INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES

K970843 · Intervascular, Inc. · DSY · Jun 5, 1997 · Cardiovascular

Device Facts

• Record ID: K970843
• Device Name: INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES
• Applicant: Intervascular, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Jun 5, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

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 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 features a collagen coating to reduce porosity, necessitating heparinization during surgical implantation to manage coagulation. The device is intended for clinical use in an operating room setting. It serves as a permanent implant to replace or bypass diseased arterial segments, thereby restoring circulatory function and preventing complications associated with aneurysms or arterial occlusions.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence determination.

Technological Characteristics

Woven vascular prosthesis; collagen-coated to achieve low porosity; intended for surgical implantation; class II device (Product Code DSY).

Indications for Use

Indicated for patients requiring surgical repair, bypass, or replacement of arteries due to aneurysmal or occlusive disease of the abdominal aorta, visceral arteries, and 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 5 1997

Ms. Melissa L. Billman
Regulatory Affairs Associate
InterVascular, Inc.
16331 Bay Vista Drive
Clearwater, Florida 34620

Re: K970843
InterGard™ Woven Collagen Coated Vascular Prostheses
Regulatory Class: II (Two)
Product Code: DSY
Dated: March 6, 1997
Received: March 7, 1997

Dear Ms. Billman:

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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and labeling, and prohibitions against 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further 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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulation.

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Page 2 - Ms. Melissa L. Billman

Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(1)(A) the device cleared for marketing by this letter as requiring postmarket surveillance.

Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.

Submit five (5) copies to:

Center for Devices and Radiological Health
Postmarket Surveillance Studies Document Center
Room 3083 (HFZ-544)
1350 Piccard Drive
Rockville, Maryland 20850

Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).

Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(1)(C) of the Act (21 U.S.C. 331 (q)(1)(C). Further, under section 502(t)(3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.

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Page 3 - Ms. Melissa L. Billman

If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at [phone].

In addition, on August 16, 1993, the Final Rule for Device Tracking was published in the *Federal Register*, pages 43442-43455 (Copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the regulation are found in 21 CFR 821 as described in the August 16, 1993 *Federal Register* beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in 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 809 for *in vitro* diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."

Sincerely yours,


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

Enclosures

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870.3460 - Vascular Graft Prosthesis of 6 Millim
or Greater Diameter
DSY II

# PRODUCT INDICATIONS FOR USE

(Page 1 of 1)

510 (k) Number: K970843

Device Name: InterGard Woven Collagen Coated Vascular Prostheses

Indications for 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.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K970843

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