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

AI/ML Overview

1. Acceptance Criteria and Reported Device Performance

Characteristic	Acceptance Criteria (from predicate devices)	Reported Stöckert Centrifugal Pump Performance
RPM Range	0-4500 RPM (Medtronic) / 0-5000 RPM (Jostra)	0-3500 RPM
RPM Accuracy	Not specified (Medtronic) / ±20 RPM (Jostra)	±10%
RPM Display Resolution	Not specified (Medtronic) / 10 RPM (Jostra)	1 RPM
LPM Range	-2 to 9.99 LPM (Medtronic) / 0 to 9.9 LPM (Jostra)	-10 LPM to +10.0 LPM
LPM Accuracy	Not specified (Medtronic) / 0.1 LPM (Jostra)	±10% or 0.1 LPM, whichever is greater
LPM Resolution	Not specified (Medtronic) / 0.01 LPM (Jostra)	0.01 LPM (Flow > 0) / 0.1 LPM (Flow < 0)

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "functional acceptance testing," "electrical/mechanical safety (IEC60601-1)," "electromagnetic compatibility (IEC60601-1-2)," "software verification and validation," "ship testing," and "battery life." These are typically engineering and bench tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the 510(k) summary. The performance testing focuses on technical and safety specifications rather than clinical evaluations requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. Given the nature of the tests mentioned (functional, electrical/mechanical safety), an adjudication method as typically understood for clinical data (e.g., 2+1) would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications and performance testing, not on measuring the improvement of human readers with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the performance testing outlined (functional acceptance testing, electrical/mechanical safety, etc.) can be considered standalone testing of the device's capabilities without human intervention beyond operating the device for the tests. The device is a "speed control device" for a pump, implying its core function is autonomous control based on its programming and sensors.

7. The Type of Ground Truth Used

The ground truth for the performance testing would be established by the functional specifications and engineering standards for each test (e.g., expected RPM, current draw, flow rate). For instance, for RPM accuracy, the ground truth would be the actual RPM measured by highly accurate instruments. For safety tests, the ground truth would be compliance with relevant IEC standards.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to this device as it is not an AI/machine learning product that learns from data. It is a control device for a mechanical pump, and its functionality is based on fixed algorithms and hardware.

9. How the Ground Truth for the Training Set Was Established

As there is no training set in the context of AI/ML, this question is not applicable. The device's operation is predetermined by its design and programming, rather than learned from a dataset.

Summary

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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: 011 49 89 323 010 011 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 .

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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	StöckertCentrifugalPump	MedtronicBIO-MEDICUS540/550	JostraRotaFlow
Indications for Use: Speed controlled pumpingthrough the cardiopulmonary bypass circuit fordurations 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 inHLM 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	StöckertCentrifugalPump	MedtronicBIO-MEDICUS540/550	JostraRotaFlow
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 +10.0LPM	-2 to 9.99 LPM	0 to 9.9 LPM
LPM Accuracy	$ \pm 10% or 0.1 $LPM, whicheveris greater	Not specified	0.1 LPM
LPM Resolution	0.01 LPM(Flow > 0)0.1 LPM(Flow < 0)	Not specified	0.01 LPM
Controls and Displays
RPM Control Method	incrementalshaft encoder	potentiometer	potentiometer
LPM Control	Yes, inAutoFlow Mode	No	Yes, inLPM ControlMode
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 sourcefrom HLM	Yes,internal probe	No
Other displays	$-$	2 Timers	$-$
Level and Air Bubble Monitoring	Yes	No	Yes
Safety Features
Low RPM protection	software detentLow RPM enableby key stroke	mechanical detentLow RPM enableby depressing thespeed controlknob	No detentLow RPM Alarm
Adjustable Alarms	High Flow,Low Flow,Negative Flow	Low Flow,High Flow	Low Flow,Low RPM,High RPM
Runaway Protection	Yes, at 1000 RPMhigher	No	Yes, at 20%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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

(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)

Over-The-Counter Use

Regulation Number and Section

§ 870.4380 Cardiopulmonary bypass pump speed control.

(a)
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.(b)
Classification. Class II (performance standards).