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.

Device Description

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.

AI/ML Overview

The provided document, K020571 for the Stöckert Centrifugal Pump Console, describes performance testing but does not explicitly detail acceptance criteria in a quantitative table or the specific results against such criteria for the device itself. Instead, it broadly states that testing was performed to confirm that the proposed SCPC System performed as designed and met user requirements.

The document outlines the types of testing performed rather than specific performance metrics against pre-defined acceptance thresholds.

Re-interpreting for Acceptance Criteria and Study Information:

Given the nature of the device (a cardiopulmonary bypass system console) and the information provided, the "acceptance criteria" can be inferred to be compliance with relevant standards and successful functionality as per design specifications and user requirements. The "study" refers to the performance testing conducted.

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria Category (Inferred)	Reported Device Performance (From Section 7: "PERFORMANCE TESTING")
Electrical Safety	Conformance with appropriate standards.
Electromagnetic Compatibility (EMC)	Conformance with appropriate standards.
Functional Performance	Performed as designed and met user requirements.
Hardware Testing	Performed as designed and met user requirements.
Software Testing	Performed as designed and met user requirements.
Validation Testing	Confirmed the system performed as designed and met user requirements.
Compatibility with Stöckert CAPS (K863541)	Demonstrated compatibility.
Compatibility with Stöckert S3	Demonstrated compatibility.
Compatibility with COBE® Century™ (K960974) HLM consoles	Demonstrated compatibility.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated. The document refers to "testing" performed, which generally implies a test set of devices or scenarios, but no specific numbers are given for units tested or duration of tests beyond the "typical durations of six hours or less" for use.
Data Provenance: Not explicitly stated, but based on the manufacturer's location (Munich, Germany) and the regulatory submission to the FDA (USA), the testing was likely conducted in a controlled environment, potentially in Germany, for submission to US regulatory bodies. The nature of the device suggests in-vitro testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable and hence not provided in the document. This device is a medical instrument console, not an AI/diagnostic software. "Ground truth" in the context of expert consensus or pathology is typically relevant for diagnostic devices or AI algorithms. The "ground truth" for this device would be its adherence to engineering specifications and regulatory standards, evaluated by engineers and regulatory compliance experts.

4. Adjudication method for the test set:

Not applicable as this is not a diagnostic device involving human interpretation requiring adjudication. Performance was assessed against engineering and regulatory standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a physical medical instrument (a pump console), not an AI-assisted diagnostic or interpretive system. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a hardware console with integrated software, not a standalone algorithm. Its performance is assessed as an integrated system.

7. The type of ground truth used:

The "ground truth" for this device is its adherence to:
- Engineering specifications and design requirements: The device was tested to confirm it "performed as designed."
- User requirements: Confirmed it "met user requirements."
- Regulatory standards: Demonstrated "conformance with the appropriate standards" for electrical safety and EMC.
- Compatibility: Demonstrated successful interaction with other specified heart-lung machine consoles.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set in the conventional sense. The "training" for such devices involves design, prototyping, and testing phases to ensure functionality, not data-driven model training.

9. How the ground truth for the training set was established:

Not applicable for the same reasons as point 8.

Summary

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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: 011 49 89 323 01100 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: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.

. 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 (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. 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:

(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

Regulation Number and Section

§ 870.4220 Cardiopulmonary bypass heart-lung machine console.

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