The Stöckert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a cardiopulmonary bypass speed control device that is indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP System TC 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.

The SCP System TC controls a Tubing Clamp that is positioned at the pump outlet to occlude the arterial line if the reservoir blood level, microbubble activity, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure.

Device Description

The Stockert Centrifugal Pump System with Tubing Clamp (SCP System TC) is a modification of the Stöckert Centrifugal Pump (SCP). The proposed SCP System TC is identical in intended use and fundamental scientific technology to the parent SCP. The parent SCP is identical to the proposed SCP System TC with the exception of the addition of an Electrical Remote-Controlled Tubing Clamp (Tubing Clamp) that is positioned at the pump outlet to occlude the arterial line. The Tubing Clamp is designed to automatically close if the reservoir blood level, microbubble activity, flow rate, or retrograde flow in the extracorporeal circuit reaches alarm levels during a cardiopulmonary bypass procedure. The Tubing Clamp can also be manually opened and closed by the operator via membrane keys on the SCP Pump Control Panel.

The proposed Tubing Clamp is connected to the Stöckert Centrifugal Pump Console (SCPC System) or a Stöckert Compact (SC) or Stöckert S3 System (S3) heart-lung machine console via a CAN/24V connection cable. Mains power and emergency power is provided by the connected SCPC System or SC/S3 System. Both automatic and manual operation of the clamp is controlled via the SCP System microprocessor control system.

AI/ML Overview

Given the provided text, here's a breakdown of the acceptance criteria and the study information for the Stöckert Centrifugal Pump System with Tubing Clamp:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Safety	Electrical Safety	Conforms to appropriate standards
Safety	Electromagnetic Compatibility	Conforms to appropriate standards
Functionality	Tubing Clamp performs as designed	Functional acceptance testing performed
Functionality	Meets user requirements	Validation testing performed
Software	Software testing	Performed
Hardware	Hardware testing	Performed

Note: The document states that the addition of the Tubing Clamp represents a "minor design change that raises no new issues of safety or effectiveness." This implies the existing safety and effectiveness criteria for the predicate Stöckert Centrifugal Pump (K011838) were considered applicable and met. The "acceptance criteria" themselves are broadly defined by the performance tests conducted.

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

The provided text does not specify a sample size for any clinical or in-vitro test set in the conventional sense (e.g., number of patients, number of test runs).

The study described is focused on the device's functional integrity rather than performance on a biological sample.

Data Provenance: Not applicable as the testing described is primarily engineering and functional validation.

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

Not Applicable. The text describes engineering and functional testing ("Functional acceptance testing, hardware and software testing, and validation testing"). There is no mention of human experts establishing ground truth in the context of clinical or diagnostic performance for the described modifications.

4. Adjudication Method for the Test Set

Not Applicable. As the testing was primarily functional and engineering-based, there is no mention of an adjudication method typical for clinical or diagnostic studies requiring expert consensus.

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

No, an MRMC comparative effectiveness study was not done. The device in question is a medical pump system with an added tubing clamp, not an AI-assisted diagnostic or decision-support system. Therefore, AI is not involved, and human reader performance improvement is not relevant to this submission.

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

Not Applicable. This device is a physical mechanical system, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not relevant. The functional tests described are essentially "standalone" in that they test the device's inherent operation.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing described is the design specifications and user requirements for the Tubing Clamp and the system. The tests confirmed that the device performed as designed and met these predefined requirements.

8. The Sample Size for the Training Set

Not Applicable. This device is a mechanical system, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of machine learning.

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

Not Applicable. As there is no training set for a machine learning algorithm, there is no "ground truth for the training set" to be established.

Summary

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K032213

AUG 2 9 2003

Special 510(k): Device Modification 510(k) Summary for Stöckert Centrifugal Pump System with Tubing Clamp

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 18, 2003

2. Device Name

Stöckert Centrifugal Pump System with Tubing Clamp Proprietary Name: Common/Usual Name: Centrifugal pump Classification Name: Cardiopulmonary bypass speed control device

3. Predicate Devices

Stöckert Centrifugal Pump (K011838) ●
Automatic Tubing Clamp Safety System (ATC) (K961364) ●

Device Description 4.

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opened and closed by the operator via membrane keys on the SCP Pump Control Panel.

INTENDED USE 5.

Both the proposed SCP System TC and the parent SCP System are cardiopulmonary bypass speed control devices indicated for speed-controlled pumping through the cardiopulmonary bypass circuit for typical durations of six hours or less. Neither the proposed or parent SCP has 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.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

As stated earlier, the proposed SCP System TC is identical in intended use and fundamental scientific technology to the parent SCP System. The modifications made to the parent SCP System to produce the proposed SCP System TC are limited to the addition of the Tubing Clamp that is positioned at the pump outlet to occlude the arterial line.

The ATC tubing clamps automatically close on the cardiopulmonary bypass circuit tubing when alarm limits for microbubble activity or retrograde flow reaches set levels. There is also a mechanism for manual override. However, the predicate ATC is a stand-alone device containing a power source, air and flow detection units, user interface, and control elements in addition to the tubing clamps.

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The addition of the Tubing Clamp to the SCP represents a minor design change that raises no new issues of safety or effectiveness. Therefore Stöckert Instrumente GmbH believes that the SCP System TC is substantially equivalent to the SCP.

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 Tubing Clamp performs as designed and met user requirements.

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Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized lines representing its wings or feathers. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 9 2003

Mr. Helmut Hofl Director, Quality Assurance & Regulatory Affairs Stockert Instrumente GmbH Lindberghstrasse D-80939 Muenchen Germany

Re: K032213

Stockert Centrifugal Pump System with Tubing Clamp Regulation Number: 21 CFR 870.4360 Regulation Name: Control, Pump Speed, Cardiopulmonary Bypass Regulatory Class: Class II (two) Product Code: DWA Dated: July 18, 2003 Received: July 21, 2003

Dear Mr. Hofl:

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.

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Page 2 - Mr. Helmut Hofl

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 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Glazer Olay for

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): Ko32213

Device Name: Stöckert Centrifugal Pump System with Tubing Clamp

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 Devices
510(k) Number K032243

Prescription Use
(Per 21 CFR 801.109) X

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Stöckert Instrumente GmbH Special 510(k) SCP System with Tubing Clamp

July 18, 2003

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).