(113 days)
The Spiral Flow Peripheral Vascular Grafts are indicated for use as vascular prostheses.
The device is intended for use in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee. Graft configurations are intended for use as arterial conduits for bypass, or reconstruction of peripheral arterial blood vessels.
ONLY trained and qualified physicians and/or surgeons, under the controlled conditions of a hospital operating theatre environment are indicated for use of this device for implantation.
Vascular Flow Technologies' (VFT) Spiral Flow™ Peripheral Vascular Graft is to be used in the bypass or reconstruction of occluded or diseased peripheral arterial blood vessels above or below the knee; it has a specially designed section to induce spiral laminar flow.
The unique design feature translates Spiral Laminar Flow (SLF™) technology to the graft lumen profile. SLF™ technology is designed to propagate spiral flow though the graft and into the distal circulation.
The starting material for the VFT Spiral Flow™ Peripheral Vascular Graft is a straight tubular vascular graft made from expanded polytetrafluoroethylene (ePTFE).
The graft includes a helical overlay of polytetrafluoroethylene (PTFE) beading over most of the grafts length. This is heat set onto the external surface of the ePTFE tube. The function of the beading is to provide reinforcement for the tube.
The unique SLF™ spiral flow inducer is injection molded onto the outer surface of the straight graft. The inducer and indicator are made from ChronoFlex® C-80A; a Biodurable Medical Grade polyurethane
The provided text does not describe an AI medical device or a study proving its performance. Instead, it is an FDA 510(k) clearance letter and summary for a Spiral Flow Peripheral Vascular Graft, which is a physical vascular prosthesis.
Therefore, I cannot provide the requested information about acceptance criteria and a study for an AI device. The document is about a Class II medical device (a vascular graft) and its substantial equivalence to a predicate device based on non-clinical tests, not an AI algorithm.
§ 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.”