TRILLIUM BIOPUMP PLUS, MODEL BPX80T

{0}------------------------------------------------ KOSD109 ## SUMMARY OF SAFETY AND EFFECTIVENESS #### COMPANY AND CONTACT PERSON Medtronic Perfusion Systems 7611 Northland Drive Minneapolis, MN 55428 (763) 391-9533 Tel: FAX: (763) 391-9603 Preeti Jain, Director, Regulatory/Clinical Affairs #### DEVICE NAME Trillium® BioPump Plus ## NAME OF PREDICATED OR LEGALLY MARKETED DEVICE BPX80 BioPump Plus (K973011) AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface (K973760) #### DESCRIPTION OF DEVICE The Trillium® BioPump Plus is a centrifugal blood pump which is a single use, disposable, non-pvrogenic device designed to move blood through the extracorporeal circuit by centrifugal forces created by smooth rotating cones. It is the disposable portion of the pumping system and is electromechanically coupled to the BioConsole which is the instrument that monitors and displays the flow and pressure of the blood flow. Venous blood enters the inlet port of the Bio-Pump. The smooth cones rotate in the polycarbonate housing. As the cones rotate, energy in the form of pressure and velocity is transferred from the cones to the blood. The blood is gently accelerated towards the outlet of the pump. The Bio-Pump moves the blood through the circuit at a desired pressure and flow rate by increasing or decreasing the speed of the rotating cones. This is accomplished by adjusting the BioConsole's RPM (revolutions per minute). The arterial blood is returned to the patient from the extracorporeal circuit. #### STATEMENT OF INTENDED USE The Medtronic Trillium® BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.) Trillium® BioPump Plus {1}------------------------------------------------ ## STATEMENT OF INTENDED USE OF PREDICATED/MARKETED DEVICE The Medtronic BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory pupport for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six lhours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory nually having mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.) ## STATEMENT OF TECHNOLOGICAL CHARACTERISTICS COMPARISON Information regarding technological characteristics comparison is provided in the following section, "Determination of Substantial Equivalence". ### DETERMINATION OF SUBSTANTIAL EQUIVALENCE This "SPECIAL 510(k)" is being submitted for a modification to the BioPump Plus. The modification to the currently marketed centrifugal pump is to coat the blood contact surfaces with Trillium. The Trillium™ BioPump Plus is being compared to the following marketed devices: - BPX80 BioPump Plus Centrifugal Blood Pump (K973011) . - AFFINITY® Hollow Fiber Oxygenator with Trillium® Biopassive Surface (K973760) . The Trillium®BioPump Plus has the same indications statement and intended uses as the presently marketed BioPump Plus. The Trillium® BioPump Plus has "no new technological characteristics (e.g., materials and manufacturing processes)" from the currently marketed centrifugal pumps. The technological characteristic is solely the coating material of the blood pathway: - Trillium® . The technological characteristic of the Trillium® BioSurface is common to other medical devices (hollow fiber oxygenators) currently in commercial distribution as follows: - AFFINITY® Hollow Fiber Oxygenator with Trillium® BioSurface (K973760) . This technological characteristic "could affect the safety and effectiveness of the device". However, these "technological characteristics do not raise new types of safety or effectiveness questions". In addition, "there are acceptable scientific methods which exist for assessing effects of these new technological characteristics". "Performance data to assess the effects of these new technological characteristics" has been performed. These "performance data demonstrate" that the Trillium® BioPump Plus is substantially equivalent to other marketed extracorporeal cardiopulmonary bypass devices. {2}------------------------------------------------ The biocompatibility and in vitro bench testing demonstrated that when compared to the predicate devices, the Trillium®BioPump Plus does not significantly affect safety and effectiveness and is substantially equivalent to other commercially distributed extracorporeal cardiopulmonary devices. . {3}------------------------------------------------ Image /page/3/Picture/2 description: The image is a logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or a bird with outstretched wings. FEB 1 1 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Medtronic Perfusion Systems c/o Mr. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive N Minneapolis, MN 55428-1088 K050109 Re: Trillium™ BioPump Plus Regulation Number: 21 CFR 870.4370 Regulation Name: Cardiopulmonary Bypass Non-Roller type blood pump Regulatory Class: Class III (three) Product Code: KFM Dated: January 14, 2005 Received: January 18, 2005 Dear Mr. Jain: We have reviewed your Section 510(k) premarket notification of intent to market the indication We nave reviewed your Section >10(x) premainer is substantially equivalent (for the indications ferenced above and nave determined the are are are are and and marketed in interstate for use stated in the encrosule for regars manatt date of the Medical Device Amendments, or to commerce prior to May 26, 1776, the enating with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Costnetic Act (Act) that do not require appear al controls provisions of the Act. The You may, therefore, market me actives, policements for annual registration, listing of general controls provisions of the rist 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 If your device is classified (see above) the existing major regulations affecting your device can may be subject to such additional controlior Linesting of Parts 800 to 898. In addition, FDA may be found in the Ood or reasis concerning your device in the Federal Register. {4}------------------------------------------------ Page 2 - Mr. Preeti Jain Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease oc actived that i Drimination that your device complies with other requirements of the Act that I DA has made a actor regulations administered by other Federal agencies. You must or any I carated and the Act's requirements, including, but not limited to: registration and listing (21 Comply with an the 11et 0704 and manufacturing practice requirements as set CI K rat 6077, moonling (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provention as described in your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premaint in the motions in a classification 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), please 11 you desire specific of Compliance at (301) 594-4646. Additionally, for questions on the contact the Office of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (2017) 27 1055. 1100, pressed and 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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, Duna R. Vochner Image /page/4/Picture/5 description: The image shows what appears to be a signature. The signature is composed of curved lines and strokes, forming a unique and stylized design. The overall impression is that of a handwritten mark, possibly representing a person's name or initials. Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use 510(k) Number (if known): Ko 5 010 9 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: The Medtronic Trillium™ BioPump Plus is indicated for use only with the Medtronic Bio-Console to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary byrass (up to six hours). It is also indicated for use in extracorporeal circulatory support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of vena cava or aorta, liver transplants, etc.) Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) oning R. Jackine Ovision Sign-Off) n ision of Cardiovascula 510(K) Number_KoS 0 Lo 9