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 Extracorporeal Blood Pumping Console is an electromechanical, software-controlled device intended to allow the user to control a Bio-Pump® or Affinity® CP centrifugal blood pump that is used to return the blood to the body of a patient on cardiopulmonary bypass. As part of the blood pumping circuit, the patient's blood is typically pumped through an oxygenator and a filter on its return path to the patient. The Bio-Console 560 is a reusable non-sterile device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Bio-Console® 560 Extracorporeal Blood Pumping Console:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Maintain the same intended use as the predicate device.	The Bio-Console 560 has the same intended use as the previously cleared Bio-Console 560.
Maintain the same hardware design as the predicate device.	The Bio-Console 560 has the same hardware design as the previously cleared Bio-Console 560.
Maintain the same basic software as the predicate device.	The Bio-Console 560 has the same basic software as the previously cleared Bio-Console 560.
Incorporate software enhancements to correct anomalies.	Software enhancements were incorporated to correct anomalies.
Incorporate IEC 60601-1 (3rd Edition) compliant alarm and alert tones.	IEC 60601-1 (3rd Edition) compliant alarm and alert tones were incorporated.
Software verification and validation testing confirms the function of the device.	"Software verification and validation testing confirms the function of the Bio-Console 560..."
Software-controlled functional characteristics are substantially equivalent to the predicate device.	"...and its software-controlled functional characteristics are substantially equivalent to the predicate device."
All test data obtained satisfy documented product and performance specifications.	"All test data obtained satisfied the documented product and performance specification."

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

This information is not provided in the given document. The document mentions "software verification and validation testing" and "all test data obtained," but does not specify the sample size (e.g., number of test cases, number of runs) or the provenance (country of origin, retrospective/prospective nature) of the data used for this testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the given document. The document describes a technical evaluation of software enhancements, not a study involving human experts establishing ground truth for a test set in the context of diagnostic interpretation or similar medical AI applications.

4. Adjudication Method for the Test Set

This information is not provided in the given document. As there's no mention of human experts establishing ground truth with potential disagreements, an adjudication method would not be relevant in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for software enhancements to an existing device and focuses on substantial equivalence based on technical verification and validation, not on evaluating human performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance evaluation was implicitly done. The "software verification and validation testing" assessed the "software-controlled functional characteristics" of the device in isolation, confirming its function and substantial equivalence. The enhancements relate to internal software corrections and alarm tones, which are tested as part of the device's inherent functionality.

7. Type of Ground Truth Used

The "ground truth" for this submission appears to be derived from documented product and performance specifications and the functional characteristics of the predicate device. The testing aimed to confirm that the updated software met these pre-defined specifications and maintained performance equivalent to the predicate.

8. Sample Size for the Training Set

This information is not provided in the given document. The device is described as an electromechanical, software-controlled device, but there is no indication that it utilizes machine learning or AI that would require a "training set" in the conventional sense of an AI model. The software enhancements are described as corrections and updates to existing functionality.

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

This information is not provided in the given document. As no "training set" is mentioned or implied for a machine learning model, the establishment of ground truth for such a set is not applicable.

Summary

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JUL 2 4 2013

510(k) Summary of Safety and Effectiveness

Date Prepared:	June 26, 2013
Applicant:	Medtronic. Inc.Medtronic Perfusion Systems7611 Northland DriveBrooklyn Park, MN 55428Establishment Registration No. 2184009
Contact Person:	Lisa StonePrincipal Regulatory Affairs SpecialistMedtronic, Inc.Cardiovascular8200 Coral Sea Street NE, MVS 83Mounds View, MN 55112Phone: (763) 514-9866Fax: (763) 367-8147Email: lisa.j.stone@medtronic.com
Trade Name:	Bio-Console® 560 Extracorporeal Blood Pumping Console
Common Name:	Cardiopulmonary bypass pump speed control
Classification Name:	Control, Pump Speed, Cardiopulmonary Bypass
Classification:	Class II, 21 CFR 870.4380
Product Code:	DWA
Name of Predicate Device:	Bio-Console® 560 Extracorporeal Blood Pumping Console(K080824)

Device Description

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Intended Use

Comparison to the Predicate Device

The Bio-Console 560 has the same intended use, hardware design and basic software as the previously cleared Bio-Console 560. The only change to the device is the incorporation of software enhancements to correct anomalies and to incorporate IEC 60601-1 (3d Edition) compliant alarm and alert tones.

Summary of Performance Data

Software verification and validation testing confirms 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 specification.

Conclusion

Based upon the technical information, intended use, and in-vitro verification and validation information for the Bio-Console 560 software enhancements addressed in this submission, the Bio-Console 560 has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three wavy lines instead of snakes.

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

July 24, 2013

Medtronic, Inc. Lisa Stone 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K131964

Trade/Device Name: Bio-Console 560 Extracorporeal Blood Pumping Console Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II Product Code: DWA Dated: June 26, 2013 Received: June 27, 2013

Dear Lisa Stone:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Lisa Stone

forth in the quality systems (OS) regulation (2) 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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,

M.A. Stilleman

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

Enclosure

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510(k) Number: K131964

Bio-Console® 560 Extracorporeal Blood Pumping Console

Indications for use:

Prescription Use X (Part 21 CFR 801 Subpart D) OR Over-The-Counter-Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH. Office of Device Evaluation (ODE)

M. A. Lillehem

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).