idea-008 · human · wrapped
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 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. A single-use device for treating internal haemorrhoids in a doctor's office rather than an operating theatre. Haemorrhoids that keep bleeding after diet and ointments are usually treated in the office by strangling them with a rubber band or burning them with heat; the larger ones come back about half the time, and the alternative is surgery with a slow, painful recovery. This is a disposable applicator that delivers radiofrequency energy to shut off the blood supply, with a sensor that measures the tissue as it heats and stops automatically at the right depth — the point being to treat the larger grade III haemorrhoids consistently enough that they do not come back, without cutting anything. It ships with its own single-use scope, and the whole kit is priced to fit inside what insurers already pay for the office procedure.
What would have to be true, quoted from each deck's load-bearing condition:
Cheapest next test: Restore the CMS cache files and re-run the ten hcpcs, payment, procedures and coverage lookups blocked on them. The file's own Unresolved-claims analysis groups these as "(b) Blocked only by a missing data/ cache — cheapest to fix, human-supplied". Selected from that grouping; this is a selection from the gap analysis, not a new judgement, and not a view about the idea. Two things a reader should know about it. The caches were populated on 2026-08-30 and used to re-verify nine claims on idea-001 the same day — this candidate was never re-run against them, so this is a scheduled pass rather than an open question. And the other half of the decisive subtraction is not a lookup at all: a contract-manufacturing quote against the applicator specification, which three successive builds of this candidate's decks have now named as the most neglected item in the file, and which involves no external party.
Where the evidence actually stands. 16 of 64 claims verified, 44 unconfirmed, 3 refuted, 1 unverified — the best-evidenced candidate in the portfolio by verified count. All 9 factors carry a score in the Stage 2 triage table and all 4 core factors do.
Read that count carefully, because it is the most misleading number in this packet. All sixteen verified claims are regulatory-database facts about what somebody else was permitted to sell: the classification and product code [claim 16: verified], [claim 17: verified], [claim 45: verified], the modality's four-clearance history under GEI [claim 40: verified], the grade scope of every nearby indication read verbatim [claim 42: verified], [claim 52: verified], a predicate with checked Indications for Use [claim 20: verified], the disposable anoscope class and a recent cleared product in it [claim 44: verified], [claim 55: verified], and rubber band ligation as a separately regulated class [claim 56: verified]. Not one is about money, and not one says the control algorithm works. No payment level, no procedure volume, no price, no share, and no patent has ever been verified here. A high verified count is a well-mapped position, not a strong one.
Three refuted claims are corrections rather than kills, and two of them are good news: the "no predicate identified, therefore possibly a De Novo" premise is [claim 46: refuted] with five predicates now named by K-number, and the reading that the panel question had moved against the frontmatter is [claim 19: refuted]. The third, [claim 23: refuted], covers only the "nothing found in openFDA" half — no product code for this device itself has been established, and that half is still open. One claim, the 25-year hemorrhoid clearance scan, has never been put to a Verifier at all [claim 47: unverified].
Eight claims were added by the research lane since 2026-08-25 and none moved a tag, but they changed the case materially and in the candidate's favour on three points a Stage 6 reader should have.
The clinical gap is measured. At grade III, rubber band ligation was not noninferior to hemorrhoidectomy on 12-month quality-adjusted life years, with 47.5% recurrence against 6.1% [claim 59: unconfirmed]; within office ligation, grade III recurrence was 32.8% against 14.6% at grade I-II [claim 60: unconfirmed]. The alternative that works carries the cost this device exists to avoid — across 79 randomized trials (n=9,232), hemorrhoidectomy had the lowest recurrence but the highest rates of postprocedural bleeding, urinary retention and bowel incontinence [claim 61: unconfirmed].
The billing rule the whole commercial logic depends on now has a source, and it points the right way. Under the CY2026 CMS Physician Fee Schedule, 46930, 46945 and 46946 each carry a 90-day global surgical period [claim 57: unconfirmed] — so re-treating a recurrence inside three months is work the physician has already been paid for, which makes durability the physician's own financial interest. The previous build named the inversion of this rule as the thing that would "dissolve the durability pitch this business is built on". And the office is the higher-paying setting, not the lower one: non-facility total RVU 7.42 against facility 4.72 [claim 58: unconfirmed].
Grade III is the only unoccupied ground, and it is where the unmet need demonstrably is. Every located bipolar/RF indication stops at grade II [claim 42: verified], [claim 52: verified]; the only grade-III-spanning predicate is a 2003 device in another panel [claim 53: verified], whose current commercial status is unchecked [claim 54: unconfirmed].
Three cautions against reading that as a clear run. The incumbent modality is improving without new hardware — a modified ligation technique reported 3-month recurrence of 5.4% against 13.6% and eliminated delayed massive bleeding, 0 of 149 cases against 5 of 125 [claim 62: unconfirmed] — so the gap this candidate aims at may narrow on its own. Both stakeholder questions are now formally recorded as evidence class 3, with the file stating that no source can settle them: whether proceduralists would switch [claim 63: unconfirmed] and whether patients accept an unsedated RF procedure [claim 64: unconfirmed]. And FTO is unexamined rather than clear [claim 11: unconfirmed], [claim 34: unconfirmed] — zero patents searched, on the rubric's one automatic-kill factor, in a field whose parties are now precisely named. That asymmetry is the sharpest thing in this packet: the best-evidenced regulatory position in the knowledge base sits alongside a gate-relevant factor nobody has looked at once.
| Intended use | For use by a physician in an office setting to coagulate and devascularise symptomatic grade II and grade III internal hemorrhoids in adults, delivered transanally through an anoscope without sedation, in patients who have failed conservative medical management. |
|---|---|
| Mechanism | Bipolar radiofrequency energy delivered to the submucosal pedicle of an internal hemorrhoid through a disposable applicator with integrated impedance-based dosimetry and automatic cutoff, deployed through a single-use anoscope, in the office without sedation |
| Device class | # Two candidate regulations, and which panel FDA reads this into; Class II — 21 CFR 878.4400 (electrosurgical cutting and coagulation device and; accessories), general and plastic surgery panel — 510(k) — launch designation. The; Generator believes this is the regulation but did not confirm it, and the product code; was not identified.; Class II — 21 CFR Part 876 (gastroenterology-urology devices), regulation number not; identified — plausible alternative route, since an anorectal applicator delivered; through an anoscope may be read into the GI panel rather than the general-surgery one.; Carried because the two panels can differ in special controls and in which predicates; are available, and because the Generator cannot tell which applies. |
| Predicate or analog | Existing thermal office treatments named by the CPT 46930 descriptor itself; — infrared coagulation, cautery, radiofrequency. Adjacent: bipolar office; devices for hemorrhoids and rubber-band ligation systems. 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. |
| Launch jurisdiction | US |
| Target | human |
| Factor | Score | What would settle it |
|---|---|---|
| Regulatory pathway | 2 | python3 -m connectors regulation 878.4400 --expect "electrosurgical cutting and coagulation" to confirm the section says what the Generator thinks; python3 -m connectors classification --device-name "hemorrhoid coagulation" and…the rest of this gap analysis--device-name "anoscope" to recover the actual product code(s) and owning panel; then python3 -m connectors 510k "<product-code device name>" to find a real predicate K-number, and python3 -m connectors clearance-summary K<number> --expect-indication "internal hemorrhoid" to confirm the predicate's Indications for Use actually covers grade II-III internal hemorrhoids in an office setting. Until a K-number exists this factor cannot rise. |
| Reimbursement pathway | 3 | CPT descriptor text (46930/46945/46946) and the one-unit-per-session rule are AMA-licensed — python3 -m connectors cpt 46930 returns unverifiable by design and must not be cited as a check. Settling them requires a human to attach…the rest of this gap analysisa licensed source: AMA CPT Professional 2026 codebook page for 46930/46945/46946, or a licensed vendor feed (AMA CPT API, Optum EncoderPro, Find-A-Code) recorded as a manual citation. Publicly checkable in parallel, code-number-keyed and license-free:python3 -m connectors payment 46930 (needs the CMS PFS non-facility rate loaded into data/hcpcs_payment_rates.csv with schedule marked PFS non-facility — confirm the schedule field, since PFS vs OPPS vs ASC differ); the 90-day global period from the CMS PFS Relative Value File GLOB DAYS column; the CCI bundling claim from the CMS NCCI PTP quarterly edit-pair file (public, no connector — a Scout download into data/); and python3 -m connectors coverage / a named Medicare LCD for hemorrhoid destruction to establish coverage, which no claim in this file currently asserts. |
| TAM | 2 | python3 -m connectors procedures 46930, procedures 46945, procedures 46946 — these are code-number-keyed CMS Part B utilisation lookups and are legally runnable (no CPT descriptor is reproduced). **Read the result as a Medicare-only…the rest of this gap analysisfloor on US volume, never as TAM:** it excludes Medicare Advantage, commercial, Medicaid, VA and cash-pay, and hemorrhoid disease skews younger than the Medicare population, so it understates the commercial market by an unknown factor. Price and share are not connector-checkable —python3 -m connectors market returns unverifiable; they need a licensed industry report (e.g. an iData/Grand View anorectal-devices report) attached by a human, plus a proctology/colorectal practice-count denominator, to move. |
| FTO / IP | 1 | A real search first — CPC A61B18/12 and A61B17/12 restricted to hemorrhoid/anorectal RF and impedance-feedback electrosurgical control, run by a human or Scout in Patents Public Search / Espacenet — to produce candidate numbers. Then each…the rest of this gap analysiscandidate number throughpython3 -m connectors patent US<number> for family, status and expiry. Assignee sweeps on the incumbent office-device and banding-system manufacturers should be part of the same pass. Only a named, checked set of patents can move this factor in either direction; a Tier 3 legal FTO opinion (Stage 7) is what would settle it definitively. |
| Moat / defensibility | 1 | This factor cannot be settled by a lookup — it resolves as a by-product of the FTO/IP search: filed or filable claims on the dosimetry algorithm and applicator geometry (Patents Public Search, then connectors patent) are the only thing…the rest of this gap analysisthat converts the asserted moat into an asset. Secondary:python3 -m connectors clearances --product-code <code once identified> --since 5y to see how quickly comparable office thermal devices have been cleared by followers, as a direct read on copyability. |
| Mechanism & clinical risk | 3 | python3 -m connectors literature "radiofrequency ablation internal hemorrhoids" --since 5y then literature-detail <PMIDs> for recurrence and complication rates at grade III specifically; `python3 -m connectors trials --condition…the rest of this gap analysis"hemorrhoids" --intervention "radiofrequency" then trial-detail <NCT> for endpoints and follow-up duration actually being used in the field; python3 -m connectors recalls --product-code <code once identified>` for the real-world thermal-injury signal on comparable office devices. Note these are Stage 0 scans and return no confidence tag — they point at evidence, they do not verify the claim. Definitive answer is bench thermal-spread and animal sphincter-injury data (Stage 7). |
| Capital intensity & time-to-revenue | 3 | Depends on Factor 1 resolving first: python3 -m connectors 510k to establish a predicate exists (or python3 -m connectors denovo "hemorrhoid radiofrequency" if it does not), since the clearance-vs-De Novo fork drives both cost and…the rest of this gap analysiscalendar. Then the special controls in the identified regulation viapython3 -m connectors regulation <section> to scope the required bench/animal package. The commercial-evidence half is settled by trial-detail reads on comparable durability studies (size, duration, cost proxy) plus a Tier 3 human budget estimate — not by any connector. |
| Competitive intensity | 1 | python3 -m connectors clearances --product-code <code once identified> --since 5y and --device-name "hemorrhoid" for who has cleared what recently; python3 -m connectors recalls --product-code <code> for incumbent trouble. The…the rest of this gap analysiscompetitor-count half of this is answerable once Factor 1 yields a product code. The adoption/switching half is not:python3 -m connectors adoption returns unverifiable by design, so physician purchasing behaviour needs licensed primary research (a commissioned proctology/colorectal practice survey, or a licensed market report) attached by a human. Do not let a clean clearances result stand in for it. |
| Strategic fit & portfolio balance | 2 | Not a connector question and not an agent question. Settled by a Tier 3 human portfolio statement at Stage 6 review (## Human Review Notes) — current portfolio composition, target hero-bet/spoke ratio, and appetite for consumable-margin…the rest of this gap analysisbusinesses.knowledge-base/calibration-log.md would be the evidence base for scoring this factor systematically, and it is currently empty; that emptiness is information, not an obstacle to route around. |
All six wrap criteria are met.
Domain dossier: internal-hemorrhoids-office-based-treatment
Source file: knowledge-base/candidates/idea-008.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.