ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA)

{0}------------------------------------------------ K090515 MAQUET #### 510(k) Summary [as required by 21 CFR 807.92(c)] DEC 1 8 2009 | Submitter | MAQUET Cardiopulmonary AG<br>Hechinger Strasse 38<br>72145 Hirrlingen<br>Germany | |----------------|----------------------------------------------------------------------------------| | Contact Person | Frank Moehrke | | | Phone: 011 49 7478 921 229 | | | Fax: 011 49 7478 921 400 | Date Prepared February 24, 2009 Device Trade Name C Centrifugal Pump Common/Usual Name Classification Names Nonroller-type cardiopulmonary bypass blood pump (21 CFR 870.4360 - Product Code: KFM) Legally Marketed Devices . - RotaFlow Centrifugal Pump with BIOLINE Coating (K080470), RotaFlow Centrifugal Pump with Softline Coating - QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating (K082117) #### Device Description The RotaFlow Centrifugal Pump is a non-occlusive pump. The pump has a spinning rotor with flow channels which imparts rotary motion to incoming liquid, directing it through a spiral housing to the outflow port. #### Indications for Use The RotaFlow Centrifugal Pump is indicated as a.component of the extracorporeal circuit for pumping liguid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated. {1}------------------------------------------------ # MAQUET #### Statement of Technical Comparison The RotaFlow Centrifugal Pump with Softline Coating is identical to the RotaFlow Centrifugal Pump with BIOLINE Coating with the only exception that the RotaFlow Centrifugal Pump with Softline Coating has been coated with Softline Coating instead of BIOLINE Coating. However, the Softline Coating is the same as with the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating. Besides this difference the RotaFlow Centrifygal Pump with Softline Coating is the same in design, intended use, method of operation, components, packaging, and fundamental scientific technology as compared to the RotaFlow Centrifugal Pump with BIOLINE Coating. #### Determination of Substantial Equivalence Evaluation on safety and effectiveness was executed to demonstrate that the RotaFlow Centrifugal Pump with Softline Coating described in this submission is substantially equivalent to the RotaFlow Centrifugal Pump with BIOLINE Coating as pump and to the QUADROX-i Adult microporous membrane Oxygenator with and without integrated Arterial Filter with Softline Coating regarding the Softline Coating. The following areas have been evaluated: - Integrity . - Performance - Biocompatibility . - Sterility - #### Conclusion The data given demonstrate that the RotaFlow Centrifugal Pump with Softline Coating is substantially equivalent to the named predicate devices which hold currently market clearance. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002 Maquet Cardiopulmonary AG c/o Mr. Frank Moehrke Regulatory Affairs Manager Hechinger Strasse 38 72145 Hirringen Germany ### DEC 1 8 2009 Re: K090515 > Maquet RotaFlow Centrifugal Pump with Softline Coating Model BO-RF-32 Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III (three) Product Code: KFM Dated: November 23, 2009 Received: November 25, 2009 Dear Mr. Moehrke: 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. {3}------------------------------------------------ Page 2 – Mr. Frank Moehrke 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 (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 go to http://www.fda.gov/AboutiFDA/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, ram D/Zuckerman, M.D. Directo Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): كاركار 09 0510 Device Name: #### RotaFlow Centrifugal Pump with Softline Coating Indications for Use: The RotaFlow Centrifugal Pump is indicated as a component of the extracorporeal circuit for pumping liquid matter e.g. blood and can be used in conjunction with the RotaFlow Console. The utilization period of this device is restricted to six hours. The device is not designed or intended for use except as indicated. 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) Page 1 of 1 (Division Sign/Off) Division of Cardiovascular Devices 510(k) Number K090513