idea-013 · human · queued-research
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. What this is, who it is for, and what it is coded to — in plain language, no rubric vocabulary. Someone who has never opened this repo should be able to read this and know what the product is.
What would have to be true. One line per lens, quoted verbatim from that deck's load-bearing condition. Do not summarise or re-rank them.
Cheapest next test: <the single piece of evidence that would move this candidate most, what it would cost, and who would have to do it. Take it from the Scores table's "What would settle it" column — this is a selection from that gap analysis, not a new judgement. One sentence.>
Where the evidence actually stands. State the coverage plainly, including what is blocked on tooling rather than on a finding — a missing CMS cache file and an unset PATENTSVIEW_API_KEY are not evidence that a code or a patent does not exist. Run python3 engine/scripts/wrap_status.py --candidate idea-XXX for the numbers.
| Intended use | An external, patient self-inserted and self-removed one-way valve and; low-profile drainable cap, seated at the stoma orifice and mucocutaneous junction, for; use by adults with a mature (post-healing, uncomplicated), non-surgically-reconstructed; ileostomy, as an alternative to continuous-wear adhesive ostomy pouching systems for the; collection and periodic voluntary evacuation of ileostomy effluent in a home setting. |
|---|---|
| Mechanism | A soft, flanged silicone one-way (duckbill/slit) valve, sized to the individual; stoma and seated at the stoma orifice and mucocutaneous junction (not advanced into the; proximal small bowel), retained by a low-profile external collar rather than adhesive; wafer alone. Effluent passes through the valve into a small, flush, low-profile external; cap/reservoir which the patient empties by unclipping or draining several times a day,; rather than wearing a continuously-filling adhesive pouch. The device is mechanical and; non-absorptive — it does not rely on absorbing or gelling liquid stool inside the bowel.; Patient self-inserts and self-removes the valve daily or per manufacturer instructions,; analogous in handling to a continent-ileostomy catheter but applied to a standard; (non-surgically-reconstructed) ileostomy. |
| Device class | # Three carried routes; none confirmed. The central open question; Class II — De Novo pathway, regulation not yet created — the route that applies if FDA; finds no substantially equivalent predicate for a non-surgical, patient-removable; indwelling stoma valve. Carried as the most likely route given claims 1-2 below.; Class I — 21 CFR 876.5030 (Continent ileostomy catheter) — repositioning route; regulation and exemption text confirmed to exist by web search (see claim 1), NOT; confirmed to read on a device used with a standard (non-surgically-modified, non-Kock-; pouch) ileostomy rather than post-continent-ileostomy-surgery drainage; Class I — 21 CFR 876.5900 (Ostomy pouch and accessories) — repositioning route for the; external low-profile cap/reservoir component only, NOT the valve-insert component; regulation, exemption, and product codes (EXB/EZQ/EZS) confirmed to exist by web search; (see claim 2), NOT confirmed to cover a device with an indwelling valve element |
| Predicate or analog | No cleared 510(k) or De Novo predicate for this exact device shape; (a non-surgical, patient-removable indwelling valve for a standard ileostomy) was; identified by the Generator — stated plainly rather than naming one that does not exist.; The closest classification analogs found are 21 CFR 876.5030 (continent ileostomy; catheter, Class I, exempt) and 21 CFR 876.5900 (ostomy pouch and accessories, Class I,; exempt) — neither's plain-language scope squarely matches this device, which is exactly; the open Factor 1 question (see claims 1-2). Historical academic (non-cleared) analogs:; a 1980 published "indwelling ileostomy valve device" using a Silastic tube with a; circumferential balloon (PMID 7457715), and the surgical continent-ileostomy nipple valve; literature generally — neither is a regulatory predicate, both are mechanism precedent. |
| Launch jurisdiction | US |
| Target | human |
| Factor | Score | What would settle it |
|---|---|---|
| Regulatory pathway | 2 | Direct FDA classification/510(k)/De Novo database query (openFDA classification connector) for indwelling stoma-valve devices; CFR-connector confirmation of 876.5030's actual scope; ideally an FDA pre-submission (Q-sub) |
| Reimbursement pathway | 1 | CMS HCPCS/DMEPOS connector lookup confirming no existing code covers this device; a coding consultant assessment of miscellaneous-code (e.g. A9999) billing vs. a new-code petition path |
| TAM | 2 | CMS DMEPOS claims-volume data for A4361–A4438 broken out where possible; a primary, ileostomy-specific epidemiological dataset rather than UOAA public materials or an aggregator report |
| FTO / IP | 2 | Full claims-scope, assignee, and expiration-date reading of US 11,395,757 B2 via a patent connector (e.g. PatentsView); a formal FTO clearance opinion from patent counsel |
| Moat / defensibility | — | A technical/manufacturing-complexity assessment of the valve+cap assembly; a review of how quickly analog devices (e.g. continent-ileostomy catheters) have been copied once cleared |
| Mechanism & clinical risk | 2 | Full-text read of PMID 7457715 for methodology/safety detail; a bench prototype plan (leak, occlusion, retention-collar irritation testing) per Stage 7 diligence |
| Capital intensity & time-to-revenue | 2 | Outcome of an FDA pre-submission (Q-sub) to resolve pathway; a contract-engineering estimate for prototype/bench-validation cost and calendar time |
| Competitive intensity | 3 | openFDA 510(k)/De Novo connector search for any recently cleared or granted stoma-valve/ostomy-cap device; a clinicaltrials.gov check on InterPoc's development stage |
| Strategic fit & portfolio balance | — | An internal portfolio review classifying this as hero bet vs. cash-generative spoke against current holdings — not a connector-checkable item |
To finish this packet:
domains: — run /research**Cheapest next test:** is still the unfilled _template.md placeholder — name the test, or the criterion checks nothingDomain dossier: none linked
Source file: knowledge-base/candidates/idea-013.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.