(57 days)
EXTRA-ANATOMICAL VASCULAR REPAIR PRIMARILY FOR AXILLO-FEMORAL/BIFEMORAL BYPASS AND FEMORO-POPLITEAL RECONSTRUCTION
VASCUTEK GELSOFT PLUS ERS VASCULAR GRAFT
The provided documents are a letter from the FDA regarding a 510(k) premarket notification for the "Vascutek Ltd. Gelsoft Plus ERS" vascular prosthesis, and an "Indications for Use" statement. These documents do not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or multi-reader multi-case studies.
The letter is a regulatory approval document stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It focuses on regulatory compliance rather than providing detailed study data.
To answer your request, I would need a different set of documents, specifically those related to the performance studies conducted for the Vascutek Gelsoft Plus ERS vascular graft.
§ 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.”