STOCKERT S5 SYSTEM

K060053 · Sorin Group Deutschland GmbH · DTQ · Jun 2, 2006 · Cardiovascular

Device Facts

• Record ID: K060053
• Device Name: STOCKERT S5 SYSTEM
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Jun 2, 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 surgery lasting six (6) hours or less.

Device Story

Modular heart-lung machine; consists of console, pumps, monitors, displays, controls, and user interfaces. Used in OR by perfusionists/clinicians during cardiopulmonary bypass. Provides extracorporeal circulation support for procedures up to 6 hours. System monitors and controls blood flow; assists clinical decision-making by providing real-time perfusion data. Benefits patient by maintaining circulatory and respiratory function during cardiac surgery.

Clinical Evidence

Bench testing only. Testing included electrical safety, electromagnetic compatibility, software validation, and functional testing to confirm fulfillment of performance criteria.

Technological Characteristics

Modular heart-lung machine console. Includes pumps, monitors, displays, and user interfaces. Operates via electrical power. Software-controlled system. Subject to electrical safety and electromagnetic compatibility standards.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass surgery for procedures lasting six 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 S3 System

Submission Summary (Full Text)

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# 510(k) Summary Stöckert S5 System

K0600053

#### 1. SPONSOR

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

Date Prepared: January 4, 2006

#### 2. DEVICE NAME

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

#### 3. PREDICATE DEVICES

Stöckert S3 System (multiple 510(k) numbers)

#### 4. DEVICE DESCRIPTION

The Stöckert S5 System, like the parent S3 System, is a modular system consisting of a console, various pumps, monitors, displays, controls, and user interfaces.

#### ડ. 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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### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The Stöckert S5 System is an upgrade of the Stöckert S3 System. The Stöckert S5 System is substantially equivalent to the Stöckert S3 System based on intended use, indication for use, operational characteristics, and fundamental technological characteristics.

#### 7. PERFORMANCE TESTING

Testing of the Stöckert S5 System demonstrated that the System fulfills prospectively defined performance criteria and included electrical safety, electromagnetic compatibility, software validation, and functional testing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 2 2006

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

Re: K060053 Stöckert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Heart Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: May 22, 2006 Received: May 23, 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) 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,

Brimmer 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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510(k) Number (if known):

Stöckert S5 System Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications för 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)

Bhumima

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