(387 days)
The ePTFEMEADS Vascular access. Mid-Flex grafts are specifically indicated for vascular --access, as are Stepped grafts which are designed to reduce the risk of steal syndrome. Externerally Supported Grafts are used where kinking and compression resistance are desired.
The ePTFEMENOx Vasular Graft is comprised of an expanded polyenced the exterior of the tube. Externally supported grafts have a continuous PTFE spiral support coil wound around a portion of the graft.
This document is a Premarket Notification (510(k)) for a medical device submitted in 1996. It does not describe a study involving an AI/Machine Learning device or software, nor does it contain acceptance criteria or performance data in the context of such studies.
Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on establishing substantial equivalence for a physical medical device (ePTFE Vascular Graft) to predicate devices already on the market, based on material, manufacturing, and general performance specifications.
§ 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.”