(46 days)
The GORE® ACUSEAL Vascular Graft is intended for use as a vascular prosthesis in patients requiring vascular access.
The GORE® ACUSEAL Vascular Graft is a synthetic graft made of an expanded polytetrafluoroethylene (ePTFE) tube with a reinforcing film for radial strength. The luminal surface of the vascular graft is coated with the CBAS® Heparin Surface.
The provided document is a 510(k) clearance letter from the FDA for a medical device called the GORE® ACUSEAL Vascular Graft. This type of document establishes substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or an academic paper describing device performance against explicit acceptance criteria.
Specifically, the document states:
- "One in vitro study was conducted to demonstrate substantial equivalence to the predicate device."
- "The GORE® ACUSEAL Vascular Graft is substantially equivalent to the predicate device. The change to the end-of-shelf-life Heparin Surface Activity specification does not raise new types of safety or effectiveness questions, and the testing provided in this application supports a determination of substantial equivalence."
Therefore, the document does not provide the information requested regarding acceptance criteria and the detailed study that proves the device meets them because it's a 510(k) clearance based on substantial equivalence, not a performance study against predefined criteria.
The 510(k) process focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria or conducting extensive clinical trials, especially for Class II devices like this vascular graft.
As a result, I cannot fill in the requested table and details about the study because that information is not present in the provided FDA clearance letter.
§ 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.”