STOCKERT CENTRIFUGAL PUMP CONSOLE

K020571 · Stockert Instrumente GmbH · DTQ · Sep 23, 2002 · Cardiovascular

Device Facts

• Record ID: K020571
• Device Name: STOCKERT CENTRIFUGAL PUMP CONSOLE
• Applicant: Stockert Instrumente GmbH
• Product Code: DTQ · Cardiovascular
• Decision Date: Sep 23, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4220
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SCPC System is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the Stöckert Centrifugal Pump and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCPC 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 Centrifugal Pump Console (SCPC) is a software-controlled system providing electrical power and operational control for the Stöckert Centrifugal Pump. It integrates S3 Sensor Modules to monitor cardiopulmonary bypass circuit parameters, including pressure, temperature, level, bubble detection, and elapsed time. Used in clinical settings during cardiopulmonary bypass procedures, the device is operated by perfusionists or clinicians. It functions as a console component for heart-lung machines, allowing speed-controlled blood pumping. The system includes an uninterruptable power supply (UPS) to ensure continuous operation. Clinicians use the console's interface to set pump parameters and monitor real-time circuit data, facilitating safe extracorporeal circulation. The device benefits patients by providing reliable, controlled blood flow during cardiac surgery.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included electrical safety, electromagnetic compatibility, functional acceptance, and hardware/software validation to confirm performance and compatibility with Stöckert CAPS, Stöckert S3, and COBE Century heart-lung machine consoles.

Technological Characteristics

Software-controlled console with integrated uninterruptable power supply (UPS) and S3 Sensor Modules. Provides electrical power and control for centrifugal pumps. Monitors pressure, temperature, level, bubble detection, and time. Compatible with Stöckert and COBE heart-lung machine consoles. Connectivity includes sensor module integration for circuit monitoring.

Indications for Use

Indicated for speed-controlled pumping through cardiopulmonary bypass circuits for patients undergoing cardiopulmonary bypass procedures for durations of six hours or less. Not indicated for long-term use, 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

• Medtronic Bio-Console 540/550
• RotaFlow Centrifugal Pump System (K991864)
• Himex Centriflow Centrifugal Perfusion Pump System (K972740)
• Stöckert Compact System (K982014)

Reference Devices

• Stöckert CAPS (K863541)
• COBE Century (K960974)

Submission Summary (Full Text)

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## SEP 2 3 2002

K020571

# 510(k) Summary for Stöckert Centrifugal Pump Console

#### 1. SPONSOR

Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich, Germany

Contact: Helmut Hofl, Director, Quality Assurance and Regulatory Affairs 011 49 89 323 010 Telephone: [phone] Facsimile:

Date Prepared: July 9, 2002

#### 2. Device Name

Proprietary Name: Stöckert Centrifugal Pump Console Common/Usual Name: Cardiopulmonary bypass device Classification Name: Multiple (see Table 1)

### Table G-1. SCPC System Classifications

| Classification Name | 21 CFR | ProCode | Classification |
|-------------------------------------------------------------------------|----------|---------|----------------|
| Cardiopulmonary bypass heart-lung console | 870.4220 | 74DTQ | Class II |
| Cardiopulmonary bypass bubble detector | 870.4205 | 74KRL | Class II |
| Cardiopulmonary bypass level sensing monitor/control | 870.4340 | 74DTW | Class II |
| Accessory to the cardiopulmonary bypass console:<br>Temperature Monitor | 870.4220 | 74DTQ | Class II |
| Accessory to the cardiopulmonary bypass console: Timer | 870.4220 | 74DTQ | Class II |
| Cardiopulmonary bypass coronary pressure gauge | 870.4310 | 74DXS | Class II |

#### Predicate Devices 3.

- . Medtronic Bio-Console 540/550 (Multiple)
- RotaFlow Centrifugal Pump System (K991864) ●
- Himex Centriflow Centrifugal Perfusion Pump System (K972740) ●
- Stöckert Compact System (K982014) ●

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#### Device Description 4.

The SCPC System provides electrical power and sets specific operational parameters for the Stöckert Centrifugal Pump Control Panel and Drive Unit described in K011838. The SCPC System also monitors the following parameters of the cardiopulmonary bypass circuit:

- . Pressure
- Temperature .
- Level monitoring/bubble detection .
- Elapsed time .

The SCPC System provides procedural flexibility for use of the Stöckert Centrifugal Pump, allowing the pump to be used as a component of other legally marketed heartlung machine consoles.

#### న. INTENDED USE

The SCPC System is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the Stöckert Centrifugal Pump and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCPC 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.

#### 6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The proposed SCPC System is identical in intended use and fundamental scientific technology to the cited predicate devices. Both the proposed SCPC System and the predicate devices provide electrical power and set operational parameters of connected pump(s) and monitor critical parameters of the cardiopulmonary bypass procedure. The differences between the proposed and predicate devices are limited to features that raise no new issues of safety or effectiveness.

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#### 7. PERFORMANCE TESTING

Electrical safety and electromagnetic compatibility testing was performed to demonstrate conformance with the appropriate standards. Functional acceptance testing, hardware and software testing, and validation testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements, including compatibility with the Stöckert CAPS (K863541), Stöckert S3, and COBE® Century™ (K960974) heart-lung machine (HLM) consoles.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines that also suggest human profiles.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 2002

Stöckert Instrumente GmbH Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant c/o Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K020571 Stöckert Centrifugal Pump Console Regulation Number: 870.4360 Regulation Name: Nonroller-type cardiopulmonary bypass blood pump Regulatory Class: Class II (two) Product Code: DTQ Dated: July 9, 2002 Received: July 11, 2002

Dear Ms. Nolte:

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.

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

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Page 2 - Cynthia J. M. Nolte, Ph.D., RAC

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

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):

Device Name: Stöckert Centrifugal Pump Console

Indications for Use:

The Stöckert Centrifugal Pump Console (SCPC System) is a software-controlled cardiopulmonary bypass device containing an uninterruptable power supply (UPS) and S3 Sensor Modules that is designed for operation of the Stöckert Centrifugal Pump (SCP) and monitoring the cardiopulmonary bypass circuit. The SCPC System, in combination with the SCP and the COBE Revolution Pump Head, is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCPC System has been qualified only for durations appropriate to cardiopulmonary bypass procedures and has not been qualified through 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)

Division of Cardiovascular & Resr
510(k) Number K02057 devices

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use -------

(Optional Format 1-2-96)

February 20, 2002