ADVANCED PERFUSION SYSTEM 1 (APS1) TUBE CLAMP ASSEMBLY, ROLLER PUMP 6 INCH CLASSIC COLOR,

{0}------------------------------------------------ K112587 Section 6 – 510(k) Summary 510(K) Premarket Notification 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<br>Corporation | | Address | 6200 Jackson Road<br>Ann Arbor MI, 48103 | | Phone number | Tel: (734) 741-6113 | | Fax number | Fax: (734) 741-6069 | | E-mail | Rebecca.andersen@terumomedical.com | | Establishment Registration Number | 1828100 | | Name of contact person | Rebecca Andersen | | Submission Co-Authors | December 2, 2011 | | Date prepared | Terumo Cardiovascular Systems<br>Corporation | | Name of Device | | | Trade or proprietary name | Large (6") Roller Pump for the<br>Terumo® Advanced Perfusion<br>System 1 | | Common or usual name | Cardiopulmonary Bypass Roller Pump | | Classification name | Pump, blood, cardiopulmonary bypass,<br>roller type | | Classification panel | 74 Cardiovascular | | Regulation | 21 CFR § 870.4370 | | Product Code(s) | DWB | | Legally marketed device(s) to which<br>equivalence is claimed | Sarns™ 8000 Roller Pump (K953901)<br>Sarns™ 9000 Universal Roller Pump<br>(K953904) | | Reason for 510(k) submission | 6" Large Roller pump for the APS1<br>- Redesign in support of Corrective | {1}------------------------------------------------ 510(K) Premarket Notification Image /page/1/Figure/4 description: The image shows a device description and indications for use of the APS 1 Large (6") Roller Pump. The device is a peristaltic pump with a 6 inch diameter race that can be mounted on the base of the Advanced Perfusion System 1 (APS1) console or positioned in an optimal location in the perfusion circuit by mounting on the pole. The large roller pump can accommodate applications requiring flow rates up to 10 L/min. 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. Section 6- Page 2 of 7 TERUMO {2}------------------------------------------------ | Summary of the technological characteristics of the device compared to the | | | | |----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | predicate device | | | | | Characteristic | Proposed Device:<br>Large (6") Roller<br>Pump for the APS 1 -<br>(K112587) | Predicate# 1:<br>SarnsTM 8000 Roller<br>Pump (K953901) | Predicate# 2:<br>SarnsTM 9000<br>Universal Roller Pump<br>(k953904) | | Indication for<br>Use | The Large (6") Roller<br>Pump for the Terumo®<br>Advanced Perfusion<br>System 1 is indicated<br>for use for up to 6<br>hours in the<br>extracorporeal<br>circulation of blood for<br>arterial perfusion,<br>regional perfusion, and<br>cardiopulmonary<br>bypass procedures,<br>when used by a<br>qualified medical<br>professional who is<br>experienced in the<br>operation of this or<br>similar equipment. | For use in<br>extracorporeal<br>circulation of blood for<br>arterial perfusion,<br>regional perfusion, and<br>cardiopulmonary<br>bypass procedures<br>only, when used by a<br>qualified medical<br>perfusionist who is<br>experienced in the use<br>of SarnsTM or similar<br>equipment | For use in<br>extracorporeal<br>circulation of blood for<br>arterial perfusion,<br>regional perfusion, and<br>cardiopulmonary<br>bypass procedures<br>only, when used by a<br>qualified medical<br>perfusionist who is<br>experienced in the use<br>of SarnsTM or similar<br>equipment | | For Use With | Terumo Advanced<br>Perfusion System 1 | Stand alone or with<br>SarnsTM 8000 Modular<br>Perfusion System | SarnsTM 9000 Perfusion<br>System | | Functional<br>Summary | Large roller pump is a<br>peristaltic roller pump<br>with 6" race and can<br>accommodate<br>applications requiring<br>flow rates up to 10<br>L/min including<br>• adult and<br>• pediatric | Peristaltic roller pump<br>with 6" race can<br>accommodate<br>applications requiring<br>flow rates up to 10<br>L/min including<br>• adult and<br>• pediatric<br>• arterial | Peristaltic roller pump<br>with 6" race can<br>accommodate<br>applications requiring<br>flow rates up to 10<br>L/min including<br>• adult and<br>• pediatric<br>• arterial | | | • arterial<br>• cardioplegia<br>• vent<br>• suction<br>pumping | • cardioplegia<br>• vent<br>• suction pumping | • cardioplegia<br>• vent<br>• suction pumping | | Tube Clamp<br>Assembly | Variable tube clamp to<br>accommodate a variety<br>of tubing sizes,<br>including dual tube<br>sets. Does not require<br>different size tubing<br>inserts. | Tube clamp mechanism<br>to accommodate a<br>variety of tubing sizes<br>including dual tube sets,<br>through the use of<br>various fixed inserts | Tube clamp mechanism<br>to accommodate a<br>variety of tubing sizes<br>including dual tube sets,<br>through the use of<br>various fixed inserts | | Tubing<br>Requirements | • Medical Grade<br>PVC tubing<br>• 11/16" OD (max)<br>• 1/16" – 3/32" wall<br>thickness | • Medical Grade PVC<br>tubing<br>• 3/4" OD (max) equals<br>12/16"<br>• 1/16" – 3/32" wall<br>thickness | • Medical Grade PVC<br>tubing<br>• 3/4" OD (max)<br>• 1/16" – 3/32" wall<br>thickness | | Panel Displays<br>and Controls | Front panel for user<br>interface controls,<br>functional displays, and<br>alarm conditions. | Front panel for user<br>interface controls,<br>functional displays, and<br>alarm conditions. | Front panel for user<br>interface controls,<br>functional displays, and<br>alarm conditions. | | Pump<br>Configurations /<br>Modes | Pump can be<br>configured using the<br>APS1 Central Control<br>Monitor (CCM) as:<br>• Arterial pump<br>• Cardioplegia<br>pump | Pump can be<br>configured via<br>corresponding cable<br>from Sarns base as<br>• Arterial pump<br>• Cardioplegia<br>pump | Pump can be<br>configured via<br>corresponding cable<br>from Sarns base as<br>• Arterial pump<br>• Cardioplegia<br>pump | | | Arterial pump can be<br>run in Continuous,<br>Pulse, Servo, or<br>Master/Follower mode. | Arterial pump can be<br>run in Continuous or<br>Pulse mode. Pulse<br>mode is enabled by<br>connecting an optional<br>Pulse Module. | Arterial pump can be<br>run in Continuous or<br>Pulse mode. Pulse<br>mode is enabled by<br>connecting an optional<br>pulse module. | | Internal<br>Monitoring,<br>Controls and<br>Safety Features | Pump continuously<br>monitors its<br>own performance and<br>reports | Pump continuously<br>monitors its own<br>performance and<br>reports status | Pump continuously<br>monitors its own<br>performance and<br>reports status | | | status information and<br>problems to the user<br>via the pump display<br>panel alarms and to the<br>CCM, including:<br>Pump jam Belt-slip Over speed Under speed Internal temperature | information and<br>problems to the user via<br>the pump display panel<br>alarms, including:<br>Pump jam Belt-slip Over speed Under speed | information and<br>problems to the user via<br>the pump display panel<br>alarms, including:<br>Pump jam Belt-slip Over speed Under speed | | Mounting | Pump can be mounted<br>on APS 1 base or pole. | Pump is mounted on<br>Sarns base. | Pump is mounted on<br>Sarns base. | | Dimensions<br>(nominal) | Height: 12.5 in (31.8<br>cm)<br>Width: 8.5 in (21.6 cm)<br>Depth: 13.1 in (33.3<br>cm) | Height: 14 in (35.6 cm)<br>Width: 8.2 in (20.8 cm)<br>Depth: 19.7 in (50.0 cm) | Height: 8.0 in (20.3 cm)<br>Width: 8.75 in (22.2 cm)<br>Depth: 14.0 in (35.6 cm) | | Weight<br>(nominal) | 26 lb (11.7 kg) | 50 lb (22.6 kg) | 31 lb (14 kg) | | Power | Low voltage, 24v DC<br>power and battery<br>backup | Pump AC/DC power<br>supply and battery<br>backup | Low voltage, 24v DC<br>power and battery<br>backup | | Flow Range | 0 - 10 L/min | 0 - 10 L/min | 0 - 10 L/min | | Speed Range /<br>Accuracy | 0 - 250 RPM ± 2 RPM<br>or 1% of actual,<br>whichever is greater | 0 - 200 RPM ± 2 RPM 200 - 258 RPM ± 1% of actual | 0 - 245 or 255 RPM ± 2<br>RPM or 1% of actual,<br>whichever is greater | | Environmental<br>Conditions<br>(Operation) | 10°C to 40°C ≤ 75%RH Non-condensing | 10°C to 40°C ≤ 95%RH Non-condensing | 10°C to 40°C ≤ 75%RH Non-condensing | | Environmental<br>Conditions<br>(Storage) | Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing | Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing | Store in ventilated area -30°C to 54°C ≤ 95%RH Non-condensing | Section 6- Page 3 of 7 (DTERUMO {3}------------------------------------------------ # 510(K) Premarket Notification Section 6- Page 4 of 7 (1) TERUMO {4}------------------------------------------------ : # Section 6 - 510(k) Summary ## 510(K) Premarket Notification {5}------------------------------------------------ ## 510(K) Premarket Notification #### PERFORMANCE DATA # SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE* The APS1 Large Roller Pump was previously found substantially equivalent to the named predicate devices under K022947. The purpose of this 510(k), K 112587, is to document a design change to the tube clamp assembly. The change addresses a failure mode, discovered during postmarket surveillance, which results in failure. Design and system verification and validation testing demonstrated that the modified design of the Tube Clamp assembly assures system reliability by enabling the internal assembly components to withstand impact forces that may be encountered during use. | Performance Test Summary-Proposed Device | | | |------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------| | Characteristic | Standard/Test/FDA<br>Guidance | Results Summary | | Strength | Design Verification<br>Protocol:<br>Knob/Cam Follower<br>Impact Strength<br>Verification | Pass –<br>All pre-defined acceptance<br>criteria met | | Reliability/Durability | Design Validation<br>Protocol:<br>Simulated use testing on<br>new and aged parts;<br>multiple cycles under<br>worst case conditions | Pass –<br>All pre-defined acceptance<br>criteria met | Section 6- Page 6 of 7 {6}------------------------------------------------ 510(K) Premarket Notification Summary of then clinied tests conducted for light of substautial equivalence . TCVS concludes that the Large 6" Roller Pump that is the subject of this 510k is substantially equivalent to the Sarns 8000, and 9000 Roller pump assemblies as cleared under K953901 and K953904. The devices have the same intended use and substantially equivalent performance. {7}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 DEC 1 9 2011 Terumo Cardiovascular Systems c/o Rebecca Andersen, Ph.D. 6200 Jackson Road Ann Arbor, MI 48103 #### Re: K112587 Trade/Device Name: Large (6") Roller Pump for Terumo Advanced Perfusion System 1 (APS1) Regulation Number: 21 CFR 870.4370 Regulation Name: Roller-type cardiopulmonary bypass blood pump. Regulatory Class: Class II Product Code: DWB Dated: December 2, 2011 Received: December 6, 2011 :・ Dear Dr. Andersen: 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 {8}------------------------------------------------ Page 2 - Rebecca Andersen, Ph.D. 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. ﻨﻴﺬ ﺎﻧﻪ 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 (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/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 vours, Filipe Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {9}------------------------------------------------ Terumo Cardiovascular Systems Corporation Indications for Use ﺎ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ 510(k) Number: K112587 #### Large (6") Roller Pump for the Terumo® Advanced Device Name: Perfusion System 1 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) Subpart C) AND/OR Over-The-Counter Use (Part 21 CFR 807 (PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Fili Gara for BDZ vision Sign Off) Division of Cardiovascular Devices 510(k) Number K112587