SARN CENTRIFUGAL PUMP

K112229 · Terumo Cardiovascular Systems · KFM · Dec 9, 2011 · Cardiovascular

Device Facts

• Record ID: K112229
• Device Name: SARN CENTRIFUGAL PUMP
• Applicant: Terumo Cardiovascular Systems
• Product Code: KFM · Cardiovascular
• Decision Date: Dec 9, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4360
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal pump systems by attaching the Sarns® Centrifugal Pump Adapter.

Device Story

Sarns® Centrifugal Pump is a sterile, single-use device for extracorporeal blood circulation during cardiopulmonary bypass surgery (up to 6 hours). Input: blood flow into pump chamber. Operation: magnetically driven acrylic vaned impeller spins (0-3600 RPM) to create centrifugal force, propelling blood from inlet to outlet port. Output: blood flow (0-9.9 LPM). Device includes a reusable Sarns® Centrifugal Pump Adapter (acetal housing) to facilitate mounting the pump onto Stöckert Centrifugal Pump Systems. Operated by perfusionists/clinicians in surgical settings. Benefits: provides mechanical circulatory support during bypass; adapter allows compatibility with third-party (Stöckert) systems, expanding clinical utility.

Clinical Evidence

Bench testing only. No clinical data. Testing included flow curve performance, adapter clip fatigue (7-year lifetime), change-out time, shipping/durability, hemolysis (plasma free hemoglobin, WBC, platelet counts), disconnection force, and interaction with Stöckert heart-lung machine control/safety components. All tests passed.

Technological Characteristics

Single-use centrifugal blood pump. Materials: Polycarbonate housing, acrylic impeller, ceramic iron ferrite magnet. Adapter: Acetal housing, NdFeB magnet with Ni plating. Dimensions: 3/8 inch (9.5mm) ports. Prime volume: 48 mL. Flow capacity: 0-9.9 LPM. Speed: 0-3600 RPM. Sterilization: Ethylene Oxide (pump only; adapter is non-sterile). Connectivity: Mechanical/magnetic coupling to Sarns or Stöckert systems.

Indications for Use

Indicated for use as an extracorporeal blood pump in cardiopulmonary bypass procedures for up to 6 hours. Intended for use with Sarns® Centrifugal Systems or Stöckert Centrifugal Pump Systems via the Sarns® Centrifugal Pump Adapter.

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

• Sarns® Centrifugal Pump with X-Coating™ (K020998)
• Sarns® Centrifugal Pump without X-Coating™ (K915363)

Submission Summary (Full Text)

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K112229

Sarns® Centrifugal Pump

Section 6 – 510(k) Summary

510(K) Premarket Notification

A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.

| Submitter Information | |
|--------------------------------------|-------------------------------------------------------|
| Name | Terumo Cardiovascular Systems Corporation |
| Address | 6200 Jackson Road<br>Ann Arbor MI, 48103 |
| Phone number | Tel: [phone] |
| Fax number | Fax: [phone] |
| E-mail | [e-mail] |
| Establishment Registration<br>Number | 1828100 |
| Name of contact person | Rebecca Andersen |
| Submission Co-Authors | Kevin Kong, RAC and Rebecca Andersen, PhD |
| Date prepared | 7/29/2011 |
| Name of Device | |
| Trade or proprietary name | Sarns® Centrifugal Pump (With or without X-Coating™ ) |
| Common or usual name | Centrifugal Pump |
| Classification name | Nonroller-type cardiopulmonary bypass blood pump |
| Classification panel | 74 Cardiovascular |
| Regulation | 21 CFR § 870.4360 |
| Product Code(s) | KFM |
| Legally marketed device(s) to | Sarns® Centrifugal Pump (With or without X-Coating™) |
| which equivalence is claimed | (K020998 & K915363) |

Section 6- Page 1 of 6

ERUMO

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# Sams® Centrifugal Pump

Section 6 – 510(k) Summary

510(K) Premarket Notification

.

| Reason for 510(k) submission | This application seeks clearance for updates to the device and to<br>expand the indications for use. This application includes the<br>reusable Sarns® Centrifugal Pump Adapter which facilitates use of<br>the sterile disposable Sarns® Centrifugal pump with Stöckert<br>Centrifugal Pump Systems. |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device description | The Sarns® Centrifugal Pump (with or without X-Coating™) is a<br>single use, sterile and disposable device.<br>It is used to pump blood through the extracorporeal circuit during<br>cardiopulmonary bypass surgery and may be used for up to 6 hours.<br>The pump has a priming volume of 48ml. The pump rotational<br>speed is 0-3600 RPM resulting in a flow capacity of 0-9.9 LPM. |
| | With this submission, the sterile disposable Sarns® Centrifugal<br>pump may be used with Stöckert Centrifugal pump systems when<br>the reusable Sarns® Centrifugal Pump Adapter is used. The Sarns®<br>Centrifugal Pump Adapter is a device designed with geometries that<br>mate the Stöckert centrifugal systems to the Sarns® Centrifugal<br>pump. The housing is a hard plastic (acetal) that slides easily onto<br>the Sarns® Centrifugal pump then clips into place. The adapted<br>pump is then mounted onto the Stöckert Centrifugal pump systems. |
| Indications for use | The Sarns® Centrifugal Pump (with or without X-Coating™) is a<br>sterile, single use device, used as an extracorporeal blood pump for<br>use in cardiopulmonary bypass procedures for up to 6 hours.<br>The pump is intended for use with the Sarns® Centrifugal Systems<br>or may be used with Stöckert Centrifugal Pump Systems by<br>attaching the Sarns® Centrifugal Pump Adapter. |
| Intended use | The pump is intended for use with the Sarns® Centrifugal Systems<br>or may be used with Stöckert Centrifugal pump systems by attaching<br>the Sarns® Centrifugal Pump Adapter. |

ﺔ ﺍﻟﻤﻮﺍﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻮﺍﺻﻞ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

TERUMO

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Sarns® Centrifugal Pump

Section 6 – 510(k) Summary

510(K) Premarket Notification

# PERFORMANCE D

| Summary of the technological characteristics of the device compared to the predicate device | | |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| Characteristic | Proposed Device:<br>Sarns® Centrifugal Pump with or without X-Coating™ and reusable Sarns® Centrifugal Pump Adapter | Predicate:<br>Sarns® Centrifugal Pump with(K020998) or without (K915363) X-Coating™ |
| Pump functionality | Propels blood through the extracorporeal circuit via centrifugal force created by an impeller. | Same |
| Pump Material: Housing | Polycarbonate (adapter housing is acetal) | Same |
| Pump Design | A polycarbonate case housing a magnetically driven acrylic vaned impeller which spins to create centrifugal force. This propels blood through the extracorporeal circuit. | Same |
| Pump Operating Principle/Technology | Movement of blood through the extracorporeal circuit via centrifugal force created by an impeller. The blood flows in to a pump chamber at the inlet port. It is moved by the impeller to the outlet port. | Same |
| Pump Prime Volume | 48 mL | Same |
| Pump Motor Interface | Magnetic Coupling (Adapter also couples magnetically) | Same |
| Pump Inlet/Outlet Port Diameters | 3/8 inch (9.5mm) | Same |
| Pump Sterilization | Ethylene Oxide (Adapter is non-sterile) | Same |
| Pump SAL | $10^{-6}$ (Adapter is non-sterile) | Same |
| Magnet | Ceramic Iron Ferrite (Adapter is NdFeB with Ni plating) | Ceramic Iron Ferrite |

Section 6- Page 3 of 6

TERUMO

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# Section 6 – 510(k) Summary

510(K) Premarket Notification

______________________________________________________________________________________________________________________________________________________________________________

| SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBSTANTIAL EQUIVALENCE* | | |
| Performance Test Summary-Proposed Device | | |
| Characteristic | Standard/Test/FDA<br>Guidance | Results Summary |
| Flow curves: A test that demonstrates<br>the performance of the sterile<br>disposable pump has not changed when<br>used with the reusable Sarns®<br>Centrifugal Pump adapter on the<br>Stöckert Centrifugal Pump System | Flow Curves Performance<br>Test | PASS:<br>Back pressure ranges for the<br>proposed device configuration<br>are within range of the<br>predicate device configuration |
| Reusable Sarns® Centrifugal Pump<br>Adapter clip fatigue test: Shows the<br>clipping mechanism is rated for the<br>lifetime use of 7yrs | Reusable Centrifugal pump<br>adapter clip fatigue Test | PASS:<br>The reusable adapter has passed<br>test meeting the lifetime use of<br>7 years |
| Reusable Sarns® Centrifugal Pump<br>Adapter change out time test: To show<br>that the change out time of the pump<br>on the proposed device configuration is<br>similar to the pump change out time of<br>the predicate device configuration: | Reusable Centrifugal pump<br>adapter change out time test | PASS:<br>The change out time between<br>the predicate device<br>configuration and the proposed<br>device configuration showed no<br>statistical difference |
| Shipping and Durability test: Show that<br>the Sarns® Centrifugal Pump Adapter<br>show no signs of damage after<br>shipment and functions as intended<br>after shipment | Shipping and Durability<br>Test | PASS:<br>Sarns® Centrifugal Pump<br>Adapter showed no signs of<br>damage and functioned as<br>intended following testing |
| Characteristic | Standard/Test/FDA | Results Summary |
| | Guidance | |
| Hemolysis test: To show that is<br>there is no statistical difference<br>of the effect on plasma free<br>hemoglobin, white blood cell<br>count and platelet count between<br>the sterile disposable Sarns®<br>Centrifugal Pump with reusable<br>adapter and without reusable<br>adapter | Hemolysis testing for the<br>reusable Sarns® Centrifugal<br>Adapter | Pass:<br>No adverse statistical differences<br>found between plasma free<br>hemoglobin, white blood cell<br>count and platelet count while<br>using the sterile disposable<br>Sarns® Centrifugal Pump with or<br>without adapter |
| Reusable Sarns® Centrifugal<br>Pump Adapter disconnection<br>force: To show that the force<br>necessary to disconnect the<br>sterile disposable Sarns®<br>Centrifugal Pump with or<br>without X-Coating™ from the<br>reusable Sarns® Centrifugal<br>Pump Adapter is similar or<br>stronger to disconnecting the<br>pump from the predicate device<br>configuration | Centrifugal adapter<br>disconnection force | PASS:<br>The average disconnection force<br>required to separate the Sarns®<br>Centrifugal Pump from the<br>reusable Sarns® Centrifugal<br>Pump Adapter was greater than<br>the force required to separate the<br>predicate Sarns® Centrifugal<br>Pump |
| Reusable Sarns® Centrifugal<br>Adapter, Interaction with the<br>Sorin Heart Lung Machine: To<br>show that usage of the reusable<br>Sarns® Centrifugal Pump<br>Adapter does not interfere with<br>the control and safety<br>components of the Stöckert<br>system | Centrifugal Adapter Interaction<br>with a Heart Lung Machine | PASS:<br>Usage of the reusable Sarns®<br>Centrifugal Pump Adapter did<br>not interfere with control and<br>safety components of the<br>Stöckert system |

.

Section 6- Page 4 of 6

TTERUMO

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# Sarns® Centrifugal Pump

# Section 6 – 510(k) Summary

510(K) Premarket Notification

(TERUMO

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Sarns® Centrifugal Pump

## Section 6 – 510(k) Summary

510(K) Premarket Notification

Summary of Non clinical tests conducted for determination of substantial equivalenc

The Sams® Centrifugal Pumps passed all the testing criteria and are shown to have the same level of performance when used with the adapter on Stöckert Centrifugal Pump Systems. Therefore the devices used with the adapter on a Stöckert Centrifugal Pump System are substantially equivalent to the devices when used on Sams® Centrifugal Pump systems.

ERUM

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the head, body, and tail feathers.

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

DEC - 9 2011

Terumo Cardiovascular Systems c/o Rebecca Andersen, Ph.D. Director, Global Regulatory Affairs 6200 Jackson Road Ann Arbor, MI 48103

Re: K112229

Sarn Centrifugal Pump Regulation Number: 21 CFR 870.4360 Regulation Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Regulatory Class: Class III (three) Product Code: KFM Dated: December 2, 2011 Received: December 5, 2011

### Dear Dr. Andersen:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Rebecca Andersen, Ph.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

M. A. Killebrew

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

#### 510(k) Number (if known): K12229

Device Name:

## Sarns® Centrifugal Pump with or without adapter

Indications for Use:

The Sarns® Centrifugal Pump with or without X-Coating™ is a sterile, single use device, used as an extracorporeal blood pump for use in cardiopulmonary bypass procedures for up to 6 hours.

The pump is intended for use with the Sarns® Centrifugal Systems or may be used with Stöckert Centrifugal Pump Systems by attaching the Sarns® Centrifugal Pump Adapter.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

.f. Hillebrand

(Division Sign-Off) Division of Cardiovascular Devices

KII2229 510(k) Number_