LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST

{0}------------------------------------------------ K131618 Terumo Cardiovascular Systems Corporation Large (6") Roller Pump 510(k) ### Section 4: 510(k) Summary This section includes a summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92. | | Submitter Information | |---------------------------------------------------------------|----------------------------------------------------------------------------| | Name | Terumo Cardiovascular Systems Corporation | | Address | 6200 Jackson Road,<br>Ann Arbor MI, 48103 | | Name of Contact Person | John Chesney | | Phone number | Tel: (734) 741-6410 | | Fax number | Fax: (734) 741-6069 | | E-mail | john.chesney@terumomedical.com | | Establishment Registration # | 1828100 | | Date prepared | September 27, 2013 | | | Name of Device | | Trade or proprietary name | Large (6") Roller Pump for Terumo® Advanced<br>Perfusion System 1 | | Common or usual name | Cardiopulmonary bypass roller pump | | Classification name | Pump, blood, cardiopulmonary bypass, roller type | | Classification panel | 74 Cardiovascular | | Regulation | 21 CFR §870.4370 | | Product Code(s) | DWB | | Legally marketed device(s) to<br>which equivalence is claimed | Large (6") Roller Pump for Terumo® Advanced<br>Perfusion System 1, K112587 | | Reason for 510(k) | Modifications to previously cleared system | {1}------------------------------------------------ # ion 4: 510(k) Summ ### evice Informati se beserbina The Lage (C) Palur Pump of the Arman Perius Portugular Prima Partialion an interesin araming of the Armania Caraman Partin Promonina Promonina Promonina Promonin ation for Use. The Large (6") Roller Pump for the System 1 in to 6 hours in the corporeal circulation of blood for arterial perfusion, and cardiopulmonary pyras prope Image /page/1/Figure/6 description: The image shows device illustrations with labels. The illustration includes a centrifugal control unit, local display and control, and centrifugal motor. Other labeled components include a lamp, small roller pump, large roller pump, roller pump local display and control, central control monitor, electronic gas blender local controls, power status indicator, on/off switch, wheel lock, hand cranks, and occluder. There is also a photograph of a lamp. otember 27, 20 TERUM {2}------------------------------------------------ | Substantial Equivalence | | | |------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | The modified Large (6") Roller Pump for the System 1 is substantially equivalent to the currently cleared Large (6") Roller Pump for the System 1 because it has the same intended use, substantially equivalent indications for use, and the same or substantially equivalent operating principles and technical specifications. The device software has been revised to improve system performance; however, there have been no changes to system functions or operating principles. | | | Item | Proposed Device<br>Modified Large (6") Roller Pump for the System 1 | Predicate Device<br>Large (6") Roller Pump for the System 1 – K112587 | | Indication for Use | The large (6") roller pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. | The large (6") roller pump for the Terumo® Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. | | Functional<br>Summary | Large roller pump with 6" race can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping | Large roller pump with 6" race can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping | | Tubing<br>Requirements | Commercially available tubing meeting the following specifications:<br>• Medical Grade PVC | Commercially available tubing meeting the following specifications:<br>• Medical Grade PVC tubing | | Item | Proposed Device<br>Modified Large (6") Roller Pump for the System 1 | Predicate Device<br>Large (6") Roller Pump for the System 1 – K112587 | | | 11/16" OD (max) | 11/16" OD (max) | | | 1/16" - 3/32" wall thickness | 1/16" – 3/32" wall thickness | | Panel Displays<br>and Controls | Front panel for user interface controls, functional<br>displays, and alarm conditions | Front panel for user interface controls, functional<br>displays, and alarm conditions | | Pump<br>Configurations /<br>Modes | Pump can be configured using the System 1<br>Central Control Monitor (CCM) as:<br>Arterial pump Cardioplegia pump | Pump can be configured using the System 1<br>Central Control Monitor (CCM) as:<br>Arterial pump Cardioplegia pump | | | Arterial pump can be run in Continuous, Pulse,<br>Servo, or Master/Follower mode. | Arterial pump can be run in Continuous, Pulse,<br>Servo, or Master/Follower mode. | | Internal<br>Monitoring,<br>Controls and<br>Safety Features | Pump continuously monitors its own performance<br>and reports status information and problems to<br>the user via the pump display panel alarms and to<br>the CCM. Pump responses to detected problems<br>can include Stop, Pause, Reduce Speed, or<br>Message Only. | Pump continuously monitors its own<br>performance and reports status information and<br>problems to the user via the pump display panel<br>alarms and to the CCM. Pump responses to<br>detected problems can include Stop, Pause,<br>Reduce Speed, or Message Only. | | Mounting | Pump can be mounted on System 1 base or pole.<br>The attachment mechanism is integral to the back<br>of the lower pump housing. | Pump can be mounted on System 1 base or<br>pole. The attachment mechanism is integral to<br>the back of the lower pump housing. | | Item | Proposed Device<br>Modified Large (6") Roller Pump for the System 1 | Predicate Device<br>Large (6") Roller Pump for the System 1 – K112587 | | Dimensions<br>(nominal) | Height: 12.5 in (31.8 cm)<br>Width: 8.5 in (21.6 cm)<br>Depth: 13.1 in (33.3 cm) | Height: 12.5 in (31.8 cm)<br>Width: 8.5 in (21.6 cm)<br>Depth: 13.1 in (33.3 cm) | | Weight (nominal) | 26 lb (11.7 kg) | 26 lb (11.7 kg) | | Housing | External: Molded ABS plastic.<br>Internal: Metal with EMC coating | External: Molded ABS plastic.<br>Internal: Metal with EMC coating | | Cover | Clear plastic cover with safety interlock | Clear plastic cover with safety interlock | | Pump Control<br>Assembly | A two-board assembly, consisting of a computer board and a motor control board are mounted to the frame. | A two-board assembly, consisting of a computer board and a motor control board are mounted to the frame. | | Power | Low voltage, 24 VDC power and battery backup supplied from APS1 via the pump power cable. | Low voltage, 24 VDC power and battery backup supplied from APS1 via the pump power cable. | | Flow Range<br>Accuracy | • 0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual<br>• 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual | • 0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual<br>• 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual | | Item | Proposed Device<br>Modified Large (6") Roller Pump for the System 1 | Predicate Device<br>Large (6") Roller Pump for the System 1 - K112587 | | Speed Range / Accuracy | 0 - 250 RPM ± 2 RPM or 1% of actual, whichever is greater | 0 - 250 RPM ± 2 RPM or 1% of actual, whichever is greater | | Environmental Conditions (Operation) | • 10°C to 40°C<br>• ≤ 75%RH<br>• Non-condensing | • 10°C to 40°C<br>• ≤ 75%RH<br>• Non-condensing | | Environmental Conditions (Storage) | • Store in ventilated area<br>• -30°C to 54°C<br>• ≤ 95%RH<br>• Non-condensing | • Store in ventilated area<br>• -30°C to 54°C<br>• ≤ 95%RH<br>• Non-condensing | | Electrical Rating | • 24 VDC (nominal)<br>• +5 VDC<br>• 10A maximum @ 24 VDC | • 24 VDC (nominal)<br>• +5 VDC<br>• 10A maximum @ 24 VDC | arge (6") Roller Pump 510(k rumo Cardiovascular Systems Corporatio ection 4: 510(k) Summar September 27, 2013 TERUMO {3}------------------------------------------------ umo Cardiovascular Systems Corporatio # Section 4: 510(k) Summar September 27, 2013 () TERUMO {4}------------------------------------------------ rumo Cardiovascular Systems Corporatio # Section 4: 510(k) Summar September 27, 2013 TTERUMO {5}------------------------------------------------ erumo Cardiovascular Systems Corporatio # Section 4: 510(k) Summar 11 Section 4 - Page 6 of TTERUMO September 27, 2013 {6}------------------------------------------------ ### Section 4: 510(k) Summary ### Performance Testing The software modifications implemented under this 510(k) were subjected to software verification and validation testing at the unit, integration and system levels. The software modifications to the Large (6") Roller Pump for the Terumo® Advanced Perfusion System 1 have not changed the device indications for use or fundamental scientific technology. Software and system testing have confirmed that the modifications improve device performance. Therefore, the modified device is substantially equivalent to the currently marketed device cleared under K112587. Image /page/6/Picture/8 description: The image shows the logo for Terumo. The logo consists of a circle with the letter T inside of it, followed by the word "TERUMO" in bold, sans-serif font. There is a small dot above and to the right of the letter O. {7}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/7/Picture/1 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 resembling an eagle or bird with three stylized wing-like shapes. ### September 27, 2013 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 Terumo Cardiovascular Systems Corporation Mr. John Chesney Sr. Manager Regulatory Affairs 6200 Jackson Rd. Ann Arbor, MI 48103 Re: K131618 > Trade/Device Name: Large (6") Roller Pump for Terumo Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4370 Regulation Name: Cardiopulmonary Bypass Roller Pump Regulatory Class: Class II Product Code: DWB Dated: August 14, 2013 Received: August 15, 2013 Dear Mr. Chesney: 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. Ilisting 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (2 1 {8}------------------------------------------------ Page 2 - Mr. John Chesney 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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. ### Bram D. Zuckerman -S Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Terumo Cardiovascular Systems Corporation Section 3: Indication for Use 510(k) Number: K131618 Large (6") Roller Pump for Terumo® Advanced Perfusion Device Name: System 1 Indications for Use: The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 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) ### Bram D. Zuckerman -S 2013.09.27 15:53:29 -04'00' TERUMO