Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are connected by flowing lines that resemble ribbons or waves. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 17, 2016 Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer - Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103 Re: K162843 Trade/Device Name: Small (4") Roller Pump for the Terumo Advanced Perfusion System 1, Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 Regulation Number: 21 CFR 870.4370 Regulation Name: Roller-Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class II Product Code: DWB Dated: October 7, 2016 Received: October 11, 2016 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 {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, 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration **Indications for Use** | Form Approved: OMB No. 0910-0120 | | |-----------------------------------|--| | Expiration Date: January 31, 2017 | | | See PRA Statement below. | | | 510(k) Number (if known) | K162843 | |--------------------------|-------------------------------------------------------------------------------------| | Device Name | Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1. | | Indications for Use (Describe) | The Small (4") and Large (6") Roller Pumps for the Terumo® Advanced Perfusion System 1 are 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. | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------------------------------------------------------| | | <span style="padding-right: 5px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | | | <span style="padding-right: 5px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (8/14) Page 1 of 1 - {3}------------------------------------------------ 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 | Bryan Hann | | Phone number | Tel: (734) 741-5816 | | Fax number | Fax: (734) 741-6069 | | email | bryan.hann@terumomedical.com | | Establishment Registration # | 1828100 | | Date prepared | October 7, 2016 | | Name of Device | | | Trade or proprietary name | Small (4") Roller Pump for the Terumo® Advanced<br>Perfusion System 1 | | Trade or proprietary name | Large (6") Roller Pump for the Terumo® Advanced<br>Perfusion System 1 | | Common or usual name | Cardiopulmonary bypass roller pump | | Classification name | Roller-type cardiopulmonary bypass blood pump | | Classification panel | 74 Cardiovascular | | Regulation | 21 CFR §870.4370 | | Product Code(s) | DWB | | Legally marketed device(s) to<br>which equivalence is claimed | Terumo® Advanced Perfusion System 1: K153376 | | Reason for 510(k) | Update to the System 1 Operator's Manual (instructions<br>for use) that incorporates the use of medical grade<br>silicone tubing with the Small (4") and Large (6")<br>System 1 Roller Pumps. | Image /page/3/Picture/5 description: The image contains the word "TERUMO" in large, bold, green letters. Above the word is a red swoosh that starts thin on the left and gets thicker as it moves to the right. The logo is simple and modern, with a focus on the company name. {4}------------------------------------------------ Image /page/4/Picture/4 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 bold. {5}------------------------------------------------ #### Device Information Indication for Use: The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 are 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. Device Description: The Small (4") and Large (6") Roller Pumps of the Terumo® Advanced Perfusion System 1 (System 1) are peristalic pumps with 4 inch and 6 inch diameter raceways. The pumps can be mounted on the base of the System 1 console or can be positioned in an optimal location in the perfusion circuit by mounting to the system poles. Operation of the pumps can be configured using the System 1 Central Control Monitor (CCM). Local user interface displays and control panels are also located on the front of the large and small roller pumps. The small roller pump can accommodate applications requiring flow rates up to 4 L/min including pediatric arterial, adult and pediatric cardioplegia, vent and suction pumping, whereas the large roller pump can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. The small and large roller pumps both have variable tube clamp mechanisms that accommodate a variety of tubing sizes, including dual tube sets. Image /page/5/Picture/6 description: The image shows the logo for Terumo. The logo consists of a red swoosh above the word "TERUMO" in green, block letters. The font is sans-serif and the letters are bold. {6}------------------------------------------------ Image /page/6/Figure/2 description: This image is a device illustration of a centrifugal control unit. The illustration includes labels for the different parts of the unit, such as the centrifugal control unit, local display and control, centrifugal motor, small roller pump, large roller pump, roller pump local display and control, central control monitor, occluder, chassis, electronic gas blender local controls, wheel lock, power status indicator, hand cranks, and on/off switch. There is also a lamp attached to the unit. Page 4 of 14 {7}------------------------------------------------ Image /page/7/Picture/3 description: The image shows two different sizes of roller pumps from the Terumo Advanced Perfusion System 1. The left image shows the small (4") roller pump, and the right image shows the large (6") roller pump. The small roller pump has a label that says "NOT FOR CLINICAL USE". The large roller pump has a screen that displays "4.86". Image /page/7/Picture/4 description: The image features the Terumo logo. The logo consists of the word "TERUMO" in bold, green letters. Above the word is a curved, red swoosh that starts thin on the left and widens as it curves over the letters. {8}------------------------------------------------ Device Function: The Small (4") or Large (6") System 1 Roller Pumps are designed to circulate fluids during extracorporeal circulation. Roller pumps rely on a pair of revolving rollers that occlude the tubing of the extracorporeal circuit against a stationary tubing guide in such a way that the fluid in the short segment of tubing between the rollers is propelled within the tubing in the direction of the rollers rotation. Pumps are typically employed for an arterial (main physiological support) circuit, delivery of cardioplegia solution directly to the heart, suction and venting. Image /page/8/Picture/5 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green. The arc is curved upwards and to the right. The word "TERUMO" is in a bold, sans-serif font. {9}------------------------------------------------ #### Substantial Equivalence The Small (4") and Large (6") Roller Pumps for the System 1 have been qualified for use with medical grade silicone tubing through performance testing. The use of medical grade silicone tubing does not adversely impact the system functions or operating principles. The Operator's Manual has been revised to include the use of medical grade silicone tubing. The subject Small (4") and Large (6") Roller Pumps for the System 1 have the indications for use, intended use, as well as substantially equivalent operating principles and technological charateristics as the predicate device. | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | Identical to predicate device. | The Small (4") and Large (6") Roller Pumps of the<br>Terumo® Advanced Perfusion System 1 are<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<br>medical professional who is experienced in the<br>operation of this or similar equipment. | | Functional<br>Summary | Identical to predicate device. | Small roller pump can accommodate applications<br>requiring flow rates up to 4 L/min including<br>pediatric arterial, adult and pediatric cardioplegia,<br>vent and suction pumping. | | | | Large roller pump can accommodate applications<br>requiring flow rates up to 10 L/min including adult<br>and pediatric arterial, cardioplegia, vent and suction<br>pumping. | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | Tubing<br>Requirements | Small Roller Pump<br>Commercially available tubing meeting the following<br>specifications:<br>Medical Grade PVC 9/16" Outer Diameter (max) 1/16" – 3/32" wall thickness <span style="color:red;">Medical Grade Silicone</span> 9/16" outer diameter (max) 1/16" – 3/32" wall thickness | Small Roller Pump<br>Commercially available tubing meeting the<br>following specifications:<br>Medical Grade PVC 9/16" outer diameter (max) 1/16" – 3/32" wall thickness | | | Large Roller Pump<br>Commercially available tubing meeting the following<br>specifications:<br>Medical Grade PVC 11/16" Outer Diameter (max) 1/16" – 3/32" wall thickness <span style="color:red;">Medical Grade Silicone</span> 11/16" outer diameter (max) 1/16 – 3/32" wall thickness | Large Roller Pump<br>Commercially available tubing meeting the<br>following specifications:<br>Medical Grade PVC 11/16" outer diameter (max) 1/16" – 3/32" wall thickness | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | Panel Displays<br>and Controls | Identical to predicate device. | Front panels for user interface controls, functional<br>displays, and alarm conditions. | | Pump<br>Configurations /<br>Modes | Identical to predicate device. | Small Roller Pump<br>Small roller pump can be configured using the<br>System 1 Central Control Monitor (CCM) as:<br>• Arterial pump (neonatal / pediatric only)<br>• Cardioplegia pump<br>• Vent pump<br>• Suction pump<br>Arterial pump can be run in Continuous, Pulse,<br>Servo, or Master/Follower mode | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | | Identical to predicate device. | <b>Large Roller Pump</b><br>Large roller pump can be configured using the<br>System 1 Central Control Monitor (CCM) as:<br>Arterial pump (adult and pediatric) Cardioplegia pump Vent pump Suction pump Arterial pump can be run in Continuous, Pulse,<br>Servo, or Master/Follower mode | | Internal<br>Monitoring,<br>Controls and<br>Safety | Identical to predicate device. | The small and large roller pumps both continuously<br>monitors its own performance and reports status<br>information and problems to the user via the pump<br>display panel alarms and to the CCM. Responses to<br>detected problems can include Stop, Pause, Reduce<br>Speed, or Message Only. | | Mounting | Identical to predicate device. | The small and large roller pumps can be mounted on<br>the System 1 base or to the poles via mounting<br>support brackets. | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | Dimensions | Identical to predicate device. | Small Roller Pump<br>• Height: 12.5 in (31.8cm)<br>• Width: 7.1 in (18.0 cm)<br>• Depth: 13.1 (30.0 cm) | | | | Large Roller Pump<br>• Height: 12.5 in (31.8cm)<br>• Width: 8.5 in (21.6 cm)<br>• Depth: 13.1 (33.3 cm) | | Weight (nominal) | Identical to predicate device | Small Roller Pump<br>• 23.5 lb (10.7 kg)<br>Large Roller Pump<br>• 28.5 lb (12.9 kg) | | Housing | Identical to predicate device | External: Molded ABS plastic.<br>Internal: Metal with EMC coating. | | Cover / Pump Lid | Identical to predicate device | Clear plastic with safety interlock. | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | Pump Control<br>Assembly | Identical to predicate device. | A two board assembly, consisting of a computer<br>board and a motor control board that are mounted to<br>the frame. | | Power | Identical to predicate device. | Low voltage, 24 VDC power and battery backup<br>supplied from APS1 via pump power cables. | | Flow Range<br>Accuracy | Identical to predicate device. | Small Roller Pump<br>0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual 0.01 L/min for 1.0 – 4.0 L/min ± 8% of actual Large Roller Pump<br>0.001 L/min for 0.0 – 1.0 L/min ± 10% of actual 0.01 L/min for 1.0 – 10.0 L/min ± 8% of actual | | Speed Range /<br>Accuracy | Identical to predicate device. | 0 - 250 RPM ± 2 RPM or 1% of actual. | | Item | Subject Devices<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | Predicate Devices (K153376)<br>Small (4") Roller Pump for the System 1<br>Large (6") Roller Pump for the System 1 | | Environmental<br>Conditions<br>(Operations) | Identical to predicate device. | 10°C to 40°C ≤ 75% Relative Humidity Non-condensing | | Environmental<br>Conditions<br>(Storage) | Identical to predicate device. | Stored in ventilated area -30°C to 54°C ≤ 95% Relative Humidity Non-condensing | | Electrical Rating | Identical to predicate device. | 24 VDC (nominal) +5 VDC 7.4 A maximum @ 24 VDC | Image /page/9/Picture/7 description: The image shows the logo for Terumo. The logo consists of a red arc above the word "TERUMO" in green, block letters. The arc is positioned above and to the left of the word, creating a dynamic and modern look. {10}------------------------------------------------ Image /page/10/Picture/4 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 bold. The logo is simple and modern. {11}------------------------------------------------ Image /page/11/Picture/4 description: The image contains 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 curved and positioned above the left side of the word "TERUMO". {12}------------------------------------------------ Image /page/12/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. The font is bold and sans-serif. {13}------------------------------------------------ Image /page/13/Picture/5 description: The image shows the logo for Terumo. The logo consists of the word "TERUMO" in green, block letters. Above the word is a red, curved line that resembles a swoosh. The logo is simple and modern. {14}------------------------------------------------ Image /page/14/Picture/4 description: The image contains the logo for Terumo. The logo consists of a red swoosh above the company name, which is written in green, block letters. The font is sans-serif and bolded. {15}------------------------------------------------ Image /page/15/Picture/4 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The swoosh starts thin on the left and gets thicker as it curves over the word. {16}------------------------------------------------ #### Performance Testing Performance testing of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has been completed successfully. #### Conclusion The use of medical grade silicone tubing with the Small and Large System 1 Roller Pumps has not changed the device indications for use or fundamental scientific technology. Performance testing has confirmed that the design input requirements were met demonstrating that medical grade silicone tubing can be used with the Small and Large System 1 Roller Pumps. The device is substantially equivalent to the current predicated device cleared under K153376. Image /page/16/Picture/7 description: The image shows the Terumo company logo. The logo features a red checkmark-like symbol on the upper left. To the right of the symbol is the company name "TERUMO" in green, block letters.