MODIFICATION TO STOCKERT S5 SYSTEM

K062396 · Sorin Group Deutschland GmbH · DTQ · Sep 28, 2006 · Cardiovascular

Device Facts

• Record ID: K062396
• Device Name: MODIFICATION TO STOCKERT S5 SYSTEM
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

Device Story

The Stöckert S5 System is a modular heart-lung machine used during cardiopulmonary bypass surgery. It consists of a console, pumps, monitors, displays, and user interfaces. Operated by perfusionists in an operating room setting, the system provides extracorporeal circulation and oxygenation of blood during cardiac procedures. The device functions as a support system to maintain patient physiological parameters during surgery. The modified system is an upgrade to the parent S5 platform, maintaining the same fundamental operational characteristics.

Clinical Evidence

Bench testing only. Testing of hardware and software demonstrated that the system fulfills prospectively defined performance criteria and meets user needs.

Technological Characteristics

Modular heart-lung machine console including pumps, monitors, and user interfaces. System is an upgrade to the parent S5 platform. Software and hardware components were verified against performance criteria.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery for procedures lasting six (6) hours or less.

Regulatory Classification

Identification

A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.

Predicate Devices

• Stöckert S5 System (K062396)

Submission Summary (Full Text)

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K062396

SEP 2 8 2006

APPENDIX C

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510(k) Summary

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Sorin Group Deutschland GmbH August 15, 2006 Special 510(k): Device Modification - Stöckert S5 System

APPENDIX C

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# 510(k) Summary Sorin Group Deutschland GmbH Stöckert S5 System (per 21 CFR 807.92)

#### 1. SPONSOR

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany Contact Person: Helmut Höfl Telephone: [phone]

Date Prepared: August 15, 2006

#### 2. DEVICE NAME

Proprietary Name: Stöckert S5 System Common/Usual Name: Heart lung machine Classification Name: Multiple

#### 3. PREDICATE DEVICES

Stöckert S5 System

#### 4. DEVICE DESCRIPTION

The modified Stöckert S5 System, like the parent S5 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.

#### 5. INTENDED USE

The Stöckert S5 System is intended to be used during cardiopulmonary bypass surgery lasting six (6) hours or less.

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### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The modified Stöckert S5 System is an upgrade of the parent Stöckert S5 System. The modified Stöckert S5 System is substantially equivalent to the parent Stöckert S5 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.

## PERFORMANCE TESTING 7.

Testing of the modified Stöckert S5 System (hardware and software) has demonstrated that the System fulfills prospectively defined performance criteria and that the modified System meets user needs.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Principal Consultant, Regulatory Services 49 Plain Street North Attleboro, MA 02760

Re: K062396 Stöckert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ Dated: September 18, 2006 Received: September 19, 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 (OS) 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) promation 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,

Anna R. Vachner

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A 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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510(k) Number (if known): K062396

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

:

The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Vachner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k 662396