(282 days)
The ScopeValet Disposable Biopsy Valves, Model Numbers 345BVO and 345BVP, are intended to provide access for endoscopic device passage and exchange, helps maintain sufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure, and provides access for irrigation.
The Ruhof Corporation ScopeValet Disposable Biopsy Valves can be manufactured with a choice of two types - regular disposable biopsy valve and irrigating biopsy valve. Each of these types can be ordered for Olympus, Fujinon, and Pentax gastrointestinal endoscopes.
The provided text describes the non-clinical performance data for the ScopeValet Disposable Biopsy Valves. This device is a biopsy valve, not an AI/ML diagnostic device, so many of the requested fields (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies) are not applicable.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Leakage Prevention | - No evidence of fluid leakage during sample biopsy or bowel irrigation. |
| Insufflation Effectiveness | - Maintained a pressure of at least 10 psi with no testing (implied leak-free during insufflation). |
- Insufflation air flow rate comparable to predicate device,
delivering enough air for insufflation in typical time. |
| Biocompatibility | - Passed cytotoxicity testing per ISO 10993-5. - Made of TPE materials (GRAS for cytotoxicity, sensitization, irritation), USP Grade VI, cleared colorants. |
| Shelf-Life | - Established for one (1) year based on physical testing data. |
| Overall Design, Safety, and Effectiveness (General) | - Met all requirements for overall design and biocompatibility. - Output meets design inputs and specifications.
- Passed all stated tests with acceptable results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify exact sample sizes (number of biopsy valves or test runs) for each non-clinical performance test (Leak testing, Insufflation air flow rate testing, Biocompatibility, Shelf-life). It states "ScopeValet Disposable Biopsy Valves" were tested, indicating multiple units were likely used, but no specific count is provided.
- Data Provenance: The data is generated from non-clinical performance testing conducted by Ruhof Corporation or its contracted labs. This is not patient-derived data, so terms like "country of origin" or "retrospective/prospective" are not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is not an AI/ML diagnostic device, and thus, "ground truth" established by experts in the context of image interpretation or diagnosis is not relevant here. The ground truth for these tests is based on objective measurements against defined engineering and biological standards.
4. Adjudication Method for the Test Set
- Not Applicable. As this is non-clinical performance testing, there is no "adjudication method" in the sense of resolving conflicting expert opinions. Results are presumably recorded and verified against test protocols and acceptance criteria by technical personnel.
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 not an AI/ML diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML diagnostic device.
7. The Type of Ground Truth Used
- The "ground truth" for the non-clinical tests is based on:
- Defined performance specifications: For leakage (no fluid leakage) and insufflation (minimum pressure/flow rate comparable to predicate).
- International and national standards: ISO 10993-1 and ISO 10993-5 for biocompatibility.
- Physical testing protocols: For shelf-life determination.
8. The Sample Size for the Training Set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is not an AI/ML device that requires a training set.
Study Summaries for Each Test:
- Leak Testing:
- Objective: To simulate withdrawal of biopsy samples, bowel irrigation, and bowel insufflation and assess fluid leakage.
- Result: No evidence of fluid leakage was observed.
- Conclusion: The device is effective in preventing fluid leakage.
- Insufflation Air Flow Rate Testing:
- Objective: To simulate bowel insufflations and assess pressure maintenance and air flow rate.
- Result: The device maintained a pressure of at least 10 psi and its air flow rate was comparable to the predicate device, delivering sufficient air for typical insufflation times.
- Conclusion: The device is effective in achieving insufflation.
- Biocompatibility Testing:
- Objective: To evaluate the biological safety of the device's materials.
- Methodology: Conducted according to ISO 10993-1 and FDA/CDRH/ODE Blue Book Memorandum G95-1, classifying the device for mucosal membrane contact, limited duration (less than 24 hours). The device's TPE materials are GRAS, USP Grade VI, with cleared colorants. Specifically tested for cytotoxicity per ISO 10993-5.
- Result: The device passed cytotoxicity testing.
- Conclusion: The device is biocompatible as per ISO 10993-1.
- Shelf-Life Testing:
- Objective: To establish the stability and functional life of the device.
- Methodology: Based on physical testing data using a defined protocol.
- Result: A shelf-life of one (1) year was established.
- Conclusion: The device is stable for one year.
The submission concludes that the ScopeValet Disposable Biopsy Valves passed all testing, demonstrating acceptable results and meeting all requirements for safety, effectiveness, overall design, and biocompatibility, thereby supporting its substantial equivalence to the predicate device.
§ 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.