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The Andorate® Disposable biopsy valve is used to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The Andorate® Disposable Biopsy Irrigator is intended to enable simultaneous irrigation and instrumentation in the endoscope's biopsy channel.

The biopsy valve is intended to cover the endoscope biopsy port during an endoscopy procedure. In addition, the valve provides access for endoscopic device passage and exchange, helps maintain insufflation and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.

The biopsy irrigator is intended to cover the endoscope biopsy port for sealing and endoscopic device passage/ exchange, at the same time use in conjunction with irrigation tubing. consists of a backflow valve which prevent the backflow of water or biomaterials from the endoscope to the irrigation tubing.

The biopsy irrigator and biopsy valve are packed individually in a sealed packed. The subject devices are supplied as sterile The subject devices in this submission have the same operation and method of action with the predicate devices.

The provided text is a 510(k) Premarket Notification for the Andorate Biopsy Valve and Andorate Biopsy Irrigator, seeking substantial equivalence to existing predicate devices. It describes the devices, their intended use, technological characteristics, and performance data. However, this document does not describe a study involving a medical device that uses AI or machine learning algorithms, nor does it contain information about expert ground truth establishment, reader studies, or training/test sets for such algorithms.

The document details the acceptance criteria and study proving the devices meet these criteria for mechanical and material performance of traditional medical devices. Therefore, I will extract information relevant to those types of devices based on the provided text.

Here's the information parsed from the document for the Andorate Biopsy Valve and Andorate Biopsy Irrigator:

1. A table of acceptance criteria and the reported device performance

The document outlines performance tests conducted for each device. The reported performance is that the tests were conducted and the results imply that the subject devices provide and maintain a sterile barrier and their intended performance before the expiration date, and that they support safety and efficacy, and substantial equivalence to predicate devices. Specific quantitative acceptance criteria values are not provided in this summary, but rather the types of tests performed.

Andorate® Disposable Biopsy Valve:

Andorate® Disposable Biopsy Irrigator:

General Performance Criteria (Both Devices):

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