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.

Device Description

The Large (6") Roller Pump for the Terumo Advanced Perfusion System 1 is a component of the Terumo Advanced Perfusion System 1. It is a large roller pump with a 6" race that can accommodate applications requiring flow rates up to 10 L/min including adult and pediatric arterial, cardioplegia, vent and suction pumping. It uses commercially available medical grade PVC tubing with 11/16" OD (max) and 1/16" - 3/32" wall thickness. It has a front panel for user interface controls, functional displays, and alarm conditions. The pump can be configured using the System 1 Central Control Monitor (CCM) as an Arterial pump or Cardioplegia pump. The Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. The pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. The pump can be mounted on System 1 base or pole.

AI/ML Overview

The Terumo Cardiovascular Systems Corporation Large (6") Roller Pump K131618 is substantially equivalent to the predicate device K112587. The modification made to the device involved software updates.

Here's a breakdown of the acceptance criteria and study information:

1. Acceptance Criteria and Reported Device Performance

The submission states that the modified device has the "same intended use, substantially equivalent indications for use, and the same or substantially equivalent operating principles and technical specifications" as the predicate device. The performance specifications are identical to the predicate device, K112587.

The study supporting the acceptance criteria explicitly states: "Software and system testing have confirmed that the modifications improve device performance."

2. Sample size used for the test set and the data provenance

The submission does not specify a distinct "test set" in the context of clinical data or patient samples. The performance testing described relates to software verification and validation testing at unit, integration, and system levels. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective) typically associated with clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance testing was for software verification and validation, not for establishing clinical ground truth on patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. The testing was for software and system performance, not for clinical assessment requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical pump, not an AI-assisted diagnostic or interpretive system that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The performance testing focused on the software modifications to the device, confirming improved device performance through unit, integration, and system level testing. This implies a "standalone" evaluation of the software's functionality and its impact on the device's overall operation, without direct human interaction as part of the performance measurement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For software verification and validation, the "ground truth" would be established specifications, requirements, and expected operational parameters of the device. The software was tested against these predefined functional and performance requirements.

8. The sample size for the training set

Not applicable. This device is a medical pump with software modifications; there is no indication of a machine learning or AI model that would require a "training set" in the context of image analysis or similar applications. The software was developed and then verified/validated.

9. How the ground truth for the training set was established

Not applicable, as there is no "training set." The software's correct functioning is validated against engineering specifications and expected device behavior.

Summary

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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,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® AdvancedPerfusion 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) towhich equivalence is claimed	Large (6") Roller Pump for Terumo® AdvancedPerfusion System 1, K112587
Reason for 510(k)	Modifications to previously cleared system

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ion 4: 510(k) Summ

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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.

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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

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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

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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:

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

Regulation Number and Section

§ 870.4370 Roller-type cardiopulmonary bypass blood pump.

(a)
Identification. A roller-type cardiopulmonary bypass blood pump is a device that uses a revolving roller mechanism to pump the blood through the cardiopulmonary bypass circuit during bypass surgery.(b)
Classification. Class II (performance standards).

Item	Acceptance Criteria (Predicate Device K112587)	Reported Device Performance (Modified Device)
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. (Identical to predicate)
Functional 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. (Identical to predicate)
Tubing Requirements	• Medical Grade PVC tubing• 11/16" OD (max)• 1/16" – 3/32" wall thickness	• Medical Grade PVC• 11/16" OD (max)• 1/16" - 3/32" wall thickness (Identical to predicate)
Panel Displays and Controls	Front panel for user interface controls, functional displays, and alarm conditions.	Front panel for user interface controls, functional displays, and alarm conditions. (Identical to predicate)
Pump Configurations / Modes	Pump can be configured using the System 1 Central Control Monitor (CCM) as: Arterial pump, Cardioplegia pump. Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode.	Pump can be configured using the System 1 Central Control Monitor (CCM) as: Arterial pump, Cardioplegia pump. Arterial pump can be run in Continuous, Pulse, Servo, or Master/Follower mode. (Identical to predicate)
Internal Monitoring, Controls & Safety	Pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only.	Pump continuously monitors its own performance and reports status information and problems to the user via the pump display panel alarms and to the CCM. Pump responses to detected problems can include Stop, Pause, Reduce Speed, or Message Only. (Identical to predicate)
Mounting	Pump can be mounted on System 1 base or pole. The attachment mechanism is integral to the back of the lower pump housing.	Pump can be mounted on System 1 base or pole. The attachment mechanism is integral to the back of the lower pump housing. (Identical to predicate)
Dimensions (nominal)	Height: 12.5 in (31.8 cm)Width: 8.5 in (21.6 cm)Depth: 13.1 in (33.3 cm)	Height: 12.5 in (31.8 cm)Width: 8.5 in (21.6 cm)Depth: 13.1 in (33.3 cm). (Identical to predicate)
Weight (nominal)	26 lb (11.7 kg)	26 lb (11.7 kg). (Identical to predicate)
Housing	External: Molded ABS plastic. Internal: Metal with EMC coating.	External: Molded ABS plastic. Internal: Metal with EMC coating. (Identical to predicate)
Cover	Clear plastic cover with safety interlock.	Clear plastic cover with safety interlock. (Identical to predicate)
Pump Control 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. (Identical to predicate)
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. (Identical to predicate)
Flow Range Accuracy	• 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	• 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. (Identical to predicate)
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. (Identical to predicate)
Environmental Conditions (Operation)	• 10°C to 40°C• ≤ 75%RH• Non-condensing	• 10°C to 40°C• ≤ 75%RH• Non-condensing. (Identical to predicate)
Environmental Conditions (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. (Identical to predicate)
Electrical Rating	• 24 VDC (nominal)• +5 VDC• 10A maximum @ 24 VDC	• 24 VDC (nominal)• +5 VDC• 10A maximum @ 24 VDC. (Identical to predicate)

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 DeviceModified Large (6") Roller Pump for the System 1	Predicate DeviceLarge (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.
FunctionalSummary	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
TubingRequirements	Commercially available tubing meeting the following specifications:• Medical Grade PVC	Commercially available tubing meeting the following specifications:• Medical Grade PVC tubing
Item	Proposed DeviceModified Large (6") Roller Pump for the System 1	Predicate DeviceLarge (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 Displaysand Controls	Front panel for user interface controls, functionaldisplays, and alarm conditions	Front panel for user interface controls, functionaldisplays, and alarm conditions
PumpConfigurations /Modes	Pump can be configured using the System 1Central Control Monitor (CCM) as:Arterial pump Cardioplegia pump	Pump can be configured using the System 1Central Control Monitor (CCM) as:Arterial pump Cardioplegia pump
	Arterial pump can be run in Continuous, Pulse,Servo, or Master/Follower mode.	Arterial pump can be run in Continuous, Pulse,Servo, or Master/Follower mode.
InternalMonitoring,Controls andSafety Features	Pump continuously monitors its own performanceand reports status information and problems tothe user via the pump display panel alarms and tothe CCM. Pump responses to detected problemscan include Stop, Pause, Reduce Speed, orMessage Only.	Pump continuously monitors its ownperformance and reports status information andproblems to the user via the pump display panelalarms and to the CCM. Pump responses todetected problems can include Stop, Pause,Reduce Speed, or Message Only.
Mounting	Pump can be mounted on System 1 base or pole.The attachment mechanism is integral to the backof the lower pump housing.	Pump can be mounted on System 1 base orpole. The attachment mechanism is integral tothe back of the lower pump housing.
Item	Proposed DeviceModified Large (6") Roller Pump for the System 1	Predicate DeviceLarge (6") Roller Pump for the System 1 – K112587
Dimensions(nominal)	Height: 12.5 in (31.8 cm)Width: 8.5 in (21.6 cm)Depth: 13.1 in (33.3 cm)	Height: 12.5 in (31.8 cm)Width: 8.5 in (21.6 cm)Depth: 13.1 in (33.3 cm)
Weight (nominal)	26 lb (11.7 kg)	26 lb (11.7 kg)
Housing	External: Molded ABS plastic.Internal: Metal with EMC coating	External: Molded ABS plastic.Internal: Metal with EMC coating
Cover	Clear plastic cover with safety interlock	Clear plastic cover with safety interlock
Pump ControlAssembly	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 RangeAccuracy	• 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	• 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
Item	Proposed DeviceModified Large (6") Roller Pump for the System 1	Predicate DeviceLarge (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• ≤ 75%RH• Non-condensing	• 10°C to 40°C• ≤ 75%RH• Non-condensing
Environmental Conditions (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
Electrical Rating	• 24 VDC (nominal)• +5 VDC• 10A maximum @ 24 VDC	• 24 VDC (nominal)• +5 VDC• 10A maximum @ 24 VDC