(84 days)
The PeriPatch Sheet is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair.
Processed Bovine Pericardial Patch
The provided text is a 510(k) premarket notification letter from the FDA regarding the "PeriPatch™ Sheet." This document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications in the way a clinical study report or a technical performance assessment would.
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 device's clearance was based on demonstrating substantial equivalence to a predicate device, not necessarily on meeting specific, predefined acceptance criteria through novel performance studies against a set ground truth.
Therefore, I cannot provide the requested information from the given text. The text does not describe an acceptance criteria study or its results.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).