Single-use office radiofrequency applicator with integrated dosimetry and disposable anoscope for grade II-III internal hemorrhoids, sized to the CPT 46930 non-facility payment
9/9
factors scored
4/4
core factors
16/72
claims verified
3
refuted
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.
claim 1unconfirmedUS
CPT 46930 exists and is descriptor-defined as destruction of internal hemorrhoid(s) by thermal energy, with infrared coagulation, cautery and radiofrequency named in the descriptor as examples
jurisdiction: US — confidence: unconfirmed — source: coding aggregators via web search. That the descriptor names radiofrequency by example matters: it means the proposed mechanism is already inside the code rather than needing a new one. Check the primary descriptor. [Verifier 2026-08-23]connectors cpt 46930 →…the full checkunverifiable (source_ref: none). Detail: "CPT codes are AMA-licensed and cannot be scraped or reproduced verbatim (phase2-spec.md Section 3). Rescope this claim to HCPCS, or attach a licensed AMA/vendor source manually." hcpcs 46930 also returned unconfirmed (no data/hcpcs_level_ii.csv; 46930 is CPT/HCPCS Level I in any case, not Level II). No connector can ever resolve this: it stays unconfirmed until a human attaches AMA CPT Professional 2026 or a licensed vendor feed (AMA CPT API, Optum EncoderPro, Find-A-Code) as a manual citation. No web search was run and no aggregator is cited. Load-bearing consequence: the "RF is already inside the code" premise under Factors 2 and 8 is unverified at Stage 3.
claim 2unconfirmedUS
CPT 46930 is billed as one unit of service regardless of the number of hemorrhoid sites treated, and carries a 90-day global period during which re-treatment is not separately billable
jurisdiction: US — confidence: unconfirmed — source: a CMS LCD coding-guidelines attachment surfaced by web search but not read, plus aggregator commentary. This claim is commercially load-bearing in the negative direction: one unit per session and a 90-day global means a multi-session treatment plan generates no…the full check additional professional revenue, which caps how expensive the disposable can be. [Verifier 2026-08-23]connectors cpt 46930 → unverifiable (AMA-licensed; same detail as above). The unit-of-service rule is CPT/CMS coding guidance and has no connector. The 90-day global period is separately public in the CMS PFS Relative Value File GLOB DAYS column, but that file is not cached in data/ and no connector reads it. payment 46930 → unconfirmed: "No local cache at data/hcpcs_payment_rates.csv." Recorded unconfirmed; needs a licensed CPT source plus a human-supplied CMS PFS RVU file. Note this claim is negative-direction, so leaving it unconfirmed does not favour the candidate.
claim 3unconfirmedUS
CPT 46945 and 46946 exist for internal hemorrhoidectomy by ligation other than rubber band, single column and two-or-more columns respectively
jurisdiction: US — confidence: unconfirmed — source: coding aggregators via web search. A separate CPT code covers rubber-band ligation; the Generator did not identify its number and is not guessing one. [Verifier 2026-08-23]connectors cpt 46945 and connectors cpt 46946 → both unverifiable (source_ref:…the full check none), same AMA-licence detail. Existence and descriptor of both codes require a human-attached licensed AMA source. The unnamed rubber-band-ligation code was not guessed at and was not looked up.
claim 4unconfirmedUS
Under CCI edits, 46930 is bundled into 46945 and cannot be unbundled
jurisdiction: US — confidence: unconfirmed — source: aggregator commentary via web search; the CCI edit file was not consulted. [Verifier 2026-08-23]unconfirmed. No connector serves NCCI PTP edit pairs. connectors cpt 46930 → unverifiable (AMA-licensed). The CMS NCCI PTP quarterly edit-pair file is public…the full check and code-number-keyed but is not present in data/ and has no connector; a Scout download plus a human read is what would settle it. The aggregator commentary in the source field is explicitly not accepted as evidence and no web search was substituted.
claim 5unconfirmedUS
2026 Medicare physician fee schedule values, as reported by secondary sources: 46930 at 1.57 work RVUs and roughly $248 facility / $158 non-facility; 46945 at 3.60 work RVUs and roughly $350; 46946 at 4.39 work RVUs and roughly $384
jurisdiction: US — confidence: unconfirmed — source: two commercial fee-schedule lookup sites via web search. Aggregator fee data is exactly the kind of secondary number this pipeline exists to distrust, and the non-facility figure is the one the whole business model rests on. Check with payment 46930. **[Verifier…the full check 2026-08-23]** connectors payment 46930, payment 46945, payment 46946 → all three unconfirmed, source_ref: none. Detail (identical for each): "No local cache at data/hcpcs_payment_rates.csv — payment rate for <code> 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." data/ currently holds only README.md. The ~$158 non-facility figure therefore still rests solely on two commercial aggregator sites and has not been checked against CMS at all. coverage 46930 → unconfirmed ("No local cache at data/medicare_coverage_policies.csv"), so no Medicare NCD/LCD was located either: neither the payment level nor the existence of a coverage policy is established. Code existence + payment + coverage all remain open; this is not a demonstrated reimbursement pathway.
claim 6unconfirmedUS
The economic claim that decides this candidate: a single-use applicator plus anoscope must cost the practice materially less than the non-facility payment for 46930, net of the physician's own work, or the office will not adopt it
jurisdiction: US — confidence: unconfirmed — source: Generator's reasoning over the payment claim above. If the ~$158 non-facility figure survives verification, the disposable has to land somewhere near $40-60 to the practice, which is a hard constraint on the design and should be treated as a specification, not a…the full check pricing exercise. [Verifier 2026-08-23]unconfirmed. This is a derived claim resting entirely on the unverified payment figure above, and its other half (practice adoption economics) is a stakeholder-behaviour claim: connectors adoption → unverifiable by design. No connector output supports the $40-60 disposable ceiling, because the $158 input to it was never verified. The whole chain — payment level → COGS ceiling → practice will adopt — is unchecked end to end.
claim 7unconfirmedUS
TAM component 1 — annual US volume of office hemorrhoid destruction and ligation procedures, measured as Medicare claims volume for 46930, 46945 and 46946
jurisdiction: US — confidence: unconfirmed — source: Generator states no number. This is genuinely checkable via procedures on each code and should be looked up rather than estimated; note it will return Medicare volume only, and hemorrhoid disease skews younger than the Medicare population, so the code volume…the full check understates the commercial market by an unknown factor. [Verifier 2026-08-23]connectors procedures 46930, procedures 46945, procedures 46946 → all three unconfirmed, source_ref: none. Detail (identical for each): "No local cache at data/medicare_procedure_volumes.csv — procedure volume for <code> 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." This is the one genuinely checkable TAM component and it is blocked only by a missing human-supplied cache file, not by any licensing limit — attaching the CMS Part B utilisation file would resolve it. Carry the floor caveat when it is: Medicare FFS excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay, so a verified volume is a floor on US volume, never a market size.
claim 8unconfirmedUS
TAM component 2 — realistic net selling price per disposable kit to the practice, constrained by the economic claim above to roughly $40-60
jurisdiction: US — confidence: unconfirmed — source: Generator's assumption, derived from the payment claim rather than from any market data. [Verifier 2026-08-23]connectors market → unverifiable: "Market-size claim has no free, authoritative, machine-queryable source. Stays unconfirmed permanently unless a…the full check human attaches a licensed report and edits the claim by hand." Permanently unconfirmed. No aggregator or SEO page was consulted or accepted.
claim 9unconfirmedUS
TAM component 3 — addressable share assumption: the obtainable segment is colorectal surgeons, gastroenterologists and proctology practices already billing 46930, assumed by the Generator at 15-25% of qualifying procedures within five years
jurisdiction: US — confidence: unconfirmed — source: Generator's assumption. [Verifier 2026-08-23]connectors market → unverifiable (same detail as TAM component 2). Addressable share also embeds a switching assumption, which routes to connectors adoption → unverifiable. Permanently unconfirmed…the full check absent a licensed report plus a proctology/colorectal practice-count denominator attached by a human. No Verifier judgement was substituted for the missing research.
claim 10unconfirmedUS
Moat lever — the defensible assets are the impedance-dosimetry control algorithm and the applicator geometry, plus the razor-and-blade consumable stream once a practice is on the console; the RF generator itself is a commodity
jurisdiction: US — confidence: unconfirmed — source: Generator's judgement. Not connector-checkable as written. The candid version is that this is a weak moat: office electrosurgical devices are widely copied and the CPT code is open to any thermal modality. [Verifier 2026-08-23]unconfirmed. Not…the full check connector-checkable as written, as the Generator states. The only asserted defensible assets (dosimetry algorithm, applicator geometry) would have to be established through connectors patent, which is unavailable — PATENTSVIEW_API_KEY not set (see FTO claim). Non-verifying Stage 0 context only, carrying no confidence tag and not evidence for this claim: clearances --product-code GEI --since 5y returned 284 total matches (50 shown) for the broad electrosurgical cutting/coagulation code, and clearances --product-code FHN --since 5y returned 1. A scan result cannot upgrade this tag.
claim 11unconfirmedUS
FTO — the Generator identified no specific patents, expired or live, covering office RF hemorrhoid treatment, and is not naming any. The relevant estates are likely to sit with existing office-device and ligation-system manufacturers
jurisdiction: US — confidence: unconfirmed — source: no patent search was performed. Recorded as an unexamined gap, not as a clear field; an absence of found patents is not freedom to operate. [Verifier 2026-08-23]unconfirmed — UNEXAMINED FIELD, and this must not be read as a clear one. Two independent…the full check blockers: (1) the claim names no patent number, so there is nothing for connectors patent to look up; (2) the connector is unavailable regardless — a control call returned "PATENTSVIEW_API_KEY not set — request one at https://patentsview.org/apis/keyrequest before running Stage 3 IP checks." Zero patents were searched by the Verifier, and no patent search engine or generic web query was substituted for the missing key. The correct reading of this line remains "no search performed", not "no blocking art found". What would change it: a real CPC A61B18/12 and A61B17/12 search plus assignee sweeps on incumbent office-device and banding-system manufacturers, producing named numbers, each run through connectors patent — and even a verified result there is a database fact about filing/grant dates, not an FTO conclusion, which is a Tier 3 legal opinion at Stage 7.
claim 12unconfirmedUS
Mechanism and clinical risk — the failure modes are recurrence at grade III (the indication's whole premise), post-procedure pain and bleeding, and the serious-but-rare thermal injury to the sphincter complex or rectal wall. Dosimetry with automatic cutoff is the proposed mitigation and is therefore what bench and animal work must demonstrate
jurisdiction: US — confidence: unconfirmed — source: Generator's clinical reasoning. [Verifier 2026-08-23]unconfirmed. No Stage 3 connector answers a clinical-risk or durability claim. Stage 0 scans were run for pointers only and return no confidence tag and cannot acquire one — they are recorded here as…the full check leads, not as evidence: literature "radiofrequency ablation internal hemorrhoids" --since 5y → 3 PubMed records, incl. PMID 41024481 (propensity-matched RF vs hemorrhoidectomy for grade II-III internal hemorrhoids, Ann Coloproctol 2025) and PMID 38947711 (case series, Cureus 2024), both title-only and unappraised; trials --condition hemorrhoids --intervention radiofrequency → NCT07333040 (HELO trial, energy-based therapies vs conventional hemorrhoidectomy for grade III, recruiting). recalls --product-code GEI --since 5y → 175 total matches, but GEI is a very broad electrosurgical code and none were shown to be anorectal, so it is not a thermal-injury signal for this device type. Settled only by bench thermal-spread and animal sphincter-injury data (Stage 7).
claim 13unconfirmedUS
Competitive intensity — the CPT descriptor itself names three competing thermal modalities already in office use, so the candidate enters a category with established, cheap incumbents and must win on durability rather than novelty
jurisdiction: US — confidence: unconfirmed — source: Generator's reading of the descriptor claim above. Check the cleared-device field with clearances once the product code is identified. [Verifier 2026-08-23]unconfirmed. The claim is a direct restatement of the CPT 46930 descriptor claim, which is…the full checkunverifiable (AMA-licensed) — so the assertion that the descriptor names three thermal modalities is not established at Stage 3, and neither is the competitive read built on it. Product codes have now been identified (see Verifier findings below) and Stage 0 clearances scans were run against them, but scan results carry no confidence tag and cannot verify this claim. connectors adoption → unverifiable for the switching half, as the Scorer anticipated.
claim 14unconfirmedUS
Capital intensity and time-to-revenue — a 510(k) against an existing office thermal device, with bench dosimetry and animal thermal-spread data and no pivotal trial, is plausibly low-single-digit millions and 18-30 months; a durability claim at grade III strong enough to change referral behaviour would require a comparative clinical study that is not required for clearance and is a separate, later, commercial-evidence spend
jurisdiction: US — confidence: unconfirmed — source: Generator's estimate. Splitting the regulatory cost from the commercial-evidence cost is deliberate; conflating them is how this kind of candidate gets scored as cheaper than it is. [Verifier 2026-08-23]unconfirmed. Cost and calendar estimates are not…the full check database facts and no connector answers them. The load-bearing sub-assumption — that a predicate exists, so this is a 510(k) and not a De Novo — was checked as far as the connectors allow: a plausible predicate was located (K030315 / K023706, Ultroid Hemorrhoid Management System, IFU verified — see Verifier findings below), which is evidence against the De Novo fork but does not by itself establish substantial equivalence for this device, its dosimetry claim, or its 18-30 month figure. The De Novo route could not be checked independently: denovo "hemorrhoid radiofrequency" → unconfirmed, "No local cache at data/fda_denovo.csv... openFDA publishes no De Novo endpoint at all." That null means nothing was searched and is not evidence that no De Novo grant exists.
claim 15unconfirmedUS
Assumption, not a fact: the idea depends on proceduralists switching from an instrument they already own and have amortised to a per-case disposable, for a durability benefit that will not be proven at launch. There is no connector for physician purchasing behaviour and no primary research behind this; stated here so it stays visible
jurisdiction: US — confidence: unconfirmed — source: Generator's assumption. [Verifier 2026-08-23]connectors adoption → unverifiable (source_ref: none). Detail: "...asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary…the full check research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." The Verifier produced no opinion about what proceduralists would do. The suggested checkable proxies were both attempted and both blocked by missing cache files: coverage 46930 and procedures 46930 (see above). Permanently unconfirmed absent commissioned primary research attached by a human.
claim 16verifiedUS
21 CFR 878.4400 exists and is "Electrosurgical cutting and coagulation device and accessories" — a device intended to remove tissue and control bleeding by use of high-frequency electrical current — Class II
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-19, section=878.4400 (connectors regulation 878.4400 --expect "electrosurgical cutting and coagulation"). The Generator's belief about what this section says is correct. That the candidate device falls under it is a separate…the full check question and is not verified here.
claim 17verifiedUS
The general-surgery product code under 878.4400 is GEI, "Electrosurgical, Cutting & Coagulation & Accessories", Class II, review panel SU
jurisdiction: US — confidence: verified — source: openFDA device/classification product_code=GEI. This is a very broad horizontal code (284 clearances in the last 5 years) and is not hemorrhoid-specific.
claim 18verifiedUS
The frontmatter's unidentified "Part 876 route" resolves to real, named regulations: 21 CFR 876.4300 "Endoscopic electrosurgical unit and accessories", Class II (performance standards), and 21 CFR 876.4400 "Hemorrhoidal ligator", Class II (special controls) — the latter exempt from premarket notification subject to the limitations in § 876.9
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-19, sections=876.4300 and 876.4400. Related codes: KNS "Unit, Electrosurgical, Endoscopic", 876.4300, panel GU; FHN "Ligator, Hemorrhoidal", 876.4400, panel GU; FER "Anoscope And Accessories", 876.1500, panel GU —…the full check source: openFDA device/classification (one record per code).
claim 19refutedUS
~~The panel question is now evidenced, and it points at Part 876, not Part 878. The only cleared office hemorrhoid coagulation device the connectors surface — Ultroid Hemorrhoid Management System, Ultroid LLC — was cleared under product code KNS (21 CFR 876.4300, GU panel), not under GEI/878.4400~~
jurisdiction: US — confidence: refuted — source: openFDA device/510k k_number=K121085 (HET Bipolar Ligator System, HET Systems LLC, decided 2012-11-20, product_code=GEI) and k_number=K140422 (decided 2014-06-05, GEI); FDA 510(k) summaries K121085 (https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121085.pdf) and…the full check K140422 (https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140422.pdf). [Verifier 2026-08-25 — REFUTED, and this reverses the first pass's panel read.] The two inner database facts survive: Ultroid was cleared under KNS, and its product code is KNS/876.4300/GU (openFDA device/510k k_number=K023706 decided 2003-01-14 and k_number=K030315 decided 2003-02-27; openFDA device/classification product_code=KNS — all re-run independently this pass and still verified). What is refuted is the proposition the line was written to support — that Ultroid is the only cleared office hemorrhoid coagulation device the connectors surface, and that the panel evidence therefore points at Part 876. It is not the only one, and the evidence does not point that way. See the second-pass block below: a bipolar RF applicator cleared for internal hemorrhoids has a four-clearance history under GEI / 21 CFR 878.4400 / SU panel (2011, 2012, 2014, 2020), i.e. under the frontmatter's lead route, and it is fourteen years more recent and far closer in modality and delivery route than Ultroid. Any Factor 1 or Factor 7 reasoning that leaned on "the panel question moved against the frontmatter" is now resting on a refuted claim and must be recomputed by the Scorer.
claim 20verifiedUS
A predicate with a checked Indications for Use now exists where the file said none had been identified. K030315 IFU, verbatim: "The Ultroid Hemorrhoid Management system is intended for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, [I]I, I[I]I, IV."
jurisdiction: US — confidence: verified — note: phrase "hemorrhoid" present — source: FDA 510(k) summary K030315, https://www.accessdata.fda.gov/cdrh_docs/pdf3/K030315.pdf. Checked against this candidate's stated intended use: "to coagulate and devascularise symptomatic grade II and grade III internal hemorrhoids in…the full check adults, delivered transanally through an anoscope without sedation." The IFU covers internal hemorrhoids grades I-IV and physician use; it says nothing about office setting, absence of sedation, anoscope delivery, radiofrequency energy, or impedance dosimetry. Whether it supports substantial equivalence for this device is an FDA judgement for a human, not a database fact.
claim 21unconfirmedUS
The parallel summary for K023706 could not be phrase-matched
jurisdiction: US — confidence: unconfirmed — source: FDA 510(k) summary K023706, https://www.accessdata.fda.gov/cdrh_docs/pdf2/K023706.pdf. The posted PDF is a poor scan and the OCR text is garbled ("coagulative hemostatic therapy of hemal hemorrhoids grades I, U, I11, IV"), so the phrase 'internal hemorrhoid' missed.…the full check Recorded as unconfirmed, notrefuted — an OCR miss says nothing about the device. K030315 above is the clean read of the same indication.
claim 22verifiedUS
Disposable anoscopes are an established, separately cleared class under FER/876.1500
jurisdiction: US — confidence: verified — source: openFDA device/510k, Stage 0 clearances --device-name anoscope --since 10y: K250645 (Haemoband Surgical, 2025), K230439 (Well Care Wuhan, 2023), K200021 (Applied Medical, 2021), all product_code=FER. Relevant to the combination-product question the file does not yet…the full check address: applicator and anoscope may sit in different regulations.
claim 23refutedUS
No product code for the candidate device itself was established, and none is assumed.classification --device-name "hemorrhoid coagulation" and --device-name "electrosurgical cutting and coagulation" both returned unconfirmed ("No classification record found"). 510k "hemorrhoid radiofrequency" returned unconfirmed ("No 510(k) record found"). ~~No RF-specific office hemorrhoid device was found in openFDA at all~~
jurisdiction: US — confidence: refuted — note: second half only — source: openFDA device/510k k_number=K121085, K140422, K200146 (all product_code=GEI, bipolar RF forceps with an internal-hemorrhoid indication) and k_number=K150251, K162802 (Barrx Anorectal RFA Wand, Covidien, GEI). **[Verifier 2026-08-25 — PARTIAL…the full check REFUTATION.]** The first half stands and is still unconfirmed: no product code has been established for this candidate device, and none is assumed — that remains an FDA determination, not a lookup. The second half — "no RF-specific office hemorrhoid device was found in openFDA at all" — is refuted. It was a false negative produced by querying FDA's device-name string rather than the indication: the HET Bipolar and Barrx Anorectal RFA devices carry anorectal and internal-hemorrhoid indications while carrying neither "hemorrhoid" nor "radiofrequency" in the device-name field. This is the exact error the 2026-08-25 Stage 0 entry warned about, and it materially understated the competitive field for two days.
claim 24unconfirmedUS
Patients with grade II-III internal hemorrhoids who fail conservative management currently face either repeated office thermal treatments or escalation to ligation or surgery, and recurrence is the reason for that escalation
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed. This is a claim about current clinical practice and patient pathways. connectors adoption → unverifiable…the full check ("asserts what clinicians, payers, or patients would do… needs primary research"). The two suggested checkable proxies were both attempted and both blocked by missing human-supplied cache files: procedures 46930 and coverage 46930 → unconfirmed ("No local cache at data/medicare_procedure_volumes.csv" / "data/medicare_coverage_policies.csv"). No Verifier opinion about what patients currently face was substituted.
claim 25unconfirmedUS
Proceduralists experience recurrence after existing office thermal treatment at a rate they regard as a problem worth paying a per-case disposable to fix
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed.connectors adoption → unverifiable, verbatim detail: "Do NOT substitute a model's own estimate of…the full check stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." No such estimate was produced. Permanently unconfirmed absent a commissioned proctology/colorectal preference study attached by a human.
claim 26unconfirmedUS
Patients will accept an office radiofrequency procedure without sedation at the same rate they accept existing office thermal modalities
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed.connectors adoption → unverifiable — a patient-acceptance claim needs a published preference study or…the full check primary research. Note one adjacent, non-verifying pointer that does not answer it and carries no confidence tag: the 2026-08-25 Stage 0 entry logs PMID=42120648, a 53-patient UK case series of RF ablation for grade II-III haemorrhoids under local anaesthesia. A structured abstract is a lead, not an acceptance rate, and it is UK practice, not US.
claim 27unconfirmedUS
The single-use anoscope adds enough value, or removes enough reprocessing burden, that practices will not simply deploy the applicator through the reusable anoscope they already own
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed. The purchasing half routes to connectors adoption → unverifiable. One verified adjacent fact is recorded…the full check in the second-pass block below and is worth reading against this claim without being mistaken for it: a single-use anoscope carrying a hemorrhoid indication through grade III is already cleared and on the market (K250645, SleeveLUX 24/16, Haemoband Surgical, 2025-10-09, FER/876.1500). That establishes the position is occupied; it says nothing about whether a practice would choose it over a reusable instrument.
claim 28unconfirmedUS
Office practices that currently own their thermal instrument outright will accept a console-plus-disposable placement model
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed.connectors adoption → unverifiable by design; this is a purchasing-behaviour claim with no primary research…the full check behind it. It is also the same assumption as the Generator's own switching claim above, restated at the business-model level, and it inherits that claim's unchecked payment input.
claim 29unconfirmedUS
The obtainable segment bills 46930 in the non-facility office setting rather than in a facility, since the candidate's economics rest on the non-facility payment
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed. This is the one deck-surfaced viability claim that is genuinely connector-shaped — a facility-vs-non-facility…the full check site-of-service split is in the CMS Part B utilisation and payment files — and it is blocked only by missing cache files, not by licensing: procedures 46930 → unconfirmed ("No local cache at data/medicare_procedure_volumes.csv"), payment 46930 → unconfirmed ("No local cache at data/hcpcs_payment_rates.csv"). Attaching those two public CMS files would resolve it. Carry the standing caveat when it is resolved: Medicare FFS excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay.
claim 30unconfirmedUS
Commercial payers reimburse office hemorrhoid destruction at rates comparable to Medicare, which matters because this patient population is not predominantly Medicare-aged
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed, and structurally so. No connector in this repo reads commercial payer fee schedules at all — coverage serves…the full check Medicare NCD/LCD only, and it returned unconfirmed here anyway ("No local cache at data/medicare_coverage_policies.csv"). So even a fully populated data/ would leave this claim unanswered. It needs licensed commercial-rate data (or contracted rates) attached by a human. Note the claim is load-bearing precisely because it points at the gap the Generator identified: the disease skews younger than the Medicare population, so the Medicare rate the whole model is built on may not be the rate that matters.
claim 31unconfirmedUS
Impedance-based dosimetry can predict depth of thermal injury in hemorrhoidal submucosa closely enough to devascularise the pedicle while preventing injury to the sphincter complex or rectal wall
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed. No Stage 3 connector answers a bench-physics or thermal-dosimetry claim; this is settled by bench thermal-spread…the full check data and an animal sphincter-injury study at Stage 7, not by any lookup. Recorded as unchecked, not as implausible — the Verifier expresses no view on the physics.
claim 32unconfirmedUS
An applicator carrying integrated dosimetry electronics can be manufactured within the disposable cost the candidate's own economic claim allows
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed.connectors market → unverifiable ("has no free, authoritative, machine-queryable source"). Worse, the cost…the full check ceiling this claim is measured against is itself derived from the ~$158 non-facility payment figure that has never been checked against CMS, so both sides of the comparison are unverified. No COGS estimate was produced by the Verifier.
claim 33unconfirmedUS
A single treatment session at grade III produces durable devascularisation at a rate materially better than the existing office thermal modalities named in the procedure code descriptor
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed — and this is the claim the candidate's own scope note calls the whole premise. No Stage 3 connector answers a…the full check comparative-durability claim. Its comparator half also depends on the CPT 46930 descriptor, which is unverifiable (AMA-licensed), so "the modalities named in the descriptor" is not itself established. Non-verifying Stage 0 leads only, carrying no confidence tag: PMID=41024481 (propensity-matched RF vs hemorrhoidectomy, grades II-III, Thailand, n=102 after matching) and NCT07333040 (HELO trial, energy-based therapies vs conventional hemorrhoidectomy for grade III, recruiting). Structured abstracts and a registry record are not appraised evidence — no methods, no risk-of-bias, no result is asserted here. Read this against the grade-III predicate finding in the second-pass block below: no US predicate IFU for a bipolar/RF applicator extends past grade II, so this claim is simultaneously the commercial premise and the regulatory-evidence burden.
claim 34unconfirmedUS
No live, enforceable US patent covering office radiofrequency hemorrhoid treatment or impedance-controlled coagulation blocks this design
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-24) — never checked; recorded so the Verifier can see it [Verifier 2026-08-25]unconfirmed — UNEXAMINED, not clear, and the wording of this claim is dangerous. It is phrased as a negative FTO conclusion,…the full check which is exactly what no connector can produce. A control call to connectors patent returned unconfirmed: "PATENTSVIEW_API_KEY not set — request one at https://patentsview.org/apis/keyrequest before running Stage 3 IP checks." Zero patents were searched, no patent number is named in the claim, and no patent search engine or web query was substituted. The second pass adds a concrete reason this line is now more urgent, not less: named commercial estates in this exact space are no longer hypothetical — Covidien/Medtronic holds the HET Bipolar (K200146) and Barrx Anorectal RFA (K162802) clearances, and F Care Systems holds K253918/K210077/K130283. Those are assignee sweeps a human can actually run. Even a verified patent result would be a database fact about filing and grant dates, not an FTO opinion, which is Tier 3 at Stage 7.
claim 35verifiedUS
K253918 exists as claimed: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St), F Care Systems USA, LLC, decided 2026-06-02, product_code GEI, regulation 21 CFR 878.4400, decision Substantially Equivalent
jurisdiction: US — confidence: verified — source: openFDA device/510k k_number=K253918 (connectors 510k "Veineo System"; clearances --device-name "Veineo" --since 15y returns 1 of 1). The Stage 0 pointer is a real record and is confirmed at the database level.
claim 36unconfirmedUS
The load-bearing half: Veineo's cleared indication is venous, not anorectal, and does not name hemorrhoids. Indications for Use, verbatim from the subject-device section of the summary: "The Veineo System is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux. The devices are prescription use (Rx) devices." Its cited predicates are ClosureFast Radiofrequency Catheter (Medtronic, K111887) and CLOSURERFG Radiofrequency Generator (Covidien, K141858) — both endovenous; K111887's own IFU was read and is identical in scope ("endovascular coagulation of blood vessels in patients with superficial vein reflux")
jurisdiction: US — confidence: unconfirmed — source: FDA 510(k) summary K253918 (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253918.pdf); FDA 510(k) summary K111887 (https://www.accessdata.fda.gov/cdrh_docs/pdf11/K111887.pdf). clearance-summary K253918 --expect-indication "internal hemorrhoid" and…the full check--expect-indication "hemorrhoid" both returned unconfirmed on a phrase miss, not refuted — an IFU is free prose and whether a differently-worded indication supports a claimed predicate is an FDA substantial-equivalence judgement, not a database fact. Recorded as unconfirmed for exactly that reason. For the human making that judgement: a direct read of the full 11-page summary through the connector's own fetch path finds zero occurrences of "hemorrhoid", "haemorrhoid", "rectal", "proctoscope" or "anoscope" in the entire document, and one occurrence of "varicose" (the CR45iT catheter "can be inserted into the varicose vein using a 6F introducer"). What this does and does not mean: Veineo is not a hemorrhoid predicate on this record. It is not evidence that RAFAELO is uncleared in the US, and it is not whitespace.
claim 37verifiedUS
F Care Systems' complete US 510(k) portfolio is three clearances, all venous or aesthetic, none anorectal — K130283 "EVRF SYSTEM" (F Care Systems NV, 2013-03-07, product_code ONQ), IFU verbatim: "The EVRF System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation"; K210077 "MED RF 4000" (F Care Systems USA, LLC, 2021-12-17, ONQ), IFU verbatim: "The MedRF4000 System is intended for the epilation and for the treatment of lower limb spider vein or telangiectasia by thermocoagulation"; and K253918 Veineo above
jurisdiction: US — confidence: verified — note: each IFU returned verified on a no-phrase clearance-summary run — source: FDA 510(k) summaries K130283 (https://www.accessdata.fda.gov/cdrh_docs/pdf13/K130283.pdf) and K210077 (https://www.accessdata.fda.gov/cdrh_docs/pdf21/K210077.pdf); openFDA device/classification…the full check product_code=ONQ ("Electrosurgical Coagulation For Aesthetic", Class II, regulation 878.4400, panel SU). Direct reads of all three full summaries find zero occurrences of "hemorrhoid" across 25 pages of extractable text.
claim 38verifiedUS
Veineo and EVRF are one corporate family; whether either is the "RAFAELO" of the literature is not established in either direction. The K253918 clearance letter addresses the correspondent as "F Care Systems NV, Uitbreidingstraat 42-46, Berchem, Antwerp 2600, Belgium" — the same legal entity named as applicant on K130283 — and the K253918 substantial-equivalence table lists the subject device's manufacturer as "F Care Systems NV"
jurisdiction: US — confidence: verified — note: corporate-family link only — source: FDA 510(k) summary K253918, pages 1 and 3-4. The RAFAELO link itself is unconfirmed:510k "Rafaelo" → no record; 510k "Rafaelo" --applicant "F Care Systems", "RAFAELO System" and "CRA probe" → no record. **These are…the full check nulls on FDA's device-name string only.** The 2026-08-25 Stage 0 entry is right that a device-name null is not a finding that a system is uncleared in the US — and this pass produced the direct proof of that principle: the HET Bipolar and Barrx devices below carry internal-hemorrhoid and anorectal indications while carrying neither "hemorrhoid" nor "radiofrequency" in FDA's device-name field. No source in reach names the manufacturer of the RAFAELO system, so the identity question stays open. Asserted in neither direction.
claim 39unconfirmed
RAFAELO's EU/UK regulatory status (CE marking, MDR class, or any EU authorisation)
jurisdiction: EU — confidence: unconfirmed — source: none. connectors 510k "Rafaelo" --jurisdiction EU returned unconfirmed by design: *"No primary-source connector for jurisdiction 'EU'. 510k queries a US source only, so it cannot answer this claim — answering it from the US database would cite evidence…the full check about a different regulatory regime than the claim is about."* The clinical literature behind the RAFAELO signal is UK and Thai practice. Nothing in this repo can check it, and no US record was substituted for it. Recorded so a later reader does not mistake the US findings above for an answer about the EU device.
claim 40verifiedUS
A bipolar RF applicator cleared for internal hemorrhoids has a four-clearance US history under GEI / 21 CFR 878.4400 / SU panel — the frontmatter's lead route.K121085 "HET Bipolar Ligator System" (HET Systems, LLC, 2012-11-20, GEI), IFU verbatim: "The HET Bipolar Electrocautery Forceps and Monitor are intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The HET Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids. The accessory monitor provides power for a temperature sensor and an LED light source mounted on the disposable forceps."K140422 (HET Systems, LLC, 2014-06-05, GEI), IFU verbatim: "…is intended to be used for grasping, manipulating and coagulating soft tissue during general surgery. The HET Bipolar Electrocautery Forceps and Monitor may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids."
jurisdiction: US — confidence: verified — note: both clearance-summary … --expect-indication "hemorrhoid" runs returned verified, "The cleared indication contains 'hemorrhoid'" — source: FDA 510(k) summaries K121085 (https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121085.pdf) and K140422…the full check (https://www.accessdata.fda.gov/cdrh_docs/pdf14/K140422.pdf); openFDA device/510k k_number=K121085, K140422; openFDA device/classification product_code=GEI (Class II, regulation 878.4400, review panel SU). Checked against this candidate's stated intended_use: — "to coagulate and devascularise symptomatic grade II and grade III internal hemorrhoids in adults, delivered transanally through an anoscope without sedation" — this is the closest analogue in the file by mechanism (bipolar RF), by anatomy (internal hemorrhoids), by disposable applicator, and by setting. The panel is SU, not GU.
claim 41unconfirmedUS
The family's most recent clearance is Covidien's: K200146 "HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor" (Covidien, LLC, 2020-05-07, GEI), and the earliest is K110143 "HET Bipolar Electrocautery Forceps" (HET Systems, LLC, 2011-06-02, GEI, IFU: "intended to be used for grasping, manipulating and coagulating soft tissue during general surgery", hemorrhoids not named)
jurisdiction: US — confidence: unconfirmed — source: FDA 510(k) summary K200146 (https://www.accessdata.fda.gov/cdrh_docs/pdf20/K200146.pdf); openFDA device/510k k_number=K200146, K110143. clearance-summary K200146 --expect-indication "hemorrhoid" returned unconfirmed: the extractor selected the…the full check substantial-equivalence discussion block rather than the Indications-for-Use form, so the phrase check missed. Recorded as unconfirmed per the connector, not upgraded. For the human: a direct read of the same PDF through the connector's fetch path shows the standalone statement "Indications for Use: The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids", and the summary states the subject device "has the same intended use and the identical design as the legally marketed predicate device… (K140422)". The substance is already carried by K121085 and K140422, which returned verified.
claim 42verifiedUS
Grade III is the gap, and it is load-bearing. Every US 510(k) IFU located this pass for a bipolar/RF applicator treating internal hemorrhoids stops at grade II (K121085, K140422, K200146: "symptomatic Grade I and Grade II internal hemorrhoids"). The only located IFU extending to grade III is K030315, Ultroid Hemorrhoid Management System (KNS, 2003) — "coagulative hemostatic therapy of internal hemorrhoids grades I, [I]I, I[I]I, IV" — a different product code, a different panel and a 23-year-old device. This candidate's intended_use: claims grade II and grade III
jurisdiction: US — confidence: verified — note: as to the IFU texts; clearance-summary K030315 --expect-indication "internal hemorrhoids" was re-run independently this pass and returned verified — source: FDA 510(k) summaries K121085, K140422, K030315 (https://www.accessdata.fda.gov/cdrh_docs/pdf3/K030315.pdf).…the full checkWhether the grade-III half of this indication is supported by any available predicate is an FDA substantial-equivalence judgement, not a database fact, and is not resolved here in either direction. What is a fact is that the nearest-modality predicates are cleared two grades short of the indication the candidate's own scope note calls its entire premise, and that the one grade-III-covering IFU sits in a different code and panel. A human should read this as a live regulatory-strategy question — narrow to grade I-II and the nearest predicate matches exactly; keep grade III and the predicate story becomes a cross-code argument.
claim 43unconfirmedUS
Anorectal radiofrequency ablation is itself an established cleared device type under the same GEI code: K150251 and K162802, both "Barrx Anorectal RFA Wand" (Covidien, LLC, 2015-07-28 and 2017-01-24, GEI). K162802 IFU verbatim: "The Barrx Anorectal RFA Wand is indicated for use in the coagulation of bleeding and non-bleeding sites in the anal canal and rectum including, but not limited to, arteriovenous malformations, angiomata, angiodysplasia, radiation proctitis (RP), and anal intraepithelial neoplasia (AIN)" — hemorrhoids are not named
jurisdiction: US — confidence: unconfirmed — source: FDA 510(k) summaries K162802 (https://www.accessdata.fda.gov/cdrh_docs/pdf16/K162802.pdf) and K150251 (https://www.accessdata.fda.gov/cdrh_docs/pdf15/K150251.pdf); openFDA device/510k k_number=K150251, K162802. Both --expect-indication "hemorrhoid" runs returned…the full checkunconfirmed — K162802 on a genuine phrase miss (quoted above), K150251 because the extractor landed on a blank FDA Indications-for-Use form page; a direct read of K150251 gives the same indication minus AIN, with zero occurrences of "hemorrhoid" in the document. So this establishes that RF energy delivered in the anal canal is cleared device territory under GEI, and does not establish that it is cleared for hemorrhoids. Both readings matter and must not be collapsed.
claim 44verifiedUS
A single-use anoscope carrying a hemorrhoid indication through grade III is already cleared and recent: K250645, "SleeveLUX 24/16 Anoscope/Proctoscope" (Haemoband Surgical, Ltd., 2025-10-09, product_code FER, 21 CFR 876.1500), IFU verbatim: "SleeveLUX Anoscope/Proctoscope is a class 2 self-illuminating disposable instrument used to assist clinicians when treating and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids"
jurisdiction: US — confidence: verified — note: clearance-summary K250645 --expect-indication "hemorrhoid" → "The cleared indication contains 'hemorrhoid'" — source: FDA 510(k) summary K250645 (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250645.pdf). The first pass recorded disposable anoscopes as an established…the full check class but did not read this IFU. It is directly relevant to the candidate's single-use-anoscope premise: the position is occupied, by a hemorrhoid-ligation-adjacent firm, with an indication that already spans this candidate's grade band. It says nothing about whether practices would buy one — that half is unverifiable (see the deck claim above).
claim 45verifiedUS
Product codes and panels re-established independently this pass, each one openFDA device/classification record: GEI "Electrosurgical, Cutting & Coagulation & Accessories", Class II, 878.4400, panel SU; ONQ "Electrosurgical Coagulation For Aesthetic", Class II, 878.4400, panel SU; KNS "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)", Class II, 876.4300, panel GU; FHN "Ligator, Hemorrhoidal", Class II, 876.4400, panel GU; FER "Anoscope And Accessories", Class II, 876.1500, panel GU
jurisdiction: US — confidence: verified — source: openFDA device/classification, one record per product code. Both Ultroid records are KNS (openFDA device/510k k_number=K023706 and K030315). **Read together with the clearance evidence: both frontmatter candidate regulations are real and both have…the full check hemorrhoid-indication devices behind them — but the modality-matched, delivery-matched, recent precedent is 878.4400/GEI/SU, and the 876 evidence is a 2003 device (KNS) plus the ligator and anoscope accessories (FHN, FER).** None of this establishes this candidate's classification, which follows from the device plus its intended_use: and is an FDA determination, not a lookup.
claim 46refutedUS
The frontmatter predicate_or_analog position is wrong and must be rewritten by the Generator/Scorer. It reads: "The Generator did not identify a specific cleared device by K-number and is not naming one; 'no specific predicate identified' is the honest state of this field." As a statement about what the Generator did, that is still true; as the operative premise this file's Factor 1 and Factor 7 reasoning rests on — that no predicate has been identified, hence a possible De Novo and a different calendar — it is refuted. At least five US 510(k) records with Indications for Use naming internal hemorrhoids or the anal canal are now identified by K-number: K121085, K140422, K200146 (bipolar RF, grades I-II, GEI/878.4400/SU), K030315 and K023706 (Ultroid, grades I-IV, KNS/876.4300/GU)
jurisdiction: US — confidence: refuted — source: FDA 510(k) summaries K121085, K140422, K030315 as cited above; openFDA device/510k k_number=K121085, K140422, K200146, K030315, K023706. **This is the second pass's headline finding and it should be read as strengthening, not weakening, the candidate's regulatory…the full check position** — the "no predicate ⇒ De Novo" fork the file carries under Factor 7 has lost its premise. The De Novo route itself remains uncheckable: denovo "hemorrhoid radiofrequency" → unconfirmed, "No local cache at data/fda_denovo.csv… openFDA publishes no De Novo endpoint at all" — that null means nothing was searched and is not evidence that no De Novo grant exists.
claim 47unverifiedUS
The 25-year device_name:"hemorrhoid" clearance scan returns only four records — K131282 (Nexus Hemorrhoid Ligator, FHN, 2013), K083781 (EEA Hemorrhoid Stapler, GDW, 2009), K030315 and K023706 (Ultroid, KNS) — and the FHN code holds 7 clearances over 20 years, all ligators
jurisdiction: US — confidence: unverified — note: this is a Stage 0 clearances scan record, not a Verifier finding; a ScanResult carries no confidence tag and cannot acquire one, so this line is unverified in the only sense available to it and contributes to no factor — source: openFDA device/510k, `clearances…the full check --device-name "hemorrhoid" --since 25y and clearances --product-code FHN --since 20y`. Recorded only as the counter-example that anchors the reading rule: those four records exclude every bipolar RF and anorectal RFA device found this pass, because FDA's device-name field does not contain the word. A device-name null is a null about a string, never about a market.
claim 48unconfirmedUS
Proceduralists treating grade III internal hemorrhoids in the office today are doing so with devices whose cleared indications stop at grade II, or are referring those patients to surgery rather than treating them in the office
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (desirability deck, 2026-08-25) — never checked; recorded so the Verifier can see it. [Verifier 2026-08-29] This is a claim about current clinical practice patterns. connectors adoption → unverifiable (source_ref: none). Detail:…the full check "…asserts what clinicians, payers, or patients would do… No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)." No Verifier opinion about practice patterns was substituted. Permanently unconfirmed absent primary research.
claim 49unconfirmedUS
The HET Bipolar hemorrhoid product line (K121085, K140422, K200146) is actively marketed and sold into US offices today rather than discontinued
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-25) — never checked; recorded so the Verifier can see it. [Verifier 2026-08-29] Market status and vendor continuity are not database facts and have no connector. clearances --product-code GEI --since 5y (Stage…the full check 0 scan, no confidence tag) shows K200146 (Covidien, 2020) is recent, but market status ("actively marketed and sold") is a commercial fact, not a regulatory database fact. Permanently unconfirmed absent a vendor contact or industry report.
claim 50unconfirmedUS
No current holder of a cleared bipolar RF internal-hemorrhoid indication has a pending or announced product extending that indication to grade III internal hemorrhoids
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (viability deck, 2026-08-25) — never checked; recorded so the Verifier can see it. [Verifier 2026-08-29] This is a negative competitive fact about vendor pipeline. No connector answers announced products or pending submissions, which are…the full check proprietary or pre-disclosure. Permanently unconfirmed without a vendor contact or industry-research report.
claim 51unconfirmedUS
FDA will accept a 510(k) for a bipolar RF applicator indicated for grade II and grade III internal hemorrhoids on predicates whose own cleared indications stop at grade II, without requiring a De Novo or a clinical study
jurisdiction: US — confidence: unconfirmed — source: deck-surfaced assumption (feasibility deck, 2026-08-25) — never checked; recorded so the Verifier can see it. [Verifier 2026-08-29] This is an FDA regulatory-interpretation claim (how FDA will view substantial equivalence for a cross-indication argument).…the full checkconnectors regulation 876.4400 and 878.4400 (both re-verified 2026-08-29 per Verifier findings block) show the sections exist and are Class II with standard controls, but they do not and cannot answer "will FDA accept a 510(k) with this specific predicate-scope mismatch". That is a substantial-equivalence determination (an FDA judgement call at the time of submission), not a regulation text fact. Permanently unconfirmed; settles at Stage 7 pre-submission meeting or Stage 8 decision.
claim 52verifiedUS
The HET Bipolar Electrocautery Forceps/Monitor's cleared indication (K121085, K140422, K200146) is limited to symptomatic Grade I and Grade II internal hemorrhoids and does not extend to Grade III
jurisdiction: US — confidence: verified — source: FDA 510(k) summary K121085 (https://www.accessdata.fda.gov/cdrh_docs/pdf12/K121085.pdf); openFDA device/510k (connectors clearance-summary K121085 --expect-indication "internal hemorrhoid" → verified; IFU verbatim: "The HET Bipolar Electrocautery Forceps and Monitor…the full check may be used for the treatment of symptomatic Grade I and Grade II internal hemorrhoids"). Grade II limit confirmed; grade III not mentioned.
claim 53verifiedUS
The Ultroid Hemorrhoid Management System (K030315) is the only located US 510(k) predicate for hemorrhoidal coagulation whose cleared indication spans internal hemorrhoids grades I through IV, including grade III
jurisdiction: US — confidence: verified — source: FDA 510(k) summary K030315 (https://www.accessdata.fda.gov/cdrh_docs/pdf3/K030315.pdf); openFDA device/510k (connectors clearance-summary K030315 --expect-indication "internal hemorrhoid" → verified; IFU verbatim: "The Ultroid Hemorrhoid Management system is intended…the full check for physician use only. It is intended for coagulative hemostatic therapy of internal hemorrhoids grades I, II, III, IV"). Grade I-IV span confirmed. Qualifier "only located" cannot be verified in the absolute but is consistent with Verifier's own field search (second-pass findings, line 142).
claim 54unconfirmedUS
Ultroid Technologies, Inc.'s Ultroid Hemorrhoid Management System line, including its sterile disposable probes sold individually, was subject to an FDA recall initiated 2016-10-19 for failure to maintain a state of control under 21 CFR 820 Quality System Regulation, status Terminated
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §5 (2026-08-27) — primary source: FDA device recall Z-0785-2017 (related 510(k)s K023706, K030315) — evidence class 1 (registry fact); not independently checked — Verifier to confirm against…the full check the primary source. [Verifier 2026-08-29] The recall ID and related K-numbers are cited as evidence class 1 (registry fact). recalls connector does not accept recall-ID lookup (--product-code and date-range filters only); python3 -m connectors recalls --product-code KNS --since 25y (Ultroid's product code per clearance records) would cover a broad search but return no targeted result for a specific recall ID. Recorded unconfirmed because the FDA device recall Z-0785-2017 identifier cannot be looked up through available connectors. This fact would need to be verified by direct access to the FDA device recall database or a human-attached document citing the recall by ID.
claim 55verifiedUS
A single-use disposable anoscope (SleeveLUX 24/16, K250645, Haemoband Surgical, Ltd., cleared 2025-10-09) already carries an FDA-cleared indication spanning 1st, 2nd, and 3rd degree hemorrhoids
jurisdiction: US — confidence: verified — source: FDA 510(k) summary K250645 (https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250645.pdf); openFDA device/510k (connectors clearance-summary K250645 --expect-indication "hemorrhoid" → verified; IFU verbatim: "SleeveLUX Anoscope/Proctoscope is a class 2…the full check self-illuminating disposable instrument used to assist clinicians when treating and/or diagnose conditions in the anal canal and the lower rectum such as 1st 2nd and 3rd degree hemorrhoids"). All claimed facts verified: device name, K-number, applicant, date, and grade I-II-III indication.
claim 56verifiedUS
Rubber band ligation devices are regulated under product code FHN (21 CFR 876.4400, Ligator, Hemorrhoidal), a 510(k)-exempt device type subject to the limitations in 21 CFR 876.9
jurisdiction: US — confidence: verified — source: eCFR versioner title-21, issue 2026-08-27, section=876.4400 (connectors regulation 876.4400 --title 21 --expect "Ligator" → verified; text: "§ 876.4400 Hemorrhoidal ligator... Class II (special controls)... Except for a hemostatic metal clip intended for use in the…the full check gastrointestinal tract, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9"); openFDA device/classification product_code=FHN. All claimed facts verified: product code, regulation section, device category, and 510(k)-exempt status with § 876.9 limitation language.
claim 57unconfirmedUS
Under the CY2026 CMS Physician Fee Schedule, HCPCS codes 46930, 46945, and 46946 each carry a 90-day global surgical period
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §6 (2026-08-27) — primary source: CMS PFS Indicators for 2026 (pfs.data.cms.gov, dataset 7c7df311-5315-4f38-b9ed-fd62f8bebe11), HCPCS 46930/46945/46946, global field — evidence class 1…the full check (registry fact); not independently checked — Verifier to confirm against the primary source. [Verifier 2026-08-29] The CMS PFS Indicators dataset is a public, code-number-keyed source and is connector-checkable in principle, but the required cache file is missing. python3 -m connectors payment 46930/46945/46946 → all returned unconfirmed: "No local cache at data/hcpcs_payment_rates.csv". The 90-day global period is a column in the CMS PFS Relative Value File (GLOB DAYS), which is not cached in data/ and has no dedicated connector. Recorded unconfirmed because the cache file is missing; this fact is cheaply resolvable once data/hcpcs_payment_rates.csv is populated by a human from pfs.data.cms.gov with the global field included.
claim 58unconfirmedUS
Under the CY2026 CMS Physician Fee Schedule, the non-facility (office) total RVU for HCPCS 46930 (7.42) is higher than its facility total RVU (4.72), meaning the non-facility payment amount is the larger of the two settings, not the smaller
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §6 (2026-08-27) — primary source: CMS PFS Indicators for 2026 (pfs.data.cms.gov, dataset 7c7df311-5315-4f38-b9ed-fd62f8bebe11), HCPCS 46930 — evidence class 1 (registry fact); not…the full check independently checked — Verifier to confirm against the primary source. [Verifier 2026-08-29] Same constraint as line 153: python3 -m connectors payment 46930 → unconfirmed: "No local cache at data/hcpcs_payment_rates.csv — payment rate for 46930 cannot be checked until it exists." The specific RVU values (7.42 non-facility vs 4.72 facility) cannot be verified without the cache file. Important note: This is commercially load-bearing — the claim correctly points out that non-facility RVU is higher than facility RVU, which reverses the common assumption that office-based care is cheaper to bill. Recorded unconfirmed because the cache file is missing; resolves on population of data/hcpcs_payment_rates.csv with non-facility and facility RVU columns separated.
claim 59unconfirmedUS
In a randomized, multicenter, noninferiority trial of grade III internal hemorrhoids, rubber band ligation was not noninferior to hemorrhoidectomy on 12-month quality-adjusted life years, with a 12-month recurrence rate of 47.5% for rubber band ligation versus 6.1% for hemorrhoidectomy (n=87, 47 vs 40)
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §5 (2026-08-27) — primary source: PMID 39952268 / NCT04621695 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who…the full check did not draft this. [Verifier 2026-08-29]python3 -m connectors literature-detail 39952268 → found (abstract retrieved). Title: "Comparison of Rubber Band Ligation and Hemorrhoidectomy in Patients With Symptomatic Hemorrhoids Grade III: A Multicenter, Open-Label, Randomized Controlled Noninferiority Trial" (Diseases of the Colon and Rectum, 2025). Abstract confirms all cited numbers: "Rubber band ligation was not noninferior to hemorrhoidectomy in quality-adjusted life years (-0.045; 95% CI, -0.087 to -0.004). Recurrence rate was worse in the rubber band ligation group (47.5% vs 6.1%), with an absolute risk difference of 41% (95% CI, 24%-59%). [Eighty-seven patients were randomly assigned (47 rubber band ligation vs 40 hemorrhoidectomy)]." Numbers match exactly. Recorded unconfirmed per Stage 3 rules: literature-detail returns findings without confidence tag, and published claims need expert appraisal including methods, risk-of-bias, and applicability — which is Stage 7 work, not Stage 3. The abstract is a lead confirming the source exists and the numbers are present; full appraisal is deferred to Stage 7.
claim 60unconfirmedUS
In a single-centre cohort undergoing multi-band single-session endoscopic rubber band ligation, the overall recurrence rate was significantly higher for grade III internal hemorrhoids (32.8%) than for grade I-II (14.6%) at a median follow-up of 14.3 months
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §5 (2026-08-27) — primary source: PMID 37059872 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who did not draft…the full check this. [Verifier 2026-08-29]python3 -m connectors literature-detail 37059872 → found (abstract retrieved). Title: "Comparison of the long-term efficacy and safety of multiple endoscopic rubber band ligations in a single session for varying grades of internal hemorrhoids" (Irish Journal of Medical Science, 2023). Abstract confirms cited numbers: "The overall recurrence rate was 25.0%, with grade III significantly higher than grade I-II (32.8% vs 14.6%, P = 0.027)." and "The median follow-up time was 14.3 ± 7.9 (1.3-30.9) months." Numbers match exactly. Recorded unconfirmed per Stage 3 rules: findings found but expert appraisal including methods, bias, and applicability deferred to Stage 7.
claim 61unconfirmedUS
A network meta-analysis of 79 randomized controlled trials (n=9,232) in grade II-III haemorrhoids found closed hemorrhoidectomy had the lowest symptom-recurrence risk of 14 treatments compared, while open and closed hemorrhoidectomy and stapled hemorrhoidopexy had the highest rates of postprocedural bleeding, urinary retention, and bowel incontinence
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §5 (2026-08-27) — primary source: PMID 34633439 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who did not draft…the full check this. [Verifier 2026-08-29]python3 -m connectors literature-detail 34633439 → found (abstract retrieved). Title: "Interventional treatments for prolapsing haemorrhoids: network meta-analysis" (BJS Open, 2021). Abstract confirms: "Seventy-nine RCTs were identified, including 9232 patients... Closed haemorrhoidectomy had the lowest recurrence risk... Open haemorrhoidectomy had the greatest risk of postprocedural bleeding, followed by stapled haemorrhoidopexy and closed haemorrhoidectomy. [Open haemorrhoidectomy and stapled haemorrhoidopexy had significantly higher odds of urinary retention] and [had the highest probability of bowel incontinence]." All cited facts present in abstract. Recorded unconfirmed per Stage 3 rules: found and numbers verified, but full appraisal including heterogeneity assessment and summary-of-findings grade deferred to Stage 7.
claim 62unconfirmedUS
In a retrospective comparison of grade II/III internal hemorrhoids, a modified rubber band ligation technique reduced delayed massive bleeding (0 of 149 vs 5 of 125 cases) and 3-month recurrence (5.4% vs 13.6%) compared to conventional rubber band ligation
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §5 (2026-08-27) — primary source: PMID 35725452 — evidence class 2 (published finding); not independently checked — needs a cold re-retrieval of the cited source by someone who did not draft…the full check this. [Verifier 2026-08-29]python3 -m connectors literature-detail 35725452 → found (abstract retrieved). Title: "Modified rubber band ligation for treatment of grade II/III hemorrhoids: clinical efficacy and safety evaluation-a retrospective study" (BMC Surgery, 2022). Abstract confirms: "[A total of 274 patients were enrolled, including] 149 patients treated with modified RBL and 125 treated with conventional RBL... Five cases of postoperative DB have been observed in the conventional RBL group, compared to none in the modified ones (0 of 149 vs 5 of 125). [Within three months after surgery,] 8 cases in the modified RBL group experienced a recurrence rate of 5.4%, whereas 17 patients in the conventional RBL group experienced a recurrence rate of 13.6%." All cited numbers match exactly. Recorded unconfirmed per Stage 3 rules: found and numbers verified, but selection bias in retrospective design and generalizability require expert appraisal at Stage 7.
claim 63unconfirmedUS
Proceduralists would switch from an owned reusable rubber-band-ligation or infrared-coagulation instrument to a per-case disposable RF applicator and single-use anoscope combination, on the basis of the grade-III recurrence gap documented in claims 59 and 60
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §9 (2026-08-27) — evidence class 3 (stakeholder future); no source can settle this — see docs/research-lane-spec.md §3.1 and rescope to the revealed-behaviour twin if one exists. **[Verifier…the full check 2026-08-29]** python3 -m connectors adoption "Proceduralists would switch from owned instruments to per-case disposables" → unverifiable (source_ref: none). Detail: "…asserts what clinicians, payers, or patients would do. No free, authoritative, machine-queryable source answers that — it needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." This is a class 3 (stakeholder future) claim and is permanently unconfirmed by design. No Verifier opinion about what proceduralists would do was produced.
claim 64unconfirmedUS
Patients would accept an office radiofrequency procedure without sedation at the same rate they currently accept rubber band ligation or infrared coagulation
jurisdiction: US — confidence: unconfirmed — source: research lane, from dossier internal-hemorrhoids-office-based-treatment §9 (2026-08-27) — evidence class 3 (stakeholder future); no source can settle this — see docs/research-lane-spec.md §3.1 and rescope to the revealed-behaviour twin if one exists. **[Verifier…the full check 2026-08-29]** python3 -m connectors adoption "Patients would accept office RF procedure at same rate as existing modalities" → unverifiable (source_ref: none). Detail: "…asserts what clinicians, payers, or patients would do… needs primary research (interviews, survey, published preference study)... Do NOT substitute a model's own estimate of stakeholder behaviour: a synthetic stakeholder opinion is a fabricated claim." This is a class 3 (stakeholder future) claim and is permanently unconfirmed by design. No Verifier opinion about patient acceptance was produced.
claim 65unverifiedUS
A contract-manufacturing quote for the single-use bipolar RF applicator with integrated impedance-dosimetry electronics, at commercial launch volumes, yields a landed cost that leaves margin under the price ceiling the candidate's own economic claim implies.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 66unverifiedUS
The RF console (generator plus impedance-dosimetry control unit) can be placed into a purchasing practice at little or no upfront capital cost, recovered through the disposable-applicator margin on a razor-and-blade model.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 67unverifiedUS
A colorectal surgery, gastroenterology, or proctology practice performs enough qualifying grade II-III procedures per year that one placed console reaches consumable-margin payback within a normal capital-equipment payback window.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 68unverifiedUS
The number of practices adopting the device by year 3-5 is large enough, at the pace of a comparable single-specialty office-device launch, to reach the 15-25% addressable-share figure inside the candidate's own five-year window.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 69unverifiedUS
The lag between 510(k) clearance and the first paid consumable order -- sales cycle, distributor onboarding, and any GPO or health-system contracting -- is short enough to finance inside a normal launch runway.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 70unverifiedUS
The cost and calendar to build a sales and distribution channel into colorectal surgery, gastroenterology, and proctology practices, separate from the clearance spend, is affordable within a launch budget.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 71unverifiedUS
The impedance-dosimetry control module can be qualified for integration into an already-cleared bipolar RF or anorectal applicator, as a licensing or OEM route, without triggering a new full 510(k) for the host device.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it
claim 72unverifiedUS
A US comparative study large enough to demonstrate that a single office RF session at grade III reduces escalation to surgical hemorrhoidectomy, relative to rubber band ligation, is affordable and can be run in a useful calendar.
jurisdiction: US — confidence: unverified — source: business-case assumption (2026-09-03) — never checked; recorded so the Verifier can see it