COBE REVOLUTION

{0}------------------------------------------------ ## FEB 1 2 2002 K011835 ## 510(k) Summary | SUBMITTER: | COBE Cardiovascular, Inc.<br>14401 W. 65th Way<br>Arvada, CO 80004 | |----------------------|---------------------------------------------------------------------| | CONTACT PERSON: | Lynne Leonard<br>Phone: (303) 467-6586<br>Fax: (303) 467-6429 | | DATE PREPARED: | June 1, 2001 | | DEVICE TRADE NAME: | COBE® Revolution™ Centrifugal Blood Pump | | COMMON/USUAL NAME: | Centrifugal Blood Pump | | CLASSIFICATION NAME: | Non-roller type cardiopulmonary bypass blood pump (21 CFR 870.4360) | | PREDICATE DEVICE: | Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698) | #### DEVICE DESCRIPTION: The COBE® Revolution™ Centrifugal Blood Pump is an extracorporeal blood pump that utilizes a rotating vaned impeller design to move blood by centrifugal force. The device is provided sterile with a nonpyrogenic fluid pathway, and is for single use only. It is indicated for use with a Stockert Instrumente GmbH Centrifugal Pump console in cardiopulmonary bypass procedures for periods of up to six hours. The device has not been qualified for longterm use (greater than six hours) as a bridge to transplant, for pending recovery of the natural heart or extracorporeal membrane oxygenation (ECMO). The Revolution Pump consists of a rotating vaned impeller within a pump housing. The pump housing has two components, a top and bottom case, and features a central, single-barbed, 3/8" inlet port and tangential, double-barbed, 3/8" outlet port. The vaned impeller is molded onto a steel shaft that supports it at its axis of rotation, with the shaft rotating on a bearing at each end. The device contains a multi-pole magnet that is fully enclosed within the magnet housing and thus does not contact the blood pathway. The magnet is designed to magnetically couple with the pump drive unit of the Stockert Instrumente GmbH Centrifygal Pump console. Rotation of the magnet causes the impeller to rotate and pump blood via centrifugal force. #### STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON The Revolution Pump is substantially equivalent to the currently marketed Medtronic BP-80 BioPump® Centrifugal Blood Pump (K852698) in intended use and operating principle. {1}------------------------------------------------ #### Substantial Equivalence Table | Parameter | COBE Revolution Pump | Medtronic BP-80 | |-----------------------------|-------------------------|-------------------------| | Priming Volume | 57 ml | 80 ml | | Maximum Blood Flow Rate | 8 liters/minute | Not specified | | Maximum Operating Pressure | 800 mm Hg | 900 mm Hg | | Impeller Design | Rotating vaned impeller | Vaneless rotating cones | | Bearing Design | No seals | Sealed bearings | | Motor Interface | Magnetic coupling | Magnetic coupling | | Inlet/Outlet Port Diameters | 3/8 inch | 3/8 inch | | Sterilization Method | Ethylene Oxide | Gamma Radiation | In-vitro test data demonstrate that the COBE® Revolution™ Centrifugal Blood Pump is substantially equivalent to the Medtronic BP-80 BioPump® Centrifugal Blood Pump. : {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 # FEB 1 2 2002 Ms. Lynne Leonard Sf. Regulatory Affairs Manager COBE Cardiovascular, Inc. 14401 W. 65th Way Arvada, CO 80004-3599 Re: K011835 Trade Name: COBE Revolution Centrifugal Blood Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class II (two) Product Code: KFM Dated: February 4, 2002 Received: February 5, 2002 Dear Ms. Leonard: We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasing to (1) for device is substantially equivalent (for the indications for referented in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suited in also encreated of the Medical Device Amendments, or to devices that prior to thay 20, 1970, also cordance 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 therefore, maintons 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 rr your device to such additional controls. Existing major regulations affecting your device can be may or beyott to carrent 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 that Federal statutes and regulations administered by other Federal agencies. You must comply with all + each statutes and 155 met limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ Page 2 - Ms. Lynne Leonard This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to begin maxioning of substantial equivalence of your device to a legally prematication: "The PDF Intently of cation for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and IT you desire specific active for you invitro diagnostic devices), please contact the Office of additionally 21 CT N Furt 607.10 for questions on the promotion and advertising of Compliance at (301) 597 1010. Timber of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division Other general information on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Rella Till Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ ## Indications For Use 510(k) Number (If known): K011835 COBE® REVOLUTION™ Centrifugal Blood Pump Device Name: Indications For Use: The COBE® REVOLUTION" Centrifugal Blood Pump is intended to be used with a Stöckert The CODE REVOLOTION - Ocharitagal Droob - asprocedures for periods of up to six hours. The pump has not been qualified through in vitro, in vivo, or clinical studies for long term use (i.e., I he pullip has not boon qualified in registed to transplant, for pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures. PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Cardiovascular & Respiratory Devices 510(k) Number K011835 Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use ___________