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The polyurethane-coated Delta Valves, polyurethane-coated CSF-Flow Control Valves, Contoured, and Burr Hole are components of polyurethane shunt systems designed for use in shunting cerebrospinal fluid from the ventricles of the brain into the right atrium of the heart or to the peritoneal cavity. The Polyurethane shunt and shunt components are designed to eliminate patient exposure to silicone elastomer.

The polyurethane-coated Delta Valve minimizes the excessive reduction of intraventricular pressure and volume due to excessive drainage of CSF, which may be caused by the siphoning effect of hydrostatic pressure of the distal catheter. The siphon effect may be created by the elevation of the ventricular catheter with respect to the distal catheter (i.e., when the patient sits, stands, or is held erect).

A Ventricular Catheter manufactured of Polyurethane tubing. A Flow Control Valve manufactured of a Polypropylene base and a silicone elastomer housing which incorporates a Tecoflex elastomer resin, polyurethane coating. A Cardiac/Peritoneal Catheter manufactured of Polyurethane tubina.

This document is a 510(k) summary for a medical device (Medtronic PS Medical Polyurethane Shunt) and a clearance letter from the FDA. It does not contain any information about acceptance criteria, study details, or performance metrics that would typically be found in a clinical study report or a detailed device performance study.

Therefore, I cannot provide the requested information. The provided text primarily focuses on:

• Device Description: What the device is made of and its components.
• Intended Use: The purpose of the device (shunting CSF).
• Technological Comparison: Statement of substantial equivalence to predicate devices based on materials, intended uses, performance characteristics, and design specifications. This implies that the device is similar to existing devices known to be safe and effective, rather than presenting new performance data.
• FDA Clearance: The letter confirming FDA's determination of substantial equivalence, allowing the device to be marketed.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or the study that proves the device meets those criteria.

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