DLP SINGLE STAGE VENOUS CANNULA INFLATABLE CUFF

{0}------------------------------------------------ K120987 JUN - 6 2012 # 510(k) Summary Date Prepared March 30, 2012 Submitter Medtronic, Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establishment Registration Number: 2184009 # Contact Person Emily Blus Regulatory Affairs Operations Specialist 8200 Coral Sea Street NE Mounds View, MN 55433 Phone: (763) 514-9853 Fax: (763) 367-836 Email: emily.blus@medtronic.com Alternate Contact: Susan Fidler Senior Regulatory Affairs Manager Medtronic Perfusion Systems Phone: 763.514.9839 763.367.8360 Fax: Email: susan.c.filder@medtronic.com #### Device Name and Classification | Trade Name: | DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff | |--------------------|----------------------------------------------------------------| | Common Name: | Cardiopulmonary bypass vascular catheter, cannula, or tubing | | Regulation Number: | 21 CFR 870.4210 | | Product Code: | DWF | | Classification: | Class II | # Predicate Device K854487 Venous Return Cannula with Cuff {1}------------------------------------------------ ### Device Description The DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff is used during cardiopulmonary bypass surgical procedures for collecting and directing blood from the right side of the heart via the superior and inferior vena cava into the bypass circuit. These cannulae are comprised of a wire-wound, kink-resistant silicone cannula body with a nominal tip outer diameter of 37Fr and an overall length of 15 inches. The DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff model features a manually inflatable silicone inflatable cuff near the distal tip of the device which, once inflated, assists in maintaining the position of the device throughout the cardiopulmonary bypass procedure. #### Indications for Use These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. #### Contraindications This device is contraindicated for long-term use. Do not use for extended terms such as Ventricular Assist procedures. ### Comparison to Predicate Device A comparison of the modified device to the currently marketed DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff notes the following similarities: - . Same intended use - . Same operating principle - . Same technological characteristics - . Same design features - Same shelf life . #### Conclusion Medtronic has demonstrated that the modifications to the DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff described in this submission result in a substantially equivalent device because the fundamental scientific technology, the intended use, operating principle and design features are unchanged since the predicate device. Any noted differences do not raise new issues of safety and effectiveness. {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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 JUN - 6 2012 Medtronic. Inc. c/o Ms. Jacqueline A. Hauge Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, MN 55112 Re: K120987 Trade/Device Name: DLP Silicone Single Stage Venous Cannula with Inflatable Cuff Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: May 10, 2012 Received: May 11, 2012 Dear Ms. Hauge: 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 {3}------------------------------------------------ Page 2 - Ms. Jacqueline A. Hauge 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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, M.A. Hillen Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K120987 DLP® Silicone Single Stage Venous Cannula with Inflatable Cuff Device Name: Indications For Use: These cannulae are intended for collection of venous blood from the right side of the heart via the superior and inferior vena cava during cardiopulmonary bypass surgery up to six hours or less. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) W.A. Hilliber Page 1 of 1 (Division Sign-Off) Division of Čardiovascular Devices 510(k) Number_k (20987