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The AquaShield CO2 System is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope procedures. It is compatible with U.S. commercially available water bottles.

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The provided document is a 510(k) premarket notification letter for a device called "AquaShield System CO2, AquaShield System-Pentax." This document itself does not contain the acceptance criteria or a study proving the device meets those criteria.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. The "Indications for Use" section describes the intended purpose of the device (supplying sterile water to endoscope procedures compatible with CO2 or air source).

To answer your request, a detailed performance study with acceptance criteria would typically be found in an accompanying submission document, clinical trial report, or biocompatibility/performance testing reports, none of which are provided in this extract.

Therefore, based solely on the provided text, I cannot furnish the requested information. The document focuses on regulatory approval and indications for use, not on specific performance data or acceptance criteria derivation.

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