The AFFINITY™ CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).

The AFFINITY™ CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.

Device Description

The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.

The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:

External Drive Motor (Model 560A)
Emergency Handcrank (Model HC150A)

AI/ML Overview

Here's an analysis of the acceptance criteria and study information based on the provided K100631 document. It's important to note that this document is a 510(k) summary for a medical device and, as such, focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results for a novel AI device. Therefore, many of the requested points, particularly those related to AI algorithm performance (e.g., MRMC studies, training set details), may not be directly applicable or fully present in this type of submission.

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

The document does not explicitly state numerical "acceptance criteria" in a table format. Instead, it describes general improvements and successful "verification and validation testing." The performance is compared qualitatively to the predicate device. For this submission, substantial equivalence to the predicate device is the primary acceptance criterion, demonstrated through comparative testing and design.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	Demonstrated as safe and effective through verification and validation testing.
Substantial Equivalence to Predicate Device	The AFFINITY CP Centrifugal Blood Pump is substantially equivalent to the predicate device (Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump) in intended use and basic design (magnetic coupling to an external motor). Necessary design changes to the motor and handcrank allow compatibility.
Reduced Heat Generation	Bearing heat generation is reduced due to a ceramic pivot system. The blood pump is more efficient.
Reduced Priming Volume	Priming volume is reduced by 50%, to a volume of 40 mL.
Reduced Hemolysis	Hemolysis is reduced compared to the predicate device; less damaging to red blood cells.
Functional Performance (Various)	Other validation tests included: maximum pressure generation, flow rates, pivot bearing wear, maximum speed, port strength, magnetic coupling force, biocompatibility, noise generation, and prime volume. (Implied: met performance standards for these parameters).
Effectiveness under Simulated Conditions with Expert Users	Validation testing under simulated conditions of use with expert users also demonstrated the effectiveness of the AFFINITY CP Centrifugal Blood Pump. (Implied: met user needs and performed effectively in a realistic setting).
Intended Use Compatibility	Used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours), and for extracorporeal support systems not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, mitral valve reoperation, surgery of vena cava/aorta, liver transplants). (Implied: aligns with intended use statement).

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

The document refers to "verification and validation testing" and "validation testing under simulated conditions of use." However, it does not specify the sample size (e.g., number of pumps tested, number of simulated runs) for these tests. There's also no information provided regarding data provenance (country of origin, retrospective/prospective). This type of detail is often found in the full testing report, not typically in the 510(k) summary.

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)

The document mentions "expert users" in the context of validation testing under simulated conditions. However, it does not specify the number of experts used or their qualifications.

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

The document does not describe any adjudication method for the test set.

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

The device is a mechanical blood pump, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

This is a mechanical device, so "standalone algorithm-only performance" is not applicable. Performance was assessed based on the physical and functional characteristics of the pump and its drive systems.

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

For this mechanical device, the "ground truth" for its performance would be established through:

Engineering specifications and standards: For parameters like maximum pressure generation, flow rates, maximum speed, port strength, magnetic coupling force, noise generation, and prime volume.
Laboratory measurements: For quantification of heat generation, priming volume, and hemolysis.
Biocompatibility testing: To ensure safety when in contact with blood.
Functional assessment by expert users: During simulated conditions of use.

There isn't a "ground truth" in the same sense as an AI diagnostic device (e.g., pathological diagnosis for an image analysis algorithm).

8. The sample size for the training set

This is a mechanical device, not an AI algorithm. Therefore, there is no training set in the context of machine learning. The device's design is based on engineering principles and previous device iterations (the predicate device), not on a data-driven training process.

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

As there is no training set for an AI algorithm (since this is a mechanical device), this question is not applicable.

Summary

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K100631

Summary of Safety and Effectiveness

I. Applicant Information:

JUN 2 2 2010

Date Prepared:	June 21, 2010
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems
Address:	7611 Northland DriveMinneapolis, MN 55428
EstablishmentRegistration No.:	2184009 (owner operator number 2112641)
Contact Person:	Sue Fidler, Regulatory Affairs ManagerMedtronic, Inc.8200 Coral Sea Street NEMounds View, MN 55112
Telephone Number:Fax Number:	(763) 514-9839(763) 367-8360

II. Device Information:

Trade Name:	Medtronic AFFINITYTM CP Centrifugal Blood Pump (ModelAP40); Medtronic External Drive Motor (Model 560A); MedtronicEmergency Handcrank (Model HC150A)
Common Name:	AFFINITYTM Cardiopulmonary Centrifugal Blood Pump; ExternalDrive Motor; Emergency Handcrank
Classification Name:	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type;Cardiovascular bypass pump speed control
Classification:	Class III, 21 CFR 870.4360; Class II, 21 CFR 870.4380
Product Code:	KFM; DWA
Predicate Devices:	Medtronic Bio-Medicus® Bio-Pump (BPX-80) Centrifugal Pump(K973011); Medtronic External Drive Motor (Model 540T)(K936091); Emergency Handcrank (Model H150) (K926357)

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Predicate Device Intended Uses:

The BPX-80 centrifugal blood pump is indicated for use only with the Medtronic Bio-Console pump speed controller to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours).

It is also indicated for use in extracorporeal support systems (for periods up to six hours) not requiring complete cardiopulmonary bypass (e.g. valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).

The External Drive Motor and Emergency Handcrank are intended for use with the Bio-Console System and Bio-Pump Centrifugal Blood Pump. The Bio-Console System is a centrifugal blood pumping system intended for use as an extracorporeal centrifugal blood pumping system during cardiopulmonary bypass procedures.

Device Description: The Medtronic AFFINITY CP Centrifugal Blood Pump is a sterile, single-use centrifugal blood pump. It is a non-invasive, nonpyrogenic device designed to move blood through the extracorporeal circuit by centrifugal force. The pump is the disposable portion of the pumping system and it is electromagnetically coupled to an instrument that monitors and displays the flow and pressure of the blood. Blood enters the inlet port of the pump, where a cone with impeller blades within the pump housing rotates and the blood is gently accelerated towards the outlet of the pump.

The AFFINITY CP Centrifugal Blood Pump can be driven through magnetic coupling by the following two devices:

External Drive Motor (Model 560A) a
. Emergency Handcrank (Model HC150A)

The AFFINITY™ CP Centrifugal Blood Pump is used to pump Intended Use: blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to 6 hours).

It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). "

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The AFFINITY™ CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.

Contraindications: The AFFINITY CP Centrifugal Blood Pump is contraindicated as a cardiotomy suction device. Comparison to Predicate Device: The AFFINITY CP Centrifugal Blood Pump is substantially equivalent to the predicate device, in that its intended use is the same, and the basic design is the same, with a magnetic coupling to an external motor that drives the rotating cones. Both pump drives are controlled with Medtronic controllers. The new pump includes the following improvements: The bearing heat generation is reduced due to a ceramic pivot system. -Priming volume is reduced by 50%, to a volume of 40 mL. Hemolysis is reduced compared to the predicate device. -The External Drive Motor and Emergency Handcrank are substantially equivalent to the predicate devices, in that their intended uses are the same and the basic design is the same. Necessary design changes were made to allow for compatibility with the AFFINITY CP Centrifugal Blood Pump: dimensional changes and rotational direction. Test Data: Verification and validation testing has demonstrated that the AFFINITY CP Centrifugal Blood Pump and its associated drive systems are safe and effective. The blood pump is more efficient, as evidenced by less heat generation, and less damaging to red blood cells, as evidenced by reduced hemolysis. Other validation tests included: maximum pressure generation, flow rates, pivot bearing wear, maximum speed, port strength, magnetic coupling force, biocompatibility, noise generation and prime volume. Validation testing under simulated conditions of use with expert users also demonstrated the effectiveness of the AFFINITY CP Centrifugal Blood Pump. Based on the accumulated technical information, intended use, Summary: laboratory verification tests and performance data provided, the AFFINITY CP Centrifugal Blood Pump and its associated drive systems are substantially equivalent to the currently marketed predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

JUN 2 2 2010

Medtronic, Inc. c/o Ms. Susan C. Fidler 8200 Coral Sea Street NE Mounds View, MN 55112

Re: K100631

Trade/Device Name: Medtronic AFFINITY™ CP Centrifugal Blood Pump (Model AP40); Medtronic External Drive Motor (Model 560A); Medtronic Emergency Handcrank (Model HC150A)

Regulation Number: 21 CFR 870.4360

Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: III Product Code: KFM, DWA Dated: May 24, 2010 Received: May 25, 2010 /_

Dear Ms. Fidler:

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

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Page 2 - Ms. Susan C. Fidler

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 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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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Statement of Indications for Use

510(k) Number: K100631

Medtronic AFFINITY™ CP Centrifugal Blood Pump (Model AP40); Medtronic External Drive Motor (Model 560A); Medtronic Emergency Handcrank (Model HC150A)

Indications for use:

The AFFINITY™ CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.

Prescription Use (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)

rrence of operative of Device

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K100631
6/22/2

Regulation Number and Section

§ 870.4360 Nonroller-type blood pump.

(a)
Nonroller-type cardiopulmonary and circulatory bypass blood pump —(1)Identification. A nonroller-type cardiopulmonary and circulatory bypass blood pump is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either:(i) Full or partial cardiopulmonary bypass (
i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or(ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.
(2)
Classification —Class II (special controls). The special controls for this device are:(i) Non-clinical performance testing must perform as intended over the intended duration of use and demonstrate the following: Operating parameters, dynamic blood damage, heat generation, air entrapment, mechanical integrity, and durability/reliability;
(ii) The patient-contacting components of the device must be demonstrated to be biocompatible;
(iii) Sterility and shelf life testing must demonstrate the sterility of patient-contacting components and the shelf life of these components; and
(iv) Labeling must include information regarding the duration of use, and a detailed summary of the device- and procedure-related complications pertinent to use of the device.
(b)
Nonroller-type temporary ventricular support blood pump —(1)Identification. A nonroller-type temporary ventricular support blood pump is a prescription device that uses any method resulting in blood propulsion to provide the temporary ventricular assistance required for support of the systemic and/or pulmonary circulations during periods when there is ongoing or anticipated hemodynamic instability due to immediately reversible alterations in ventricular myocardial function resulting from mechanical or physiologic causes. Duration of use would be less than 6 hours.(2)
Classification. Class III (premarket approval).(c)
Date premarket approval application (PMA) or notice of completion of product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with FDA on or before September 8, 2015, for any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976, or that has, on or before September 8, 2015, been found to be substantially equivalent to any nonroller-type temporary ventricular support blood pump that was in commercial distribution before May 28, 1976. Any other nonroller-type temporary ventricular support blood pump shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.