(126 days)
The Disposable Endoscope Valves System includes an air/water valve, a biopsy valve, a biopsy valve and a water connector.
Disposable Biopsy Valve, it is intended to be fitted to an endoscope biopsy port to enable access for/exchange of endoscopic devices while maintaining insufflation and minimizing leakage of biomaterial during an endoscopic procedure.
Disposable Air/Water Valve, it is intended to be fitted to an endoscope Air/water channel to enable the operator to control inflow of medical gases and water.
Disposable Suction Valve, it is intended to be fitted to an endoscope suction channel to enable the operator to control suction.
Water Jet Connector, it is intended to prevent liquid backflow when providing sterile water to the endoscope during endoscopic surgery.
The Endoscope Valves System are used to fit to multiple endoscopes working channels/ports to enable an endoscope operator control the function of the working channels/ports and prevent retrograde flow of the fluids, gases, and other materials.
It includes an air/water valve, a suction valve, a biopsy valve and a water connector. All valves are single-use device and packed individually in a sealed package or different types of valves products is packed into one package units. The valves are manufactured for use with OLYMPUS Endoscope Series, FUJIFILM Endoscope 700 Series, and Pentax 90 series endoscope. Some valve mav be sold as both sterile and non-sterile.
The provided text is a 510(k) summary for a medical device (Disposable Endoscope Valves System) submitted to the FDA. It details the device, its intended use, comparison to predicate devices, and non-clinical testing performed to demonstrate substantial equivalence.
However, this document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. The device described is a physical medical device (valves for endoscopes), not an AI/ML algorithm.
Therefore, many of the requested points related to AI/ML device studies (such as sample size for test/training sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, etc.) are not applicable to this submission.
The document discusses the following types of testing for this physical device:
- Biocompatibility testing: Performed in accordance with ISO 10993-1:2009 for "Surface – Mucosal Membrane" with limited contact duration. Tests included Cytotoxicity, Irritation, and Intracutaneous Reactivity. All acceptance criteria were met.
- Performance testing: Specific tests for each valve type:
- Biopsy Valves: Sealing performance test, Strength of assemble.
- Air/Water Valves: Air leakage test, Water flow test.
- Suction Valves: Suction flow test.
- Water Jet Connectors: Positive pressure performance test, Backpressure performance test, Backflow Prevention Test.
- Compatibility testing: To confirm compatibility with commercial endoscopes (Pentax, Olympus, Fujifilm Gastrointestinal Endoscopes).
- Sterilization and Shelf-life testing: Sterilization validated to ISO11135, and a 3-year shelf-life determined by accelerated aging.
The document explicitly states: "No clinical study is included in this submission." This further confirms that the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML algorithm's performance is not present in this document.
In summary, as the provided document pertains to a physical medical device (endoscope valves) and not an AI/ML medical device, the specific information requested about AI/ML acceptance criteria and performance studies is not available.
§ 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.