INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS

• K Number: K013651
• Device Name: INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS
• Manufacturer: INTERVASCULAR
• Date Cleared: 2002-02-27 ( 113 days)
• Product Code: DSY
• Regulation Number: 870.3450
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K013031

Intended Use

InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and 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

Not Found

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) clearance letter from the FDA for two vascular prostheses: InterGard HemaBridge Collagen Coated Vascular Prosthesis and InterGard Aortic Arch Collagen Coated Vascular Prosthesis. It confirms that the devices are substantially equivalent to legally marketed predicate devices for the specified indications for use.

While the letter mentions the devices are "substantially equivalent" for specific indications, it does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about a specific study proving the device meets acceptance criteria.
3. Sample sizes used for test sets or their data provenance.
4. Number or qualifications of experts used for ground truth establishment.
5. Adjudication methods.
6. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
7. Details on standalone algorithm performance.
8. The type of ground truth used.
9. Sample size for the training set or how ground truth for the training set was established.

The letter is a regulatory approval document, not a clinical study report.

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.”