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: Cardiovascular
• Reference & Predicate Devices: K013031
• Predicate For: N/A

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.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 7 2002

Mr. Amy Aulwes Intervascular c/o Health Policy Associates, Inc. 20 Walnut Street, Suite 12 Wellesley, MA 02481

Re: K013651

K013031
InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prosthesis Regulation Number: 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: II (two) Product Code: DSY Dated: January 18, 2002 Received: January 31, 2002

Dear Mr. Aulwes:

We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(t) premier is substantially equivalent (for the indications ferenced above and nave determined with marketed predicate devices marketed in interstate for use stated in the encrosule) to regard to togen. I the Medical Device Amendments, or to conimetee prior to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have been recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not requent of the general controls provisions of the Act. The I ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (600 a00 10) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations an may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overning your device in the Federal Register.

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Page 2 - Mr. Amy Aulwes

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast of advised that I Drivesantes a your device complies with other requirements of the Act that I Dri has Intact a aver a word regulations administered by other Federal agencies. You must or any I cochar statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the role of countinents) ; good manufacturing practice requirements as set Of IT at 6077, laboring (21 CER regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty byeveline (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begal finding of substantial equivalence of your device to a legally premarket notineation. "The a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Fax 646. Additionally, for questions on the promotion and advertising of Compinance at (301) 27 - 1 the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionnalion turers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Deale Tule

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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PRODUCT INDICATIONS FOR USE (Page 1 of 1)

510(k) Number:

Device Names:

Coated Vascular HemaBridge Collagen InterGard Prosthesis

Collagen Coated Vascular InterGard Aortic Arch Prosthesis

• HemaBridge and InterGard Aortic Arch Indications for Use: InterGard 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.
  OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻟﺴ Prescription Use 1 (Per 21 CFR 801.109)

Over-The-Counter Use _

Denkt Hell

Division of Cardiovascular & Respiratory Devices
510(k) Number K013651

000005

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.”