The Terumo® Advanced Perfusion System 1 is indicated for up to 6 hours of use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only, and intended to be used by a qualified perfusionist who is experienced in the operation of Sarns™ brand or similar equipment.

The centrifuqal pump is indicated for use in cardiopulmonary bypass procedures only.

Device Description

The Terumo® Advanced Perfusion Svstem 1 is a highly configurable 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. Within reason, the system should allow users to define and configure a system to meet their individual requirements, and as needed, adapt the configuration as their needs change. The basic Terumo® Advanced Perfusion System 1 consists of a Chassis platform which provides operating power and battery back-up power for all other devices of the system that enable, facilitate or improve the intended use of the product and integrated functions, the Central Control Monitor which through its software and display touch screen facilitates the configuration and control of all other components, the Air Bubble Detect Module which is used to detect gross air bubbles in the arterial line of the perfusion circuit with the Terumo® Air Sensor, and the Level Detect Module which is used to monitor blood levels within a hard shell reservoir with the Terumo® Level Sensors. The following modules may also be used to enhance the abilities of the Terumo® Advanced Perfusion System 1: Temperature Module, Pressure Module, Flowmeter Module, Occluder Module, RS-232 Interface Module, RS-485 Interface Module, CDI™ 100 Interface Module, CDI™ 500 Interface Module, 6" diamter race Roller Pump, 4" diameter race Roller Pump, Centrifuqal Control Module, and a 33" or 15" Lamp. This design allows perfusionists to select the number and types of the accessory devices needed to control and monitor patient perfusion during cardiopulmonary bypass.

AI/ML Overview

The provided document is a 510(k) summary for the Terumo® Advanced Perfusion System 1. It details the device's description, indications for use, and a comparison to predicate devices, along with a statement about performance testing. However, it does not include specific quantitative acceptance criteria or detailed results from a study proving the device meets those criteria.

The document states: "The performance characteristics of the Terumo® Advanced Perfusion System 1 were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ 8000 Modular Perfusion System, Sarns™9000 Heart-Lung Console, Sarns™ 8000 Roller Pump, Sarns™ 9000 Universal Roller Pump, Flow Sensor Centrifugal Control Module, and Delphin II/Stand-Alone Centrifugal Module. All new and existing performance characteristics of the Terumo® Advanced Perfusion System 1 have been validated."

And "The Terumo® Advanced Perfusion System 1 perform as intended according to its performance specifications. The Terumo® Advanced Perfusion System 1 is substantially equivalent to its predicated devices."

This indicates that internal performance specifications were used as acceptance criteria, and testing was conducted to demonstrate substantial equivalence to predicate devices. However, the specific metrics, thresholds, and study designs are not disclosed in this summary.

Therefore, based on the provided text, I cannot complete a table of acceptance criteria with reported device performance, nor can I provide answers to most of the specific questions regarding the study design (sample size, ground truth, experts, adjudication, MRMC, or standalone performance).

The document focuses on demonstrating substantial equivalence to existing devices rather than providing detailed quantitative efficacy data that would be typical for an AI/ML diagnostic device with clear performance metrics.

Here's what can be extracted and what cannot be from the provided document:

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

Acceptance Criteria	Reported Device Performance
(Not specified quantitatively in the document)	"The Terumo® Advanced Perfusion System 1 perform as intended according to its performance specifications."
Substantial equivalence to predicate devices (Functional equivalence, safety, effectiveness)	"The Terumo® Advanced Perfusion System 1 is substantially equivalent to its predicated devices."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, likely laboratory-based, comparing performance to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable/Not specified. This is a medical device (perfusion system), not an AI/ML diagnostic requiring expert ground truth in the same way. The "ground truth" would be established by engineering specifications and direct measurement/testing.
Qualifications of Experts: Not applicable/Not specified.

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

Adjudication Method: Not applicable/Not specified. This type of adjudication is typically for subjective interpretations, which isn't directly relevant to the performance testing of a perfusion system described here.

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 is not an AI/ML diagnostic requiring human reader interpretation. The device is for "extracorporeal circulation of blood" and operated by a "qualified perfusionist."
Effect Size: Not applicable.

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

Standalone Performance: Not applicable as an AI/ML algorithm. The device itself is a system with components, and its "standalone" performance would refer to its functional operation as designed, independent of human interaction beyond normal operation by a perfusionist. The document states its performance was "exhaustively tested."

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

Type of Ground Truth: For this type of medical device, the "ground truth" for performance testing would be established by engineering specifications, direct physical measurements, and comparison to the known performance of predicate devices under controlled conditions. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its design and functionality are based on established engineering principles and existing technologies.

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

Ground Truth for Training Set: Not applicable. There is no AI/ML training set mentioned or implied for this device.

Summary

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1622947

TERUMO CARDIOVASCULAR SYSTEMS CORPORATION

MAR 2 0 2003

ન ર 510(k) SMDA Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) Number is

Submitter's Name: Terumo Cardiovascular Systems Corporation Submitter's Address: 6200 Jackson Road, Ann Arbor, Michigan 48103-9300 Contact Person: Mark A. Bur (734) 741-6117 Phone Number: FAX Number: (734) 663-5062 Summary Date: July 31, 2002

Device Trade Name: Terumo® Advanced Perfusion System 1

Device Classification Name: Cardiopulmonary bypass heart-lung machine (21 CFR 870.4220)

Predicate Devices:

Sarns™9000 Heart-Lung Console (K871131) Sarns™ 8000 Modular Perfusion System (K915183) Sarns™ 8000 Roller Pump (K953901) Sarns™ 9000 Universal Roller Pump (K953904) Flow Sensor Centrifugal Control Module (K950739) Delphin II/Stand-Alone Centrifugal Module (K935978)

Indication for Use

Device Description:

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RUMO CARDIOVASCULAR SYSTEMS CORPORATION

accessory devices needed to control and monitor patient perfusion during cardiopulmonary bypass.

Technological Characteristics:

The Terumo® Advanced Perfusion System 1 is a combination of the technologies from the current legally marketed devices, Sarns™ 8000 Modular Perfusion System, Sarns™9000 Heart-Lung Console, Sarns™ 8000 Roller Pump, Sarns™ 9000 Universal Roller Pump, Flow Sensor Centrifugal Control Module, and Delphin II/Stand-Alone Centrifugal Module and present day technology for computer controlled systems. The main differences between the predicate devices, Sarns™ 8000 Modular Perfusion System, Sarns™9000 Heart-Lung Console, and Delphin II/Stand-Alone Centrifygal Module, and the Terumo® Advanced Perfusion System 1 are:

· individual modules applications compared to the subsystem modules in the 8000 system.
· enhanced parameter entry for all modules via the Central Control Monitor compared to the minimal parameter user entry of the 9000 system via its touch screen.
· ability to control Electronic Gas Blender, Roller Pumps, and Centrifygal Control Module of the system via the Central Control Monitor or individual module controls compared to the individual controls required of the 8000, 9000, and Delphin standalone system.
ability to setup multiple case configurations parameters on the Central Control Monitor software and recall the configuration parameters for use in a future cases compared to only one past systems setup and parameter setup each time,
· ability to configure a multi-module system for use of the users choice desired components rather than be constricted to only the few components available and the manufacturers platform layout on past systems.

Non-clinical Performance:

The performance characteristics of the Terumo® Advanced Perfusion System 1 were exhaustively tested and compared with the performance characteristics of the currently marketed Sarns™ 8000 Modular Perfusion System, Sarns™9000 Heart-Lung Console, Sarns™ 8000 Roller Pump, Sarns™ 9000 Universal Roller Pump, Flow Sensor Centrifugal Control Module, and Delphin II/Stand-Alone Centrifugal Module. All new and existing performance characteristics of the Terumo® Advanced Perfusion System 1 have been validated.

Conclusion from Conducted Testing:

The Terumo® Advanced Perfusion System 1 perform as intended according to its performance specifications. The Terumo® Advanced Perfusion System 1 is substantially equivalent to its predicated devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 0 2003

Terumo Cardiovascular Systems Corporation c/o Mr. Mark A. Bur 6200 Jackson Road Ann Arbor, MI 48103-9300

Re: K022947

Advance Perfusion System 1 Regulation Number: 21 CFR 870.4220 Regulation Name: CPB Heart Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: December 20, 2002 Received: December 23, 2002

Dear Mr. Bur:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Mark A. Bur

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours,

N.D. Zuckerman, M.D.

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

Enclosure

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K022947 510(k) Number (if known):

Terumo® 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 centrifuqal pump is indicated for use in cardiopulmonary bypass procedures only.

Mark A. Burr

Mark A. Bur Regulatory Affairs Specialist Terumo Cardiovascular Systems

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

N. Cole Th

510(k) Number K022947

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109)

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).