STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER

K080832 · Sorin Group Deutschland GmbH · DTQ · Jul 30, 2008 · Cardiovascular

Device Facts

• Record ID: K080832
• Device Name: STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Jul 30, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Stöckert S5 System is a heart-lung machine console used during cardiopulmonary bypass; includes optional Stöckert Gas Blender accessory. Device operates as integrated system; gas blender cannot function independently. Used in clinical settings (e.g., OR) by perfusionists/physicians to manage extracorporeal circulation. Provides gas control for oxygenation during bypass procedures. Benefits include support of patient physiological function during cardiac surgery. Modification involves integration of gas blender to existing S5 platform.

Clinical Evidence

No clinical data. Evidence consists of design verification and validation testing to demonstrate performance against prospectively defined specifications.

Technological Characteristics

Cardiopulmonary bypass heart-lung machine console. Integrated gas blender accessory. System is Class II, 21 CFR 870.4220. Operates as a console for extracorporeal circulation.

Indications for Use

Indicated for patients undergoing cardiopulmonary bypass 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 S5 System (Parent Device)
• Terumo® Advanced Perfusion System 1 (K022947)

Submission Summary (Full Text)

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108832

JUL 30 2008

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

### SPONSOR 1.

| Sorin Group Deutschland GmbH | |
|------------------------------|-------------------|
| Lindberghstrasse 25 | |
| 80939 Munich | |
| Germany | |
| Contact Person: | Helmut Höfl |
| Telephone: | 011 49 89 323 010 |

Date Prepared: May 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) Terumo® Advanced Perfusion System 1, K022947

#### DEVICE DESCRIPTION 4.

The Stöckert Gas Blender is an optional accessory to and designed to be operated with the Stöckert S5 System. It cannot be operated independently from the heart lung machine console.

#### เก่ INTENDED USE

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

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#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Sorin Group Deutschland GmbH bases the claim of substantial equivalence of the Stöckert Gas Blender 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 Gas Blender integrated with the S5 System Stöckert Gas Blender 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 2008

Sorin Group Deutscland c/o Ms. Rosina Robinson, RN, Med, RAC Principal Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K080832

Stockert S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II (two) Product Code: DTQ, DWB, DTR, KRI, DTW, DXS, DWA, KRL, DTX Dated: June 13, 2008 Received: June 19, 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 vour 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 sct 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 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.

Dmen R. hohner

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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# Indication for Use

510(k) Number (if known): K080832

Stöckert S5 System Device Name:

Indications for Use:

The modified 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)

Dina R. Vollmer

ivision Sign-Off) (Division Sign-Olf)
Division of Cardiovascular Devices

510(k) Number K080832