STOCKERTIR PURGE CONTROL (APC) SYSTEM

K041558 · Stockert Instrumente GmbH · DTW · Jul 2, 2004 · Cardiovascular

Device Facts

• Record ID: K041558
• Device Name: STOCKERTIR PURGE CONTROL (APC) SYSTEM
• Applicant: Stockert Instrumente GmbH
• Product Code: DTW · Cardiovascular
• Decision Date: Jul 2, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4340
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six 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 S3 System.

Device Story

Stöckert Air Purge Control (APC) is a modification of the S3 Level Control/Bubble Detector; detects air in venous lines; removes air from venous bubble traps in Synergy System tubing circuits. Operates within S3 Perfusion System; used by qualified perfusionists in clinical settings. Modifications include display panel artwork changes, replacement of 'Alarm Clear' key with 'Purge Control' key, and firmware/software updates. Hardware and electronics remain unchanged from predicate. System provides automated air detection and removal to assist perfusionists during cardiopulmonary bypass, potentially reducing air embolism risks.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modification of existing S3 Level Control/Bubble Detector. Retains original hardware and electronics. Includes updated firmware/software and modified display panel. Operates as a bubble detector and air purge controller for cardiopulmonary bypass circuits.

Indications for Use

Indicated for patients requiring cardiopulmonary bypass support for durations of six hours or less. Used by qualified perfusionists for blood pumping, left ventricular venting, cardiotomy suction, and cardioplegia administration.

Regulatory Classification

Identification

A cardiopulmonary bypass level sensing monitor and/or control is a device used to monitor and/or control the level of blood in the blood reservoir and to sound an alarm when the level falls below a predetermined value.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.

Predicate Devices

• Stöckert S3 Level Control and Bubble Detector (K955152)

Submission Summary (Full Text)

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# K041558 Special 510(k): Device Modification 510(k) Summary for Stöckert Air Purge Control

#### 1. SPONSOR

Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich Germany

Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Telephone: [phone] Facsimile: 011 49 89 323 01100

Date Prepared: June 30, 2004

# DEVICE NAME 2.

Proprietary Name: Stöckert Air Purge Control (APC) System Common/Usual Name: Cardiopulmonary bypass bubble detector and sensor Classification Name: Cardiopulmonary bypass bubble detector

## 3. PREDICATE DEVICE

Stöckert S3 Level Control and Bubble Detector (K955152)

# 4. DEVICE DESCRIPTION

The Stöckert Air Purge Control is a modification of the cleared S3 Level Control/Bubble Detector with the new Air Purge Control module replacing the Bubble Detector. The APC System uses the same Level Control module, Level Control sensor as the predicate device above. The modifications being made to the parent Stöckert S3 Level Control and Bubble Detector consist of three changes: (1) a change to the artwork of the display panel to show "APC" rather than "Bubble Detector," (2) replacement of the "Alarm Clear" key with the "Purge Control" key,

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and (3) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components.

#### 5. INTENDED USE

The Stockert Air Purge Control (APC) detects air in the venous line and removes air from the venous bubble trap of the Synergy System tubing circuit that is intended to be used with the Stockert S3 Perfusion System. The S3 System is indicated for speed-controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six 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 S3 System.

### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed APC is identical in intended use and fundamental scientific technology to the parent Stöckert S3 Level Control and Bubble Detector. The differences between the proposed and parent device is limited to the display panel and firmware/software. Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k) that the APC System complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, representing the department's focus on people and health.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 0 2 2004

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

Re: K041558 Stöckert Air Purge Control Dated: June 9, 2004 Received: June 10, 2004

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Duna D. Lochner

( 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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K041558

Device Name: Stöckert Air Purge Control

Indications for Use:

The Stockert Air Purge Control (APC) detects air in the venous line and removes air from The Stocker An Furge Oontrol ( = 3) System tubing circuit that is intended to be used the vehous oubote thip of the System. The S3 System is indicated for speed-controlled whill the Stocker US Forfastor Dystems
pumping of blood through the cardiopulmonary bypass circuit for durations of six hours pulliping of violou arrowenting, cardiotomy suction, and administration of cardioplegia of tess, for ventreatir valuages and serfusionist who is experienced in the operation of the S3 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna P. Vochner

Ision Sign-Off) (Division of Cardiovascular Device

510(k) Number k041558