement
Competitive — patient-specific, 3D-printed pessaries are an active clinical-research direction aimed at the same trial-and-error fitting problem this candidate targets, with a 2025-2026 Obstetrics & Gynecology paper on patient-specific pessaries after suboptimal outcomes with standard pessary use (PubMed record PMID 42314178 surfaced in a web search and not opened)
jurisdiction: US — confidence: unconfirmed — note: the PMID is real and the record is exactly what the claim says it is — tag held only by the ScanResult ceiling, and the content should worry the Scorer more than the claim line suggests. Retrieved: "Patient-Specific Pessaries After Suboptimal Outcomes With…the full check Standard Pessary Use", Obstetrics and Gynecology, 2026. Its abstract: a retrospective case series of 113 patients fitted with patient-specific pessaries between February 2024 and September 2025 across 18 clinical sites in Canada, all fittings recorded on "a centralized cloud-based platform", with clinicians able to "design up to two pessaries per round with iterative refinement"; initial fitting success 87/113 (77.0%, 95% CI 68.5-83.7), and 72/113 (63.7%) retained and continued use at final follow-up. Two readings a Scorer needs: this is not an early-stage research direction but a commercially deployed competitor at 18 sites with published outcomes in a population selected for prior pessary failure — i.e. the same iterative-refit value proposition this candidate proposes, reached by manufacturing rather than by a mechanism, and already evidenced; and it is a Canadian series, so it says nothing about US regulatory or reimbursement position. Not appraised for design or bias beyond what the abstract states. — source: literature-detail 42314178 → ScanResult status found, 1 record, PubMed PMID=42314178 (efetch), https://pubmed.ncbi.nlm.nih.gov/42314178/, Obstetrics and gynecology, 2026, full structured abstract retrieved
Competitive — ClinicalTrials.gov registration NCT04275089 (a ClinicalTrials.gov registration number), "Early Feasibility Study of the Reia Vaginal Pessary," is a registered clinical study of a collapsible vaginal pessary, indicating that the self-removal/collapsible pessary concept is in active clinical development by a third party
jurisdiction: US — confidence: unconfirmed — note: registry record retrieved and every element of the claim matches; tag held by the same ScanResult ceiling as the literature claims. Confirmed from the protocol record: title exactly as claimed, sponsor Reia, LLC (INDUSTRY), interventional, single-group,…the full check unmasked, enrollment 15 (actual), status COMPLETED with posted results, eligibility "Women with Stage II pelvic organ prolapse or greater" who are "Current ring style or Gellhorn pessary users inclusive of sizes 1.5\"-3.5\"", primary outcomes comparing retention of the study device against the subject's own current pessary during Valsalva. Update the claim's framing, though: "in active clinical development" is now understated in one direction and overstated in another — the study is completed, not active, and Reia has since moved past feasibility to a cleared device (K232677, decided 2024-05-21, verified under claim 4unconfirmed). The competitive read is therefore stronger than the claim states: this is a cleared competitor, not a trial. Note also the eligibility criteria are themselves a small piece of evidence for the fitting-size-ladder premise behind claim 14unconfirmed. — source: trial-detail NCT04275089 → ScanResult status found, 1 record, ClinicalTrials.gov NCTId=NCT04275089, https://clinicaltrials.gov/study/NCT04275089, status COMPLETED, hasResults=true, full protocol record retrieved
Assumption, not a fact: the idea depends on fitting clinicians (gynecologists, urogynecologists, women's-health NPs) preferring to stock a single adjustable SKU over a multi-size fitting set, and on practices that currently decline to offer pessary fitting because of inventory and chair-time burden beginning to offer it once that burden falls. There is no connector for clinician purchasing or practice-line behaviour and no primary research is cited here; this is stated as an assumption so it stays visible rather than being phrased as a fact
jurisdiction: US — confidence: unconfirmed — note: confirmed unverifiable, permanently, and the Verifier did not substitute its own judgement about what clinicians would do. The connector's own instruction is explicit that a model-generated stakeholder opinion here would be a fabricated claim. The claim is…the full check correctly framed as an assumption and stays one. Checkable proxies that exist and were run, offered as the rescoping this needs rather than as an answer to it: procedures 57160 gives 73,363 Medicare FFS (fee-for-service) fittings a year with ~91% office-based (claim 10verified), which bounds how much practice behaviour there is to change; and K153422, a cleared "Panpac Disposable Pessary Fitting Set", evidences that multi-size fitting inventory is a real product category someone thought worth clearing. Neither says anything about a purchasing preference. — source: adoption "fitting clinicians would prefer to stock a single adjustable SKU over a multi-size fitting set" → unverifiable, "asserts what clinicians, payers, or patients would do … it needs primary research (interviews, survey, published preference study). Stays unconfirmed permanently unless a human attaches real research and edits the claim by hand."
Assumption, not a fact: the idea depends on in-visit re-adjustment producing a better-tolerated fit than the next discrete size from a stocked set, and therefore on adjustable-device patients continuing pessary use at a higher rate than the 30-50% twelve-month discontinuation reported for conventional pessaries. No comparative data exists for a device that does not yet exist; this is the central clinical bet and is stated as an assumption
jurisdiction: US — confidence: unconfirmed — note: unverifiable by construction — no comparative data can exist for an unbuilt device — and two findings from this pass bear on it without resolving it. First, the comparator baseline the assumption is stated against is shakier than the claim assumes: the source…the full check behind claim 15unconfirmed reports 20-60% discontinuation at 24 months, not 30-50% at 12, so the bar this device must beat is not currently a settled number. Second, the nearest available read on whether iterative refitting helps is PMID 42314178 (claim 20unconfirmed): patient-specific pessaries in patients who had already failed standard pessaries achieved 77.0% initial fitting success and 63.7% continued use at final follow-up — directionally supportive of the premise that refitting rescues failures, but it is a single-arm Canadian case series about a different intervention (bespoke manufacture, not in-visit mechanical adjustment), with no comparator, so it is a lead and not evidence for this device. Settling it needs a prospective comparative fitting study, as the Factor 6 row already says. — source: adoption "in-visit re-adjustment produces a better-tolerated fit and higher 12-month continuation than the next discrete size" → unverifiable, "needs primary research (interviews, survey, published preference study) … Do NOT substitute a model's own estimate of stakeholder behaviour"
Assumption, not a fact: the idea depends on a DMEPOS payment of roughly A4562 scale per device supporting a viable gross margin on a reusable silicone device containing a ratcheting locking mechanism, i.e. on the mechanism being manufacturable at a cost materially below a single fixed-size pessary's allowed amount. No bill-of-materials or contract-manufacturing quote informs this; it is an unsourced assumption and is the most likely place the unit economics break
jurisdiction: US — confidence: unconfirmed — note: Re-checked 2026-09-29 (Verifier, re-check queue): tag held at unconfirmed, now on one side of the inequality only. The payment ceiling is resolved: the July 2026 DMEPOS fee schedule gives A4562 (no modifier, category PO) a Medicare allowed amount of $70.81-$73.34…the full check non-rural across the contiguous states/DC. Beneficiary coinsurance comes out of that figure, and a DMEPOS supplier margin sits inside it before the manufacturer is paid. The assumption itself is about manufacturing cost falling materially below that ceiling, and that side has no connector, BOM (bill of materials) or contract-manufacturing quote. The payment replay being verified confirms the ceiling, not the margin. — source: history (earlier pass, superseded where it conflicts): [earlier note:] unconfirmed on both sides of the inequality, and worth flagging as the compounding gap in this file. The cost side has no connector and no quote — a contract-manufacturing quote is the instrument, and it is a commissioned item. The payment side, which is the ceiling the cost must sit under, is also unconfirmed — not because CMS is silent but because this environment has no cached DMEPOS rate file (claim 11refuted). So the assumption is currently untestable in both directions at once: an unknown cost against an unquantified ceiling. Fetching the CMS DMEPOS fee-schedule file would at least fix the ceiling and make the remaining question a single sourceable number. [earlier source:] market "a reusable silicone pessary with a ratcheting lock is manufacturable materially below the A4562 allowed amount" → unverifiable, "has no free, authoritative, machine-queryable source"; and payment A4562 --jurisdiction US → unconfirmed, no local cache at data/hcpcs_payment_rates.csv. Re-checked 2026-09-29: payment A4562 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4562, modifier=none, schedule=DMEPOS, release=July 2026 (non-rural $70.81 AZ to $73.34 CO); the cost side is still a market-shaped question with no connector and no quote (see the earlier market record above)
Assumption, not a fact: the idea depends on a locking, re-adjustable mechanism surviving repeated cleaning and long-term intravaginal wear without crevice contamination, biofilm, or loss of lock — a reusable device with a mechanical joint has a cleaning-validation and biocompatibility burden that a solid-silicone ring does not, and this is the principal bench-evidence risk. No bench or materials data informs this
jurisdiction: US — confidence: unconfirmed — note: no connector in this repo can answer a bench-performance or biocompatibility question about an unbuilt device — this is not a registry fact, a payment fact or a published finding, and it is correctly stated as an assumption. Recorded as an attempted check with no…the full check available instrument. One lead a human should follow rather than a check: a non-tagging MAUDE (Manufacturer and User Facility Device Experience) sweep of product code HHW (2021-01-01 to 2026-09-18) returned 102 adverse-event reports in the window, a mix of malfunction and injury across marketed pessaries and bladder supports — MAUDE has no denominator and cannot support a rate, but reading those narratives is the cheapest available read on how existing pessaries fail in the body, and it would sharpen the cleaning-validation and retention protocol this claim says has to be written. Settling it needs bench cleaning-validation and ISO (International Organization for Standardization) 10993 biocompatibility work on a real joint. — source: no connector reaches a bench-evidence claim; lead only from a non-tagging sweep (connectors maude --product-code HHW --since 2021-01-01 --until 2026-09-18, 102 reports in the window)
All four of the K-numbers named in claim 4unconfirmed are confirmed real FDA 510(k) clearances in product code HHW (21 CFR 884.3575): K132313 "PESSARY" / Eis Corporation, decided 2014-12-05; K231786 "Gynethotics Pessary" / Cosm Medical, decided 2024-03-06; K232677 "Reia pessary" / Reia, LLC, decided 2024-05-21; and K233548 "Uresta®" / Resilia, Inc., decided 2024-04-03 — but only the first three are prolapse-pessary clearances: K233548's cleared Indications for Use are stress urinary incontinence only, so it is not a POP predicate for this candidate
jurisdiction: US — confidence: verified — note: appended rather than edited into claim 4unconfirmed, because claim 4unconfirmed's own text asserts that none of the four had been confirmed and claims are append-only — this is the confirmed restatement and claim 4unconfirmed carries the same findings in its note. Indications quoted verbatim from the…the full check FDA summary PDFs: K132313 "EIS Vaginal Pessaries are indicated for the use as removable structures placed in the vagina to treat uterine prolapse, including cystocele and rectocele, as well as stress urinary incontinence in women"; K231786 covering ring, ring-with-support, ring-with-knob, Marland, Gellhorn and cube pessaries across Stage I-III prolapse and SUI; K232677 "The Reia pessary is indicated for the temporary, non-surgical management of Pelvic Organ Prolapse"; K233548 "The Uresta bladder support is indicated for use in adult women over 18 years of age who experience stress urinary incontinence". Two consequences for the Scorer, neither of which is mine to score: K231786 shows a single 510(k) covering an entire multi-shape, multi-size pessary line, which is the incumbent regulatory posture this single-SKU candidate would compete against; and none of the four IFUs describes a clinician-adjustable or lockable diameter, which is consistent with claim 5unconfirmed without confirming it. — source: clearance-summary K132313 --jurisdiction US, clearance-summary K231786 --jurisdiction US, clearance-summary K232677 --jurisdiction US, clearance-summary K233548 --jurisdiction US → all four verified, FDA 510(k) summary PDFs at https://www.accessdata.fda.gov/cdrh_docs/pdf13/K132313.pdf, /pdf23/K231786.pdf, /pdf23/K232677.pdf, /pdf23/K233548.pdf; holders, decision dates and HHW product code from a non-tagging sweep (connectors clearances --product-code HHW, 2010-01-01 to 2026-09-18)
Fitting clinicians will adopt an in-visit adjust-and-lock fitting procedure in place of trial-and-error progression through discrete stocked sizes, and will record the set diameter in the chart so it can be re-set at follow-up
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: clinician adoption/behaviour claim, both halves (switching fitting method and charting the set diameter). The connector returned unverifiable; it needs primary research (clinician interviews or a survey), and none exists here. Not answered from…the full check judgment. A checkable proxy is procedures 57160 (not run), which gives fitting volume, not preference. — source: deck-surfaced assumption (desirability deck, 2026-09-20); checked 2026-09-29: adoption "Fitting clinicians will adopt an in-visit adjust-and-lock fitting procedure in place of trial-and-error progression through discrete stocked sizes" → unverifiable, "asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that"
Women with symptomatic stage II-III pelvic organ prolapse will accept a reusable intravaginal device containing a mechanical ratcheting joint as readily as they accept a one-piece silicone pessary
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: patient acceptance claim. The connector returned unverifiable; it needs a published preference study or patient research, and none exists here. — source: deck-surfaced assumption (desirability deck, 2026-09-20); checked 2026-09-29: `adoption…the full check "Women with symptomatic stage II-III pelvic organ prolapse will accept a reusable intravaginal device containing a mechanical ratcheting joint as readily as a one-piece silicone pessary"` → unverifiable, "asserts what clinicians, payers, or patients would do"
A patient's out-of-pocket cost for the adjustable single-SKU pessary is no higher than for a conventional fixed-size pessary fitted and dispensed under the same CPT and HCPCS codes
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: no connector reads patient cost-sharing. The nearest primary fact: under Medicare FFS a silicone pessary of either design bills A4562 at one fee-schedule allowed amount ($70.81-$73.34 non-rural), so Medicare coinsurance on the device would be the…the full check same if both are dispensed under A4562 by an assigning supplier. That does not settle the claim. Out-of-pocket also depends on non-assigned supplier pricing, deductibles, the fitting-visit share, and every non-Medicare plan, none of which is read here. The code descriptor also leaves open whether the adjustable device is coded the same as a conventional one, which is a DME MAC coding decision. — source: deck-surfaced assumption (desirability deck, 2026-09-20); checked 2026-09-29: payment A4562 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4562, modifier=none, schedule=DMEPOS, release=July 2026 (allowed amount only, not patient cost)
Commercial insurers and state Medicaid programs reimburse pessary fitting and pessary supply at rates comparable to Medicare fee-for-service, so pessary fittings outside Medicare fee-for-service are addressable device revenue
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: every reimbursement connector here reads Medicare fee-for-service files. No free, authoritative source reads commercial or state Medicaid rates, so the comparison has one side only. The connector returned unverifiable. Needs a licensed claims/rate…the full check dataset or state Medicaid fee schedules, attached by a human. — source: deck-surfaced assumption (viability deck, 2026-09-20); checked 2026-09-29: market "Commercial insurers and state Medicaid programs reimburse pessary fitting and pessary supply at rates comparable to Medicare fee-for-service" → unverifiable, "has no free, authoritative, machine-queryable source"
A DME MAC local coverage determination or policy article covers pessary supply for stage II-III pelvic organ prolapse without a prior-authorisation or failed-trial-of-alternative requirement that a single-SKU clinician-adjustable device would not satisfy
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the connector returned refuted, and I have NOT carried that onto the tag, because the refutation describes our cache's reach, not CMS. coverage reports that no policy in the cached Coverage Database file names A4561 or A4562. But that file…the full check holds Billing & Coding / policy Articles only (1,970 current articles; no LCDs, no NCDs). And 60 of its 74 DME MAC "Policy Article" rows, including Urological Supplies A52521, Ostomy Supplies A52487 and Lower Limb Prostheses A52496, have a blank code column. A DME MAC article naming A4562 would therefore be invisible to a code lookup (idea-001 claim 9unconfirmed trap; see .claude/skills/connectors/references/reimbursement.md). What the cache does say is a real, weaker negative signal: no current article title in the export mentions a pessary. Flag for the Scorer: that negative points toward this claim being false as worded. No pessary-specific DME MAC policy may exist at all (coverage left to contractor adjudication), in which case the premise "an LCD (local coverage determination) or article covers pessary supply" fails even though the practical access concern (no prior-auth hurdle) might still hold. Resolving it needs the MCD LCD export cached with DME MAC code linkage, or a human reading the DME MAC jurisdiction supplier manuals. — source: deck-surfaced assumption (viability deck, 2026-09-20); checked 2026-09-29: coverage A4561 --jurisdiction US → refuted, local cache of CMS Medicare Coverage Database (no policy names this code), code=A4561; coverage A4562 --expect-stance covered --jurisdiction US → refuted, local cache of CMS Medicare Coverage Database (no policy names this code), code=A4562. Both are linkage artifacts per the note, not coverage findings
The ratcheting, lockable, re-adjustable support-diameter mechanism is patentable over the published prior art, including the expired deflatable-pessary disclosure US 6,189,535
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: patentability over prior art is a legal novelty and non-obviousness judgment (Tier 3 FTO/patentability opinion), not a database fact. The one checkable fragment, that US 6,189,535 is expired, resolves: filed 1993-04-02, naive 20-year term to…the full check 2013-04-02 (naive estimate; ignores PTA and terminal disclaimers). That supports the "expired disclosure" aside, not the patentability claim. No patent-scan was run and none would settle it, because a sweep returns leads, never a tag. A search on the ratcheting-diameter concept is still the open item (claim 18unconfirmed). — source: deck-surfaced assumption (viability deck, 2026-09-20); checked 2026-09-29: patent US6189535B1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.6189535.B1, "Deflatable vaginal pessary: filed 1993-04-02, naive 20yr term expiration 2013-04-02 (expired)"
An incumbent pessary manufacturer cannot add a clinician-settable, lockable support diameter to its existing cleared multi-size pessary line without filing a new 510(k)
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the regulation text is verified. 21 CFR 807.81(a)(3)(i) requires a new premarket notification for "a change or modification in the device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or…the full check modification in design, material". Whether adding a lockable adjustable diameter to an incumbent's cleared pessary is such a change is FDA's interpretation, which sits in its device-modifications guidance and is out of this connector's reach. The regulation does not settle the interpretation. It is also contingent on claim 2unconfirmed: if HHW turns out to be 510(k)-exempt, no incumbent needs a 510(k) for the change at all, and the claim fails. — source: deck-surfaced assumption (viability deck, 2026-09-20); checked 2026-09-29: regulation 807.81 --expect "significantly affect the safety or effectiveness" --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=807.81
Market entry requires no clinical investigation: the device reaches first commercial sale on a substantial-equivalence argument about geometry and materials supported by bench performance and biocompatibility testing only
jurisdiction: US — confidence: unconfirmed — note: Verifier re-attempt 2026-09-29 (second pass; first pass lost to a tooling crash): what clinical evidence FDA will require for this device is an FDA review judgment and no connector reaches it, so the tag stays unconfirmed on that ground and not on the crash. The…the full check regulation confirms only the classification: 21 CFR 884.3575(b) reads "Class II (performance standards)", with no special-controls text naming clinical data. clearance-summary still crashes in this environment, now as pyo3_runtime.PanicException: Python API call failed inside cryptography's Rust bindings (reached via pypdf's crypt-provider import; same _cffi_backend root fault). That is a tooling failure, not a finding. Context only, not a tag basis: the FDA summary PDFs at the URLs in the connector records were read directly (WebFetch plus raw stream decode). They show a mixed precedent. K231786 Gynethotics (clinician-set "personalized configurations of certain shape features") lists only mechanical testing ("folding, 3-point bend, cord detachment, end of life, squeeze, knob displacement"), ISO 10993 biocompatibility, TSST-1, cleaning and packaging validation, with no clinical testing. K232677 Reia (collapsible, novel mechanism) includes a "Clinical Testing" section: "A prospective open label single-arm study ... performed at seven sites in the United States". K233548 Uresta says "Non-clinical and clinical data submitted within K083185 is being leverage[d]" plus a self-selection/labeling usability study. So one clinician-configured HHW pessary cleared on bench plus biocompatibility alone, and one novel-mechanism HHW pessary needed a clinical study. Which precedent FDA applies to a ratcheting, lockable diameter is the open question. Re-run clearance-summary once the environment is fixed — source: deck-surfaced assumption (feasibility deck, 2026-09-20); checked 2026-09-29: regulation 884.3575 --jurisdiction US → verified, eCFR versioner title-21, issue 2026-09-25, section=884.3575; clearance-summary K232677 --expect-indication "clinical" --jurisdiction US → crashed (PanicException via pypdf/cryptography), no status; clearance-summary K231786 --expect-indication "patient" --jurisdiction US → crashed (same); summary PDFs read: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231786.pdf,https://www.accessdata.fda.gov/cdrh_docs/pdf23/K232677.pdf,https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233548.pdf
A ratchet with enough holding force to resist Valsalva loading can be realised without a rigid component breaching the medical-grade silicone envelope that contacts the vaginal mucosa
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a bench/engineering feasibility claim (ratchet holding force under Valsalva load versus envelope integrity). no connector in this repo reaches this claim type, so no lookup was run; adoption and market are not recorded as if they were checks of…the full check it. Needs bench testing or a prototype; genuinely unreachable here. — source: deck-surfaced assumption (feasibility deck, 2026-09-20); checked 2026-09-29: none run (no applicable connector)
A fitting clinician can set and re-lock the device's support diameter with the device in situ, without withdrawing it from the patient
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: an engineering and usability feasibility claim (in-situ adjustment). no connector in this repo reaches this claim type, so no lookup was run; adoption and market are not recorded as if they were checks of it. Needs a prototype and simulated-use or…the full check clinical fitting data. — source: deck-surfaced assumption (feasibility deck, 2026-09-20); checked 2026-09-29: none run (no applicable connector)
The device can be cleaned and maintained by the patient at home using the same routine as a conventional silicone pessary, with no additional disinfection step and no clinician-performed reprocessing
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a cleaning and reprocessing claim. no connector in this repo reaches this claim type, so no lookup was run; adoption and market are not recorded as if they were checks of it. It is also the hinge of claim 25unconfirmed's cleaning-validation burden. FDA…the full check reprocessing expectations live in guidance, which regulation cannot read. Needs cleaning-validation and biocompatibility testing on a prototype. — source: deck-surfaced assumption (feasibility deck, 2026-09-20); checked 2026-09-29: none run (no applicable connector)
Fitting clinicians require published comparative fitting data - retained fit and continued use against a stocked multi-size fitting set - before replacing a fitting set with a single adjustable pessary
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: an adoption/stakeholder-behaviour claim. The adoption connector returns unverifiable by design: it needs primary research (clinician interviews, a survey, a published preference study) and none is attached. No synthetic clinician opinion was…the full check substituted. adoption takes no --jurisdiction flag (argparse rejects it), so it was run without one. — source: deck-surfaced assumption (desirability deck, 2026-09-29) — evidence class 3 (stakeholder future); checked 2026-09-29: adoption "Fitting clinicians require published comparative fitting data before replacing a fitting set with a single adjustable pessary" → unverifiable
Women who have failed an initial conventional pessary fitting accept a further fitting attempt with an adjustable-diameter pessary rather than declining pessary therapy
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a patient-behaviour claim. The adoption connector returns unverifiable by design: it needs primary patient research and none is attached. No synthetic patient opinion was substituted. adoption takes no --jurisdiction flag, so it was run without…the full check one. — source: deck-surfaced assumption (desirability deck, 2026-09-29) — evidence class 3 (stakeholder future); checked 2026-09-29: adoption "Women who failed an initial pessary fitting accept a further fitting attempt with an adjustable-diameter pessary" → unverifiable
With the adjustable-diameter pessary, a fitting clinician reaches a retained, comfortable fit in fewer device insertions per fitting visit than with a stocked multi-size fitting set
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a comparative clinical-performance claim about a device that has not been built or tested. No connector answers it: it needs a fitting study (insertions per visit, adjustable vs. multi-size set), and no such study is attached. literature/trials…the full check are scans and cannot tag it. — source: deck-surfaced assumption (desirability deck, 2026-09-29); checked 2026-09-29: no connector for this claim type
The adjustable single-SKU silicone pessary is assigned HCPCS A4562 by the Medicare DMEPOS coding process, rather than A4561 or a miscellaneous or not-otherwise-classified code
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the code-level facts check out, but the assertion does not. Nobody has confirmed that this device will be assigned A4562. A4562 exists with descriptor "Pessary, reusable, non rubber, any type" (A4561 = "Pessary, reusable, rubber, any type"), so a…the full check silicone device matches A4562's text. The assignment itself is a DMEPOS coding determination (PDAC (Pricing, Data Analysis and Coding contractor) coding verification) that no connector reads and that has not been made. A descriptor match is not an assignment. Payment is on record: A4562, no modifier, category PO, Medicare allowed amount $70.81 (AZ) to $73.34 (CO) non-rural across 49 contiguous states/DC, DMEPOS fee schedule July 2026 (allowed amount, not payment). coverage A4562 returned refuted, meaning no NCD or LCD in the cached index names A4562 and claims are left to contractor adjudication. That is a reimbursement risk signal on a different question, not a refutation of the coding assertion, and not a denial. — source: deck-surfaced assumption (viability deck, 2026-09-29); checked 2026-09-29: hcpcs A4562 --expect "pessary" --jurisdiction US → verified, local cache of CMS HCPCS Level II file, code=A4562; hcpcs A4561 --jurisdiction US → verified, local cache of CMS HCPCS Level II file, code=A4561; payment A4562 --jurisdiction US → verified, local cache of CMS DMEPOS fee schedule, code=A4562, modifier=none, schedule=DMEPOS, release=July 2026; coverage A4562 --jurisdiction US → refuted, local cache of CMS Medicare Coverage Database (no policy names this code), code=A4562
A fitting physician's practice can enroll as a Medicare DMEPOS supplier and bill A4562 for a pessary dispensed at the fitting visit, so the fitting clinician and the device supplier can be the same entity
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: this is a compound claim, and only its first half resolved. The "same entity" premise is supported by regulation text: 42 CFR 424.57(a) defines "DMEPOS supplier means an entity or individual, including a physician ...". What is not resolved is…the full check whether a given practice can meet the 424.57(c) supplier standards and accreditation (424.58), and whether A4562 dispensed at a physician visit is billed to the DME MAC as a supplier claim rather than to the Part B MAC incident to the physician service. Those are enrollment and jurisdiction questions that no connector reaches. The billing half also inherits claim 41unconfirmed's unresolved code assignment. Regulation text does not settle how CMS applies it. — source: deck-surfaced assumption (viability deck, 2026-09-29); checked 2026-09-29: regulation 424.57 --title 42 --expect "DMEPOS supplier means an entity or individual, including a physician" --jurisdiction US → verified, eCFR versioner title-42, issue 2026-08-13, section=424.57
No patient-specific or 3D-printed vaginal pessary holds an FDA 510(k) clearance in product code HHW
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a universal negative over a registry, and it has a probable counterexample. No connector call returned refuted, so the tag is not refuted, but this is a strong unconfirmed that a human should read. HHW is Class II, 21 CFR 884.3575, panel OB…the full check (checked against intended_use: removable intravaginal support for stage II-III anterior/apical POP). The clearances scan (all dates, 41 HHW 510(k)s, not truncated) is a pointer only and carries no tag. It surfaced K231786 Gynethotics Pessary (Cosm Medical, SE 2024-03-06), confirmed by the 510k connector. Its FDA 510(k) summary, read directly because clearance-summary crashes (PanicException via pypdf/cryptography, a tooling failure), says: "The key difference between the subject and predicate devices is that Gynethotics pessaries allow for personalized configurations of certain shape features, as determined by the clinician" and "Subject device sizes increment with greater degrees of freedom within the cleared ranges". The summary uses neither "patient-specific" nor "3D-printed" and says nothing about manufacturing method. Whether "personalized configurations ... as determined by the clinician" is a patient-specific pessary is a terminology and substantial-equivalence call for a human. If it is, the claim is false. Name searches for "patient-specific pessary" and "3D printed pessary" returned no record, which is a device-name miss and not an absence. For Competitive intensity, the relevant fact is that FDA has already cleared a clinician-configured, personalized-dimension silicone pessary in HHW, with bench and biocompatibility data only. — source: deck-surfaced assumption (viability deck, 2026-09-29) — evidence class 1 (registry fact); checked 2026-09-29: classification --product-code HHW --jurisdiction US → verified, openFDA device/classification product_code=HHW; 510k "Gynethotics" --jurisdiction US → verified, openFDA device/510k k_number=K231786; 510k "patient-specific pessary" --jurisdiction US → unconfirmed, no record; 510k "3D printed pessary" --jurisdiction US → unconfirmed, no record; clearance-summary K231786 --expect-indication "patient" --jurisdiction US → crashed, no status; summary PDF read: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K231786.pdf
The lockable support-diameter range of a single adjustable device spans the full range of ring-pessary sizes fitted to women with stage II-III pelvic organ prolapse, so one SKU replaces a multi-size fitting set
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a mechanism/design-performance claim about an unbuilt device, and no connector answers it. Two facts are needed: the ring-pessary size range actually fitted to stage II-III women (clinical fitting data or a cleared product's size range) and the…the full check device's achievable lockable diameter range (bench data), and neither is attached. Context only: K231786's summary says "The min and max feature sizes are within range of predicate pessaries", which describes that device, not this one. — source: deck-surfaced assumption (feasibility deck, 2026-09-29); checked 2026-09-29: no connector for this claim type
The adjustable pessary goes through the same insertion and removal handling as a conventional ring pessary without its lock slipping or its set diameter changing
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: a bench-performance claim about an unbuilt locking mechanism, and no connector answers it. It needs lock-retention and diameter-stability testing under folding/insertion/removal loads, and none exists. Context only: cleared HHW summaries show the…the full check relevant test types (K231786: folding, squeeze, end-of-life; K232677: insertion and removal force, hinge strength). — source: deck-surfaced assumption (feasibility deck, 2026-09-29); checked 2026-09-29: no connector for this claim type
FTO landscape sweep, 2026-09-29 (EPO OPS, any publication date): CPC A61F6/08 (pessaries) holds at least 1,015 publications; within it the title/abstract terms 'adjustable' match 19 families, 'lock' 3, 'expandable' 27, 'size' 30 and 'ratchet' 0; the free-text phrase 'pessary ratchet' matches 0 and 'adjustable pessary' 8; applicant sweeps return Cosm Medical 7, Reia 7 and CooperSurgical (within A61F6/08) 1 families. This records what was swept, not that any field is clear — a keyword miss is not an absence, and claims 47-54 carry the questions the sweep could not answer
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: all eleven recorded sweeps were re-run and every count reproduces exactly (cpc A61F6/08: found, 100 families returned of 1,015 publications, truncated; +adjustable 19; +lock 3; +ratchet none/0; +expandable 27; +size 30; 'adjustable pessary' 8;…the full check 'pessary ratchet' none/0; Cosm Medical 7; Reia 7; A61F6/08+CooperSurgical 1). A sweep returns a ScanResult, which carries no tag, so this stays scan-supported rather than verified. The zero results are keyword misses, not a clear field — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text lock --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text ratchet --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text expandable --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text size --limit 100 --jurisdiction US; patent-scan --text "adjustable pessary" --limit 100 --jurisdiction US; patent-scan --text "pessary ratchet" --limit 100 --jurisdiction US; patent-scan --applicant "Cosm Medical" --limit 100 --jurisdiction US; patent-scan --applicant Reia --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --applicant "CooperSurgical" --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it; re-run 2026-09-29: same eleven patent-scan invocations → counts reproduced (ScanResult, no tag)
US 10,687,977 B1, 'Device and method to optimize the form and function of a pessary' (applicant Anne Hardart; family including US 2021/0315730 A1 and WO 2020/181103 A1, FP Medtech), is a granted US patent filed 2016-03-16 with a naive 20-year term to 2036-03-16, and is the closest live granted US patent the sweep surfaced to a size-adjustable pessary
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the registry facts check out. patent US10687977B1 resolves to a B1 publication (a granted US patent, published 2020-06-23) titled 'Device and method to optimize the form and function of a pessary', filed 2016-03-16, with a naive term to…the full check 2036-03-16 that models no PTA, terminal disclaimer or maintenance lapse. The applicant, HARDART ANNE [US], comes from patent-scan --applicant Hardart. Three parts stay open. (1) 'Live': in-force status is out of reach because the connector has no legal-status service, and a maintenance-fee lapse cannot be seen. (2) 'Family including US 2021/0315730 A1 and WO 2020/181103 A1' is not supported by the record: OPS puts the three in three different DOCDB families (71105058, 78005700 and 72337327). They may still be linked by a CIP or extended-family relationship, but nothing here shows that. (3) 'Closest to a size-adjustable pessary' is a judgement about claim scope that no connector can answer — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): the grant half is now confirmed and the 'live' half is not. patent-status US10687977B1 --expect in-force returned verified: the one US application in the family, US10687977B1, is 'granted, no lapse recorded, naive term to 2036-03-16'. But the INPADOC record was last exchanged 2023-12-30, more than 2.5 years ago, and the tool warns about that. For a B1 published 2020-06-23, the 3.5-year maintenance fee fell due around 2023-12-23, with the surcharge grace period running to about 2024-06-23. A lapse for non-payment would therefore be recorded after this snapshot and would not show. A record that old cannot establish 'currently in force' today, so 'live' stays unconfirmed. The connector's verified means 'in force as of 2023-12-30'. It does not mean in force on 2026-09-30, and I have not rounded it up. The family grouping is still unsupported, and it is now contradicted at the family level as well: this publication's family has one US member (itself), US2021315730A1's family has one US member (itself), and WO2020181103A1's family has no US member. None of the three lists another as a member. It is secondary to the claim, so I have not tagged the claim refuted on it. 'Closest to a size-adjustable pessary' is still a claim-scope judgement that no connector reads. What would close it: a fresh USPTO (United States Patent and Trademark Office) maintenance-fee or Patent Center status read on US10687977, which is a human lookup or a newer INPADOC exchange. Verifier 2026-09-30 (re-run): patent-status US10687977B1 --expect in-force --jurisdiction US was re-run and changed nothing — still verified at the database level, US10687977B1 'in-force (granted, no lapse recorded, naive term to 2036-03-16)', with the INPADOC record still last exchanged 2023-12-30 and the connector's stale-record warning still firing. Tag stays unconfirmed for the same reason: the 3.5-year maintenance-fee window (due ~2023-12-23, grace to ~2024-06-23) falls after the snapshot. A primary-source maintenance-fee check needs USPTO: Patent Center read by a human, or a USPTO Open Data Portal API key, which this environment does not have (api.uspto.gov answers 401). — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text expandable --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US10687977B1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.10687977.B1 (bibliographic facts only); checked 2026-09-30: patent-status US10687977B1 --expect in-force --jurisdiction US → verified (stale record, last exchanged 2023-12-30), EPO OPS family/publication docdb=US.10687977.B1/legal (INPADOC), family=71105058; patent-status WO2020181103A1 --expect pending --jurisdiction US → unconfirmed, no US publication in family, EPO OPS family/publication docdb=WO.2020181103.A1/legal (INPADOC), family=72337327; re-checked 2026-09-30: patent-status US10687977B1 --expect in-force --jurisdiction US → verified (stale record, last exchanged 2023-12-30), EPO OPS family/publication docdb=US.10687977.B1/legal (INPADOC), docdb families=71105058
US 2021/0315730 A1, 'Device and method to optimize the form and function of a pessary' (FP Medtech), a continuation-family publication filed 2020-04-09 with a naive term to 2040-04-09, is pending or has issued as a US patent whose claims are not yet on record here
jurisdiction: US — confidence: refuted — note: Verifier 2026-09-29: the bibliographic facts check out. patent US2021315730A1 → FP MEDTECH INC, 'Device and method to optimize the form and function of a pessary', filed 2020-04-09, naive term 2040-04-09. Whether it is pending, issued or abandoned is out of reach…the full check because the connector has no legal-status service. The 'continuation-family' description is also unsupported: OPS puts this publication in DOCDB family 78005700 and US10687977B1 in 71105058. The naive term is misleading too. If this application is a continuation of the 2016 filing, any patent from it would run from the earliest non-provisional US date (2016-03-16, so about 2036), not to 2040. If it is a CIP, the new matter could run to 2040. Counsel should read the application's related-application data — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): REFUTED. The claim says 'pending or has issued'. INPADOC shows the application abandoned: US2021315730A1 'abandoned (STCB 2022-12-31: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION)'. The family has no other US member, so no granted sibling exists. I ran both halves: --expect pending → refuted and --expect granted → refuted. Caveat on record: the INPADOC record was last exchanged 2023-01-23, more than a year ago, so a later revival petition would not show. A revival would be a new event, though. The latest record positively contradicts the claim, and a refuted result is not softened on the chance that something happened after it. The 'continuation-family' description is also unsupported: this family's only US member is itself, and US10687977B1's family does not list it. Consequence: on the record, the 2020 FP Medtech application is not a live source of US claims. — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --text expandable --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US2021315730A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.2021315730.A1 (bibliographic facts only); checked 2026-09-30: patent-status US2021315730A1 --expect pending --jurisdiction US → refuted: abandoned (STCB 2022-12-31), EPO OPS family/publication docdb=US.2021315730.A1/legal (INPADOC), family=78005700 (record last exchanged 2023-01-23); patent-status US2021315730A1 --expect granted --jurisdiction US → refuted: abandoned, same source_ref
US 2014/0107402 A1, 'Adjustable Pessary Device and Method' (AMS Research), filed 2013-10-17 with a naive term to 2033-10-17, issued as a US patent that is currently in force
jurisdiction: US — confidence: refuted — note: Verifier 2026-09-29: the bibliographic facts check out. patent US2014107402A1 → 'Adjustable Pessary Device and Method', AMS RES CORP, DOCDB family 50475940, filed 2013-10-17, naive term 2033-10-17. The load-bearing part ('issued as a US patent that is currently in…the full check force') cannot be checked. A title sweep (patent-scan --text "Adjustable Pessary Device") and a cpc A61F6/08 + 'AMS Res' applicant sweep surface only this A1 in the family. Because a sweep keeps one record per family, that does not show a granted member is absent — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): REFUTED on the load-bearing half. The application did issue, as US9717582B2 ('Adjustable pessary device and method', filed 2013-10-17, same application as the A1). That grant is recorded as 'lapsed (FP 2021-09-28: ... LAPSED DUE TO FAILURE TO PAY MAINTENANCE FEE Effective DATE 20210801)'. The INPADOC record is current (last exchanged 2025-12-13), so it is not stale, and no reinstatement is recorded. 'Currently in force' is false on the record. The 2021-09-28 FP event is also the reason the 2026-09-29 sweeps surfaced only the A1. Consequence: the one publication titled 'Adjustable Pessary' that has a US grant is a lapsed patent, not a live one. — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US; patent-scan --text "adjustable pessary" --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US2014107402A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.2014107402.A1 (bibliographic facts only); checked 2026-09-30: patent-status US2014107402A1 --expect in-force --jurisdiction US → refuted: lapsed (US9717582B2, maintenance fee, effective 2021-08-01), EPO OPS family/publication docdb=US.2014107402.A1/legal (INPADOC), family=50475940 (record last exchanged 2025-12-13); patent US9717582B2 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.9717582.B2 (bibliographic: title, filed 2013-10-17)
US 2019/0321215 A1, 'Anatomical support systems, devices, and related methods' (Emory University), filed 2019-04-24 with a naive term to 2039-04-24, issued as a US patent that is currently in force
jurisdiction: US — confidence: verified — note: Verifier 2026-09-29: the bibliographic facts check out. patent US2019321215A1 → 'Anatomical support systems, devices, and related methods', UNIV EMORY, DOCDB family 68236184, filed 2019-04-24, naive term 2039-04-24. Grant and in-force status cannot be checked, and…the full check title and applicant sweeps surface only this A1 (one record per family, so that is not an absence) — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): VERIFIED as a database state. The application issued as US11497647B2 ('Anatomical Support Systems, Devices, and Related Methods', filed 2019-04-24, same application). INPADOC records it as 'in-force (granted, no lapse recorded, naive term to 2039-04-24)'. The record was last exchanged 2026-05-23, less than a year ago, so the tool raises no stale warning. Limits: the connector does not report the grant date, and a maintenance fee due near that exchange date would only show as a lapse after its six-month grace period had run out. That is a residual risk, not a contradiction. PTA and terminal disclaimers are not modelled. 'In force' is an INPADOC database state. It says nothing about FTO or claim scope, and nothing here says what US11497647B2 claims or whether those claims read on a ratchet-locked, clinician-set-diameter ring pessary (claim 54unconfirmed). — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US2019321215A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.2019321215.A1 (bibliographic facts only); checked 2026-09-30: patent-status US2019321215A1 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.2019321215.A1/legal (INPADOC), family=68236184 (US11497647B2 in force, record last exchanged 2026-05-23); patent US11497647B2 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.11497647.B2 (bibliographic: title, filed 2019-04-24)
WO 2025/141535 A1, 'Adjustable device for organ prolapse' (Weichselbaum, Dach, Mansano; filed 2024-12-29), has entered the US national phase or has a pending US counterpart
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the bibliographic facts check out. patent WO2025141535A1 → 'ADJUSTABLE DEVICE FOR ORGAN PROLAPSE', WEICHSELBAUM AMNON / DACH ITAMAR / MANSANO ROY ZION, DOCDB family 94598984, international filing 2024-12-29. US national-phase entry cannot be…the full check checked: a title sweep and an applicant sweep ('Weichselbaum') surface no US publication, but a sweep keeps one record per family, so that is not an absence. Timing context: with a 2024-12-29 filing, the PCT (Patent Cooperation Treaty) 30-month deadline runs to about mid-2027 (earlier if the application claims an earlier priority, which this connector does not report). So a US entry may simply not be due yet — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): still unconfirmed, and the new tool cannot answer this claim. patent-status WO2025141535A1 --expect pending → unconfirmed: 'no US publication in this DOCDB family. US members: none. INPADOC record last exchanged unknown.' The tool's rules put a family with no US member at unconfirmed. That is not a refutation. With an international filing date of 2024-12-29, the PCT 30-month national-phase window runs to about mid-2027, or earlier if priority is claimed from an earlier filing, which the connector does not report. A US entry may not be due yet. Even once one is made, it may reach INPADOC only with a lag. An empty US member list today is therefore consistent with 'not yet entered', 'entered but not yet visible' and 'will not enter'. What would close it: a re-run of patent-status after the 30-month date, or a human read of WIPO PATENTSCOPE national-phase data. — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text expandable --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent WO2025141535A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=WO.2025141535.A1 (bibliographic facts only); checked 2026-09-30: patent-status WO2025141535A1 --expect pending --jurisdiction US → unconfirmed: no US publication in family, EPO OPS family/publication docdb=WO.2025141535.A1/legal (INPADOC), family=94598984
Cosm Medical's fitting-method family — US 2020/0214617 A1 (filed 2018-09-18, naive term to 2038) and US 2025/0127604 A1 (filed 2024-12-23, naive term to 2044), both 'Methods and systems for vaginal therapeutic device fitting' — includes an issued US patent in force, bearing on this candidate's single-SKU fitting workflow rather than its lock mechanism
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: the bibliographic facts check out. patent US2020214617A1 → 'Methods and systems for vaginal therapeutic device fitting', filed 2018-09-18, naive term 2038-09-18. patent US20250127604A1 → the same title, filed 2024-12-23, naive term 2044-12-23.…the full check The two are not one DOCDB family, though. US2020214617A1 is family 65722215 (SHAM DEREK; COSM MEDICAL). US20250127604A1 is family 84285978, which it shares with US2022387158A1 (SHAM DEREK), and CA3204253A1 is a third family, 82357056. None of the sweeps surfaces a granted B-kind member, and 'includes an issued US patent in force' cannot be checked — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): the registry half is now confirmed, and the claim stays unconfirmed because of its scope half. Confirmed: the family includes an issued US patent that is in force, US11826162B2 ('Methods and systems for vaginal therapeutic device fitting', filed 2018-09-18, the same application as US2020214617A1). INPADOC records it as 'in-force (granted, no lapse recorded, naive term to 2038-09-18)', and the record was last exchanged 2026-08-29, which is fresh. patent-status returns the same per-application breakdown from either publication, with the other members being US2022387158A1 'abandoned (STCB 2025-04-05)' and US20250127604A1 'pending (no grant, abandonment or lapse event on record)'. That supersedes the 2026-09-29 'not one DOCDB family' finding at the family-member level, although the two publications do carry different DOCDB ids (see the tooling observation). Not confirmed: 'bearing on this candidate's single-SKU fitting workflow rather than its lock mechanism'. That is a claim-scope judgement read off titles, and no connector reads claim text. Tagging the line verified would put an FTO-favourable scope statement (that the patent does not reach the lock) on a verified line, so the tag stays unconfirmed. I recommend the Scorer split this into a pure registry claim and a scope claim. Tooling observation: the tool's detail says 'one DOCDB simple family', but the member list it reads spans more than one DOCDB family id (the Cosm result lists US2020214617A1, DOCDB 65722215, and US20250127604A1, DOCDB 84285978, together), so the member set behaves like the INPADOC extended family and the family= in its source_ref is the first member's id. — source: connector sweep (2026-09-29): patent-scan --applicant "Cosm Medical" --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US2020214617A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.2020214617.A1; patent US20250127604A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.20250127604.A1 (bibliographic facts only); checked 2026-09-30: patent-status US2020214617A1 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.2020214617.A1/legal (INPADOC), family=65722215 (US11826162B2 in force, record last exchanged 2026-08-29); patent-status US20250127604A1 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.20250127604.A1/legal (INPADOC), family=84285978 (same breakdown; US20250127604A1 itself pending); patent-status US11826162B2 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.11826162.B2/legal (INPADOC), family=65722215; patent US11826162B2 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.11826162.B2 (bibliographic: title, filed 2018-09-18)
US 2018/0256389 A1, 'Pelvic organ support devices and related methods' (CooperSurgical, an incumbent pessary maker), filed 2018-01-08 with a naive term to 2038-01-08, issued as a US patent that is currently in force
jurisdiction: US — confidence: refuted — note: Verifier 2026-09-29: the bibliographic facts check out. patent US2018256389A1 → 'PELVIC ORGAN SUPPORT DEVICES AND RELATED METHODS', COOPERSURGICAL INC, DOCDB family 63446759, filed 2018-01-08, naive term 2038-01-08. Grant and in-force status cannot be checked. A title…the full check sweep and a cpc A61F6/08 + CooperSurgical sweep surface only this A1 (one record per family, so that is not an absence) — the connector reads OPS bibliographic data only and does not call the INPADOC /legal service (connectors/patents.py docstring), so grant, lapse, maintenance-fee and in-force status cannot be answered by any connector here; a missing answer is a tooling gap, not evidence the patent was not granted or has lapsed Verifier 2026-09-30 (patent-status pass): REFUTED. The claim says the application 'issued as a US patent that is currently in force'. INPADOC shows it abandoned: US2018256389A1 'abandoned (STCB 2021-07-08: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION)'. The family has no other US member, so no grant exists anywhere in it. The record was last exchanged 2026-01-31, so it is not stale. Consequence: on the record, this CooperSurgical family is not a live source of US claims. — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --applicant "CooperSurgical" --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); patent US2018256389A1 --jurisdiction US → verified, EPO OPS published-data/publication docdb=US.2018256389.A1 (bibliographic facts only); checked 2026-09-30: patent-status US2018256389A1 --expect in-force --jurisdiction US → refuted: abandoned (STCB 2021-07-08), EPO OPS family/publication docdb=US.2018256389.A1/legal (INPADOC), family=63446759 (record last exchanged 2026-01-31)
No claim of a live US patent in the families surfaced by the 2026-09-29 sweep — US 10,687,977 B1 and its continuation US 2021/0315730 A1, US 2014/0107402 A1, US 2019/0321215 A1, any US counterpart of WO 2025/141535 A1, the Cosm fitting-method family, and US 2018/0256389 A1 — reads on a ring pessary whose support diameter is clinician-set and held by a ratcheting lock; this is a claim-construction question for patent counsel, not a lookup
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-29: whether any claim in these families reads on a clinician-set ring pessary held by a ratcheting lock is a claim-construction question, and no connector answers it. The patent connector returns titles and dates, never claim text, and OPS terms bar…the full check pasting records. It needs a patent counsel's read of the issued claims, which is Tier 3 legal work. The underlying publications all resolve bibliographically (see claims 47-53), and no grant or in-force status is on record for any of them except that US10687977B1 is a B1 grant — source: connector sweep (2026-09-29): patent-scan --cpc A61F6/08 --limit 100 --jurisdiction US; patent-scan --cpc A61F6/08 --text adjustable --limit 100 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it; checked 2026-09-29: no connector for claim construction; patent <id> --jurisdiction US → verified (bibliographic only) on all eight publications in claims 47-53
US 11,826,162 B2 (Cosm Medical; the grant of the US application filed 2018-09-18 and published as US 2020/0214617 A1, 'Methods and systems for vaginal therapeutic device fitting') is an issued US patent currently in force, naive term to 2038-09-18 — split from claim 52unconfirmed's registry half
jurisdiction: US — confidence: verified — note: Verifier 2026-09-30: judged on the per-application row for US11826162B2 itself, not the family roll-up. patent-status US11826162B2 --expect in-force → verified; the breakdown reads 'US11826162B2: in-force (granted, no lapse recorded, naive term to 2038-09-18)', and the…the full check same row appears from patent-status US2020214617A1, which INPADOC lists as a US member of the same family (the A1 publication of the application that became the B2). INPADOC record last exchanged 2026-08-29, about a month old, so no stale-record warning; a maintenance-fee lapse after that date would not show. 'Naive term' models no PTA or terminal disclaimer, so 2038-09-18 is the 20-years-from-filing date, not a computed expiry. Other US members, for the record: US2022387158A1 abandoned (STCB 2025-04-05), US20250127604A1 pending. 'In force' is a database state, not an FTO opinion — scope is claim 56unconfirmed. — source: connector lead (2026-09-30): patent-status US2020214617A1 --jurisdiction US; patent-status US20250127604A1 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it — evidence class 1 (registry fact); checked 2026-09-30: patent-status US11826162B2 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.11826162.B2/legal (INPADOC), docdb families=65722215,84285978; patent-status US2020214617A1 --expect in-force --jurisdiction US → verified, EPO OPS family/publication docdb=US.2020214617.A1/legal (INPADOC), docdb families=65722215,84285978
No claim of US 11,826,162 B2 (Cosm Medical, vaginal therapeutic device fitting methods) reads on this candidate's ratchet-locked, clinician-set-diameter pessary or its single-SKU in-clinic fitting procedure; the patent bears on fitting workflow, not on the lock mechanism — split from claim 52unconfirmed's scope half; a claim-construction question for patent counsel, not a lookup
jurisdiction: US — confidence: unconfirmed — note: Verifier 2026-09-30: not checkable by any connector here. Whether a claim of US11826162B2 reads on this device is a claim-construction question; it needs the patent's US claim text, and no connector returns it — EPO OPS answers CLIENT.InvalidCountryCode for US claims,…the full check and patent/patent-status read bibliographic and INPADOC legal data only. The patent's title ('Methods and systems for vaginal therapeutic device fitting') is not its claim scope. This stays unconfirmed until patent counsel reads the claims (Tier 3 FTO work); a missing answer here is a tooling gap, not evidence either way. — source: connector lead (2026-09-30): patent-status US2020214617A1 --jurisdiction US — a lead, never a finding; recorded so the Verifier can see it
Words on this page36 abbreviation(s) and code(s), with what each stands for — copied from _shared/plain-language.md
21 CFR
Title 21 of the Code of Federal Regulations — the US food-and-drug rulebook; a number after it is one regulation, often the one that classifies a device type
510(k)
premarket notification — the FDA route for a device shown to be as safe and effective as one already on the market; months, no clinical trial as a rule
A####
a HCPCS code for a supply — one billing code for a supply or an accessory; the letter A and four digits
BOM
bill of materials — the list of parts in a product and what each costs
Class II
FDA device class II — moderate-risk devices, usually cleared by 510(k)
Class III
FDA device class III — the highest-risk devices, usually approved by PMA
CMS
Centers for Medicare & Medicaid Services — the US agency that runs Medicare, and so decides what Medicare pays for
CPT
Current Procedural Terminology — the US billing codes for what a clinician does; owned by the American Medical Association
De Novo
De Novo classification request — the FDA route for a new, lower-risk device with no comparable product to point at; longer than a 510(k), usually needs clinical data
DME
durable medical equipment — equipment a patient uses at home, such as a pump or a stimulator, that Medicare pays for under its own rules
DME MAC
durable medical equipment Medicare administrative contractor — one of the four regional contractors that process Medicare's home-equipment claims and write its local coverage rules
DMEPOS
durable medical equipment, prosthetics, orthotics and supplies — the Medicare benefit and fee schedule that home equipment is paid under
EPO
European Patent Office — the European patent office
FDA
US Food and Drug Administration — the US regulator that clears or approves a device before it can be sold
FFS
fee-for-service — the traditional form of Medicare that pays per item or service
FTO
freedom to operate — whether a product can be sold without infringing someone else's live patent
HCPCS
Healthcare Common Procedure Coding System — the US billing codes for equipment, supplies and some services; a code is how a payer recognises what to pay for
IFU
instructions for use — the labelling that says what a device is for and how to use it
ISO
International Organization for Standardization — the body whose numbered standards devices and laboratories are tested against
K######
an FDA 510(k) clearance number — the public record of one cleared device; the letter K and six digits
LCD
local coverage determination — a Medicare contractor's rule, valid in its region, saying when something is covered
MAC
Medicare administrative contractor — a regional contractor that processes Medicare claims and writes local coverage rules
MAUDE
Manufacturer and User Facility Device Experience — the FDA's public database of reported device problems
Medicare Advantage
Medicare Advantage — Medicare delivered through a private insurer; must cover at least what Medicare covers
Medicare Part B
Medicare Part B — the part of Medicare that pays for outpatient care and equipment used at home
NCD
national coverage determination — a Medicare rule, valid everywhere in the US, saying whether and when something is covered
NCT########
a ClinicalTrials.gov registration number — the public id of one registered clinical trial
PCT
Patent Cooperation Treaty — the route for filing one patent application in many countries at once
PDAC
Pricing, Data Analysis and Coding contractor — the Medicare contractor that decides which billing code a specific product falls under
PFS
physician fee schedule — the Medicare price list for what clinicians do
PMA
premarket approval — the FDA route for the highest-risk devices; years and clinical trials
PMID
PubMed identifier — the public id of one published medical paper
RVU
relative value unit — the unit Medicare uses to price a clinician's work
SUI
stress urinary incontinence — leaking urine on a cough, a laugh or a lift
TAM
total addressable market — how much money the whole market would be worth if every possible buyer bought
USPTO
United States Patent and Trademark Office — the US patent office