AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE

K111658 · Medtronic, Inc. · KFM · Jun 28, 2011 · Cardiovascular

Device Facts

• Record ID: K111658
• Device Name: AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
• Applicant: Medtronic, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Jun 28, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Affinity CP Centrifugal Blood Pump with Carmeda BioActive Surface; extracorporeal blood pump for cardiopulmonary bypass or circulatory support. Device moves blood via centrifugal force using smooth rotating cone and low-profile impeller fins; energy transferred as pressure and velocity toward outlet port. Features dual ceramic pivot bearing design. Blood-contacting surfaces coated with nonleaching heparin-based Carmeda BioActive Surface to enhance blood compatibility and thromboresistance. Driven by external drive motor or emergency handcrank. Used in clinical settings (e.g., OR) by trained medical professionals. Provides circulatory support during surgical procedures; benefits patient by maintaining blood flow during extracorporeal bypass.

Clinical Evidence

Bench testing only. 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.

Technological Characteristics

Centrifugal blood pump; dual ceramic pivot bearing; heparin-based Carmeda BioActive Surface coating. Driven by external motor or handcrank. Non-roller type pump. Materials include blood-contacting surfaces treated for thromboresistance.

Indications for Use

Indicated for patients requiring extracorporeal circulatory support during cardiopulmonary bypass or other extracorporeal support procedures (e.g., valvuloplasty, mitral valve reoperation, vena cava/aorta surgery, liver transplants) for durations up to 6 hours.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Affinity CP Centrifugal Blood Pump (K100631)
• BioPump Centrifugal Blood Pump with Carmeda BioActive Surface (K973011)

Submission Summary (Full Text)

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JUN 28 2011

### 5 Summary of Safety and Effectiveness

K111628

#### I. General Information:

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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: [phone] Fax: [phone] Email: [e-mail] 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:

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

Model CBBPX-80 (K973011)

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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.

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.

#### 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 [phone] or [phone] 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 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.

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