DLP Vein Graft Cannula

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the graphic. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 7, 2015 Medtronic, Inc. Kevin Lam Senior Regulatory Affairs Specialist 7611 Northland Drive Minneapolis, MN 55428 Re: K143107 Trade/Device Name: DLP Vein Graft Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 4, 2014 Received: December 8, 2014 Dear Mr. Lam, We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, M.A. Hilleman for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use ### Device Name DLP® Vein Graft Cannula #### Indications for Use (Describe) This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft. Type of Use (Select one or both, as applicable) � Prescription Use (Part 21 CFR 801 Subpart D) [ ]Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 510(k) Summary | Date Prepared: | December 4, 2014 | |-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428<br>Establishment Registration Number: 2184009 | | Contact Person: | Kevin T. Lam<br>Senior Regulatory Affairs Specialist<br>Medtronic, Inc.<br>Phone: (763) 526-2360<br>Fax: (763) 367-8360<br>Email: kevin.t.lam@medtronic.com | | | Alternate Contacts:<br>Susan C. Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic, Inc.<br>Phone: (763) 514-9839<br>Fax: (763) 367-8360<br>Email: susan.c.fidler@medtronic.com | | Device Name and Classification<br>Trade Name: | DLP® Vein Graft Cannula | Common Name: Product Code: Regulation Number: Product Classification: Models: 10010 and 10011 Cardiopulmonary bypass vascular catheter, cannula, or tubing DWF 21 CFR 870.4210 Class II Classification: # Predicate Device DLP® Vein Graft Cannula K791832 {4}------------------------------------------------ ## Indications for Use This cannula is intended for use in conjunction with cardiopulmonary bypass surgery for up to 6 hours. When properly placed, it can be used to deliver blood (or fluids) to the proximal end of a vein graft. ## Device Description The cannula has a graduated, soft silicone, rubber tip to accommodate vessels of various sizes. The attached 50.8 cm (20 in) flexible tube has a clamp to stop flow through the cannula. Model 10011 has an additional clamp on the antegrade outlet line to stop the flow of fluid into the antegrade cannula. The antegrade cannula connector is a male luer adapter. The cardioplegia inlet fitting is a female luer port. Sterile, nonpyrogenic, single use. ## Comparison to Predicate Devices - Same intended use - Same technological characteristics - . Same operating principle - . Same design features - Same base materials Acrylic, Polypropylene, Polyvinyl chloride (PVC), Silicone ● - Same shelf life ● ## Summary of Performance Data Testing has demonstrated that the DLP® Vein Graft Cannula is substantially equivalent to the predicate. The following performance tests were conducted: | Change | Verification/Validation | Results | |-------------------------------------------------------------------------|--------------------------------------------------|----------------------| | <b>For Model 10010</b><br>Bonding to male luer | Air Flow Test<br>Leak Test<br>Bond Strength Test | Pass<br>Pass<br>Pass | | <b>For Model 10010</b><br>Y-Connector changed to in-house manufacturing | Air flow test | Pass | {5}------------------------------------------------ ## Conclusion Medtronic has demonstrated that the modifications made to the DLP® Vein Graft Cannulae products described in this submission resulted in a substantially equivalent device because the fundamental scientific principle, operating principle, design features, and intended use are unchanged from the predicate device.