INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

• K Number: K970843
• Device Name: INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
• Manufacturer: INTERVASCULAR, INC.
• Date Cleared: 1997-06-05 ( 90 days)
• Product Code: DSY
• Regulation Number: 870.3450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: N/A

Intended Use

InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Device Description

InterGard™ Woven Collagen Coated Vascular Prostheses

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the InterGard™ Woven Collagen Coated Vascular Prostheses. This document does not contain information on acceptance criteria, reported device performance, or any study details that would demonstrate the device meets acceptance criteria.

The letter primarily:

• Confirms that the device is substantially equivalent to legally marketed predicate devices.
• Outlines post-market surveillance study requirements under Section 522(a) of the act.
• Details device tracking requirements under Section 519(e) of the act.
• Provides general information on regulatory responsibilities.
• Includes an "Indications for Use" statement for the device.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study details.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. Ground truth establishment for the training set.

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.”