(90 days)
The Gelweave™ vascular graft (bifurcated configuration) is indicated for repair or replacement of damaged and diseased vessels of the abdomen in cases of aneurysmal or occlusive disease.
The Gelweave™ vascular graft (bifurcated configuration) is a gelatin-sealed, woven polyester graft, with a base graft porosity of 350 ml/min/om2. The woven polyester material has been impregnated with an absorbable mammalian gelatin which seals the prosthesis in the same manner as the fibrin deposited in traditional procedures. The gelatin sealant obviates the need for preclotting prior to implantation. The gelatin is of United States Pharmacopeia (USP) standard and is derived from bovine bone. The result is a vascular prosthesis that does not require preclotting even when patients have been anticoagulated or when bleeding is a prime concern.
This document is a 510(k) summary for a medical device called the Vascutek Gelweave™ Vascular Graft (bifurcated configuration). It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria or a study proving that a device meets such criteria, as it's not describing a new AI/software-based medical device performance study.
Therefore, I cannot provide the requested information about acceptance criteria and a study proving a device meets them, because that information is not present in the provided text. The document is primarily focused on demonstrating substantial equivalence of a new configuration (bifurcated) to an existing one (straight) for a physical vascular graft, not an AI or software device.
§ 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.”