FLUORO-TEX CARDIOVASCULAR PATCH

{0}------------------------------------------------ JUL - 7 2000 K994032 ## Section 9 ## 5.10 (k) Summary | Contact Person: | Bruce Ruefer<br>2430 N. 7th Ave., Ste. 4<br>Bozeman, MT 59715<br>Ph: 406-58607666, Fax 406-586-5665 | |----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date Prepared: | July 7, 2000 | | Classification Name: | PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE,<br>POLYPROPYLENE | | Common Name: | Cardiovascular Patch | | Trade Name: | Fluoro-Tex™ Cardiovascular Patch | | Classification Code: | DXZ | | Device Predicates: | Gore-Tex® Cardiovascular Patch<br>Impra® Cardiovascular Patch | | Device Description: | Fluoro-Tex Cardiovascular Patch consists of a sheet of porous<br>expanded polytetrafluoroethylene (ePTFE) internally reinforced<br>with fluorinated ethylene propylene (FEP). | | Statement of Intended Use: | | The Fluoro-Tex Cardiovascular Patch is intended for the repair of the cardiovascular system. Substantial Equivalence: The Fluoro-Tex Cardiovascular Patch is substantially equivalent to Gore-Tex® Cardiovascular Patch and IMPRA Cardiovascular Repair Patch. The predicate devices consist of a sheet of porous expanded polytetrafluoroethylene (ePTFE); The Fluoro-Tex Cardiovascular Patch and the predicate devices are intended for the repair of cardiovascular defects {1}------------------------------------------------ ## 5.10 (k) Summary (page 2) Discussion of Testing Performed: - The Fluoro-Tex Cardiovascular Patch was mechanically tested and 1. compared to the predicate devices according to the following table: | | Gore-Tex®<br>Cardiovascular Patch | IMPRA®<br>Cardiovascular<br>Patch | Fluoro-Tex™<br>Cardiovascular<br>Patch | |------------------------------|-----------------------------------|-----------------------------------|----------------------------------------| | Tensile Strength<br>(kg/cm2) | 26.7, n=4 | 20.5, n=4 | 20.7, n=6 | | Suture Strength<br>(kg/pin) | 2.1, n=4 | 1.8, n=4 | 2.0, n=6 | | Burst Strength<br>(psi) | Na | 294, n=5 | 284, n=5 | - The Fluoro-Tex Cardiovascular Patch was tested and found 2. biocompatible via cytotox, FTIR, and extensive in-house cleanliness testing. Full biocompatibility testing for this device was not done as the device is constructed of PTFE, a polymer known and demonstrated to be safe, biocompatible, non-reactive, and the same polymer from which the legally marketed predicate devices are made. ## CONCLUSION: Mechanical and chemical tests, including material strength and chemical identification of the materials demonstrate that the Fluoro-Tex™ Cardiovascular Patch, the GORE-TEX® Cardiovascular Patch and the IMPRA® Cardiovascular Repair Patch are substantially equivalent Bruce G. Ruefer, President date GORE-TEX is a Registered Trademark of W.L. Gore and Associate Fluoro-Tex is a Trademark of Bridger Biomed Inc. IMPRA is a Registered Trademark of C.R. Bard Inc. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 7 2000 Mr. Bruce G. Ruefer President Bridger Biomed, Inc. 2430 N.7th Street, Ste. 4 Bozeman, MT 59715 K994032 Re: Fluoro-Tex Cardiovascular Patch Regulatory Class: II (two) Product Code: DXZ Dated: April 6, 2000 Received: April 10, 2000 Dear Mr. Ruefer: We have reviewed your Section 510(k) notification of intent to market We have reviewed your becerem or (i), (i) (in the device is a the device referenced above and no have to use stated in the s substancially equivalemarketed predicate devices marketed in enclosure) to regally markeed problems and has monthest of the interstate Commence prior of the connects that have been reclassified Medical Device Amendments) of to active Federal Food, Drug, and in accordance with the provisions or the market the device, subject to Cosmetic Act (Acc). "Ioa maj/ controls of the general controls che general concrolo provide requirements for annual registration, provisions of the nee increase solucing practice, labeling, and Frocing or a against misbranding and adulteration. If your device is classified (see above) into either class II (Special II your device IS Classilled (800 abbroval), it may be subject to such Controls) of Class III (Fremands off) additional controls. Existing major regulations affection Repto 800 additional concrors. Enrostigations, Title 21, Parts 800 can be round in the out equivalent determination assumes compliance co oys. It babbandood Manufacturing Practice requirements, as set with the current oose natem Regulation (QS) for Medical Devices: rorth in the gaardy of CFR Part 820) and that, through periodic QS General regulation od Drug Administration (FDA) will verify such Inspections, the rood and Buy with the GMP regulation may result in assumptions. Furral of compari regarders in the Federal Register . Please notė: this concerning your acremarket notification submission does not affect any response to your pat have under sections 531 through 542 of the Act obligation you might have and one of the Control provisions, or other Federal laws or regulations. {3}------------------------------------------------ Page 2 - Mr. Bruce G. Ruefer 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 Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Brim E. Harvey James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Page 510(k) Number (if known): _K994032 Device Name: Fluoro-Tex™ Cardiovascular Patch Indications For Use: The Fluoro-Tex™ Cardiovascular Patch is intended to be used for the repair of the cardiovascular system. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Tom E. Haneym Blina Shanker (Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devi 510(k) Number _ (Optional Format 3-10-98)