The Stöckert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

Device Description

The Stöckert SCP Rhythm is a modification of the S3 Cyclic RPM Control Module. The modifications consist of two changes: ( 1 ) a change to the artwork of the display panel to show SCP Rhythm rather than Cyclic RPM Control and (2) firmware and software modifications. No modifications are being made to the hardware or electronics of any of the components. The Stöckert SCP Rhythm is intended for use with the SCP System as mounted on an S3 Cardiopulmonary Bypass Console.

AI/ML Overview

Here's an analysis of the provided text regarding the Stöckert SCP Rhythm device, focusing on the requested information about acceptance criteria and the supporting study:

Important Note: The provided text is a 510(k) summary for a device modification, focusing on establishing substantial equivalence to a predicate device. It explicitly states: "Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness."

However, this type of summary does not typically include detailed performance study results or acceptance criteria in the format you've requested for AI/medical imaging devices. The "testing provided in the 510(k)" would ordinarily be in a separate, more comprehensive test report that is referenced but not fully detailed in the 510(k) summary itself. The text provided is a high-level regulatory document.

Therefore, many of the specific details you've asked for (like a table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, MRMC studies, standalone performance, and ground truth specifics) are not present in this document. The document mainly focuses on the nature of the modification and the claim of substantial equivalence based on underlying verification and validation.

Despite the limitations of the provided text, I will address each of your points based on what can be inferred or what is explicitly stated:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in this document. The document claims the device "complies with specifications" and "meets user requirements."	Not explicitly stated in this document. The document implies successful performance through general statements of compliance and equivalence.

Explanation: The 510(k) summary does not list specific numerical performance metrics or acceptance thresholds. It broadly states that the modifications (artwork, firmware, and software) were "verified and validated" to ensure compliance with specifications and user requirements, and that they "do not raise new issues of safety or effectiveness." This suggests that the device performs as intended and similarly to its predicate, but no quantitative performance data is provided here.

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

Sample Size for Test Set: Not specified in this document.
Data Provenance (e.g., country of origin, retrospective or prospective): Not specified in this document.

Explanation: The document mentions "testing provided in the 510(k)," but it doesn't detail the methodology, sample sizes, or type of data used for that testing. Given it's a modification to a mechanical/electronic control system, the "testing" would likely involve engineering verification and validation (e.g., functional tests, electrical safety, software validation) rather than clinical data from patients in the way an AI diagnostic device would.

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

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified.

Explanation: This type of information (experts, ground truth) is typically relevant for diagnostic devices, especially those using AI to interpret medical images or signals where human expert consensus or pathology is used as the reference standard. For a device like the Stöckert SCP Rhythm, which is an accessory controlling cyclic RPM for a cardiopulmonary bypass pump, the "ground truth" would be established through engineering specifications, functional testing, and safety parameters—not through expert clinical interpretation of outputs.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/Not specified.

Explanation: Similar to point 3, adjudication methods (like 2+1, 3+1 consensus) are used when there is subjective interpretation involved, usually in diagnostic image or signal analysis to establish a definitive "ground truth." This is not relevant for the functional testing of a pump control accessory.

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

MRMC Study: No.
Effect Size of Human Readers Improvement: Not applicable.

Explanation: MRMC studies are used to assess the impact of a diagnostic aid (e.g., AI) on human reader performance. The Stöckert SCP Rhythm is a device controlling a pump's cycling, not a diagnostic tool that humans read or interpret. Therefore, an MRMC study is not relevant or applicable for this device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Standalone Study: The verification and validation mentioned ("verified and validated the device modifications") would constitute "standalone" testing of the device's functionality. However, it's not a "standalone algorithm performance" study in the context of AI.

Explanation: For a mechanical/software control system, "standalone" performance is its inherent functional operation according to its design specifications. The 510(k) summary implies that such testing was performed to demonstrate that the device functions correctly on its own and in conjunction with the S3 Cardiopulmonary Bypass Console. The text does not detail the specifics of this testing (e.g., specific parameters measured, test environments).

7. The Type of Ground Truth Used

Type of Ground Truth: Engineering specifications, functional requirements, and safety parameters.

Explanation: For this device, "ground truth" refers to the established engineering design parameters, performance specifications (e.g., accuracy of RPM control, cyclical nature of delivery), and safety standards the device must adhere to. The "testing provided in the 510(k)" would have compared the device's actual performance against these predefined technical and functional requirements.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable.

Explanation: This device is a control system with firmware and software; it's not described as an AI/machine learning device that would require a "training set" in the conventional sense for a diagnostic algorithm. The software modifications would have been developed via standard software engineering practices (requirements, design, coding, testing) rather than machine learning training.

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

Ground Truth for Training Set: Not applicable.

Explanation: As explained in point 8, there's no mention or indication of a "training set" for an AI/ML model for this device. The "ground truth" for the software's functionality would stem from its detailed design specifications and requirements.

Summary

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SEP 2 3 2004

04237

Special 510(k): Device Modification 510(k) Summary for Stöckert SCP Rhythm

1. SPONSOR

Stöckert Instrumente GmbH Lindberghstrasse 25 80939 Munich Germany

Helmut Hofl, Director, Quality Assurance and Regulatory Affairs Contact: Telephone: 011 49 89 323 010 011 49 89 323 01100 Facsimile:

Date Prepared: August 31, 2004

2. DEVICE NAME

Stöckert SCP Rhythm Proprietary Name: Common/Usual Name: Cyclic RPM Control Accessory to cardiopulmonary bypass console Classification Name:

3. PREDICATE DEVICE

Stöckert S3 Cyclic RPM Control Module (K971520)

4. DEVICE DESCRIPTION

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న. INTENDED USE

The Stockert SCP Rhythm is an accessory to the S3 Cardiopulmonary Bypass Console that allows for cyclically controlled delivery of blood with the Stöckert SCP during cardiopulmonary bypass for periods of up to six hours.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

The proposed Stöckert SCP Rhythm is identical in intended use and fundamental scientific technology to the parent Stöckert S3 Cyclic RPM Control. The differences between the proposed and parent device are limited to the display panel and firmware/software. Stöckert Instrumente GmbH has verified and validated the device modifications and has demonstrated, through the testing provided in the 510(k), that the Stöckert SCP Rhythm complies with specifications, meets user requirements, and the differences between the parent and the proposed device do not raise new issues of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or waves.

Public Health Service

SEP 2 3 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Medical Device Consultants, Inc. c/o Ms. Rosina Robinson Senior Staff Consultant 49 Plain Street North Attleborn, MA 02760

Re: K042374 Stöckett SCP Rhythm Regulation Number: 21 CFR 870.9380 Regulation Name: Cardiopulmonary Bypass Pump Speed Control Regulatory Class: Class II (two) Product Code: DWA Dated: August 31, 2004 Received: September 1, 2004

Dear Ms. Robinson:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encrosule) to trgans actment date of the Medical Device Amendments, or to commerce pror to thay 2017 3, in accordance with the provisions of the Federal Food, Drug, devices that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controlly proficions or actice, 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 If your device is classified (600 a00 rols. Existing major regulations affecting your device can may be subject to back adder and 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 - Ms. Rosina Robinson

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. 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) you may obtain. 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,

onner R. Vochner

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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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Indications for Use

510(k) Number (if known): Ko 42 3 7 4

Device Name: Stöckert SCP Rhythm

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duma R. Wchines

(Division Sign-Off) (Division Sign-on)
Division of Cardiovascular Devices

510(K) Number Kodz 274

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).