STOCKERT HEATER-COOLER SYSTEM 3T

K052601 · Sorin Group Deutschland GmbH · DWC · Jun 6, 2006 · Cardiovascular

Device Facts

• Record ID: K052601
• Device Name: STOCKERT HEATER-COOLER SYSTEM 3T
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DWC · Cardiovascular
• Decision Date: Jun 6, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4250
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.

Device Story

Stöckert Heater-Cooler System 3T provides temperature-controlled water to heat exchangers and thermal blankets; used during cardiopulmonary bypass procedures up to 6 hours. System comprises heater-cooler base unit, water connectors, CAN-connecting cable for S3 System, and potential equalization cable. Operated by perfusionists or clinical staff in OR settings. Device connects to heart-lung machines to regulate patient temperature via extracorporeal perfusion. Output is temperature-controlled water flow; healthcare providers monitor patient temperature and adjust settings to warm or cool patient as clinically indicated. Benefits include precise thermal management during bypass.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Cardiopulmonary bypass temperature controller. Includes heater-cooler base unit, water connectors, and CAN-bus connectivity for S3 system integration. Provides temperature-controlled water to external heat exchangers and blankets. Class II device.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass procedures lasting up to 6 hours, requiring extracorporeal perfusion temperature control via heat exchangers or thermal regulating blankets.

Regulatory Classification

Identification

A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.

Predicate Devices

• Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742)
• Alpha Omega, Inc. Dual2 Cooler-Heater (K.001520)
• Jostra AB Heater-Cooler Unit 30 (K031544)

Submission Summary (Full Text)

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L052601

## Traditional 510(k) Premarket Notification 510(k) Summary Sorin Group Deutschland GmbH, Stöckert Heater-Cooler System 3T

#### 1. SUBMITTER/HOLDER

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany

Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Telephone: [phone]

Date Prepared: September 19, 2005

#### 2. DEVICE NAME

Proprietary Name: Stöckert Heater-Cooler System 3T Common/Usual Name: Heater-Cooler Classification Name: Cardiopulmonary bypass temperature controller

#### 3. PREDICATE DEVICE

- . Cincinnati Subzero Hemotherm (CSZ Hemotherm) (K811742)
- . Alpha Omega, Inc. Dual2 Cooler-Heater (K.001520)
- . Jostra AB Heater-Cooler Unit 30 (K031544)

#### 4. DEVICE DESCRIPTION

The Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T consists of standard and optional components. The standard components comprise the heater-cooler base unit, water connectors, CAN-connecting cable for the S3 System, potential equalization cable, and Operating Instructions. Patient blankets used with the System are already legally marketed in the United States.

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#### 5. INTENDED USE

The Stöckert Heater-Cooler System 3T is intended to provide temperature-controlled water to heat exchanger devices (cardiopulmonary bypass heat exchangers, cardioplegia heat exchangers, and thermal regulating blankets) to warm or cool a patient during cardiopulmonary bypass procedures lasting six (6) hours or less.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Heater-Cooler System 3T to the cited predicate devices based on equivalence in intended use, fundamental technological and operational characteristics. Testing submitted in this premarket notification demonstrates that the Stockert Heater-Cooler System 3T complies with specifications, meets user requirements, and the differences between the proposed device and cited predicate devices do not raise new issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 6 2006

Sorin Group Deutschland GmbH c/o Ms. Rosina Robinson Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, MA 02760

Re: K052601 Stockert Heater-Cooler System 3T Regulation Number: 21 CFR 870.4250 Regulation Name: Cardiopulmonary Bypass Temperature Controller Regulatory Class: Class II Product Code: DWC Dated: May 15, 2006 Received: May 16, 2006

Dear Ms. Robinson:

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 - Ms. Rosina Robinson

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,

ina R. Holmes

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

K052601 510(k) Number:

Stöckert Heater-Cooler System 3T Device Name:

### Indications for Use:

The Stöckert Heater-Cooler System 3T is used with a Stöckert S3 heart-lung machine and/or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

uma R. Varlmer

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K052601