The Medtronic Performer CPB Advanced Extracorporeal Circulatory Support System is indicated for use up to 6 hours in the extracorporeal circulation of fluids for 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 pumping blood through an extracorporeal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

Device Description

The Performer CPB, is a next generation heart lung machine that integrates the primary functions and safety features needed to perform cardiopulmonary bypass and related circulatory support procedures, along with enhanced user conveniences, into a reduced sized instrument. The product is designed and manufactured by RAND S.r.1., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.

This version of the device has been changed to add conventional bypass capability to the existing device which previously only supported the use of Medtronic Resting Heart Disposable Module. The conventional bypass refers to already marketed cardiopulmonary circuits that utilize a reservoir. Typical conventional circuits include oxygenators, reservoirs, centrifugal pump, filters, tubings, connectors etc. This updated version of the Performer only supports the Medtronic Bio-Medicus centrifugal Pump as the arterial pump.

The changes included in Version 1.5 of the device include the following:

. Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode.
Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Performer CPB System, which is a cardiopulmonary bypass heart-lung machine console. This document is a regulatory submission for a medical device that assists in surgery and not an AI/ML device. Therefore, the requested information for acceptance criteria and a study to prove the device meets those criteria, specifically concerning AI/ML performance, cannot be fully provided from the given text.

The document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against detailed AI/ML-specific acceptance criteria.

However, I can extract information related to the device's enhanced features and the general performance data mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a formal table of acceptance criteria with specific quantitative thresholds. Instead, it states that "comprehensive testing has been completed on the machine including performance and Software Verification and Validation" and references the results of this testing as supporting substantial equivalence. It highlights the capabilities of the newly added features: Level Sensing and AutoClamp Retrograde Detection.

Feature/Capability	Reported Device Performance
Level Detection Capability	- Monitors changes in fluid or blood volume in reservoirs.- System can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit.- User can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues.- Utilized only when operating with reservoirs in conventional cardiopulmonary bypass mode.
Retrograde Detection and Occlusion Capability (AutoClamp System)	- Utilizes a Remote Tube Clamp (RTC) placed on the arterial line to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes.- Can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, preventing retrograde flow and potential entrainment of air around the aortic cannulation site.- Utilized only when operating in the conventional cardiopulmonary bypass mode.
Overall Performance	Performance data, such as level sensing capabilities and AutoClamp retrograde detection capabilities, were provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System to predicate devices (RMR Automatic Tubing Clamp System, Terumo System 1, and Cobe system). In addition, comprehensive testing was completed on the machine including performance and Software Verification and Validation. The conclusion is that the device is "safe and effective for its intended use" based on these tests and similarities to predicate devices.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not detail specific sample sizes for particular tests. It generally refers to "performance data" and "comprehensive testing." The data provenance (country of origin, retrospective/prospective) is not specified. Given this is a device for sale internationally by a US-based company with manufacturing in Italy, the testing location might be in either country, but this is not stated. The type of testing suggests a prospective, controlled validation, but the methodology details are absent.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to the provided document. The device in question is a medical hardware system, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth on medical images or patient data. The "ground truth" for this device's performance would be engineering specifications and functional testing results.

4. Adjudication Method for the Test Set:

Not applicable for a medical device hardware system as described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for ground truth establishment in AI/ML model validation, neither of which is explicitly described here in detail.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

Not applicable. MRMC studies are used to assess the performance of diagnostic tools (often involving medical imaging) with and without AI assistance, comparing human reader performance. This device is a cardiopulmonary bypass system, not a diagnostic imaging tool. Therefore, no effect size of human readers improving with AI assistance is mentioned.

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

While the device has automated functions (like the AutoClamp and Level Detection triggering pump actions or alarms), the concept of "standalone algorithm only performance" in the context of AI/ML is not directly relevant here. The device itself operates as a standalone system during a procedure, guided by predefined logic and user configuration, without an explicit "AI algorithm" in the modern sense that needs standalone validation. Its performance is integrated into the overall machine functionality.

7. The Type of Ground Truth Used:

The ground truth for this medical device would be based on engineering specifications, functional safety requirements, and established design principles for cardiopulmonary bypass systems. For example, the ground truth for the level detection would be the actual fluid levels in a reservoir, and the device's alarm/response mechanism would be validated against these known levels. For the AutoClamp, the ground truth would involve simulated retrograde flow conditions to verify proper clamping action. The document implies that these functional aspects were tested to show equivalence to predicate devices.

8. The Sample Size for the Training Set:

Not applicable. This document describes a medical device, not an AI/ML model that would have a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of medical device as described.

In summary: The provided 510(k) summary focuses on demonstrating that the Medtronic Performer CPB System is substantially equivalent to existing, legally marketed predicate devices. It affirms that "performance data" and "comprehensive testing" for its new features (level sensing and AutoClamp) were conducted, along with "Software Verification and Validation," to support this equivalence. However, it does not provide the specific detailed breakdown of acceptance criteria and study methodologies typically requested for AI/ML device validation.

Summary

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APPENDIX I

510(k) Summary

KO702/3

Medtronic Performer CPB System

MAR 2 1 2007

(As required by 21CFR 807.92)

Submitter Information A.

Submitter's Name:	RAND S.r.l.
Address:	Via Sparato, 6041036 Medolla (MO) – ITALY
Telephone Number:	763.391.9533 (for contact)
Contact Person:	Preeti Jain
Date Submission Prepared:	January 19, 2007

Device Information

Trade Name	Performer Cardiopulmonary Bypass System
Common Name	Cardiopulmonary bypass heart-lung machine console

Address of Manufacturing

Facilities	Manufacturing Site
	RAND S.r.l.
	Via Sparato, 60
	41036 Medolla (MO) – ITALY
	Establishment Registration Number
	3003793891
FDA Classification	Class II
FDA ProductClassification Code	DTQ
FDA Regulation Number	21 CFR 870.4220
FDA Classification Panel	Cardiovascular

Predicate Devices:

· Medtronic Performer CPB Advanced Extracoporeal Circulatory Support System (K052555)
COBE Century Precision Blood Pump (K960974) ●
Terumo Advanced Perfusion System 1 (K022947) .
RMR Automatic Tubing Clamp System (K961364) .

Device Description:

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The changes included in Version 1.5 of the device include the following:

. Optional Level Detection capability for reservoirs: Level detectors have been added to monitor changes in fluid or blood volume in the reservoirs. The system can be configured by the user to cause the Bio-Pump to either Stop or Coast in response to a level sensor being activated, preventing emptying the reservoir and transmitting air into the circuit. The user can also configure this safety link to not change the Bio-Pump function, but only produce visual and audible alarm cues. The level detection system is only utilized when operating with the reservoirs in the conventional cardiopulmonary bypass mode.
Optional Retrograde Detection and Occlusion capability: An AutoClamp System . has been added that utilizes a Remote Tube Clamp (RTC), placed on the arterial line which serves to prevent retrograde flow from the aorta into the venous reservoir if the Bio-Pump run mode changes. The AutoClamp System can be configured to automatically clamp the arterial line when the Bio-Pump speed changes, prevent retrograde flow and thereby prevent the potential to entrainment air around the aortic cannulation site. The AutoClamp System is only utilized when operating in the conventional cardiopulmonary bypass mode.

Indications for Use:

The centrifugal pump is indicated for use in pumping blood through an extracomoreal perfusion circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

C. Comparison of Required Technological Characteristics

Medtronic Performer CPB System is a system comprised of standard components of an extracorporeal circuit for use during cardiopulmonary circulatory support. The

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system has the same technological characteristics as a traditional circuit and the single components have the same technological characteristics as the predicate.

D. Performance Data

Performance data, such as, level sensing capabilities and AutoClamp retrograde detection capabilities have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System to RMR Automatic Tubing Clamp System, Terumo System 1 and Cobe system. In addition comprehensive testing has been completed on the machine including performance and Software Verification and Validation.

E. Conclusion

Medtronic Performer CPB System is substantially equivalent to the noted predicate devices based on the similarities of technological characteristics, indications for use and the results of performance comparative testing and is safe and effective for its intended use.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or bird-like figure. The emblem is composed of three curved lines that form the shape of the bird's head, body, and tail.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 1 2007

Rand S.R.L. c/o Ms. Preeti Jain Director, Regulatory/Clinical Affairs 7611 Northland Drive Minneapolis, MN 55428

Re: K070213

Performer CPB System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine Regulatory Class: Class II Product Code: DTQ Dated: January 19, 2007 Received: January 22, 2007

Dear Ms. Jain:

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 - Ms. Preeti Jain

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 (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. 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 (240) 276-0120. 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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Bram B. Zuckerman, M.D.

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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Appendix II

Indications for Use

510(k) Number (if known):

Device Name: ___ Performer CPB

Indications For Use:

Prescription Use X

AND/OR Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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)

Page 1 of
(gn-Off) of Cardiovascular Devices Lot Number	K070213

Page 71 of 71

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).