(16 days)
The SwirlGraft™ Vascular Access Graft is intended for use as a subcutaneous arterio-venous conduit for vascular access.
Not Found
The provided text is an FDA 510(k) clearance letter for the Veryan SwirlGraft™ Vascular Access Graft. It confirms the device's substantial equivalence to a legally marketed predicate device.
However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific details requested in your prompt.
Therefore, I cannot fulfill your request using only the provided text. To answer your questions, I would need a detailed study report or clinical trial summary for the Veryan SwirlGraft™ Vascular Access 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.”