The Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface 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 with Carmeda® BioActive Surface is driven by the External Drive Motor or the Emergency Handcrank.

Device Description

The Affinity™ CP Centrifugal Blood Pump with Carmeda® Bioactive Surface is intended to be used in medical procedures requiring extracorporeal circulation circuits. Functionality and intended use of the coated pump are the same as those for the uncoated pump. 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 utilizes a pivot bearing design on a dual ceramic pivot.

The Affinity CP Centrifugal Blood Pump with Carmeda Bioactive Surface is coated with a nonleaching bioactive surface (heparin) to enhance blood compatibility and provide thromboresistant blood-contacting surfaces.

As with the uncoated Affinity CP pump the Affinity CP Centrifugal Blood Pump with Carmeda Bioactive Surface is driven by the External Drive Motor or the Emergency Handcrank (K100631). There have been no changes to these accessory devices.

AI/ML Overview

This 510(k) summary describes a modification of an existing device, the Affinity CP Centrifugal Blood Pump, by adding a Carmeda BioActive Surface. Therefore, the "acceptance criteria" discussed are largely related to demonstrating that the coated pump is substantially equivalent to the uncoated predicate device and another coated predicate device. The performance data presented shows that the modified device meets the necessary safety and effectiveness requirements for this substantial equivalence claim.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance values in the way one might see for a diagnostic device's sensitivity/specificity. Instead, it lists the types of performance testing conducted to demonstrate substantial equivalence. The "acceptance criteria" implicitly are that the device performs comparably to the predicate devices and meets relevant safety standards for each test.

Acceptance Criteria (Implicit)	Reported Device Performance
Functional Equivalence	Demonstrated function and intended use are the same as the uncoated pump.
Flow Rates	Performance testing included flow rates. (Implied acceptability given substantial equivalence conclusion.)
Heat Generation	Performance testing included heat generation. (Implied acceptability given substantial equivalence conclusion.)
Maximum Differential Pressure	Performance testing included maximum differential pressure. (Implied acceptability given substantial equivalence conclusion.)
Maximum Rotational Speed	Performance testing included maximum rotational speed. (Implied acceptability given substantial equivalence conclusion.)
Noise Generation	Performance testing included noise generation. (Implied acceptability given substantial equivalence conclusion.)
Duration of Performance (up to 6 hours)	Performance testing included duration of performance. (Implied acceptability given substantial equivalence conclusion and intended use up to 6 hours.)
Hydraulic Performance	Performance testing included hydraulic performance. (Implied acceptability given substantial equivalence conclusion.)
Pivot Bearing Wear	Performance testing included pivot bearing wear. (Implied acceptability given substantial equivalence conclusion.)
Prime Volume	Performance testing included prime volume. (Implied acceptability given substantial equivalence conclusion.)
Sterilization Efficacy	Performance testing included sterilization. (Implied acceptability given substantial equivalence conclusion.)
Biocompatibility	Performance testing included biocompatibility. (Implied acceptability given substantial equivalence conclusion and the nature of adding a bioactive surface.)
Hemolysis	Performance testing included hemolysis. (Implied acceptability given substantial equivalence conclusion; critical for blood-contacting devices.)
Bioactivity (of Carmeda surface)	Performance testing included bioactivity. (Implied acceptability given substantial equivalence conclusion; this confirms the heparin coating's intended function).
Heparin Leaching	Performance testing included heparin leaching. (Implied acceptability given substantial equivalence conclusion; critical to ensure coating stability and safety).
Heparin Coverage	Performance testing included heparin coverage. (Implied acceptability given substantial equivalence conclusion; critical to ensure the coating is uniformly applied and effective).
Mechanical Compatibility with accessories	The device is still driven by the External Drive Motor or Emergency Handcrank, with "no changes to these accessory devices." This demonstrates continued compatibility and acceptable performance with existing accessories.
Substantial Equivalence to Predicate Devices	"Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is substantially equivalent to the predicates."
Safety and Effectiveness (overall)	Based on all data, the device is deemed "substantially equivalent to the currently marketed predicate devices."

Study Details:

This document is a 510(k) summary, which provides a high-level overview of the device and the studies supporting its substantial equivalence. It does not contain detailed study protocols, raw data, or comprehensive statistical analysis that would typically be found in a full study report.

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not specify the sample sizes (e.g., number of pumps tested) for any of the verification and validation tests listed.
- The data provenance (e.g., country of origin, retrospective/prospective) is not mentioned. These types of tests are typically prospective laboratory bench and animal tests, not human clinical trials, when demonstrating substantial equivalence for a device modification like this.
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):
- This document describes engineering and biological performance testing for a medical device, not a diagnostic algorithm. Therefore, the concept of "ground truth established by experts" in the context of image interpretation or clinical diagnosis by human readers is not applicable here. The "ground truth" for these tests would be established by validated measurement techniques and established engineering/biological standards in a laboratory setting.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interpretation studies, usually for clinical endpoints or image readings. This document discusses bench and biocompatibility testing for a blood pump.
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 a physical medical device (blood pump), not an AI diagnostic tool. Therefore, MRMC studies are not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (blood pump), not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the performance tests listed (flow rates, heat generation, hemolysis, bioactivity, etc.), the "ground truth" would be established by standardized laboratory measurement protocols and validated analytical tests. For example, hemolysis would be measured using spectrophotometry against established benchmarks, and bioactivity (heparin effectiveness) would be measured through anti-coagulant assays. These are objective, quantitative measures rather than subjective expert consensus.
The sample size for the training set:
- Not applicable. This refers to a physical medical device, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable. As above, this document does not describe an AI model.

Summary

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JUN 28 2011

5 Summary of Safety and Effectiveness

K111628

I. General Information:

Submitter's Name and Address: Medtronic, Inc. Medtronic Perfusion Systems 8200 Coral Sea Street NE Mounds View, MN 55112 Lisa Stone Contact Person: Principal Regulatory Affairs Specialist Tel: 763-514-9866 Fax: 763-367-8360 Email: lisa.j.stone@medtronic.com Date of Summary: June 13, 2011 Proprietary Name of Device: Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface (model CBAP40) Common/Usual Name: Centrifugal Blood Pump Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Class III, 21 CFR 870.4360 Classification: Product Code: KFM Affinity™ CP Centrifugal Blood Pump -Predicate Device: Model AP40 (K100631) BioPump Centrifugal Blood Pump with Carmeda® BioActive Surface -

II. Device Description:

Model CBBPX-80 (K973011)

ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮ

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for the uncoated pump. 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 utilizes a pivot bearing design on a dual ceramic pivot.

III. Intended Use:

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

IV. Comparison to Predicate Devices:

The Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is substantially equivalent to the predicate uncoated Affinity CP Centrifugal Blood Pump, in that its intended use and design are exactly the same. The only difference is the addition of Carmeda BioActive Surface to the blood contacting surfaces of the pump. The Carmeda BioActive Surface is exactly the same as that used on the BioPump with Carmeda BioActive Surface.

V. Summary of Performance Data:

Verification and validation testing has demonstrated that the Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is substantially

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equivalent to the predicates. Performance testing included: flow rates, heat generation, maximum differential pressure, maximum rotational speed, noise generation, duration of performance, hydraulic performance, pivot bearing wear, prime volume, sterilization, biocompatibility, hemolysis, bioactivity, heparin leaching and coverage.

VI. Conclusion:

Based on the accumulated technical information, intended use, verification tests and performance data provided, the Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface is substantially equivalent to the currently marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image contains a circular logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of an eagle or bird-like figure with three wing-like strokes. The emblem is positioned in the center of the circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.

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

JUN 2 8 2011

Medtronic, Inc. c/o Ms. Lisa Stone Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View. MN 55112

Re: K111658

Trade/Device Name: Affinity™ CP Centrifugal Blood Pump with Carmeda™ BioActive Surface (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: June 13, 2011 Received: June 14, 2011

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.

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Page 2 - Ms. Lisa Stone

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 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/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/ReportalProblem/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,

B. D. Zukerman, M.D.

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 1

KIII 658 510(k) Number:

Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface (Model CBAP40)

Indications for use:

The Affinity™ CP Centrifugal Blood Pump with Carmeda® BioActive Surface 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)

on of Cardiovascular Devices

510(k) Number K111658

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.