Advanced Perfusion System 1

{0}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/13 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, with flowing lines suggesting movement or connection. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 7, 2017 Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer-regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103 Re: K163531 Trade/Device Name: Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: May 5, 2017 Received: Mav 8. 2017 Dear Bryan Hann: 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. 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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, Fernando Aguel-S Bram D. Zuckerman, M.D. for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K163531 Device Name Advanced Perfusion System 1 Indications for Use (Describe) 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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### Attachment 1 #### Terumo Cardiovascular Systems Advanced Perfusion System 1 Traditional 510(k) Section 4: 510(k) Summary ### Premarket Notification K163531 Terumo® Advanced Perfusion System 1 510(k) Summary This section is prepared in accordance with 21 CFR Part 807.92 ## General Information | Submitter's Name and Address | Terumo Cardiovascular Systems Corporation<br>6200 Jackson Road<br>Ann Arbor MI, 48103 | |------------------------------|---------------------------------------------------------------------------------------| | Name of Contact Person | Bryan Hann | | Phone number | Tel: (734) 741-5816 | | Fax number | Fax: (734) 741-6069 | | email | bryan.hann@terumomedical.com | | Establishment Registration # | 1828100 | | Date prepared | May 3, 2017 | ## Device Information | Trade Name | Terumo® Advanced Perfusion System 1 | |----------------------|--------------------------------------------------------| | Common/Genric Name | Heart-Lung Machine | | Classification name | Console, Heart-Lung Machine,<br>Cardiopulmonary Bypass | | Classification panel | 74 Cardiovascular | | Device Class | Class II | | Regulation Number | 21 CFR §870.4220 | | Product Code(s) | DTQ | ## Predicate Device Information The modified Terumo® Advanced Perfusion System 1 is substantially equivalent in function and intended use to the Terumo® Advanced Perfusion System 1 cleared in Premarket Notification K153376. Image /page/3/Picture/14 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and bolded. {4}------------------------------------------------ Advanced Perfusion System 1 Traditional 510(k) ## Indications for Use and Device Description #### Indications for Use The Terumo® Advanced Perfusion System 1 is indicated for use for up to six 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 centrifugal pump is indicated for use in cardiopulmonary bypass procedures only. #### Device Description The Advanced Perfusion System 1) is a configurable heart-lung system with a distributed network architecture that allows the user to customize the number and types of system components, which can then be configured, displayed, and controlled from a central monitor. The system is designed to enable users to choose from the Terumo CVS supplied components to define and configure a heart-lung system to meet individual institution requirements. The System 1 components are listed below. - · System 1 Base: - Chassis platform Provides operating power and back up battery power for all o system components (100/120V or 220/240V) - Central Control Monitor (CCM) A touch screen display used for o configuration and control of system components - o Two roller pump hand cranks and hand crank bracket - Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following: - 6'' Roller Pump O - o 4" Roller Pump - Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O - Pods - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor - o Level Detection Pod Used to monitor liquid levels within a hard shell reservoir. - O Pressure Pod - Used to monitor the pressure in the extracorporeal circuit - Temperature Pod Used to monitor the temperature in the extracorporeal O circuit and / or the patient - Flowmeter Pod Used to monitor flow volume and generate an alarm if O backflow is detected Image /page/4/Picture/28 description: The image shows the word "TERUMO" in green, with a red angled line above the word. The font is sans-serif and bold. The red line is angled upwards from left to right. {5}------------------------------------------------ #### Section 4: 510(k) Summary ### Premarket Notification K163531 - Venous Line Occluder Pod Used with the Occluder Head to provide a o computer controlled tube clamping mechanism to regulate flow in the venous line - Interface Pods to enable data transfer between cardiac monitoring and data o display systems (i.e., Terumo CDI™ 500 Monitor, and TLink™ Data Management System) - · Electronic Gas Blender Provides control and monitoring of the gas output to the oxygenator - Flexible Lamps (15 inch or 33 inch) for local illumination - · Mounting hardware (e.g., center poles, crossbars, and brackets) ### Device Illustration Image /page/5/Figure/12 description: This image shows a labeled diagram of a Centrifugal Control Unit. The diagram labels the Centrifugal Control Unit Local Display and Control and Centrifugal Motor, Small Roller Pump, Lamp, Large Roller Pump, Roller Pump Local Display and Control, Central Control Monitor, Occluder, Electronic Gas Blender Local Controls, Wheel Lock, Power Status Indicator LED, Hand Cranks, and On/Off Switch. The diagram provides a detailed overview of the different components and their locations within the Centrifugal Control Unit. Image /page/5/Picture/13 description: The image shows the Terumo company logo. The logo features a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and appears to be bolded. {6}------------------------------------------------ # Comparison of Technological Characteristics to Predicate Device Extracorporeal circulation of blood is the technological principle for both the subject and predicate System 1 devices. This is based on the use of centrifugal pumps as well as roller pumps for the circulation of blood in arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures. The subject and predicate devices are based on the following technological principles: - · Central Control Monitor used for configuration and control of system components - · Centrifugal and roller type pumps used for extracorporeal circulation of blood - · The use of pods to connect peripheral components and devices for safety, monitoring, and data transfer - · Electronic gas blender for control and monitoring of the gas output to the oxygenator The following technological differences exist between the subject and predicate devices: - · The addition of a daughterboard to the Power System to support software modifications that enable power system diagnostics that were not previously available - · The addition of service messages to the Central Control Monitor to inform users for backup battery maintenance - · Central Control Monitor update to the Power Status Display (battery icon) to provide additional information related to the power status of the battery backup system. Image /page/6/Picture/12 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The red swoosh is curved and positioned above the left side of the word "TERUMO." {7}------------------------------------------------ Advanced Perfusion System 1 Traditional 510(k) ### Section 4: 510(k) Summary # Performance Data ### Biocompatibility Testing The Terumo® System 1 does not come into contact with the patient. Therefore, Terumo CVS is not submitting biocompatibility testing as part of this premarket notification. ### Electrical Safety and Electromagnetic Compatibility (EMC) Evaluation of the hardware modification for electrical safety and EMC testing was conducted on the System 1 with the modifications described in this premarket notification. The System 1 complies with the IEC 60601-1 standard for electrical safety and the IEC 60601-1-2 standard for EMC. ### Software Verification and Validation Testing Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device is considered a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. ### Design Verification and Validation Testing Design Verification and Validation testing were conducted and have resulted in data that demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications. The following test characteristics were performed on the subject device: - Battery Backup supply voltage and calculated charge . - Battery Backup Health signal ● - Battery Capacity ● - AC Mains to Battery Backup power switching ● - Battery Backup function status diagnostic ● - . Simulated use case testing ## Animal Study Animal testing was not required to demonstrate the substantial equivalence of the System 1 to the predicate device. Therefore, Terumo CVS is not submitting animal performance testing as part of this premarket notification. ## Clinical Studies Clinical testing was not required to demonstrate the substantial equivalence of the System 1 to the predicate device. Therefore, Terumo CVS is not submitting clinical performance testing as part of this premarket notification. Image /page/7/Picture/26 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The swoosh is positioned above and to the left of the word. {8}------------------------------------------------ Advanced Perfusion System 1 Traditional 510(k) Section 4: 510(k) Summary Premarket Notification K163531 ### Conclusion The hardware modification as well as the software modifications to the System 1 have not changed the device indications for use, technical characteristics, or fundamental scientific technology. Software verification and validation, electrical safety, electromagnetic compatibility, and design verification and validation testing have confirmed that the modifications do not adversely impact system performance. The modified System 1 is substantially equivalent to the currently marketed device cleared under K153376. Image /page/8/Picture/8 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, with a red swoosh above the letters "TE". The font is bold and sans-serif. The logo is simple and modern.