INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS

{0}------------------------------------------------ ## 510(K) SUMMARY This summary of safety and effectiveness information is being submitted in accordance with This summer 1917 A 4980 - d 21 CFR . Part 807.92. I his suffifiary of safety and executive and 21 CFR, Part 807.92. 4990800 Robert Hill, Director Regulatory Affairs & Quality Assurance Name: InterVascular, La Ciotat, France Address: 33-442087786 Telephone: 33-442081349 Fax: InterGard Knitted Collagen Coated & Heparin Bonded Trade Names: Vascular Prostheses. Vascural Prosulesos. InterGard Knitted Ultra-Thin Collagen Coated & Heparin Bonded Vascular Prostheses. Vascular Prostheses or Grafts Common Names: 21 CFR 870.3460, Vascular graft prostheses of 6 mm and Classification Name: greater diameter InterGard Knitted Collagen Coated Vascular Prostheses Predicate Names: InterGard Knitted Ultra-Thin Collagen Coated Vascular Prostheses The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prostheses including The Interesati Khinee Conagen Grafts made of Dacron fabric and coated with bovine Natied Onla-Xhin, are Visousan Shares are offered in numerous lengths and diameters exceeding 6 mm. The InterGard Knitted Collagen Coated & Heparin Bonded Vascular Prosthesis is indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive disease of the abdominal aotta, visceral arteries and pexipheral arteries. Due to the low porosity of the InterGard vascular grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery. The Indications for these products are the same as the predicate devices. The InterGard Knitted Collagen Coated and Heparin Bonded Vascular Prostheses have similar technological characteristics as their predicate devices, including the use of the same underlying fabric and collagen coating material. These products also meet the same strength (circumferential probe burst and radial strength), collagen adherence, and water permeability {1}------------------------------------------------ specifications as the predicate devices. Testing was conducted consistent with AAMI n benefit and specifications as the predicate cevits: "These results were validated by bench and animal studies and further supported by published clinical data. Based on the conclusions drawn from the safety analysis conducted on this device, the Based on the conclusions wawn from the sace, and you conded grafts are safe and perform in a manner equivalent to the predicate devices mentioned above. . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three overlapping, curved shapes that resemble an abstract representation of the human form. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 8 2001 Mr. Vincent Bucci President President Health Policy Associates, Inc. c/o InterVascular, Inc. C70 Walnut Street, Suite 12 Wellesley, MA 02181 K990800/S3 Trade Name: InterGard Knitted Ultra Thin Collagen Coated and Re : InterGard Knifted Urcra Thin Corpos and InterGard Heparin Bonded Vascular Proschebro and Grafts Regulatory Class: II Product Code: DSY Froddo. November 21, 2000 Baccived: December 11, 2000 Dear Mr. Bucci: We have reviewed your Section .510 (k) notification of intent to market is a more and show and shows and we have determined the device is We have reviewed your wection we have determined the device is the device referenced above and we indications for use stated in the substantially equivalent (for the indications for use ted in substantially equivalent (for the increase devices marketed in enclosure) to legally marketed predicate activent date of the interstate commerce prior to May 20, 1970, che bare been reclassified Medical Device Amendment, or to devices that have been Food, Drug, and Medical Device Amendments, of the Federal Food, Drug, and in accordance with the provisions of the rederal room, season of the productions of the productions Cosmetic Act (Act). You may, the Act. The general controls the general controls provisions of the neers for annual registration, provisions of the Act include requirements for annual registration, and provisions of the Act Include requirements rise and the listing of devices, good mandidor. prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special If your device is classified (see above) incoles may be subject to such (Premiarket Approval)) is major regulations affecting your device additional controls. additional controls. Existing mayor roylations, Title 21, Parts 800 can be found in the Code of Federal Regioninations, assumes compliance can be found in the Code of regulvation assumes compliance to 895. A substantially equivalent determination assumes as set to 895. A substantially equivating assessments, as set with the Current Good Manufacturing Practice requirements, Devices: with the Current Good nameraccaring (QS) for Medical Devices: forth in the Quality System Regulation (QS) for Medical periodic forth in the Quality System Regulation (20) - , through periodic QS General regulation (21 CFR Part 820) and that, FDD) will verify Su General regulation (2) Crk rate book (FDA) will verify such the rood and brug Administration may result in assumptions. assumptions. Frailure to Compry with the end asy and any our ements regulatory action. In addition, FDA may publish further announcements {3}------------------------------------------------ Page 2- Mr. Vincent Bucci concerning your device in the Federal Register. Please note: this concerning your actroon submission submission does not affect any response to your premains under sections 531 through 542 of the Act obligation you might have ander broduct Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described inis recei will arrow you co icention. The FDA finding of substantial in your 510(x) premainte noto a legally marketed predicate device equivalence or 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 regulation (21 crk rare over and the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 807.97). MESDIanding by Formation on your responsibilities under the Act may other general information on your as a manufacturers Assistance at its be obtained rrom the broad-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Stacey Anthony Lee or James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health {4}------------------------------------------------ ## PRODUCT INDICATIONS FOR USE (Page 1 of 1) 1990800 510(k) Number: Device Names: Indications for Use: InterGard Knitted Collagen Coated and Heparin Bonded Vascular Prosthesis : . . InterGard Knitted Ultra Thin Collagen Coated and Heparin Coated College Presthasis Bonded Vascular Prosthesis InterGard Collagen Coated and Heparin Bonded vascular Collagen Collage Collection ourgical repair, hypass, of InterGard Collagen Coated for surgical repair, bypass, or prostheses are indicated for surgical repair, of aneurysmal prostheses are indicated in the treatment of aneurysmal replacement of arenes in the abdominal and and wisceral and occusive disease of the unceries. Due to the low porceity arteries, and penpheral arteries. Fecommended for use in of the grans, these products are resomment. 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 Aram Patrus. 1-5- OR **Division of Cardiovascular & Respiratory Devices** 510(k) Number K990800