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The EchoBrush™ is used to sample targeted submucosal gastrointestinal lesions through the accessory channel of an ultrasound endoscope.

The EchoBrush™ consists of a cytology brush for sampling submucosal gastrointestinal lesions. There is a handle attached to the proximal end of the device. The handle can be attached and locked onto the ECHO-19 Ultrasound needle. A white piece of shrink tube can be seen for a length of 9mm from the handle along the nitinol shaft. This will indicate to the user that the brush is about exit the tip of the needle.

The provided text describes a 510(k) summary for the Cook Ireland EchoBrush™ Device. It does not contain information about specific acceptance criteria, device performance metrics, or a study design that proves the device meets such criteria in terms of clinical effectiveness or diagnostic accuracy.

The "Test Data" section only mentions:

• "Non-Clinical testing was performed on characteristics and operational functions of the EchoBrush™ deemed necessary to verify safety and performance."
• "Genotoxicity (Ames Test): The results of this test indicated that under the experimental conditions, the extracts of this test article were not mutagenic for any tester strain, with or without any S9 activation."
• "Mentor also performed chemical testing to support a 36 month shelf life for the SCHG." (Note: "SCHG" appears to be a typo, likely referring to the device itself or a component).

This information pertains to safety and shelf-life testing, not clinical performance or diagnostic accuracy. Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria, as such details are not present in the given text.

The document's purpose is a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, primarily through safety and functional characteristics, rather than extensive clinical performance studies.

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