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.

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.

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Sorin Group Deutschland GmbH Stöckert Heater-Cooler System 3T. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive independent clinical study data to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically seen in submissions requiring clinical performance data.

Specifically, the document states:

"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."

This indicates that internal testing was performed to ensure the device met its design specifications and user requirements, which is a standard part of device development. However, the details of these "specifications" and "user requirements" are not provided, nor is information on the methodology, sample size, or outcomes of such testing in the context of comparative performance against specific, quantifiable acceptance criteria that would typically be described in a clinical study report.

In summary, the document addresses substantial equivalence based on technological characteristics and intended use, and mentions compliance with specifications and user requirements, but it does not detail a study proving the device meets acceptance criteria in the manner of performance, diagnostic accuracy, or clinical outcome as would be required for a different kind of regulatory submission or a standalone effectiveness study.

Summary

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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: 011 49 89 323 010

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

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5. INTENDED USE

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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:

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

Regulation Number and Section

§ 870.4250 Cardiopulmonary bypass temperature controller.

(a)
Identification. A cardiopulmonary bypass temperature controller is a device used to control the temperature of the fluid entering and leaving a heat exchanger.(b)
Classification. Class II (performance standards).