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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.

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