(19 days)
REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA IN ANEURYSM, DISSECTION OR CASES OF COARCTATION.
Not Found
I am sorry, but the provided text does not contain any information regarding the acceptance criteria of a device, performance studies, sample sizes, expert qualifications, or ground truth establishment. The document is an FDA 510(k) clearance letter for "Gelweave Siena Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers," indicating that the device has been determined substantially equivalent to a legally marketed predicate device. It outlines regulatory requirements and the device's indications for use but does not delve into the specifics of a performance study or acceptance criteria.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”