VENAFLO II VASCULAR GRAFT

{0}------------------------------------------------ ## Venafio II Vascular Graft 510(k) Summary of Safety and Effectiveness 21 CFR 807.92(a). ### General Information: | Submitter Name: | Bard Peripheral Vascular, Inc. | |----------------------|----------------------------------------------------------------| | Address: | 1625 W. Third Street<br>P. O. Box 1740<br>Tempe, AZ 85280-1740 | | Telephone Number: | (480) 894-9515 ext. 2836 | | Fax Number: | (480) 449-2546 | | Contact Person: | Glenn Norton | | Date of Preparation: | August 19, 2005 | ### Device Information: | Device Name: | Venaflo™ II Vascular Graft | |-----------------------|--------------------------------------------------------------------------------------------------------------------------------| | Trade Name: | Venaflo™ II | | Common/Usual Name: | Arteriovenous Vascular Graft | | Classification Name: | 74 DSY - Prosthesis, Vascular Graft,<br>Of 6mm and Greater Diameter<br>21 CFR 870.3450 - Class II<br>Vascular graft prosthesis | | Classification Panel: | Cardiovascular | ### Predicate Device: IMPRA Venaflo™ Vascular Graft, K981079, concurrence date 05/07/1998. ## Summary of Change: The Venaflo Vascular Graft is being modified with printed trim lines on a more The Vehance Vaboutived venous cuff profile to enhance the good hemodynamic surformance of the predicate design. All other aspects of the modified device remain performance of the predicate device. The changes optimize venous cuff sizing for the the bains as are rimming the cuff for veins 8mm and smaller, and improve hemodynamic performance at the venous anastomosis. ### Device Description: Venaflo II arteriovenous vascular grafts have a pre-formed venous cuff to promote venano II atterrovenous variate at the venous anastomosis. Venaflo II grafts are {1}------------------------------------------------ available in various lengths and diameters, in straight and stepped configurations, with and without external support. ## Intended Use of Device: Venaflo™ II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only. ## Technological Comparison to Predicate Device: The technological characteristics of Venaflo II vascular grafts are substantially equivalent to those of the predicate Venaflo vascular graft in terms of intended use, oquireation, user population, basic design, performance, labeling, packaging, and sterilization method. ## Non-Clinical Performance Data: Design verification of the modified device was done with conformance to or evaluated based on the following FDA Guidance and industry standards: - Guidance Document for Vascular Prosthesis 510(k) Submissions, dated . 11/01/2000 - ANSI/AAMI VP20-1994, Cardiovascular Implants Vascular Prosthesis ● - ANSI/AAMI/ISO 7198: 1998/2001, Cardiovascular implants Tubular . vascular implants - AAMI/ANSI/ISO 10993-1: 1997, Biological evaluation of medical devices -. Part 1: Evaluation and testing, and the FDA Modified ISO 10993 Test Profile - AAMI/ANSI/ISO 10993-7: 1995, Biological evaluation of medical devices -. Part 1: Ethylene Oxide Sterilization Residuals - AAMI/ANSI/ISO 11135:1994, Medical Devices -- Validation and Routine . Control of Ethylene Oxide Sterilization All test results confirm the modified device to be substantially equivalent to the predicate device. ## Conclusions: Venaflo II Vascular Grafts met all predetermined acceptance criteria of design verification and validation as required by the risk analysis, and as specified by applicable standards, guidance's, test protocols and/or customer inputs. Venaflo II Vascular Grafts are substantially equivalent to the legally marketed predicate device, the Venaflo Vascular Graft, K981079, concurrence date May 5, 1998. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized lines that appear to be a symbol or logo for the department. SEP 2 0 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Bard Peripheral Vascular, Inc. c/o Mr. Glenn Norton 1625 W. Third Street P.O. Box 1740 Tempe, AZ 85280-1740 Re: K052282 Venaflo™ II Vascular Graft Venano - Frances 21 CFR 870.3450 Regulation Number: 21 CFR 8 70.3430 Regulation Name: Vascular Graft Prosthesis of Less than 6MM Diameter S Regulatiory Class: Class II (two) Product Code: DSY Dated: August 19, 2005 Received: August 23, 2005 Dear Mr. Norton: Deal 110.00 We have reviewed your Section 510(t) premarket notification of the indications referenced above and have determined the device is substantially equivalent in interstate welered above and have determined the devices marketed in interstate for use stated in the enclosure) to legally marketed in interstate for use stated in the enclosure) to legally market predical Device Amendents, or to commerce prior to May 28, 1976, the enactment date of the Medical Device Amendents, or to for as a more of the mastment and of the wedness of the Federal Food. Dough, the Federal Food, Drug, devices that have been reclassified in accordance with the provisited app devices that have been reclassified in accordance with the proval application (PMA). devices that have been reclassified in accordance approval opproval oppiocions of the Ac de cosmetic Act (Act) that do not require approval of a previsions of the Act. The Act. The You may, therefore, market the device, subject to the general ontrols provisions and Course, market the Act include requirements for amual registration, listing of general controls provisions of the Act include requirements for annual misbranding and s and of the Act include requirements for millian regultents for minds regional would be devices, good manufacturing practice, labeling, and prohibitions against misbranding adulteration. additions is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (see above) into either class if (special connelle) may be subject to such additional controls. Existing major regulations affecting your device n your article of Federal Regulations, Title 21, Parts 800 to 898. In addition, PDA may may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may b be found in the Code of Federal Regulations, Title 21, Farls C publish further announcements concerning your device in the Federal Register. {3}------------------------------------------------ Page 2 - Mr. Glenn Norton Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ### Section 1-B ## Venaflo™ II Vascular Graft Special 510(k) # INDICATION(S) FOR USE STATEMENT* I state in my capacity as Regulatory Affairs Associate Project Manage of Bard I state in my capacity as regulatery - taxion [510(k)] for the Venaflo™ II Vascular Graft is indicated for the following: " Venaflo ™ II Vascular Grafts are indicated for use as subcutaneous arteriovenous conduits for blood access only." Signature of 510(k) Submitter: Printed Name of Submitter: Glenn Norton Glenn Norton Date: 8/19/05 *Suggested language and format to meet the requirements of sections 513(i) of the *Suggested fallguage and format to meet the required and sections 807.92(a)(5) and 801.4 of the Code of Federal Regulations, Title 21. X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) | | Concurrence of CDRH, Office of Device Evaluation (ODE) | |-------------------|---------------------------------------------------------------------------| | | <div><img alt="Signature" src="signature.png"/></div> (Division Sign-Off) | | 510(k) Number | k052282-Division of Cardiovascular Devices | | | 510(k) Number k052282 | | Division Sign-Off | | | | Office of Device Evaluation |