MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

K984294 · Intervascular, Inc. · DSY · Feb 22, 1999 · Cardiovascular

Device Facts

• Record ID: K984294
• Device Name: MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
• Applicant: Intervascular, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Feb 22, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

InterGard Woven 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 Story

InterGard Woven collagen coated vascular prostheses are synthetic grafts used by vascular surgeons for arterial repair, bypass, or replacement. The device functions as a conduit to restore blood flow in patients with aneurysmal or occlusive arterial disease. The graft is coated with collagen to reduce porosity, necessitating patient heparinization during surgical implantation. The device is intended for use in an operating room setting by qualified surgeons. It serves as a permanent implant to replace or bypass diseased arterial segments, thereby restoring hemodynamic function and preventing complications associated with aneurysms or arterial occlusions.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on regulatory review of the 510(k) submission.

Technological Characteristics

Woven vascular prosthesis; collagen-coated surface; low-porosity design. Intended for permanent implantation in the arterial system.

Indications for Use

Indicated for patients requiring surgical repair, bypass, or replacement of arteries due to aneurysmal or occlusive disease of the thoracic aorta, abdominal aorta, visceral arteries, or proximal peripheral arteries. Recommended for patients requiring heparinization due to low graft porosity.

Regulatory Classification

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.

Special Controls

*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.”

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 1999

Mr. James S. Miller Director Director
Regulatory Affairs and Quality Assurance InterVascular, Inc. 16331 Bay Vista Drive Clearwater, FL 34620

Re : K984294 Rooms Requlatory Class: II Product Code: DSY Dated: November 30, 1998 Received: December 1, 1998

Dear Mr. Miller:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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## Page 2 - Mr. James S. Miller

This letter will allow you to begin marketing your device as Inis lecter will arrow you oo boyer management. The FDA finding described in your stority promises of your device to a legally marketed of Subscancial equivalence on possification for your device and production as a read to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advice for paintionally 809.10 for in viron regulation (21 crk rare our and active of Compliance at Glaghostic devices), proase y, for questions on the promotion and (Joi) 391 1010. The device, please contact the Office of auvertising or your actise/9. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (21CFK 807.97). Octice general in ormacobtained from the Division responsibilities and one one of its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,
Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## PRODUCT INDICATIONS FOR USE (Page 1 of 1)

- K Q8 4294 510(k) Number:
- InterGard Woven Collagen Coated Vascular Prostheses Device Name:
- Indications for Use: InterGard Woven 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

y Over-The-Counter Use Prescription Use OR (Per 21 CFR 801.109)

Bert R. Groulx

(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K984294