INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN

K983819 · Intervascular, Inc. · DSY · Nov 24, 1998 · Cardiovascular

Device Facts

• Record ID: K983819
• Device Name: INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN
• Applicant: Intervascular, Inc.
• Product Code: DSY · Cardiovascular
• Decision Date: Nov 24, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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. The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Device Story

InterGard Knitted Ultra Thin Collagen Coated Vascular Grafts and HemaCarotid Patch Ultra Thin are implantable devices used by surgeons for arterial repair, bypass, replacement, or patch angioplasty. Grafts treat aneurysmal and occlusive disease of proximal peripheral arteries; patches are used in cardiac and vascular procedures. Devices feature low-porosity fabric coated with collagen to minimize leakage; recommended for patients requiring heparinization. Implantation occurs in surgical settings. Devices provide structural support for vascular reconstruction, facilitating blood flow restoration and vessel wall repair.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Knitted vascular grafts and patches; collagen-coated; low-porosity fabric construction. Designed for surgical implantation.

Indications for Use

Indicated for patients requiring surgical repair, bypass, or replacement of arteries for aneurysmal and occlusive disease of proximal peripheral arteries (grafts) or cardiac/vascular patch graft angioplasty (patches). Recommended for patients requiring heparinization due to low 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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## NOV 2 4 196

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James S. Miller Director Regulatory Affairs and Quality Assurance InterVascular, Inc. 16331 Bay Vista Drive Clearwater, FL 33760

Re: K983819 InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches Regulatory Class: II (Two) Product Code: 74 DSY Dated: October 28, 1998 Received: October 29, 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 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 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 Existing major regulations affecting your device additional controls. can be found in the Code of Federal Requlations, 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 regulatory action. In addition, 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 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 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 809.10 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]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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. Callahon

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)

- 510(k) Number: K983819
- InterGard Knitted Ultra Thin Collagen Coated Vascular Grafts Device Name: · HemaCarotid Patch Ultra Thin Collagen Coated Vascular Patches

1.1.12.2.1.2.2.1.2.0.1.

Indications for Use:

InterGard Knitted Ultra Thin Vascular Graft

- InterGard knitted Ultra Thin collagen coated vascular grafts are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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.
HemaCarotid Patch Ultra Thin

The HemaCarotid Patch Ultra Thin is indicated for cardiac and vascular patch graft angioplasty. Due to the low porosity of the fabric, these products are recommended for use in patients requiring heparinization prior to or during surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Bea Reynolds

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_K 988819

OR