(26 days)
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.
InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches
This document is a 510(k) clearance letter from the FDA, which declares substantial equivalence for the InterGard™ Knitted Ultra Thin Collagen Coated Vascular Grafts and Patches. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the way a clinical trial report or a performance study would.
Therefore, I cannot provide the requested information based on the provided text, as this document type typically does not include the details of performance studies or acceptance criteria tables. The FDA 510(k) clearance process relies on demonstrating substantial equivalence to a predicate device, rather than requiring extensive new performance studies in all cases.
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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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
§ 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.”