(29 days)
The Atrium (Wrapped) Advanta™ Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Insufficient data is available at this time to support Atrium (Wrapped) Advanta™ Graft use in aortocoronary bypass applications or for use as a patch.
Not Found
I am sorry, but the provided text from the FDA 510(k) notification for the Atrium Advanta™ Graft does not contain the information needed to answer the questions about acceptance criteria and a study proving a device meets those criteria.
This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It defines the "Indications for Use" for the device, but it does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Training set details.
The document pertains to regulatory clearance based on substantial equivalence, not a detailed performance study report.
§ 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.”