idea-008 · feasibility deck
Every slide states a condition that would have to be true, then reports where it stands using the candidate file's own claim and its own confidence tag. A deck never upgrades a tag, invents a number, or recommends anything, and there is no ask slide.
The chair: the engineers who have to devascularise a grade III pedicle with radiofrequency energy, stop before the sphincter, put the electronics that decide when to stop inside a disposable, and then get the kit cleared.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-008.md. The number is the claim's position in its ## Claims list, and the tag is copied from that line and never adjusted here. A [no claim] marker means nothing in the file speaks to the condition at all. Where this deck needed a condition the file did not carry, it appended the condition to the file as an unverified claim before this deck was written, so the Verifier can see it. See docs/deck-spec.md.
What the 2026-09-29 Verifier pass changed for this chair: one tag moved. The 25-year hemorrhoid clearance scan is now claim 47unconfirmed, because a scan returns counts and no check connector can confirm a count. The De Novo (De Novo classification request) cache is now present. Every query containing "hemorrhoid" returns one spurious row, a device called "Rho" matched as a substring, so it supports nothing. The queries that avoid that collision, "radiofrequency" and "anoscope", return no granted De Novo, and the file reads both as nulls about a string, not about a market claim 14unconfirmed, claim 46refuted. So the De Novo route is still not established either way. Rebuilt from the file, not patched.
Would have to be true: A disposable bipolar applicator deployed through a single-use anoscope would have to deliver RF (radiofrequency) energy to the submucosal pedicle of a grade II and grade III internal hemorrhoid in an office without sedation, under a written dosimetry specification: energy, impedance threshold and cutoff criterion, each stated as a number. For a start, the parameters FDA (US Food and Drug Administration) has already accepted in this anatomy would have to be readable off the cleared bipolar predicates.
Where it stands: No energy, impedance or cutoff figure appears anywhere in the file, so this deck states none. Whether the predicates' public summaries carry those parameters is this deck's own write-back claim 81unverified. What is verified is the envelope the spec has to sit inside. The regulation is 21 CFR (Title 21 of the Code of Federal Regulations) 878.4400, Class II (FDA device class II), product code GEI claim 16verified, claim 17verified. The Part 876 alternative resolves to named regulations claim 18verified, with codes and panels re-established independently claim 45verified. A bipolar RF applicator for internal hemorrhoids has a four-clearance US history under GEI claim 40verified. No product code for this device has been established; the refutation on that line covers only its "nothing found in openFDA" half claim 23refuted.
What would settle it: A human read of the K121085 (an FDA 510(k) clearance number), K140422 and K200146 summaries for stated power, temperature or impedance parameters claim 81unverified, then IEC 60601-2-2 for the electrosurgical envelope. Neither of those writes the dosimetry spec. It is an internal engineering document that nobody has drafted.
If it's false: If the predicates disclose nothing, the dosimetry spec starts from zero rather than from an accepted envelope. The one feature the product is differentiated by then has no specification, and Factor 6 has nothing to score beyond the fact that the modality is cleared territory at grade I-II claim 52verified.
Would have to be true: One office RF session at grade III would have to give durable devascularisation at a rate materially better than office ligation, which the literature puts at 47.5% 12-month recurrence against 6.1% for hemorrhoidectomy. It would have to do that without taking on the bleeding, retention and incontinence profile that makes surgery the thing patients are avoiding.
Where it stands: This device's own durability is unbacked claim 33unconfirmed. The target it is measured against is sourced and still unconfirmed, because published findings wait for Stage 7 appraisal. At grade III, rubber band ligation was not noninferior to hemorrhoidectomy on 12-month QALYs, with 47.5% recurrence against 6.1% claim 59unconfirmed. Within office ligation, grade III recurred at 32.8% against 14.6% at grade I-II claim 60unconfirmed. Across 79 randomized trials (n=9,232), closed hemorrhoidectomy had the lowest recurrence and the surgical options the worst complication profile claim 61unconfirmed. The bar is moving too: a modified ligation technique reported 3-month recurrence of 5.4% against 13.6% claim 62unconfirmed. The failure modes are named and unmitigated on evidence: recurrence, pain, bleeding, and rare thermal injury to the sphincter or rectal wall claim 12unconfirmed.
What would settle it: Bench and animal work characterise dose consistency and cannot show durability. Durability needs a comparative study at grade III powered against the ligation figure above. The file prices that study as a separate spend outside the clearance budget claim 72unconfirmed, claim 14unconfirmed.
If it's false: The device does at grade I-II what a cleared bipolar RF applicator has done since 2012 claim 40verified, claim 52verified, with a per-case cost attached. Factor 6 loses the only thing that distinguishes it.
Would have to be true: FDA would have to accept a 510(k) (premarket notification) for grade II and grade III on predicates whose RF indications stop at grade II, with bench dosimetry and animal thermal-spread data and no pivotal trial. The applicator (878.4400) and the disposable anoscope (876.1500) would also have to be clearable and marketable together as one kit.
Where it stands: The predicate ground is mapped and verified up to a hard edge. A predicate with a checked Indications for Use exists claim 20verified. The "no predicate, therefore possibly De Novo" premise is refuted, with five predicates named by K-number claim 46refuted. The reading that the panel question had moved to Part 876 is also refuted claim 19refuted. The edge is that every located bipolar/RF IFU (instructions for use) stops at grade II claim 42verified, claim 52verified. The only grade-III-spanning predicate is a 2003 device in another code and panel claim 53verified, and its commercial status is unchecked claim 54unconfirmed. Whether FDA accepts the cross-grade argument is open claim 51unconfirmed. The De Novo list cannot settle the fork from the other side: this pass's usable queries returned nulls about a string claim 14unconfirmed. The kit question is this deck's write-back claim 83unverified. The anoscope class itself is established claim 22verified. The OEM alternative, putting the dosimetry module into an already-cleared applicator, turns on a verified regulatory test claim 75verified whose application nobody has answered claim 71unconfirmed.
What would settle it: An FDA pre-submission that puts the grade III indication, the predicate strategy and the kit configuration in front of the review division. That is a human act, and it is the only thing that settles claim 51unconfirmed and claim 83unverified. The special controls under the chosen regulation then scope bench, biocompatibility, electrical-safety and human-factors work.
If it's false: A clinical study joins the critical path, and Factor 7's cost and calendar claim 14unconfirmed change category. The indication the candidate's own scope note calls its entire premise then has two options: evidence it expensively, or narrow it to grade I-II, where the nearest predicate matches exactly and the ground is already occupied.
Would have to be true: Tissue impedance would have to predict depth of thermal injury in hemorrhoidal submucosa closely enough to stop the cutoff after the pedicle is devascularised and before the internal sphincter or rectal wall is reached, at the larger, more vascular grade III pedicle as well as the grade II one.
Where it stands: Unbacked claim 31unconfirmed, and the Verifier records that no connector answers bench physics. The size of the margin the cutoff has to find is also unmeasured: whether the anatomy gives a usable pedicle-to-sphincter depth at grade II and grade III is this deck's write-back claim 82unverified. The consequence of missing on either side is sourced. Under-treat, and the device inherits ligation's grade III recurrence claim 59unconfirmed. Over-treat, and it acquires the complication profile that makes surgery unattractive claim 61unconfirmed.
What would settle it: Ex vivo thermal-spread mapping with histology at defined impedance endpoints, on tissue that spans the grade II to grade III pedicle range, to characterise the cutoff rather than merely pass it. What happens after that bench result is a Tier 3 decision this repo does not make.
If it's false: The differentiator becomes a feature on a commodity generator. Factor 5's only asserted defensible assets go with it claim 10unconfirmed, and the one serious complication has no mitigation behind it.
Would have to be true: A written maximum thermal-spread limit would have to be derivable from published anatomy before any animal is involved. Thermal spread, cutoff behaviour and applicator geometry would then have to be characterised against that limit on the bench.
Where it stands: No acceptance criterion exists, and the anatomical input to one is this deck's write-back claim 82unverified. The durability side of the criterion has a sourced target claim 59unconfirmed, claim 60unconfirmed. The safety side has a sourced ceiling in the surgical complication profile claim 61unconfirmed. The dosimetry physics under both is unbacked claim 31unconfirmed.
What would settle it: A literature search for pedicle-to-internal-sphincter depth by grade claim 82unverified. No connector returns a measurement with a tag, so this is analyst work that ends in a claim for the Verifier. After that comes ex vivo mapping against the limit. No animal is needed for the first pass.
If it's false: If anatomy gives no usable limit, the animal work is spent characterising a device whose boundary was never defined, the submission inherits the ambiguity, and the bench package becomes exploratory rather than confirmatory.
Would have to be true: An applicator with impedance-sensing electronics would have to be built at a landed cost that leaves margin under the payment. It would have to survive terminal sterilisation with its impedance measurement intact. And practices would have to use the kit as a kit, not the applicator through a reusable anoscope they already own.
Where it stands: The cost is unsourced claim 32unconfirmed, claim 65unconfirmed. It is still the half of the decisive subtraction claim 6unconfirmed that involves no outside party. The ceiling side has moved: the non-facility payment carries $188.99 of practice expense claim 74verified. Whether that is headroom or already allocated to staff, supplies and equipment is the viability deck's write-back claim 80unverified, and that deck carries it. Sterilisation of the electronics is this deck's write-back claim 84unverified. On the anoscope, a single-use anoscope cleared through grade III is already on the market claim 44verified, claim 55verified, so unbundling is live claim 27unconfirmed.
What would settle it: A contract-manufacturing quote against the applicator specification, which also forces the spec to be written. Then a sterilisation-compatibility test of the sensing electronics claim 84unverified. Then a build-versus-source decision on the anoscope against the cleared one.
If it's false: Either the dosimetry moves into the console and the disposable becomes a commodity, taking Factor 5 with it claim 10unconfirmed, or the kit cost breaks the switching case the whole candidate rests on claim 15unconfirmed, claim 63unconfirmed.
Would have to be true: Impedance-controlled bipolar RF coagulation of internal hemorrhoids through an anoscope would have to be buildable around the patents held by the named parties in this field.
Where it stands: Never examined claim 11unconfirmed, claim 34unconfirmed. Zero patents searched, so the field is unexamined, not clear. The parties are named: the bipolar RF hemorrhoid line claim 40verified, claim 52verified, whose latest clearance is Covidien's claim 41unconfirmed, the 2003 grade-III predicate holder claim 53verified, the recent disposable-anoscope entrant claim 55verified, and a Doppler-guided hemorrhoidal-artery-ligation system in the ligator code, surfaced only by a scan claim 47unconfirmed.
What would settle it: A CPC A61B18/12 and A61B17/12 search, narrowed to anorectal RF and impedance-feedback electrosurgical control, plus assignee sweeps on those parties. That produces named numbers, and each one goes through the patent connector once a PatentsView key exists. Then counsel, because a verified patent record is a fact about dates, not an FTO (freedom to operate) opinion.
If it's false: FTO blocked is an automatic kill under the rubric, regardless of every other score. If a workaround exists, it probably sits in the cutoff logic, which is the one component this deck has no spec for (Slide 1).
Every condition above with nothing verified behind it. Read the tags, not the count. After write-back almost every line has a claim number, and nearly all of them are unconfirmed or unverified.
All twenty-one verified claims in the file are facts about the envelope, the codes, the payment, or somebody else's cleared scope. Not one says the cutoff works, what the applicator costs to build, or whether anyone else owns the approach.
If only one thing from this chair could be checked: whether this device can be evidenced and cleared at grade III, the half of its own indication for which no bipolar or RF applicator predicate exists claim 42verified, claim 51unconfirmed.
Grade III is where the engineering, the evidence and the regulatory strategy meet. It sets the pedicle size the impedance cutoff has to handle claim 31unconfirmed, claim 82unverified. It sets the endpoint the bench and animal package is written against, and the sourced number there is 47.5% 12-month recurrence for the incumbent office modality claim 59unconfirmed. It is the durability the physician's switch depends on claim 33unconfirmed, claim 63unconfirmed. And it is the only ground here that no verified record shows is already occupied by an RF applicator claim 52verified.
This pass did not move it. The De Novo lookups that now run cannot see a hemorrhoid device through the substring collision, and their other nulls are about strings claim 14unconfirmed. So the fork stays where the file left it. Narrow to grade I-II and the nearest predicate matches exactly, on ground a cleared bipolar device has held since 2012 claim 40verified. Keep grade III and the predicate story becomes a cross-code argument against a 2003 device in another panel claim 53verified. Which way that goes is an FDA judgement and a human decision.
Naming it is not a recommendation, a gate, or a kill.
_shared/plain-language.md