AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

K091007 · Sorin Group Deutschland GmbH · DTQ · Jul 2, 2009 · Cardiovascular

Device Facts

• Record ID: K091007
• Device Name: AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05
• Applicant: Sorin Group Deutschland GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Jul 2, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit. The Synergy/ECC.O shall only be used in conjunction with the Stöckert S5 System and SCP Plus (Stöckert Centrifugal Pump Plus) System and the S5 System. The Stöckert S5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.

Device Story

The Stöckert S5 System is a modular heart-lung machine console comprising pumps, monitors, and user interfaces. The Air Purge Control (APC) System integrates with the S5 console to monitor the venous line for air bubbles. Upon detection, the system automatically removes air from the venous bubble trap within the Synergy/ECC.O tubing circuit. Used in clinical settings (e.g., OR) by perfusionists during cardiopulmonary bypass procedures. The system provides real-time monitoring and automated air removal, reducing the risk of air embolism during bypass. Output is displayed on the S5 console, allowing the perfusionist to manage the bypass circuit safely. The device benefits patients by maintaining circuit integrity and preventing air from entering the patient's bloodstream.

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; includes pumps, monitors, and displays. Integrates air detection and removal functionality for venous bubble traps. Software-controlled operation. Designed for use with Synergy/ECC.O tubing circuits and SCP Plus centrifugal pumps.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass support for durations of 6 hours or less. Used for speed-controlled blood pumping, left ventricular venting, cardiotomy suction, and cardioplegia solution administration. Operated by qualified, experienced perfusionists.

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
• Stöckert Air Purge Control System

Submission Summary (Full Text)

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KC091007

**JUL - 2 2009**

# 510(k) Summary (Per 21 CFR 807.92) Addition of the Stöckert Air Purge Control System to the Stöckert S5 System

#### 1. SPONSOR

| | Sorin Group Deutschland GmbH |
|---------------------|------------------------------|
| Lindberghstrasse 25 | |
| 80939 Munich | |
| Germany | |
| Contact Person: | Helmut H\u00f6fl |
| Telephone: | 011 49 89 323 010 |
| | |

Date Prepared: April 8, 2009

#### 2. DEVICE NAME

Proprietary Name: -Stöckert S5 System, Stöckert Air Purge Control System Common/Usual Name: Heart lung machine and accessories Classification Name: Multiple

#### 3. PREDICATE DEVICES

- Stöckert S5 System .
- . Stöckert Air Purge Control System

#### DEVICE DESCRIPTION 4.

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/INDICATIONS FOR USE

The Stöckert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit that is intended to be used with the Stöckert S5 System.

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The (integrated) S5 Stöckert is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.

## 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The modified Stöckert S5 System is an upgrade of the parent Stöckert S5 System and APC 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.

#### 7. PERFORMANCE TESTING

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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#### Public Health Service

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 2 2009

Sorin Group Deutschland Gmbh c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K091007

> Air Purge Control System for S5 System Model 23-45-05 Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary bypass heart-lung machine console Regulatory Class: Class II (two) Product Code: DTQ Dated: May 28, 2009 Received: June 2, 2009

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 [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,

Ashley B. Barr

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): K091007

# Device Name: Stöckert Air Purge Control System (Model Number 23-45-05)

Indications for Use:

The Stockert Air Purge Control System detects air in the venous line and removes air from the venous bubble trap of the Synergy/ECC.O System tubing circuit. The Synergy/ECC.O shall only be used in conjunction with the Stöckert S5 System and SCP Plus (Stöckert Centrifugal Pump Plus) System and the S5 System.

The Stöckert S5 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six (6) hours or less, left ventricular venting, cardiotomy suction, and administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the S5 System.

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)

Aulley Boann for BDZ

rdiovascular Devices

**510(k) Number** K091007