(42 days)
The Chase Cardiovascular Patch Kit is indicated for cardiac and vascular patch grafting.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Chase Cardiovascular Patch Kit). It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.
The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... [because] 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 indicates that the clearance is based on substantial equivalence to a predicate device, rather than a detailed study proving the device meets specific performance acceptance criteria as would be described in a clinical or performance study report.
Therefore, I cannot provide the requested information from this document.
§ 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).