PRESSURE DISPLAY BOX,DLP DISPOSABLE PRESSURE DISPLAY SETS-NON STERILE VERSIONS

{0}------------------------------------------------ <113235 pg 1 of 2 DEC - 2 2011 ## 510(k) Summary Date Prepared October 28, 2011 Submitter Medtronic. Inc. Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 Establish Registration Number: 2184009 Contact Person Amra Racic Regulatory Affairs Specialist 8200 Coral Sea Street NE. Mounds View, MN 55433 Phone: (763) 514-9838 Fax: (763) 367-8360 Email: amra.racic@medtronic.com ### Device Name and Classification Trade Name: Common Name: Regulation Number: Product Code: Classification: Pressure Display Box DLP® Disposable Pressure Display Set Cardiopulmonary bypass coronary pressure gauge Box: 21 CFR 870.4310 DXS Class II #### Predicate Device . Pressure Display Box and Pressure Tubing Set (K852232 - Cleared August 09, 1985) #### Comparison to Predicate Device A comparison of the modified device and the currently marketed Pressure Display Box and DLP Disposable Pressure Display Sets show the following similarities: - · Same intended use since the proposed labeling changes. - · Same operating principle. - · Same technological characteristics. - · Same performance claims. {1}------------------------------------------------ # KU3235 P92052 #### Description of Device Modification and the Reasons for Implementation No modifications have been made to the Devices as a result of this change. This submission is a result of a change to the labeling. The devices operating principle and technological characteristics are remaining the same. As described in this submission, minor modifications since the original submission have been made to the Devices Directions for Use and the device packaging labels for the convenience of the user. #### Intended Use The intended use remains unchanged for both devices from the current version of the IFU. #### Pressure Display Box This product is intended for use in displaving line pressures during cardiopulmonary bypass surgery. #### DLP® Disposable Pressure Display Set This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products. #### Conclusion The modifications to the Pressure Display Box and the DLP Disposable Pressure Display Set described in this submission result in a substantially equivalent device because the fundamental scientific technology and the intended use are unchanged since the proposed labeling change. {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 stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC - 2 2011 Medtronic. Inc. c/o Ms. Amra Racic Regulatory Affairs Specialist Medtronic Cardiovascular MVS83 8200 Coral Sea Street NE Mounds View, MN 55112 Re: K113235 Trade/Device Name: Medtronic Pressure Display box and DLP Disposable Pressure Display Regulation Number: 21 CFR 870.4310 Regulation Name: Cardiopulmonary bypass coronary pressure gauge Regulatory Class: Class II Product Code: DXS Dated: October 28, 2011 Received: November 2, 2011 Dear Ms. Racic: 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. Amra Racic 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 vours. M. A. Hillebrenner سر Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ KU3235 # Indications for Use 510(k) Number (if known): Device Name: Pressure Display Box DLP® Disposable Pressure Display Set ## Pressure Display Box Indications for Use: This product is intended for use in displaying line pressures during cardiopulmonary bypass surgery. ## DLP® Disposable Pressure Display Set Indications for Use: This product is intended for use in monitoring catheter, cannula, or line pressures associated with cardiopulmonary bypass equipment and/or related products. 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 IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) M. 7 . Willels (Division Sign-Off) Division of Cardiovascular Devices KII 3235 510(k) Number