AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER

K132712 · Medtronic, Inc. · KFM · Nov 19, 2013 · Cardiovascular

Device Facts

• Record ID: K132712
• Device Name: AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER
• Applicant: Medtronic, Inc.
• Product Code: KFM · Cardiovascular
• Decision Date: Nov 19, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Affinity CP Centrifugal Blood Pump moves blood via centrifugal force using a smooth rotating cone and low-profile impeller fins; energy transferred as pressure and velocity. Internal impeller magnetically couples to drive motor, eliminating need for shaft through housing. Used in extracorporeal bypass circuits for circulatory support up to 6 hours. Operated by perfusionists/clinicians in clinical settings. This submission introduces Affinity CP Adapter (reusable, non-sterile) to enable compatibility with Stöckert, Sorin, Sarns, and Terumo centrifugal pump systems. Adapter allows pump to interface with these third-party motor drives without modifying pump performance or compatible system safety responses. Benefits include expanded system compatibility for existing pump technology.

Clinical Evidence

Bench testing only. Included mechanical and performance verification, reliability testing, system verification, and labeling/IFU validation. Testing confirmed the adapter maintains compatibility with third-party systems without affecting safety-related RPM control response conditions or causing decoupling.

Technological Characteristics

Polycarbonate housing; magnetic coupling motor interface; 40 mL prime volume; 9.5 mm inlet/outlet ID; max flow 10 L/min; max speed 4000 rpm (pump) / 3600 rpm (adapter). Uncoated or coated (Balance/Carmeda) options. Sterilization: EtO (pump), non-sterile (adapter). Connectivity: Mechanical interface via adapter to third-party centrifugal pump systems.

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 up to 6 hours. Contraindicated for use as a cardiotomy suction device.

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, K111657, K111658)
• Sarns Centrifugal Pump (K112229)

Submission Summary (Full Text)

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# 510(k) Summary of Safety and Effectiveness

| Date Prepared: | August 26, 2013 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic, Inc.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Brooklyn Park, MN 55428<br>Establishment Registration No. 2184009 |
| Contact Person: | Lisa Stone<br>Principal Regulatory Affairs Specialist<br>Medtronic, Inc.<br>Cardiovascular<br>8200 Coral Sea Street NE, MVS 83<br>Mounds View, MN 55112<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| 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 without<br>coatings – Model AP40 (K100631), Model BBAP40<br>(K111657), Model CBAP40 (K111658)<br>Sarns™ Centrifugal Pump with or without X-Coating<br>(K112229) |

#### 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

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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.

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.

# Intended Use

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.

#### 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: Affinity<br>CP Centrifugal Blood<br>Pump (with or without<br>coating) | PREDICATE: Sarns<br>Centrifugal Pump | MODIFIED DEVICE:<br>Affinity CP Centrifugal<br>Blood Pump (with or<br>without coating) used<br>with Affinity CP Adapter |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K100631<br>K111657<br>K111658 | K112229 | Modified device - subject<br>of this 510(k) |
| Device Name | PREDICATE: Affinity<br>CP Centrifugal Blood<br>Pump (with or without<br>coating) | PREDICATE: Sarns<br>Centrifugal Pump | MODIFIED DEVICE:<br>Affinity CP Centrifugal<br>Blood Pump (with or<br>without coating) used<br>with Affinity CP Adapter |
| Indications for Use | The Affinity CP<br>Centrifugal Blood Pump<br>*is used to pump blood<br>through the extracorporeal<br>bypass circuit for<br>extracorporeal circulatory<br>support for periods<br>appropriate to<br>cardiopulmonary bypass<br>(up to 6 hours).<br>It is also indicated for use<br>in extracorporeal support<br>systems (for periods up to 6<br>hours) not requiring<br>complete cardio-pulmonary<br>bypass (e.g. valvuloplasty,<br>circulatory support during<br>mitral valve reoperation,<br>surgery of the vena cava or<br>aorta, liver transplants).<br>The Affinity CP<br>Centrifugal Blood Pump is<br>driven by the External<br>Drive Motor or the<br>Emergency Handcrank. | The Sarns Centrifugal<br>Pump with or without X-<br>Coating is a sterile, single<br>use device, used as an<br>extracorporeal blood pump<br>for use in cardiopulmonary<br>bypass procedures for up to<br>6 hours.<br>The pump is intended for<br>use with the Sarns<br>Centrifugal Systems or<br>may be used with Stöckert<br>Centrifugal Pump Systems<br>by attaching the Sarns<br>Centrifugal Pump Adapter. | The Affinity CP<br>Centrifugal Blood Pump<br>is used to pump blood<br>through the extracorporeal<br>bypass circuit for<br>extracorporeal circulatory<br>support for periods<br>appropriate to<br>cardiopulmonary bypass<br>(up to 6 hours).<br>It is also indicated for use<br>in extracorporeal support<br>systems (for periods up to 6<br>hours) not requiring<br>complete cardiopulmonary<br>bypass (e.g. valvuloplasty,<br>circulatory support during<br>mitral valve reoperation,<br>surgery of the vena cava or<br>aorta, liver transplants).<br>The Affinity CP<br>Centrifugal Blood Pump is<br>driven by the External<br>Drive Motor or the<br>Emergency Handcrank.<br>The Affinity CP<br>Centrifugal Blood Pump is<br>intended for use with<br>Medtronic controllers or<br>may be used with the<br>StöckertTM and SorinTM<br>centrifugal pump systems<br>or the SarnsTM and<br>TerumoTM centrifugal<br>systems by attaching the<br>Affinity CP adapter. |
| Device Name | PREDICATE: Affinity<br>CP Centrifugal Blood<br>Pump (with or without<br>coating) | PREDICATE: Sarns<br>Centrifugal Pump | MODIFIED DEVICE:<br>Affinity CP Centrifugal<br>Blood Pump (with or<br>without coating) used<br>with Affinity CP Adapter |
| Contraindications | The Affinity CP<br>Centrifugal Blood Pump is<br>contraindicated for use as a<br>cardiotomy suction device.<br>This device, used for any<br>other purposes than the<br>intended use, is the<br>responsibility of the user. | This device is<br>contraindicated for use as a<br>suction device. | The Affinity CP<br>Centrifugal Blood Pump is<br>contraindicated for use as a<br>cardiotomy suction device.<br>This device, used for any<br>other purposes than the<br>intended use, is the<br>responsibility of the user. |

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비

^* With or without coatings

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.

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| Device Name | PREDICATE: Affinity CP<br>Centrifugal Blood Pump (with or<br>without coating) | MODIFIED DEVICE: Affinity<br>CP Centrifugal Blood Pump (with<br>or without coating) used with<br>Affinity CP Adapter |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Pump Functionality | Propels blood through the<br>extracorporeal circuit via a<br>combination of a smooth rotating<br>cone and low-profile impeller fins | Same |
| Pump Operating Principle/<br>Technology | Energy is transferred from the pump<br>in the form of pressure and velocity<br>as the blood is driven toward the<br>outlet 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: Same<br>Adapter: 3600 rpm |
| Uncoated and Coating Options | AP40: Uncoated Pump | Same |

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| Device Name | PREDICATE: Affinity CP<br>Centrifugal Blood Pump (with or<br>without coating) | MODIFIED DEVICE: Affinity<br>CP Centrifugal Blood Pump (with<br>or without coating) used with<br>Affinity CP Adapter |
|----------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | BBAP40: Pump with Balance<br>Biosurface<br>CBAP40: Pump with Carmeda<br>BioActive Surface | |
| Sterilization Method | Ethylene Oxide (EtO) | Pump: Same<br>Adapter: Non-sterile |
| Compatible Systems | Medtronic Controller, External<br>Drive Motor and Hand Crank | Pump: Same<br>Adapter: Stöckert and Sorin<br>centrifugal pump systems or Sarns<br>and Terumo centrifugal systems as<br>defined 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 [phone] or [phone] 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 [phone] or [phone] 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).

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 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)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)