STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)

K082344 · Sorin Group Deutschland GmbH · DWF · Dec 17, 2008 · Cardiovascular

Device Facts

• Record ID: K082344
• Device Name: STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO)
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DWF · Cardiovascular
• Decision Date: Dec 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.

Device Story

Stöckert S5 System is a heart-lung machine console used in cardiopulmonary bypass. The Electrical Venous Occluder is an optional accessory consisting of an Occluder Unit and a Control Unit. It integrates with the S5 system to provide venous occlusion. Operated by perfusionists in clinical settings (e.g., OR) during cardiac surgery. The device assists in managing blood flow during bypass. It does not operate independently of the S5 console.

Clinical Evidence

Bench testing only. Design verification and validation information demonstrated that the product meets prospectively defined design and performance specifications.

Technological Characteristics

The device is a cardiopulmonary bypass heart-lung machine console. The Electrical Venous Occluder accessory comprises an Occluder Unit and a Control Unit. It is designed for integration with the Stöckert S5 System. No specific materials or software architecture details provided.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass for procedures lasting six hours or less.

Regulatory Classification

Identification

A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.

Predicate Devices

• Stöckert S5 System (Parent device)
• Terumo® Advanced Perfusion System 1 (K022947)

Submission Summary (Full Text)

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KO8234/4

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

# 1. SPONSOR

Sorin Group Deutschland GmbH Lindberghstrasse 25 80939 Munich Germany

DEC 1 7 2008

| Contact Person: | Helmut Höfl |
|-----------------|-------------------|
| Telephone: | 011 49 89 323 010 |

Date Prepared: August 14, 2008

# 2. DEVICE NAME

| Proprietary Names: | Stöckert S5 System |
|-----------------------|-------------------------------------------------------------------|
| Common/Usual Names: | Heart Lung Machine |
| Classification Names: | Cardiopulmonary bypass heart lung machine console and accessories |
| Proprietary Name: | Stöckert S5 System |

#### 3. PREDICATE DEVICES

Stöckert S5 System (Parent device), K071318 Terumo® Advanced Perfusion System 1, K022947

#### 4. DEVICE DESCRIPTION

The Stöckert Electrical Venous Occluder is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the S5 heart lung machine console. It consists of an Occluder Unit and Control Unit to provide

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# 5. INTENDED USE

The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of six (6) hours or less.

# 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Electrical Venous Occluder to the cited predicate devices based on equivalence in intended use, fundamental technological and operational characteristics. Information and testing submitted in this Special 510(k): Device Modification demonstrates that the Stöckert Electrical Venous Occluder integrated with the S5 System do not raise new issues of safety or effectiveness.

### 7. PERFORMANCE INFORMATION

Design verification and validation information provided in this Special 510(k): Device Modification demonstrates that the product meets prospectively defined design and performance specifications.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Principal consultant 49 Plain Street North Attleboro, CA 02760

DEC 1 7 2008

Re: K082344

> Stöckert S5 System Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II (two) Product Code: DWF Dated: December 1, 2008 Received: December 2, 2008

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 cquivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced 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,

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): K082344

Device Name: Stöckert S5 System

# Indications for Use:

The modified Stöckert S5 System is intended to be used for cardiopulmonary bypass for periods of 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)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K082344

Sorin Group Deutschland GmbH August 14, 2008 Special 510(k): Device Modification Addition of the Stöckert Electrical Venous Occluder to the Stöckert S5 System