STOCKERT COMPACT SYSTEM

K982014 · Stoeckert Instrumente · DTQ · Sep 4, 1998 · Cardiovascular

Device Facts

• Record ID: K982014
• Device Name: STOCKERT COMPACT SYSTEM
• Applicant: Stoeckert Instrumente
• Product Code: DTQ · Cardiovascular
• Decision Date: Sep 4, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System. The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

Device Story

The Stöckert Compact System (SC System) is an integrated heart-lung machine designed for cardiopulmonary bypass. It consolidates pumps, monitoring, and control elements onto a single chassis. The device is operated by a qualified perfusionist in a clinical setting. It provides speed-controlled blood pumping, suction, and cardioplegia delivery during cardiac surgery. The system functions as a modification of the Stöckert S3 System, maintaining the same fundamental technological characteristics and operational principles. It is intended for short-term use (≤ 6 hours). The perfusionist monitors the system output to manage patient hemodynamics during bypass procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Integrated heart-lung machine on a single chassis. Includes roller pumps, speed control, bubble detectors, level sensing, temperature monitoring, timers, and pressure gauges. Operates as a cardiopulmonary bypass console. Complies with 21 CFR 870.4220, 870.4370, 870.4380, 870.4205, 870.4340, and 870.4310.

Indications for Use

Indicated for speed-controlled pumping in cardiopulmonary bypass circuits for durations ≤ 6 hours, left ventricular venting, cardiotomy suction, and cardioplegia administration. For use by qualified, experienced perfusionists. Not indicated for long-term bridge-to-transplant or ECMO.

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 Modules

Submission Summary (Full Text)

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K982014

- SEP 4 1998
510(k) Summary Special 510(k): Device Modification Stöckert Compact System (per 21 CFR 807.92)

#### SPONSOR/APPLICANT 1.

Stöckert Instrumente GmbH Lilienthalallee 5-7 D-80939 Munich 45, Germany

| Contact: | Helmut Höfl,<br>Manager, Quality Assurance |
|------------|--------------------------------------------|
| Telephone: | 011 49 89 323 010 |
| Facsimile: | 011 49 89 323 4238 |

#### 2. DEVICE NAME

| Proprietary Name: | Stöckert Compact System (SC System) |
|-----------------------|-------------------------------------|
| Common/Usual Name: | Heart Lung Machine |
| Classification Names: | Multiple (See Table E-1) |

# Table E-1. SC System Classifications

| Classification Name | 21 CFR | ProCode |
|----------------------------------------------------------------------|----------|---------|
| Cardiopulmonary bypass heart-lung console | 870.4220 | 74DTQ |
| Roller type cardiopulmonary bypass blood pump | 870.4370 | 74DWB |
| Cardiopulmonary bypass pump speed control | 870.4380 | 74DWA |
| Cardiopulmonary bypass bubble detector | 870.4205 | 74KRL |
| Cardiopulmonary bypass level sensing monitor/control | 870.4340 | 74DTW |
| Accessory to the cardiopulmonary bypass console: Temperature Monitor | 870.4220 | 74DTQ |
| Accessory to the cardiopulmonary bypass console: Timer | 870.4220 | 74DTQ |
| Cardiopulmonary bypass coronary pressure gauge | 870.4310 | 74DXS |
| Optional SC System Accessories | | |
| Venous Line Clamp (Class I and Exempt) | 870.4200 | 74KRI |

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#### PREDICATE DEVICES 3.

Stöckert S3 System Modules: Multiple 510(k) Numbers

#### INTENDED USE 4.

The Stöckert Compact System is an integrated heart-lung machine consisting of pumps, monitoring, and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

#### DEVICE DESCRIPTION 5.

The Stöckert Compact System is a modification of the Stöckert S3 System, which integrates its components into a single chassis. There is no change to the indications for use or the fundamental technological characteristics.

#### BASIS FOR DETERMINATION OF EQUIVALENCE 6.

The Stöckert Compact System is a modification of the Stöckert S3 System and is therefore substantially equivalent to the S3 System. This determination is based on equivalence in intended use and technological characteristics (design and operation). System modifications have been validated according to Stöckert Instrumente Design Control procedures, in compliance with the Quality Systems Stöckert Instrumente GmbH also believes that any differences Regulations. between the SC and S3 Systems are minor and raise no new issues of System safety or effectiveness.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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 an abstract symbol resembling an eagle or bird with three stylized profiles facing to the right.

SEP 4 1998

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

Re: K982014 Stöckert Compact System Requlatory Class: II Product Code: DTQ Dated: August 4, 1998 Auqust 5, 1998 Received:

Dear Ms. Robinson:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS ... inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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### Page 2 - Ms. Rosina Robinson

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): K982014

Device Name: Stöckert Compact System

Indications For Use:

The SC System is an integrated heart lung machine consisting of pumps and monitoring and control elements on a single chassis. It is indicated for speed controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less, left ventricular venting, cardiotomy suction, administration of cardioplegia solution, when used by a qualified perfusionist who is experienced in the operation of the SC System.

The SC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through in vitro, in vivo, or clinical studies, for long term use as a bridge to transplant, pending recovery of the natural heart, or extracorporeal membrane oxygenation (ECMO) procedures.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bera L. Campbell
Division Sign-Off

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number_________________________________________________________________________________________________________________________________________________________________

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

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