CENTRIFUGAL PUMP

K011838 · Stockert Instrumente GmbH · DWA · Feb 5, 2002 · Cardiovascular

Device Facts

• Record ID: K011838
• Device Name: CENTRIFUGAL PUMP
• Applicant: Stockert Instrumente GmbH
• Product Code: DWA · Cardiovascular
• Decision Date: Feb 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4380
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP has been qualified only for typical durations of six hours or less, 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

Stöckert Centrifugal Pump (SCP) provides speed-controlled pumping for cardiopulmonary bypass circuits; used exclusively with COBE Revolution Disposable Pump Head. System components: SCP Control Panel, Drive Unit, Flow Probe, Emergency Drive Unit. Integrates with Stöckert S3/SC systems via CAN Bus; utilizes S3/SC system battery backup. Operator (perfusionist/clinician) adjusts pump speed via incremental shaft encoder; system provides real-time RPM and flow rate (LPM) monitoring. Includes AutoFlow mode for automated flow control and optional remote control for automatic clamping. Safety features: low RPM protection (software detent), runaway protection, and adjustable alarms (high/low/negative flow). Output displayed on control panel; assists clinicians in maintaining hemodynamic support during bypass. Benefits: precise flow control and integrated monitoring during short-term cardiac procedures.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including functional acceptance testing, electrical/mechanical safety (IEC60601-1), electromagnetic compatibility (IEC60601-1-2), software verification and validation, ship testing, and battery life testing.

Technological Characteristics

System includes control panel, drive unit, flow probe, and emergency drive unit. Magnetic pump head coupling. Connectivity via CAN Bus to Stöckert S3/SC systems. Power: 24V DC. RPM range: 0-3500; LPM range: -10 to +10. Control: incremental shaft encoder. Safety: software-based low RPM detent, runaway protection at 1000 RPM threshold. Displays: RPM and LPM (numeric and bar graph).

Indications for Use

Indicated for speed-controlled pumping through cardiopulmonary bypass circuits for durations of 6 hours or less. For use exclusively with COBE Revolution Disposable Pump Head. Not indicated for long-term bridge to transplant, heart recovery, or ECMO.

Regulatory Classification

Identification

A cardiopulmonary bypass pump speed control is a device used that incorporates an electrical system or a mechanical system, or both, and is used to control the speed of blood pumps used in cardiopulmonary bypass surgery.

Predicate Devices

• Jostra RotaFlow (K991864)
• Medtronic Bio-Medicus BioConsole 540/550 (Multiple)

Submission Summary (Full Text)

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# FEB 0 5 2002

# 510(k) Summary for the Stöckert Instrumente GmbH Centrifugal Pump (SCP) K011838

#### 1. SPONSOR

Stöckert Instrumente GmbH Lindberghstrasse 25 D80939 München Germany

Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Contact: Telephone: [phone] 011 49 89 323 4238 Facsimile:

Date Prepared: November14, 2001

### DEVICE NAME 2.

Stöckert Centrifugal Pump Proprietary Name: Common/Usual Name: Centrifugal Pump Cardiopulmonary bypass speed control device Classification Name:

### PREDICATE DEVICES 3.

- Jostra RotaFlow (K991864) .
- Medtronic Bio-Medicus BioConsole 540/550 (Multiple) .

### 4. DEVICE DESCRIPTION

The Stöckert Centrifugal Pump, developed to address the needs of the health care marketplace, consists of the following components:

- SCP Control Panel .
- SCP Drive Unit .
- Flow Probe .
- Emergency Drive Unit .

The SCP is designed to be used exclusively with the COBE® Revolution Disposable Pump Head and in connection with Stöckert S3 and SC Systems. The power supply voltage (24 V DC) as well as the CAN Bus connection is provided through a

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connection cable. The SCP utilizes the battery backup power from the S3/SC System Uninterruptible Power Supply in case of mains power failure.

### క. INTENDED USE

The Stockert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP 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.

#### 6. PERFORMANCE TESTING

Testing submitted in this premarket notification consists of functional acceptance testing, electrical/mechanical safety (IEC60601-1), and electromagnetic compatibility (IEC60601-1-2), software verification and validation, ship testing, and battery life. Test results demonstrate that the SCP and associated software perform as intended.

#### 7. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

Stöckert Instrumente GmbH claims equivalence to cited predicate devices based on equivalence in indications for use, operational characteristics, and technological characteristics. A side-by-side comparison of the SCP to the predicate devices is provided in the table below.

| Characteristic | Stöckert<br>Centrifugal<br>Pump | Medtronic<br>BIO-MEDICUS<br>540/550 | Jostra<br>RotaFlow | | |
|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------|-------------------------------------|--------------------|--|--|
| Indications for Use: Speed controlled pumping<br>through the cardiopulmonary bypass circuit for<br>durations of six hours or less | Yes | Yes | Yes | | |
| Design | | | | | |
| Mounting System | Mast | Console | Console | | |
| Magnetic Pump Head Coupling | Yes | Yes | Yes | | |
| Communication with heart lung machine | Yes | No | Yes | | |
| Battery | Uses Battery in<br>HLM console | Yes | Yes | | |
| Data Output | via HLM | serial port | serial port | | |

Side-by-Side Comparison of the SCP with Cited Predicate Devices

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| Characteristic | Stöckert<br>Centrifugal<br>Pump | Medtronic<br>BIO-MEDICUS<br>540/550 | Jostra<br>RotaFlow |
|-----------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------|
| Operational Specifications | | | |
| RPM Range | 0-3500 RPM | 0-4500 RPM | 0-5000 RPM |
| RPM Accuracy | $ \pm 10% $ | Not specified | $ \pm 20 RPM $ |
| RPM Display Resolution | 1 RPM | Not specified | 10 RPM |
| LPM Range | -10 LPM to +10.0<br>LPM | -2 to 9.99 LPM | 0 to 9.9 LPM |
| LPM Accuracy | $ \pm 10% or 0.1 $<br>LPM, whichever<br>is greater | Not specified | 0.1 LPM |
| LPM Resolution | 0.01 LPM<br>(Flow > 0)<br>0.1 LPM<br>(Flow < 0) | Not specified | 0.01 LPM |
| Controls and Displays | | | |
| RPM Control Method | incremental<br>shaft encoder | potentiometer | potentiometer |
| LPM Control | Yes, in<br>AutoFlow Mode | No | Yes, in<br>LPM Control<br>Mode |
| Remote Control for automatic clamp (optional) | Yes | No | Yes |
| Secondary RPM display | Yes, Bar display | Yes, Bar display | No |
| Secondary LPM display | Yes, Bar display | Yes, Bar display | No |
| Pressure display | Yes, value source<br>from HLM | Yes,<br>internal probe | No |
| Other displays | $-$ | 2 Timers | $-$ |
| Level and Air Bubble Monitoring | Yes | No | Yes |
| Safety Features | | | |
| Low RPM protection | software detent<br>Low RPM enable<br>by key stroke | mechanical detent<br>Low RPM enable<br>by depressing the<br>speed control<br>knob | No detent<br>Low RPM Alarm |
| Adjustable Alarms | High Flow,<br>Low Flow,<br>Negative Flow | Low Flow,<br>High Flow | Low Flow,<br>Low RPM,<br>High RPM |
| Runaway Protection | Yes, at 1000 RPM<br>higher | No | Yes, at 20%<br>higher |
| Emergency Hand crank | Yes | Yes | Yes |

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Image /page/3/Picture/1 description: The image shows a logo for the Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH &" are arranged vertically along the left side of the logo, following a curved path.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 0 5 2002

Mr. Helmut Höfl Director, Ouality Assurance and Regulatory Affairs Stöckert Instrumente GmbH Lindberghstrasse 25 D80939 München Germany

Re: K011838

> Trade Name: Stöckert Centrifugal Pump Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: Class II (two) Product Code: DWA Dated: November 27, 2001 Received: November 28, 2001

Dear Mr. Höfl:

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 - Mr. Helmut Höfl

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.

Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 510(k) Number (if known): K011838

Device Name: Stöckert Centrifugal Pump (SCP)

Indications for Use:

The Stöckert Centrifugal Pump (SCP) is a cardiopulmonary bypass speed control device (21 CFR 870.4380) indicated for use exclusively with the COBE Revolution Pump Head, for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less.

The SCP has been qualified only for typical durations of six hours or less, 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)

Division of Cardiovascular & Respiratory Devices
510(k) Number K011838

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use