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.

The Affinity CP Centrifugal Blood Pump is intended for use with Medtronic controllers or may be used with the Stöckert and Sorin centrifugal pump systems or the Sams and Terumo centrifugal systems by attaching the Affinity CP adapter.

Device Description

Affinity CP Centrifugal Blood Pumps are intended to be used in medical procedures requiring extracorporeal circulation circuits. The pump is designed to move blood by centrifugal force generated by a combination of a smooth rotating cone and low-profile impeller fins. Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump internal impeller magnetically couples to a drive motor. Magnetic coupling is used since it precludes the need for a shaft through the pump housing. The pump is supplied uncoated or coated.

This submission covers expanded indications for use for the pump when used with the Affinity CP Adapter - Model AP40AST. These updates will allow the Affinity CP Pump to couple with the Affinity CP Adapter and enable the pump to be operated with the Stöckert and Sorin, or Sams and Terumo centrifugal pump systems. No changes are being made to Affinity CP Pump or its' performance specifications. The Affinity CP Adapter is a reusable non-sterile device. The use of the adapter does not require modification of the compatible systems.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Medtronic Affinity™ CP Centrifugal Blood Pump:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence of the modified device (Affinity CP Pump with Adapter) to predicate devices, rather than establishing new acceptance criteria against specific performance metrics for a novel device. The "acceptance criteria" are implied to be meeting the performance specifications of the predicate devices and ensuring the adapter does not negatively impact safety or performance.

Acceptance Criteria (Implied)	Reported Device Performance
Pump Functionality: Propels blood through the extracorporeal circuit via a combination of a smooth rotating cone and low-profile impeller fins	Same as predicate
Pump Operating Principle/Technology: Energy is transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump	Same as predicate
Housing Material: Polycarbonate	Same as predicate (pump and adapter)
Pump Motor Interface: Magnetic coupling	Same as predicate (pump and adapter)
Pump Prime Volume: 40 mL	Same as predicate
Inlet/Outlet ID: 9.5 mm (3/8 in)	Same as predicate
Maximum Operating Pressure: 760 mm Hg (101 kPa)	Same as predicate
Maximum Flow Rate: 10 L/min	Same as predicate
Maximum Outlet Pressure: 700 mm Hg (93.3 kPa)	Same as predicate
Maximum Pump Speed: 4000 rpm	Pump: Same as predicate; Adapter: 3600 rpm
Uncoated and Coating Options: AP40: Uncoated Pump, BBAP40: Pump with Balance Biosurface, CBAP40: Pump with Carmeda BioActive Surface	Same as predicate
Sterilization Method: Ethylene Oxide (EtO)	Pump: Same as predicate; Adapter: Non-sterile
Compatible Systems: Not negatively affected by adapter	System verification and validation tests showed that the use of the adapter does not affect how a compatible system responds when safety-related RPM control response conditions are triggered. The adapter does not decouple from compatible system motor drives.
Safety and Effectiveness: Meeting established requirements	All testing passed by meeting the established requirements set forth for the Affinity CP Adapter with Affinity CP Centrifugal Blood Pumps.

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

Sample Size: The document does not specify exact sample sizes (e.g., number of pumps, adapters, or test runs) used for the in-vitro testing. It refers to "formal data collection, mechanical and performance verification, reliability verification, system verification, labeling and Instructions for Use (IFU) verification and validation tests."
Data Provenance: The study was "In-vitro testing." The country of origin for the data is not explicitly stated, but given Medtronic's headquarters in Brooklyn Park, MN, USA, it is highly likely the testing was conducted within the United States. The testing is prospective for the purpose of this 510(k) submission, i.e., new tests were conducted for this submission.

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

This information is not provided in the document. The study described is primarily an in-vitro engineering and performance verification study, not one that typically involves expert human interpretation and ground truth establishment in the way, for example, a diagnostic imaging AI study would.

4. Adjudication Method for the Test Set:

This information is not provided and is not applicable given the nature of the in-vitro engineering and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No, an MRMC comparative effectiveness study was not done. This device is a mechanical blood pump and adapter, not an AI-powered diagnostic tool, so such a study would not be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Yes, a standalone study was done. The entire evaluation was focused on the purely technical and mechanical performance of the Affinity CP Centrifugal Blood Pump when used with the Affinity CP Adapter, without any human-in-the-loop performance evaluation. The "algorithm" in this context would be the mechanical design and operating principles of the pump and adapter.

7. The Type of Ground Truth Used:

The "ground truth" for this type of device and study is based on defined engineering specifications, performance standards, and safety requirements for centrifugal blood pumps. The tests were designed to verify that the modified device (pump + adapter) met these established technical and functional requirements, and that the adapter did not introduce new risks or degrade performance. This is evidenced by statements like: "All testing passed by meeting the established requirements set forth for the Affinity CP Adapter with Affinity CP Centrifugal Blood Pumps."

8. The Sample Size for the Training Set:

This information is not applicable as this is not an AI/machine learning device that requires a training set. The device is a mechanical medical device for which performance is verified through physical testing rather than data-driven model training.

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

This information is not applicable for the same reason as point 8.

Summary

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510(k) Summary of Safety and Effectiveness

Date Prepared:	August 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:	Affinity™ CP Centrifugal Blood Pump
Common Name:	Centrifugal blood pump
Classification Name:	Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Classification:	Class III, 21 CFR 870.4360
Product Code:	KFM
Name of Predicate Device:	Affinity™ CP Centrifugal Blood Pump with or withoutcoatings – Model AP40 (K100631), Model BBAP40(K111657), Model CBAP40 (K111658)Sarns™ Centrifugal Pump with or without X-Coating(K112229)

Device Description

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transferred from the pump in the form of pressure and velocity as the blood is driven toward the outlet port of the pump. The pump internal impeller magnetically couples to a drive motor. Magnetic coupling is used since it precludes the need for a shaft through the pump housing. The pump is supplied uncoated or coated.

Intended Use

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

Comparison to the Predicate Device

The Affinity CP Centrifugal Blood Pump with the Affinity CP Adapter is substantially equivalent to the predicates outlined in the following comparison tables. There have been no changes to the pump or its' performance specification.

Device Name	PREDICATE: AffinityCP Centrifugal BloodPump (with or withoutcoating)	PREDICATE: SarnsCentrifugal Pump	MODIFIED DEVICE:Affinity CP CentrifugalBlood Pump (with orwithout coating) usedwith Affinity CP Adapter
510(k) Number	K100631 K111657 K111658	K112229	Modified device - subjectof this 510(k)
Device Name	PREDICATE: AffinityCP Centrifugal BloodPump (with or withoutcoating)	PREDICATE: SarnsCentrifugal Pump	MODIFIED DEVICE:Affinity CP CentrifugalBlood Pump (with orwithout coating) usedwith Affinity CP Adapter
Indications for Use	The Affinity CPCentrifugal Blood Pump*is used to pump bloodthrough the extracorporealbypass circuit forextracorporeal circulatorysupport for periodsappropriate tocardiopulmonary bypass(up to 6 hours).It is also indicated for usein extracorporeal supportsystems (for periods up to 6hours) not requiringcomplete cardio-pulmonarybypass (e.g. valvuloplasty,circulatory support duringmitral valve reoperation,surgery of the vena cava oraorta, liver transplants).The Affinity CPCentrifugal Blood Pump isdriven by the ExternalDrive Motor or theEmergency Handcrank.	The Sarns CentrifugalPump with or without X-Coating is a sterile, singleuse device, used as anextracorporeal blood pumpfor use in cardiopulmonarybypass procedures for up to6 hours.The pump is intended foruse with the SarnsCentrifugal Systems ormay be used with StöckertCentrifugal Pump Systemsby attaching the SarnsCentrifugal Pump Adapter.	The Affinity CPCentrifugal Blood Pumpis used to pump bloodthrough the extracorporealbypass circuit forextracorporeal circulatorysupport for periodsappropriate tocardiopulmonary bypass(up to 6 hours).It is also indicated for usein extracorporeal supportsystems (for periods up to 6hours) not requiringcomplete cardiopulmonarybypass (e.g. valvuloplasty,circulatory support duringmitral valve reoperation,surgery of the vena cava oraorta, liver transplants).The Affinity CPCentrifugal Blood Pump isdriven by the ExternalDrive Motor or theEmergency Handcrank.The Affinity CPCentrifugal Blood Pump isintended for use withMedtronic controllers ormay be used with theStöckertTM and SorinTMcentrifugal pump systemsor the SarnsTM andTerumoTM centrifugalsystems by attaching theAffinity CP adapter.
Device Name	PREDICATE: AffinityCP Centrifugal BloodPump (with or withoutcoating)	PREDICATE: SarnsCentrifugal Pump	MODIFIED DEVICE:Affinity CP CentrifugalBlood Pump (with orwithout coating) usedwith Affinity CP Adapter
Contraindications	The Affinity CPCentrifugal Blood Pump iscontraindicated for use as acardiotomy suction device.This device, used for anyother purposes than theintended use, is theresponsibility of the user.	This device iscontraindicated for use as asuction device.	The Affinity CPCentrifugal Blood Pump iscontraindicated for use as acardiotomy suction device.This device, used for anyother purposes than theintended use, is theresponsibility of the user.

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비

* With or without coatings

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ﺗﻘﺪ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

Device Name	PREDICATE: Affinity CPCentrifugal Blood Pump (with orwithout coating)	MODIFIED DEVICE: AffinityCP Centrifugal Blood Pump (withor without coating) used withAffinity CP Adapter
Pump Functionality	Propels blood through theextracorporeal circuit via acombination of a smooth rotatingcone and low-profile impeller fins	Same
Pump Operating Principle/Technology	Energy is transferred from the pumpin the form of pressure and velocityas the blood is driven toward theoutlet port of the pump	Same
Housing Material	Polycarbonate	Same (pump and adapter)
Pump Motor Interface	Magnetic coupling	Same (pump and adapter)
Pump Prime Volume	40 mL	Same
Inlet/Outlet ID	9.5 mm (3/8 in)	Same
Maximum Operating Pressure	760 mm Hg (101 kPa)	Same
Maximum Flow Rate	10 L/min	Same
Maximum Outlet Pressure	700 mm Hg (93.3 kPa)	Same
Maximum Pump Speed	4000 rpm	Pump: SameAdapter: 3600 rpm
Uncoated and Coating Options	AP40: Uncoated Pump	Same

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Device Name	PREDICATE: Affinity CPCentrifugal Blood Pump (with orwithout coating)	MODIFIED DEVICE: AffinityCP Centrifugal Blood Pump (withor without coating) used withAffinity CP Adapter
	BBAP40: Pump with BalanceBiosurfaceCBAP40: Pump with CarmedaBioActive Surface
Sterilization Method	Ethylene Oxide (EtO)	Pump: SameAdapter: Non-sterile
Compatible Systems	Medtronic Controller, ExternalDrive Motor and Hand Crank	Pump: SameAdapter: Stöckert and Sorincentrifugal pump systems or Sarnsand Terumo centrifugal systems asdefined in the Instructions for Use

Summary of Performance Data

In-vitro testing was performed to demonstrate both substantial equivalence with the predicate devices and also to comply with user needs and safety and effectiveness requirements.

Testing supplied in the 510(k) Notification includes formal data collection, mechanical and performance verification, reliability verification, system verification, labeling and Instructions for Use (IFU) verification and validation tests.

The system verification and validation tests showed that the use of the adapter does not affect how a compatible system responds when the safety related RPM control response conditions are triggered. Additionally, the adapter does not decouple from the compatible system motor drives.

All testing passed by meeting the established requirements set forth for the Affinity CP Adapter with Affinity CP Centrifugal Blood Pumps (with or without coatings).

Conclusion

The data included in this submission is sufficient to provide reasonable assurance that the Affinity CP Pump when used with the Affinity CP Adapter is substantially equivalent to the legally marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three talons or claws extending downwards.

Public Health Service

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

November 19, 2013

Medtronic, Inc. Medtronic Perfusion Systems Lisa Stone, RAC 7611 Northland Drive Brooklyn Park, MN 55428

Re: K132712

Trade/Device Name: Affinity CP Centrifugal Blood Pump (uncoated, Balance coated, Carmeda coated) Model AP40, Model BBAP40, Model CBAP40 Regulation Number: 21 CFR 870.4360 Regulation Name: Non-roller Type Cardiopulmonary Bypass Blood Pump Regulatory Class: Class III Product Code: KFM Dated: August 26, 2013 Received: August 29, 2013

Dear Ms. 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 - Ms. Lisa Stone

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 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.

MDA

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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Indications for Use Statement

K132712 510(k) Number:

Affinity™ CP Centrifugal Blood Pump (Model AP40)

Indications for use:

The Affinity" CP Centrifygal 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).

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

The Affinity CP Centrifugal Blood Pump is intended for use with Medtronic controllers or may be used with the Stockert™ and Sorin™ centrifugal pump systems or the Sarns™ and Terumo™ centrifugal systems by attaching the Affinity CP adapter.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

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.