ADVANTA T-GRAFT

• K Number: K051332
• Device Name: ADVANTA T-GRAFT
• Manufacturer: ATRIUM MEDICAL CORP.
• Date Cleared: 2005-09-29 ( 129 days)
• Product Code: DSY
• Regulation Number: 870.3450
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: N/A
• Predicate For: K093934

Intended Use

The Atrium Advanta™ T-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 Advanta™ T-Graft use in aortocoronary bypass applications or for use as a patch.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA to Atrium Medical Corporation regarding their Atrium Advanta™ T-Graft. It does not contain primary study data or detailed acceptance criteria for the device's performance.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, and adjudication methods for a test set.
3. Information on multi-reader multi-case studies or standalone algorithm performance.
4. Type of ground truth used.
5. Sample size and ground truth establishment for a training set.

This document merely confirms that the FDA has reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices for the stated indications for use. It lists the regulation number, regulation name, and product code, and outlines general regulatory provisions. It does not disclose the specific studies or data submitted to demonstrate substantial equivalence or the acceptance criteria used in those studies.

Regulation Number and Section

§ 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.”