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 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
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 Patient Gas System (EPGS) 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)

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Terumo Advanced Perfusion System 1, which involves software modifications to an existing device. It discusses software verification and validation, and design validation testing, but does not provide explicit acceptance criteria or detailed study results in the format requested.

Here's an analysis based on the information provided and what is missing:

The document states: "Software verification and validation testing were conducted and discussion of the these activities (i.e. protocols, acceptance criteria, and test results) at the unit, integration, and system level are included as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."". However, the actual acceptance criteria and test results are not included in the provided text.

Similarly, for design validation: "Design validation testing was conducted and demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications. The following testing was performed on the subject device: . Simulated use case testing . Validation of the Instructions For Use changes". Again, the specific acceptance criteria and detailed results are not provided.

Therefore, I cannot populate the table and answer all questions directly from the given text.

Based on the available information, here's what can be extracted and what remains unknown:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Stated/Inferred)	Reported Device Performance (Stated/Inferred)
Software Verification & Validation: The document states that protocols, acceptance criteria, and test results were included in the full submission, as recommended by FDA guidance.	Software Verification & Validation: "Software verification and validation testing... confirmed that the modifications do not adversely impact system performance." (Specific data not provided)
Design Validation: The document states design validation demonstrates the system performs within defined design input requirements. This would imply criteria for successful simulated use and validation of Instructions For Use changes.	Design Validation: "design validation testing ... demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications." (Specific data not provided for simulated use cases or IFU validation)
Biocompatibility: Device does not come into patient contact.	Not applicable - no biocompatibility testing performed or required.
Electrical Safety and EMC: Software modifications do not impact these aspects.	Not applicable - no testing performed.

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

Test set sample size: Not specified in the provided text.
Data provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are internal manufacturer testing.

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

Number of experts: Not specified.
Qualifications of experts: Not specified. The document mentions "qualified medical professional who is experienced in the operation of this or similar equipment" for the device's use, which might imply involvement in validating the simulated use cases, but this is an inference, not a direct statement about ground truth establishment.

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

Adjudication method: Not specified.

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

MRMC study: No. This device is a heart-lung machine console, not an AI diagnostic tool involving human readers.
Effect size: Not applicable.

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

Not applicable in the context of an "algorithm only" device in this submission. The software modifications are for a console that operates a heart-lung machine; its performance is intrinsically linked to the machine's function.

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

For the software verification and validation, and design validation, the "ground truth" would likely be adherence to defined software requirements, design input requirements, and successful operation during simulated use testing. Specific "ground truth" types like pathology or outcomes data are not relevant for this type of device modification.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI model that requires a training set in the conventional sense. The "training" here would refer to the software development and testing cycles.

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

Not applicable for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 17, 2017

Terumo Cardiovascular Systems Corporation Bryan Hann Senior Engineer - Regulatory Affairs 6200 Jackson Road Ann Arbor, Michigan 48103

Re: K172220

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, KFM, DWB Dated: July 19, 2017 Received: July 24, 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 of medical device

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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 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.

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for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K172220

Device Name Advanced Perfusion System 1

Indications for Use (Describe)

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)

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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 Corporation6200 Jackson RoadAnn Arbor MI, 48103
Name of Contact Person	Bryan K. Hann
Phone number	Tel: (734) 741-5816
Fax number	Fax: (734) 741-6069
email	bryan.hann@terumomedical.com
Establishment Registration #	1828100
Date prepared	19 July 2017

Device Information

Trade Name	Terumo® Advanced Perfusion System 1
Common/Genric Name	Heart-Lung Machine
Classification name	Console, Heart-Lung Machine,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 K163531.

Image /page/3/Picture/11 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.

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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 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/25 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 appears to be bolded.

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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 Patient Gas System (EPGS) 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/9 description: The image shows a labeled diagram of a centrifugal control unit. The diagram labels the different parts of the unit, including the centrifugal control unit, small roller pump, large roller pump, central control monitor, occluder, electronic gas blender local controls, wheel lock, power status indicator LED, hand cranks, and on/off switch. The diagram also includes a lamp and labels the roller pump local display and control.

Image /page/5/Picture/10 description: The image shows the Terumo logo. The logo consists of a red swoosh above the word "TERUMO" in green. The font is bold and sans-serif.

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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:

· CCM 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
· EPGS for control and monitoring of the gas output to the oxygenator

The following technological differences exist between the subject and predicate devices:

· The O2 analyzer calibration routine has been modified to calibrate at two gas flow rates instead of one.
The addition of notifications to the CCM to inform users of the EPGS calibration status.

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Premarket Notification K16####

Performance Data

Biocompatibility Testing

The Terumo® System 1 does not come into contact with the patient. Therefore biocompatibility testing is not included as part of this premarket notification.

Electrical Safety and Electromagnetic Compatibility (EMC)

This premarket notification is limited to the software modifications to the EPGS and the CCM of the System 1. These software modifications do not impact Electrical Safety and Electromagnetic Compatibility of the product, therefore testing was not conducted.

Software Verification and Validation Testing

Software verification and validation testing were conducted and discussion of the these activities (i.e. protocols, acceptance criteria. and test results) at the unit, integration, and system level are included as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Design Verification and Validation Testing

Design verification testing was not required as software verification and validation testing has addressed the design input requirements and software requirement specifications.

Design validation testing was conducted and demonstrates that the System 1 performs within the defined design input requirements for the proposed modifications. The following testing was performed on the subject device:

. Simulated use case testing
. Validation of the Instructions For Use changes

Animal Study

Animal testing was not required to demonstrate the substantial equivalence of the System 1 to the predicate device and is not included 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 and is not included as part of this premarket notification.

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Image /page/7/Picture/21 description: The image contains the word "TERUMO" in a bold, green font. A red swoosh is above the word. The word is the logo for the Terumo Corporation, a Japanese medical device company.

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Conclusion

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, and design 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 K163531.

Image /page/8/Picture/6 description: The image shows the Terumo logo. The logo consists of a red arc above the word "TERUMO" in green. The arc is curved and positioned above the left side of the word. The word "TERUMO" is in a bold, sans-serif font.

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).