HEMOCONCENTRATOR

{0}------------------------------------------------ K123288 JUN 2 6 2013 ## MAQUET GETINGE GROUP ### 510(k) Summary [as required by 21 CFR 807.92(c)] | Submitter | MAQUET Cardiopulmonary AG<br>Kehler Strasse 31<br>76437 Rastatt<br>Germany | |----------------------|--------------------------------------------------------------------------------------------------------------------| | Contact Person | Dr. Ingrid Richter<br>Phone: 011 49 7478 921 337<br>Fax: 011 49 7478 921 8667<br>e-mail: ingrid.richter@maquet.com | | Date Prepared | October 19, 2012 | | Device Trade Name | Hemoconcentrators : BC 60 plus, BC 140 plus | | Common/Usual Name | Hemoconcentrator | | Classification Names | High Permeability Hemodialysis System<br>Hemoconcentrator<br>(21 CFR 876.5860 - Product Code: KDI) | | Predicate Devices | Hemocor HPH® 700, Minntech Corp. USA,<br>K983085<br>Hemocor HPH® 1400, Minntech Corp. USA, | #### Device Description BC 60 plus, BC 140 plus Hemoconcentrators are used to remove excess fluid from the blood during and/or following cardiopulmonary bypass procedures. Hemoconcentrators are ready for use after they have been filled and vented as the membrane contains no stabilizers. The type of Hemoconcentrator used is determined by the protocol used. Page 1 of 2 {1}------------------------------------------------ # MAQUET GETINGE GROUP #### Indications for Use The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator. #### Statement of Technical Comparison The Hemoconcentrators, BC 60 plus, BC 140 plus are comparable to the Hemocor HPH® 700 K983085, Hemocor HPH® 1400 K923139 from Minntech Corp. USA, reqarding the principals of operation, performance and indications for use. #### Non-clinical Testing The Hemoconcentrators BC 60 plus and BC 140 plus have been tested to and met the requirements of ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing as well as the requirements of ISO 8637 Cardiovascular implants and extracomoreal systems - Haemodialysers. haemodiafilters, haemofilters and haemoconcentrators. #### Determination of Substantial Equivalence Evaluation and testing on safety and effectiveness was executed to demonstrate that the Hemoconcentrators BC 60 plus, BC 140 plus described in this submission are substantially equivalent to the Hemocor HPH® 700 (K983085), Hemocor HPH® 1400 (K923139) from Minntech Corp., USA. The following areas have been tested and / or evaluated: - Integrity . - Performance - - Biocompatibility - - Sterility . #### Conclusion The data given demonstrate that the Hemoconcentrator BC 60 plus and BC 140 plus are substantially equivalent to the named predicate devices which have FDA market clearance. {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" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized waves or lines. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002 #### June 26, 2013 MAQUET Cardiopulmonary AG % Ms. Ingrid Richter Regulatory Affairs Manager Kehler Strasse 31 RASTATT 76437 GERMANY Re: K123288 Trade/Device Name: BC 60 plus, BC 140 plus Hemoconcentrator Regulation Number: 21 CFR§ 876.5860 Regulation Name: High permeability hemodialysis system Regulatory Class: II Product Code: KDI Dated: May 17, 2013 Received: May 20, 2013 Dear Ms. Richter: 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. {3}------------------------------------------------ Page 2 - Ms. Ingrid Richter 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/ReportalProblem/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 vours. # Herbert P. Lerner -S for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known): __K123288 Device Name: #### BC 60 plus, BC 140 plus Hemoconcentrator Indications for Use: The MAQUET Hemoconcentrators are used to remove excess fluid from the blood or to concentrate highly diluted blood solutions. They are only intended for use for blood concentration during and/or following cardiopulmonary bypass procedures. The maximum duration of use is 6 hours. The physician in charge of treatment has sole responsibility for decisions concerning use of the hemoconcentrator. Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use AND/OR (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 Herbert P. Lerner -S K123288 30