idea-015 · 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: engineering. The people who have to build it, test it, manufacture it, and produce the evidence a reviewer will ask for.
How to read this: every slide is a condition, not a conclusion. A bracketed claim reference points into knowledge-base/candidates/idea-015.md. The number is the claim's position in its ## Claims list, and the tag is copied from that claim as it stands at build time, never adjusted here. A [no claim] marker means nothing in the file speaks to the condition. Where another lens holds a condition, this deck points at that deck rather than restating it. See docs/deck-spec.md.
What the file looks like from this chair. The classification is verified: 21 CFR (Title 21 of the Code of Federal Regulations) 884.3575, Class II (FDA device class II), product code HHW. Everything the engineering team would actually have to build and prove is unconfirmed, because no connector in this repo reaches a bench, materials or usability question about a device that does not exist. That includes lock holding force, cleaning of a mechanical joint, adjustment with the device in place, home reprocessing, the size range one device spans, and lock stability through insertion and removal. The Verifier's 2026-09-29 pass on those last two (claims 44, 45) ran no lookup because none applies. There is no prototype. The pass did add one useful thing: the Verifier read three recent HHW clearance summaries directly, and they show which bench tests FDA (US Food and Drug Administration) has accepted and a mixed precedent on clinical data (claim 34unconfirmed). None of the file's specification quantities exist yet: no diameter range, no step resolution, no holding force. They appear below as visible blanks. This build appended nothing: every condition below already has a claim line.
Would have to be true: A single reusable silicone ring-with-support would have to lock its outer support diameter at any clinician-chosen point across a continuous range spanning the ring-pessary sizes fitted to stage II-III patients. The diameter would have to be readable off the device for the chart and re-settable at follow-up. And the device would have to support an anterior or apical compartment the way a fixed ring of that diameter does.
Where it stands: The intended use and the pessary classification it sits under are verified. The Verifier's own note limits this: it establishes what HHW is, not that a mechanically set diameter stays inside HHW claim 1verified. That one device's range can span the full size ladder needs two facts, the size range actually fitted and the lockable range the mechanism achieves, and neither is attached. K231786 (an FDA 510(k) clearance number)'s statement that its "min and max feature sizes are within range of predicate pessaries" describes that device, not this one claim 44unconfirmed. The only size range the file mentions is the 1.5"-3.5" eligibility band in the Reia early feasibility study, and that is a trial's inclusion criterion, not a specification claim 21unconfirmed. The K231786 clearance covers a whole multi-shape, multi-size line, which is the ladder being replaced claim 26verified. The step resolution, the locking-force target and the readout format are not in the file [no claim]. Charting the diameter is a clinician behaviour, held on desirability Slide 2 claim 27unconfirmed.
What would settle it: A published or registry size-distribution for fitted ring pessaries in stage II-III patients, or a cleared product's full size range, which would give the target. A human with clinical input would have to supply it. Then a design-input document written by engineering against it, and bench measurement of the achieved lockable range on a prototype.
If it's false: If one mechanism cannot span the ladder, the product needs two or three SKUs. The single-SKU premise, which the desirability deck (Slide 2) and the viability deck's share (Slide 3) both rest on, goes with it. The device becomes a smaller fitting set.
Would have to be true: The ratchet would have to hold its set diameter against the loads of daily wear and Valsalva, and it would have to do so without a rigid part breaking through the medical-grade silicone envelope that touches the vaginal mucosa. A clinician would also have to be able to set and re-lock it with the device in place.
Where it stands: Holding force against envelope integrity is a bench question with no connector claim 35unconfirmed. Adjusting in place is an engineering and usability question with no connector claim 36unconfirmed. Retention under Valsalva is the endpoint the field already tests, since it was the primary outcome of the Reia feasibility study claim 21unconfirmed. How much Valsalva load the ratchet must resist is not in the file [no claim]. The clinical bet that in-visit adjustment beats the next discrete size depends on this mechanism working, and it cannot be checked claim 23unconfirmed.
What would settle it: A bench rig applying a cyclic load to a prototype lock at a pelvic-load value taken from published pelvic-floor biomechanics. A human would have to pick the reference, because none is in the file. Then an envelope-integrity inspection after load cycling. In-place adjustment needs a simulated-use test on a pelvic model with fitting clinicians.
If it's false: A lock that slips gives a drifting diameter, which is a retention and safety failure. An envelope breach puts a rigid part against mucosa, which is a biocompatibility and injury failure. A lock that can only be set with the device out makes the device a fitting set with extra steps. Factor 6 has nothing under it.
Would have to be true: The pathway would have to call only for the bench performance, biocompatibility and cleaning-validation testing a substantial-equivalence argument on geometry and materials needs, and no clinical investigation. The locking mechanism would have to be read as falling inside HHW's existing type and not as a new technological characteristic that sends it to De Novo (De Novo classification request).
Where it stands: Class II under 884.3575, "Class II (performance standards)", with no special-controls text naming clinical data claim 1verified. 510(k) (premarket notification) or exempt is unresolved claim 2unconfirmed. De Novo is live if the mechanism is read as new, with no adjustable predicate found claim 5unconfirmed. Entry without clinical data is unconfirmed, and the precedent the Verifier found is mixed. clearance-summary still crashes in this environment (a PanicException in the pypdf/cryptography bindings, a tooling fault and not a finding), so the Verifier read the summary PDFs directly, as context and not a tag basis. K231786, a clinician-configured HHW pessary, lists only mechanical testing (folding, 3-point bend, cord detachment, end of life, squeeze, knob displacement), ISO (International Organization for Standardization) 10993 biocompatibility, TSST-1, cleaning and packaging validation, and no clinical testing. K232677 (Reia), a novel collapsible mechanism, includes a prospective single-arm clinical study at seven US sites. K233548 leveraged clinical data from an earlier clearance. Which precedent applies to a ratcheting, lockable diameter is the open question claim 34unconfirmed claim 21unconfirmed. The biocompatibility and cleaning-validation burden of a jointed reusable device is the file's principal bench risk claim 25unconfirmed. Desirability Slide 5 adds that clinicians may demand comparative data even if FDA does not claim 38unconfirmed.
What would settle it: An FDA pre-submission on the locking mechanism, asking whether it stays in HHW and whether the K231786 or the K232677 pattern applies. That is a human act. Before it, fix the environment's pypdf/cryptography fault and re-run clearance-summary on K232677, K231786 and K233548 so claim 34unconfirmed has a connector result. Read the HHW exemption flag from the FDA Product Classification database (human, or a connector change).
If it's false: A clinical investigation, or a De Novo with special controls written from scratch, turns this from a bench build into a clinical programme. Capital and calendar (viability Slide 4) go up by an amount no claim carries.
Would have to be true: The joint in the ratchet (teeth, pawl, whatever gap exists between band and envelope) would have to survive repeated cleaning and long-term intravaginal wear with no crevice contamination, no biofilm, and no loss of lock. It would also have to survive the folding and handling of conventional ring insertion and removal without the set diameter changing.
Where it stands: Cleaning, biofilm and lock retention on a mechanical joint are named in the file as the principal bench-evidence risk. No bench or materials data exists claim 25unconfirmed. That insertion and removal handling leaves the lock undisturbed needs lock-retention and diameter-stability testing under folding, insertion and removal loads, and none exists. The Verifier noted the test types cleared HHW devices used: folding, squeeze and end-of-life for K231786, insertion and removal force and hinge strength for K232677 claim 45unconfirmed. The only field evidence the file points to is a lead, not a check: 102 MAUDE (Manufacturer and User Facility Device Experience) reports in HHW from 2021 to 2026, with no denominator, recorded in claim 25unconfirmed's note. The wear interval the lock must last, the number of cleaning cycles, and the acceptable diameter drift are not in the file [no claim].
What would settle it: A human reading those 102 MAUDE narratives for how marketed pessaries fail in the body, which is the cheapest available input to the test protocol. Then bench cleaning validation and biofilm challenge on a prototype joint, and an insertion/removal handling test modelled on the cleared devices' test types, measuring diameter before and after.
If it's false: A joint that can't be cleaned makes a reusable device single-use, and a single-use device changes the billing picture (viability Slide 3, replacement cadence). A lock that shifts when the patient inserts it makes the charted diameter meaningless, and with it the re-set-at-follow-up workflow.
Would have to be true: Before any patient is involved, a bench programme would have to show four things on the same prototype. The lock holds under cyclic loading (Slide 2). The diameter does not drift through repeated set and re-set cycles or insertion handling. The joint passes cleaning validation under the patient's home routine. The materials and the joint pass ISO 10993 biocompatibility.
Where it stands: None of it exists. Holding force and envelope integrity claim 35unconfirmed. Lock retention, cleaning and biocompatibility claim 25unconfirmed. Insertion handling claim 45unconfirmed. Home cleaning with no extra disinfection step claim 37unconfirmed. The test categories a cleared clinician-configured HHW pessary submitted are on record in a claim's note, which gives the programme a shape claim 34unconfirmed. The file names no bench protocol, pass criteria or test lab [no claim].
What would settle it: A bench protocol drafted by engineering, with pass criteria from the Slide 1 specification once it exists, using the K231786 test list as a starting inventory. This is the shape of the minimum viable bench-evidence list the Diligence Lead drafts at Stage 7. Anything past the bench, animal or human, is a Tier 3 decision. No agent in this repo makes it.
If it's false: A failed bench programme ends the feasibility case before it costs a clinical study. That is the reason the bench comes first in the sequence, not a verdict on the idea.
Would have to be true: The ratchet-and-lock would have to be manufacturable in medical-grade silicone at a unit cost well below what reaches the manufacturer out of a once-per-device allowed amount near A4562 (a HCPCS code for a supply)'s. The patient would have to be able to clean it at home with the same routine as a one-piece silicone pessary, with no extra disinfection and no clinic reprocessing. And a clinician in an ordinary exam room would have to read and set the diameter without a tool the practice does not have.
Where it stands: The file's original device price is refuted: A4561 is $28.43-$29.45 non-rural, and the silicone code A4562 is $70.81-$73.34 claim 11refuted. Whether this device gets A4562 has not been determined (viability Slide 2) claim 41unconfirmed. The manufacturing cost that has to fall under that ceiling has no BOM (bill of materials) or quote claim 24unconfirmed. The cost is held on viability Slide 7. Home cleaning with the same routine is unconfirmed, and FDA's reprocessing expectations sit in guidance no connector reads claim 37unconfirmed. Whether setting the diameter needs a tool is not in the file [no claim].
What would settle it: A contract-manufacturing quote on the moulded band, ratchet and envelope assembly, commissioned by a human. Cleaning validation under a written home-cleaning instruction. A simulated-use study in an exam-room setting.
If it's false: A high cost of goods closes the business on the viability side, however well the lock works. Needing clinic reprocessing adds visits and puts the device on the unpaid maintenance burden (desirability Slide 4, claim 9unconfirmed). A setting tool is one more thing the practice has to stock, in a product whose pitch is stocking less.
Would have to be true: The ratchet-and-lock would have to be practicable without infringing any live patent on adjustable- or locking-diameter intravaginal supports. The device would also have to work without the collapse-for-removal or finger-loop removal-stem features next to the live patent US 11,865,033, whose assignee is not confirmed. If those features are off the table, the workaround would have to be the design itself and not a compromise of it.
Where it stands: US 11,865,033 is real, filed 2021-05-26, naive term to 2041, not expired. That is verified as a register fact only. Its assignee, legal status and issued claim scope are not confirmed, and what it reads on is a legal opinion the repo does not generate claim 16verified. The deflatable-pessary patent US 6,189,535 has expired, which gives comfort for that one concept claim 17verified. The art field for the core novelty, a ratcheting, lockable, adjustable diameter, has not been examined. It is "not yet knowable", not clear claim 18unconfirmed. Patentability of the lock over that art is on the viability deck's Slide 5 claim 32unconfirmed.
What would settle it: A commissioned professional FTO (freedom to operate) and landscape search on the locking mechanism, which the file calls a paid, multi-week item. A patent-scan on the ratchet-lock field would at least give claim 18unconfirmed named patents to check. A human pull of the issued claims, assignee and maintenance status of US 11,865,033 from USPTO (United States Patent and Trademark Office) Patent Center.
If it's false: A live patent covering the locking mechanism with no workaround is the rubric's one automatic kill (FTO blocked). That call is Stage 5 arithmetic over verified claims, not this deck's. From engineering's chair, an unexamined field means every design decision on the lock carries risk nobody has priced.
Every condition above with nothing verified behind it, whether a [no claim] marker or a claim still short of verified. Read this slide first. All seven conditions are here. The verified claims cited are the classification (1), the incumbent line (26) and the two patent register facts (16, 17). They back the frame around Slides 1, 3 and 7, not the condition on any of them.
Nothing on this deck is unverified any more. The feasibility conditions earlier builds put on record (34 to 37, 44, 45) have all had a Verifier pass and are all unconfirmed, five of them with no connector that could reach them.
If only one thing from this chair could be checked: whether a ratcheting, lockable joint inside a reusable silicone pessary can survive repeated home cleaning and long-term intravaginal wear with no crevice contamination, no biofilm and no loss of lock claim 25unconfirmed.
Why this one: the other mechanism conditions (holding force, adjustment in place, insertion handling) are all conditions about the lock. This one decides whether a device with a lock can be reusable at all. The file names it as the principal bench-evidence risk. A solid-silicone ring does not carry it. And if it fails, the device loses the reusable premise that its billing code and its cost ceiling assume.
Naming it is not a recommendation, a gate, or a kill.
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