idea-015 · human · active
For fitting by a licensed clinician and subsequent wear by the patient, as a; removable intravaginal support device to reduce the symptoms of stage II or stage III; anterior-compartment or apical pelvic organ prolapse in adult women who have elected; non-surgical management; not indicated for the treatment of stress urinary incontinence, not; indicated for stage IV or procidentia, and not a substitute for surgical repair.
| Mechanism | A reusable medical-grade silicone ring-with-support pessary containing a ratcheting; internal band whose outer supporting diameter the fitting clinician sets, and locks, at any; point across a continuous range spanning the standard ring-pessary size ladder. A failed or; uncomfortable fit is corrected by re-adjusting the same device within the same visit rather; than by withdrawing it and trying the next discrete size from a stocked fitting set, and the; set diameter is readable off the device so it can be recorded in the chart and re-set at; follow-up. Insertion, removal, cleaning and wear are otherwise those of a conventional ring; pessary. One SKU replaces a multi-size fitting inventory. |
|---|---|
| Device class | Class II — 510(k) — 21 CFR 884.3575 (vaginal pessary), FDA product code HHW — most likely; launch route. Rests on the pessary regulation and product code being read to cover a; device whose support diameter is set mechanically rather than chosen from a size ladder; (claims 1, 3, 4). Not confirmed against an FDA classification record.; Class II, premarket-notification exempt — 21 CFR 884.3575 subject to the limitations; in 21 CFR 884.9 — carried because the Generator could NOT establish from a primary FDA; record whether HHW carries a 510(k) exemption flag (claim 2). Web sources assert 510(k) is; required and real 510(k)s exist in the code, but devices are routinely cleared voluntarily; inside exempt codes, so the existence of K-numbers does not settle it. If this route is the; live one, market entry is registration/listing plus QSR only, and Factor 7 changes; completely.; De Novo — FD&C Act section 513(f)(2) — repositioning route if FDA reads the ratcheting,; lockable, re-adjustable diameter mechanism as a new technological characteristic raising; different questions of safety and effectiveness than any HHW predicate (no cleared; adjustable-diameter pessary was identified — claim 5). |
| Predicate or analog | K190277 — ConTIPI Medical Ltd., a disposable, self-inserted, collapsible; vaginal device for non-surgical management of pelvic organ prolapse (the ProVate device),; with a 2019 FDA decision — is the closest cleared analog the Generator identified in this; space, but it is single-use and non-adjustable, so it is an analog rather than a predicate; for the adjustment mechanism. Four further K-numbers (K132313, K231786, K232677, K233548); surfaced in a web search restricted to 21 CFR 884.3575 / vaginal pessary and may be; additional pessary clearances, but none was individually confirmed (claim 4). Conventional; ring, Gellhorn, donut and cube pessaries (e.g. the CooperSurgical/Milex and Bioteque lines); are the commercial incumbents; no K-number was identified for any of them. The Reia; collapsible pessary (registered study NCT04275089) and 3D-printed patient-specific pessaries; are the closest development-stage competitors. No FDA-cleared pessary with a; clinician-adjustable, lockable support diameter was identified — that is the proposed; novelty, not a claim that such a device already exists. |
| Launch jurisdiction | US |
| Target | human |
Read this before anything else on the page. A low count here is usually a
statement about this repo's tooling rather than about the idea — a
unconfirmed reimbursement claim most often means the CMS cache file
is absent and nothing was searched, which is not evidence that a code
does not exist.
The coverage above says how much is known. This says what any of it is for: the propositions this opportunity rests on, ordered by what a failure would cost and, inside that, by what settling it would take. Derived from the pillars and the claims' current tags, not written.
This packet is unassessed. Its claims carry tags, so the file says how sure anybody is about each one — and nothing says which of them the idea actually rests on, or what it would cost to be wrong about one. Run /assess idea-015 to add that. Unassessed is a state, not a failing score.
The packet a human reads. See docs/wrap-spec.md. This section says nothing about whether the idea is good — it says the file is finished enough to be read, and names what to do next. Filling it in advances no candidate and approves nothing.
The one-paragraph version.
What would have to be true.
Cheapest next test:
Where the evidence actually stands.
| Factor | Score | Why | What would settle it |
|---|---|---|---|
| Regulatory pathway | 3 | Claims 1, 3, 4, 5. intended_use: is stated, so this factor is scorable. Scored on the assumption that 884.3575 / HHW is read to cover a mechanically-set diameter. Pulled down from 4 by claim 2 (510(k)-vs-exempt unresolved) and claim 5…the rest of this reasoning(no cleared adjustable-diameter predicate, so a De Novo reading is live). Note claim 5 is absence-of-evidence over a non-exhaustive search, not confirmed absence. | An openFDA device/classification lookup on product code HHW — settles the class and the premarket-notification exemption flag in one call, near-zero cost. Opening the K190277 clearance letter and the four candidate K-numbers confirms…the rest of this gap analysiswhether a real adjustable-mechanism predicate exists. |
| Reimbursement pathway | 3 | Claims 6, 7, 8, 11. Scored as "codes plausibly exist," not "pathway exists": A4561/A4562 and CPT 57160 are asserted active, which is better than most candidates, but the ~$69-89 device allowed amount (claim 11) is a hard ceiling on a…the rest of this reasoningdevice that bills once, claim 7 puts a DMEPOS supplier channel in the way, and margin at that payment is only assumption claim 24 — an assumption, not evidence. No coverage policy was checked at all. | The CMS DMEPOS fee-schedule file for A4561/A4562 and the PFS relative-value file for 57160 — both free downloads, one lookup each. A DME MAC LCD/policy-article search for pessary coverage criteria is the missing coverage half. |
| TAM | 2 | Claims 10, 11, 12, 13. All three TAM components are the candidate's own unsourced guesses (10 and 12 say so explicitly). Taken at face value the arithmetic is thin: ~50-200k fittings × ~$69-89 × 30-50% addressable ≈ low single-digit $M of…the rest of this reasoningMedicare device revenue, once per patient on a reusable SKU. Claim 13 (2.9% symptomatic POP prevalence) sizes the disease, not the billable device market. Sits at the 2/5 kill floor. | CPT 57160 Medicare Part B allowed-services volume from the CMS Physician & Other Practitioners utilization data via this repo's procedures volume lookup — cheap, and it fixes the one component with a real source. Price comes from the…the rest of this gap analysissame DMEPOS file as Reimbursement; addressable share has no primary source and needs commissioned practice-level research. |
| FTO / IP | 2 | Claims 16, 17, 18. Not an honest blank: claim 16 names US 11,865,033 as live-looking, directly adjacent art that already steered the design away from a collapse-for-removal feature, and claim 18 records that **no landscape search was run…the rest of this reasoningon the locking mechanism itself** — the core novelty's FTO field is unexamined, not clear. Claim 17 (US 6,189,535 expired) is minor comfort on a different concept. Scored low for unexamined blocking risk, not scored as blocked — that call needs verified claims. | Pull the issued claims, assignee of record, legal status and maintenance-fee state for US 11,865,033 from USPTO/Patent Center — one lookup. The ratcheting-lock landscape needs a commissioned professional FTO search; that is a paid,…the rest of this gap analysismulti-week item and the single most expensive gap in this file. |
| Moat / defensibility | 2 | Claims 5, 18, 20, 21. The moat is one mechanical ratchet-and-lock on an otherwise commodity silicone ring, with no filed application recorded and no landscape work (claim 18) to say what is even patentable. Claims 20 and 21 put third…the rest of this reasoningparties (3D-printed patient-specific pessaries, Reia) on the same trial-and-error fitting problem. Regulatory exclusivity is nil on a 510(k)/exempt route. | A patentability opinion on the locking mechanism, which falls out of the same commissioned search as FTO — no extra search cost, added attorney time. |
| Mechanism & clinical risk | 3 | Claims 14, 15 establish the problem is real (56-80% initial fitting success; 30-50% 12-month discontinuation), and mechanical support of a prolapsed compartment is an incumbent mechanism, so plausibility is high. Held at 3 by assumption…the rest of this reasoningclaim 23 — that in-visit re-adjustment beats the next discrete size — which is the central clinical bet and has no data behind it, and by assumption claim 25, cleaning validation and lock retention on a reusable mechanical joint. Both are assumptions and are not scored as evidence. | Retrieve the actual fitting-success and discontinuation papers via PubMed (claims 14, 15 name no confirmed PMID) — cheap. Claim 23 can only be settled by a prospective comparative fitting study; claim 25 by a bench cleaning-validation and…the rest of this gap analysisISO 10993 biocompatibility protocol on a real joint. |
| Capital intensity & time-to-revenue | 4 | Claims 1, 2, 6. Silicone moulding plus a mechanical joint, no expected clinical trial on a substantial-equivalence argument about geometry and materials, and an existing DMEPOS code to bill against — this is a cheap, fast route to first…the rest of this reasoningdollar by medtech standards. The spread is wide: claim 2's exempt route would make entry registration/listing plus QSR, while a De Novo reading (claim 5) would add years. Claim 25's cleaning-validation burden is the main hidden cost. | Same openFDA HHW classification lookup as Regulatory — it collapses the exempt-vs-510(k)-vs-De Novo spread that drives this factor. A contract-manufacturing quote on the ratcheting mechanism would settle the cost side and also test…the rest of this gap analysisassumption claim 24. |
| Competitive intensity | 2 | Claims 4, 20, 21, and the predicate_or_analog incumbents (CooperSurgical/Milex, Bioteque, ConTIPI/ProVate K190277). A crowded, commoditised, low-price category with named development-stage entrants attacking the same fitting problem from…the rest of this reasoningother directions. No adjustable-diameter competitor was identified (claim 5), which is the only thing holding this above 1. | An openFDA product-code sweep of HHW plus a ClinicalTrials.gov pull on NCT04275089 — both cheap, and together they confirm the incumbent field and Reia's actual status. |
| Strategic fit & portfolio balance | 3 | Reads as a cash-generative spoke, not a hero bet: existing codes, modest ceiling, short path. Structurally distinct from idea-001's continence lane by the deliberate SUI exclusion (indication-scope note). Held at 3 because domains: is…the rest of this reasoningdeliberately empty — no dossier covers pelvic organ prolapse, so this candidate has no in-house domain evidence base behind it, and that named absence is itself a gap. | A human portfolio call, plus commissioning a POP domain dossier so a later candidate in this area inherits an evidence base — dossier work is a Scout-lane item, not a lookup. |
To finish this packet:
domains: — run /researchDomain dossier: none linked
Source file: knowledge-base/candidates/idea-015.md
Nothing on this page is a recommendation. Shortlist review, legal and clinical sign-off and capital allocation are human-only decisions, and no agent in this repo may make or simulate one. This is a compilation of what the candidate file says.