LEVITRONIX PEDIMAG BLOOD PUMP, MODEL 201-90052

{0}------------------------------------------------ ## 510(k) Summary - Levitronix PediMag Blood Pump This summary of 510(k) safety and effectiveness information is being submitted in accordance with the Safe Medical Devices Act (SMDA) of 1990 and Title 21 of the Code of Federal Regulations, Part 807, and in particular §807.92. #### A. Application Information OCT - 8 2009 Date Prepared: Submitter's Name & Address: Levitronix LLC 45 First Avenue Waltham, MA 02451 October 2, 2009 Contact Person: Susan K. Hamann Regulatory Affairs Manager Ph: (781) 466-6553 Fax: (781) 622-5090 e-mail: shamann@levitronix.com #### B. Device Information PediMag® Blood Pump Trade or Proprietary Name: Common or Usual Name: Classification Name: Performance Standard: Pump, blood, cardiopulmonary bypass, nonroller type (21 CFR 870.4360, Product Code Centrifugal Pump KFM) Performance standards do not currently exist for these devices. None established under section 514 of the Food, Drug and Cosmetic Act. #### C. Legally Marketed Predicate Devices - Levitronix CentriMag Blood Pump (K020271) . - Medtronic Bio-Pump BP-50 Centrifugal Blood Pump (K852807) . #### D. Device Description The PediMag Blood Pump is a sterile, single-use, disposable, non-coated, polycarbonate centrifuqal blood pump. The pump has a 14 ml priming volume. The pump inlet is on the rotational axis of the impeller whereas the pump outlet is perpendicular to the inlet and tangent to the outer diameter. Both the inlet and outlet ports include standard 1/4 inch barbed connectors for easy mating to {1}------------------------------------------------ standard medical grade 1/4 inch tubing. The Pump is designed to move blood by centrifuqal force created by the magnetically suspended rotating impeller. #### ប៉ Intended Use The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.). The PediMag Pump can generate a maximum pump flow equal to 1,5 liters per minute, limiting its use to pediatric patients. The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor. #### F. Technological Characteristics The technological characteristics of the Levitronix PediMag Blood Pump are the same as the predicate devices. #### Comparison to Predicate Devices G. The Levitronix PediMag Blood Pump has an indication for use, design features, and functional characteristics which are substantially equivalent to the predicate devices. The device raises no new safety or effectiveness issues. #### H. Summary of Performance Data The Levitronix PediMag Blood Pump has successfully undergone functional testing demonstrating substantial equivalence to the predicate devices. #### 1. Clinical Performance Clinical testing was not performed on this system. #### J. Conclusion The Levitronix PediMag Blood Pump is substantially equivalent to the Levitronix CentriMag Blood Pump (K020271) and to the Medtronic Bio-Pump BP-50 Centrifugal Blood Pump (K852807). {2}------------------------------------------------ Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized depiction of an eagle, with three wavy lines representing its wings and body. ### DEPARTMENT OF HEALTH & HUMAN SERVICES Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002 Levitronix LLC c/o Ms. Susan K. Hamann 45 First Avenue Waltham, MA 02451 OCT - 8 2009 Re: K090051 Trade/Device Name: Levitronix PediMag Blood Pump, Model 201-90052 Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class III Product Code: KFM Dated: August 31, 2009 Received: September 1, 2009 Dear Ms. Hamann: 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. 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 {3}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical Page 2 - Ms. Susan, K. Hamann 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/ResourcesforYou/Industry/default.htm. Sincerely yours, Duna R. Lahner O 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): K090051 Device Name: Levitronix PediMag Blood Pump, Model 201-90052 Indications For Use: The PediMag Blood Pump is indicated for use with the CentriMag Console and Motor to pump blood through a complete extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours) for surgical procedures such as a mitral valve reoperation. It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, surgery of the vena cava or aorta, liver transplants etc.). The PediMag Pump can generate a maximum pump flow equal to 1.5 liters per minute, limiting its use to pediatric patients. The Levitronix PediMag Blood Pump is indicated for use only with the Levitronix CentriMag Console and Motor. 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) Dunae D. Ause Division Sign-Off) Division of Cardiovascular Devices 510(K) Number Ko 9005 L Page 1 of 1