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The BioGuard Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI endoscopic procedure.

The BioGuard Suction Valve is intended to be used to control the suction function on an endoscope during a GI endoscopic procedure.

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This document is a 510(k) clearance letter for the BioGuard Air/Water Valve and BioGuard Suction Valve. It does not contain information about acceptance criteria or a study proving device performance in the context of clinical metrics or AI/algorithm performance.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976...". This means the submission focuses on demonstrating substantial equivalence to existing devices, primarily through mechanical performance and safety, rather than presenting a study on clinical effectiveness or AI performance.

Therefore, I cannot provide the requested information from this document, as it is not present.

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