(71 days)
The Boa Endoscopic Valve™ is intended to provide access for endoscopic device passage and exchange throughout the endoscopic procedure.
The Boa Endoscopic Valve™ is used with endoscopes and endoscopic devices with a maximum outer diameter up to 0.167 in. Endoscopic devices are inserted through the Boa Endoscopic Valve™ and through the endoscope. The Boa Endoscopic Valve™ forms a seal around endoscopic devices, supports the endoscopic device, and maintains the position relative to the endoscope biopsy channel port. It is compatible with biopsy port valves and is positioned against the biopsy valve of the endoscope. The Boa Endoscopic Valve™ is non-sterile and is designed for single patient use.
The provided document is a 510(k) summary for the Boa Endoscopic Valve™. It states that the device is substantially equivalent to a predicate device (EndoChoice Seal Biopsy Valve, K111821).
Here's an analysis of the acceptance criteria and supporting studies based on the provided text, using the structure you requested:
The document does not specify "acceptance criteria" in terms of performance metrics like sensitivity, specificity, accuracy, or specific thresholds for leakage rates or device passage force. Instead, the "acceptance criteria" in this context appear to be met by demonstrating substantial equivalence to a predicate device through various non-clinical tests.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Pass: Biocompatibility testing was performed in accordance with FDA Blue Book Memorandum #G95-1 and ISO 10993-1. |
| Physical Performance | Pass: Design verification and validation testing performed. |
| Simulated Use Performance | Pass: Design verification and validation testing performed. |
| Reliability | Pass: Design verification and validation testing performed. |
| Safety | Pass: Design verification and validation testing performed. |
| Clinical Attributes | Equivalent to predicate. |
| Technological Characteristics | Equivalent to predicate (attached to proximal biopsy channel port, aids in insertion/use/removal of accessories, minimizes leakage, used in hospitals/sub-acute care/surgery centers/doctor's office, single-patient disposable). The only stated difference is the rotation mechanism vs. pull-up mechanism. |
| Expected Performance | Comparable to legally marketed predicate (K111821). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for any of the bench or biocompatibility tests. It also does not mention data provenance (country of origin) or whether the tests were retrospective or prospective, as these are non-clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is a mechanical endoscopic valve, and the evaluation involved non-clinical performance and biocompatibility testing, not expert interpretation of medical images or data requiring ground truth established by medical experts in that context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this was a non-clinical evaluation that did not involve human adjudication for ground truth.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (endoscopic valve), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this type of device would be established by engineering specifications, material standards, and performance test methods. For example:
- Biocompatibility: Adherence to ISO 10993 standards and FDA guidance.
- Physical/Simulated Use/Reliability/Safety: Meeting pre-defined engineering specifications and performance benchmarks (e.g., specific force to pass a device, seal integrity tests, durability tests) that are typically established by the manufacturer and validated by test results.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for a machine learning model, this question is not relevant.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.