The Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).

Device Description

The Bio-Console® 560 is an extracorporeal blood pumping console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.

AI/ML Overview

The provided text is a 510(k) summary for the Medtronic Bio-Console® 560. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on minor software modifications and provides no information about a clinical study, acceptance criteria, or performance data for the device. The "Test Data" section explicitly states: "Software verification and validation testing confirms that the function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specifications." This indicates that the assessment was based on engineering and software verification, not clinical performance with human data.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text. The device is a "cardiopulmonary bypass pump speed control," which is a piece of medical equipment, not an AI/ML algorithm that predicts or analyzes medical data and thus does not typically involve the kinds of studies described in your request (e.g., MRMC studies, standalone AI performance).

To directly answer your specific points based only on the provided text, without making assumptions:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of clinical performance metrics. The document implies that the acceptance criteria were based on software verification and validation satisfying "documented product and performance specifications" for substantial equivalence to the predicate device.
- Reported Device Performance: Not reported in clinical terms. The document states "All test data obtained satisfied the documented product and performance specifications," but these specifications and the test results are not detailed.
Sample sized 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 applicable/not provided. No clinical test set involving patient data is mentioned. The testing focused on software verification and validation.
- Data Provenance: Not applicable/not provided.
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):
- Not applicable/not provided. No clinical ground truth was established as no clinical study is described. The "ground truth" for software validation would be adherence to design specifications, which is typically assessed by engineers and testers.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/not provided.
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:
- No MRMC study was done or mentioned. This device is not an AI diagnostic or assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of typical AI device evaluation. The "software verification and validation testing" could be considered an "algorithm only" test for the embedded control software, but it's not a standalone diagnostic algorithm in the sense of modern AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the software modifications would be the functional requirements and design specifications of the device.
The sample size for the training set:
- Not applicable/not provided. This is not an AI/ML device that requires a training set of data.
How the ground truth for the training set was established:
- Not applicable/not provided.

Summary

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K080824

510(k) SUMMARY of Safety and Effectiveness

MAY - 7 2008

l. Applicant Information:

Date Prepared:	March 21, 2008
Submitter:	Medtronic, Inc.
Address:	7611 Northland DriveBrooklyn Park, MN 55428
EstablishmentRegistration No.	2184009
Contact Person:	Preeti JainDirector of Regulatory and Clinical Affairs
Telephone Number:	(763) 391-9533
Fax Number:	(763) 391-9100

II. Device Information:

Trade Name:	Bio-Console® 560
Common Name:	Cardiopulmonary bypass pump speed control
Classification Name:	Control, Pump Speed, Cardiopulmonary Bypass
Classification:	Class II, 21 CFR 870.4380
Product Code:	DWA
Predicate Device:	Medtronic Bio-Console® 560510(k) No. K070286, Reg. No. 870.4380; Product Code: DWA
	Device Intended Use: The Medtronic centrifugal bloodpumping system is intended to pump blood through theextracorporeal bypass circuit for extracorporeal support forperiods appropriate to cardiopulmonary bypass procedures (upto 6 hours).

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The Bio-Console® 560 is an extracorporeal blood pumping Device Description: console consisting of a Base Unit with a display and a User Interface (touch screen) with integrated flow control knob. In order to perform its intended function, the Bio-Console 560 is compatible with the Medtronic External Drive Motor, disposable Centrifugal Pump, Flow Transducer with disposable Insert, and Emergency Handcrank.
The Medtronic centrifugal blood pumping system is intended to Intended Use: pump blood through the extracorporeal bypass circuit for extracorporeal support for periods appropriate to cardiopulmonary bypass procedures (up to 6 hours).
Comparison to The Bio-Console 560 has the same intended use, hardware Predicate Device: design and basic software as the previously cleared Bio-Console 560. The only change to the device is the incorporation of some minor software modifications, which modify the way the Base Unit and User Interface control sensors and alarms, control the Coast Speed and ensure that the Pump Speed is greater than the Coast Speed to open the clamp.
Software verification and validation testing confirms that the Test Data: function of the Bio-Console 560 and its software-controlled functional characteristics are substantially equivalent to the predicate device. All test data obtained satisfied the documented product and performance specifications.
Based upon the technical information, intended use, and in Summary: vitro verification and validation information provided in previous pre-market notifications, the Bio-Console 560 addressed in this submission has been shown to be substantially equivalent to the currently marketed predicate device.

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Public Health Service

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ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 7 2008

Medtronic, Inc. c/o Ms. Preeti Jain Director of Regulatory and Clinical Affairs 7601 Northland Drive Minneapolis, MN 55428

Re: K080824

Bio-Console® 560 Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II (two) Product Code: DWA Dated: March 21, 2008 Received: March 24, 2008

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 sct 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,

Ouna R. Kirchner

/ 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): Ko80824

Bio-Console® 560 Device Name:

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (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)

Dana E. Lechner

(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices

510(k) Number_Ko&ox24

Regulation Number and Section

§ 870.4380 Cardiopulmonary bypass pump speed control.

(a)
Identification. A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.(b)
Classification. Class II (performance standards).