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.l., Medolla, Italy for Medtronic and exclusively distributed by Medtronic Perfusion Systems.

It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).

The key differences between the competitive heart lung machines and the Performer CPB arc:

. A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
. Electrically adjustable height and stability system.
. Integrated Active Air Removal System.
. A built in printer.
Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
. Integrated "Memory Card" for treatment data recording and software updates.
. Integrated SatO2/Hct and Tcmperature monitoring system.
. Cardioplegia delivery air detector with pump stop feed back.
Selectable alcrt/alarm tones (including voice). .
. Active Air removal with arterial flow servo control.
. Predominant 'icon' based GUI.
Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.
Roller pump cover sensors.
. . Real time integrated parameters' trending.

AI/ML Overview

This document describes a 510(k) submission for the Medtronic Performer CPB System, a heart-lung machine. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance criteria against predefined acceptance thresholds in the typical sense of a new medical AI device.

Therefore, many of the requested categories are not applicable to this submission. The document focuses on demonstrating equivalence to existing legally marketed predicate devices through performance testing and comparison of technological characteristics.

Here’s a breakdown of the information that can be extracted or deduced, along with an explanation of why other requested categories are not directly addressed:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not present in the provided text. The submission aims to show "equivalence" rather than meeting pre-defined, quantitative acceptance criteria for novel performance claims. The performance data mentioned is for demonstrating this equivalence.

Acceptance Criteria (Implied for Equivalence)	Reported Device Performance
Air handling capabilities equivalent to predicate devices	Performance data provided in the 510(k) submission
Blood trauma equivalent to predicate devices	Performance data provided in the 510(k) submission
Cardioplegia delivery equivalent to predicate devices	Performance data provided in the 510(k) submission
Machine performance and Software Verification and Validation	Comprehensive testing completed
Technological characteristics similar to predicate devices	Stated as having the same technological characteristics as traditional circuits and predicate components
Indications for Use similar to predicate devices	Stated as having similar indications for use

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

Sample Size for Test Set: Not explicitly stated. The document refers to "performance data" and "comprehensive testing" but does not detail the number of units or test subjects involved in these tests.
Data Provenance (country of origin, retrospective/prospective): Not explicitly stated. The manufacturing site is RanD S.r.l., Medolla (MO) – ITALY. The testing would likely have been conducted by or for the manufacturer. The nature (retrospective/prospective) of the performance data tests is not specified.

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

Not applicable. For a device like a heart-lung machine, "ground truth" is not established by expert consensus on interpretations but rather by physical measurements and engineering validation against established standards or predicate device performance. The performance data would involve technical measurements and comparisons.

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

Not applicable. This is typically relevant for studies involving human interpretation (e.g., radiology images) where expert consensus resolves discrepancies. For a mechanical medical device, direct measurements and engineering analysis are performed.

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 is not an AI-assisted diagnostic or interpretive device. It is a cardiopulmonary bypass system.

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

Not applicable. This is a physical medical device, not an algorithm. Performance tests would inherently be "standalone" in the sense that the device's functional outputs are measured, but it's not an "algorithm only" study.

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

Not explicitly stated using these terms. For a physical device, "ground truth" for performance would be established through objective physical measurements, engineering specifications, and comparison against established performance benchmarks of predicate devices. For example, air handling capabilities would be measured using technical equipment and compared to the predicate's measured capabilities or accepted standards.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. This device is not an AI/ML model.

In summary, this 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device to already approved predicate devices through performance data and comparison of technological characteristics, rather than establishing performance against novel statistical acceptance criteria typical of AI/ML or diagnostic devices.

Summary

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MAR 1 5 2006

Medtronic Performer CPB 510(k) Submission

APPENDIX I

05 2555
page 1 of 3

510(k) Summary

Medtronic Performer CPB System

(As required by 21CFR 807.92)

A. Submitter Information

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:	September 15, 2005

Device Information

Trade Name	Performer Cardiopulmonary Bypass System
Common Name	Cardiopulmonary bypass heart-lung machine console
Address of Manufacturing Facilities	Manufacturing SiteRanD S.r.l.Via Sparato, 6041036 Medolla (MO) – ITALY
	Establishment Registration NumberPending
FDA Classification	Class II
FDA Product Classification Code	DTQ
FDA Regulation Number	21 CFR 870.4220
FDA Classification Panel	Cardiovascular

Predicate Devices:

COBE Century Perfusion Pump (K960974) .
Terumo Advanced Perfusion System 1 (K022947) .

The Performer CPB has incorporated capabilities from five stand alone Medtronic devices which are:

Medtronic Resting Heart System (K031700) .

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Image /page/1/Picture/0 description: The image shows the text "Medtronic Performer CPB 510(k) Submission" on the left side of the image. On the right side of the image, the text "K052555" and "page dof 3" are written in a handwritten font. The text on the left side of the image is written in a more formal font. The image appears to be a page from a document.

Medtronic 560 BioConsuole System (K051303) .
Medtronic Oxygen Saturation and Hematocrit System (K954501) .
CSS Cardioplegia Safety System (K973237) .
Medtronic Pressure Display Box and Tubing Set (K852232) .

Device Description:

It's initial configuration and features are optimized for use with the Medtronic Resting Heart System (K03170).

The key differences between the competitive heart lung machines and the Performer CPB arc:

. A small foot print for the machine and pump's layout optimized (vertical orientation) for extracorporcal volume reduction. Collapsible feature for storage and easy transportation.
. Electrically adjustable height and stability system.
. Integrated Active Air Removal System.
. A built in printer.
Pre configured roller pump rotation . (unidirectional) and built in Handcrank in roller pumps for emergencies.
. Integrated "Memory Card" for treatment data recording and software updates.
. Integrated SatO2/Hct and Tcmperature monitoring system.
. Cardioplegia delivery air detector with pump stop feed back.
Selectable alcrt/alarm tones (including voice). .
. Active Air removal with arterial flow servo control.
. Predominant 'icon' based GUI.
Independent status colored LED system (traffic . light style) for alerts and alarms in addition to the audio and visual set ups on the actual user interface screen.

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Medtronic Performer CPB 510(k) Submission

Roller pump cover sensors.
. . Real time integrated parameters' trending.

Indications for Use: 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.

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 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, air handling capabilities, blood trauma, cardioplegia delivery have been provided in the 510(k) submission to show equivalence of the Medtronic Performer CPB System, when working with Resting Heart Disposable Module to COBE Century System and other referenced devices. 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2006

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

Re: K052555

Performer CPB Heart Lung Machine Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: Class II (Two) Product Code: DTQ Dated: March 3, 2006 Received: March 6, 2006

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, Fi)A 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Bhummar 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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Appendix II

Indications for Use

510(k) Number (if known):

05d555

Device Name:

Indications For Use:

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use X AND/OR

(Part 21 CFR 801 Subpart D)

510(k) Number KO50555

(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)

(Division Sign-Off)	Page 1 of 1
Division of Cardiovascular Devices

Confidential

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).