Advanced Perfusion System 1

{0}------------------------------------------------ Public Health Service Image /page/0/Picture/2 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" arranged around the perimeter. Inside the circle is a stylized image of a human figure embracing a bird, which is a symbol representing the department's mission to protect and promote the health and well-being of Americans. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 27, 2015 Terumo Cardiovascular Systems Corporation John Chesney Senior Manager Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103 Re: K151349 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: DTO Dated: July 17, 2015 Received: July 20, 2015 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, 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 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 yours, M.A. Hillebrand for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number: K151349 Advanced Perfusion System 1 Device Name: Indications for Use: 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. 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) Image /page/2/Picture/13 description: The image shows the Terumo company logo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and appears to be bolded. {3}------------------------------------------------ # K151349 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 | | email | John.Chesney@terumomedical.com | | Establishment Registration # | 1828100 | | Date prepared | May 18, 2015 | | Name of Device | | | Trade or proprietary name | Terumo® Advanced Perfusion System 1 | | Common or usual name | Heart-Lung Machine | | Classification name | Console, Heart-Lung Machine, Cardiopulmonary<br>Bypass | | Classification panel | 74 Cardiovascular | | Regulation | 21 CFR §870.4220 | | Product Code(s) | DTQ | | Legally marketed device(s) to<br>which equivalence is claimed | Advanced Perfusion System 1: K131041 | | Reason for 510(k) | Software modifications to previously cleared system | Image /page/3/Picture/5 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 swoosh is positioned above and to the left of the company name. {4}------------------------------------------------ #### 510(k) Summary #### Device Information Indication for Use: 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. Device Description: The Advanced Perfusion System 1) is a configurable heartlung 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 - Two roller pump hand cranks and hand crank bracket o - · Pump(s) and pump mounting hardware Up to eight pumps can be used with System 1, including the following: - 6" Roller Pump o - 4" Roller Pump o - Centrifugal Control Unit with Centrifugal Drive Motor (up to 2) O - Pods May 18, 2015 - Air Bubble Detection Pod Used to detect air bubbles in the extracorporeal O circuit, in conjunction with the air sensor - Level Detection Pod Used to monitor liquid levels within a hard shell o reservoir. - Pressure Pod Used to monitor the pressure in the extracorporeal circuit O - 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/22 description: The image contains the word "TERUMO" in a bold, sans-serif font. The letters are green, except for a red graphic above the word. The graphic is a stylized, angled shape that appears to be a design element associated with the brand. {5}------------------------------------------------ #### 510(k) Summary - 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 (e.g., Terumo CDI™ 100 Monitor, 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) Image /page/5/Figure/8 description: This image is a device illustration that shows a centrifugal control unit with a local display, control, and centrifugal motor. The illustration also shows a lamp, small roller pump, large roller pump, roller pump local display and control, and a central control monitor. Other components include an occluder, electronic gas blender local controls, wheel lock, power status indicator, hand cranks, and an on/off switch. Image /page/5/Picture/9 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. {6}------------------------------------------------ #### Substantial Equivalence The device software has been revised to improve system performance. There have been no changes that adversely impact system functions or operating principles. The Operator's Manual has been revised to clarify verbiage and revise some instructions for use. The modified System 1 is identical to the currently cleared System 1 because it has the same intended use, indications for use, and substantially equivalent operating principles and technical specifications. | Item | Proposed Device | Predicate Device | |----------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Modified System 1 | System 1 (K131041) | | Indication for Use | Identical to predicate device. | The Terumo® Advanced Perfusion System 1 is<br>indicated for use for up to 6 hours in the<br>extracorporeal circulation of blood for arterial<br>perfusion, regional perfusion, and cardiopulmonary<br>bypass procedures, when used by a qualified medical<br>professional who is experienced in the operation of<br>this or similar equipment. The centrifugal pump is<br>indicated for use in cardiopulmonary bypass<br>procedures only. | | System<br>Components | Identical to predicate device. | • System 1 Base with CCM and various hardware<br>accessories | | | | • Large (6") and/or Small (4") Roller Pumps | | | | • Centrifugal Control Unit and centrifugal drive<br>motor | | | | • Optional pods and accessories, including: | | | | • Air bubble detector | | | | • Level sensor | | Item | Proposed Device<br>Modified System 1 | Predicate Device<br>System 1 (K131041) | | | | Optional Pressure monitor Temperature monitor Flow monitor Occluder Electronic Gas Blender Interface pods for external cardiac and data monitoring systems Halogen lamps | | Principles of<br>Operation | Identical to predicate device. | Configurable heart-lung system with a distributed<br>network architecture that allows the user to customize<br>the number and types of system components, which<br>can then be configured, displayed, and controlled<br>from a central monitor. | | | | Each component connects to the system network via<br>points on the Base. There are six pump connections,<br>two connections for the CCM, eighteen connections<br>for pods and two dedicated connections for a lamp. | | Power Supply | Identical to predicate device. | The power system within the Base transforms AC<br>power into the DC levels required by the system<br>components. Integrated batteries provide backup<br>power in the event of AC power loss during use and<br>when power needed exceeds power available. | Image /page/6/Picture/7 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in large, green, bold letters. Above the word, there is a red swoosh that starts thin on the left and gets thicker as it moves to the right, arching over the letters. {7}------------------------------------------------ ## 510(k) Summary Image /page/7/Picture/5 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 sans-serif and bolded. {8}------------------------------------------------ #### 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, system, and regression levels. #### Conclusion The software modifications to the System 1 have not changed the device indications for use or fundamental scientific technology. Software verification and validation has confirmed that the modifications improve system performance. Therefore, the modified device is substantially equivalent to the currently marketed device cleared under K131041. Image /page/8/Picture/7 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is sans-serif and the letters are bold.