The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy™/ECC.OTM for for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the SS firmware versions of 3.0. or greater) and the Stöckert Air Purge Control (APC) System.

The SCP Plus 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 SCP Plus System is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the S5 firmware versions of 3.0. or greater) and with the Stöckert Air Purge (APC) System. The System consists of the drive unit, a mounting receptacle for the pump head, a retaining key, splash protection, and a 3-joint mast holder with fast clamp connector.

The Stöckert Centrifugal Pump (SCP) Plus System consists of hardware, firmware, and electronics that are used to drive the centrifugal pump for surgical procedures requiring cardiopulmonary bypass for typical durations of six (6) hours or less. The SCP drive unit uses magnetic coupling with the centrifugal pump.

AI/ML Overview

This document describes the acceptance criteria and accompanying study for the Sorin Group Deutschland GmbH Stöckert Centrifugal Pump (SCP) Plus System.

No information regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or training set details is available in the provided text, as this is a traditional 510(k) for a medical device (a pump), not an AI/ML-driven device.

1. Acceptance Criteria and Reported Device Performance

The SCP Plus System was evaluated against prospectively defined performance criteria. The document states that the device's performance characteristics remain unchanged from its predicate device (K091008). Therefore, the acceptance criteria are implicitly tied to maintaining the established performance and safety standards of the predicate device.

Acceptance Criteria Category	Reported Device Performance
Safety	Tested in accordance with IEC60601-1 (with National Deviations), demonstrating safety.
Electromagnetic Compatibility (EMC)	Tested in accordance with IEC60601-1-2, demonstrating EMC compliance.
Performance	Fulfills prospectively defined functional acceptance tests and meets user needs. The system performs in an identical manner to the predicate device integrated with a different system (Sorin C5).
Intended Use Durations	Qualified for typical durations of six hours or less for cardiopulmonary bypass procedures.
Technological Characteristics	Identical in hardware, firmware, electronics, and components (drive unit, control panel, flow probe, emergency drive unit, flexible drive shaft, connection cables) to the predicate device (K091008).

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

The provided document does not specify a "test set" in the context of diagnostic performance evaluation with a defined sample size for images or patient data. This is a submission for a physical medical device (a pump), not a diagnostic algorithm.

The testing conducted was primarily non-clinical performance testing (safety, EMC, functional acceptance tests) of the physical device and its components. The document does not describe any studies involving human subjects or data derived from patients.

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

This section is not applicable as the document does not describe a "test set" requiring ground truth established by experts (e.g., radiologists, pathologists). The evaluation focused on engineering and performance criteria for a physical pump.

4. Adjudication Method for the Test Set

This section is not applicable as there was no test set requiring expert adjudication.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The provided text describes a 510(k) submission for a physical medical device (a centrifugal pump), not an AI/ML-driven diagnostic or assistive tool. Therefore, there is no mention of human readers improving with or without AI assistance.

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

No, a standalone performance study (in the context of an algorithm) was not done. The device is a physical pump designed to operate within a cardiopulmonary bypass circuit, and its performance is assessed through engineering and functional tests, not as an "algorithm only."

7. The Type of Ground Truth Used

For the non-clinical performance testing, the "ground truth" was established by:

Compliance with international and national standards (IEC60601-1 for safety, IEC60601-1-2 for EMC).
Adherence to formal prospectively defined functional acceptance test specifications.
Meeting user needs and performance identical to the predicate device.

There was no "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy, as this is not a diagnostic device.

8. The Sample Size for the Training Set

This section is not applicable. The SCP Plus System is a hardware device with firmware, not a machine learning model, so there is no concept of a "training set" for an algorithm.

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

This section is not applicable for the same reasons as above.

Summary

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510(k) Summary for the Sorin Group Deutschland GmbH Stöckert Centrifugal Pump (SCP) Plus System

(21 CFR 807.92 and http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.html

1. SPONSOR/APPLICANT

Sorin Group Deutschland GmbH

Lindberghstrasse 25 D የብባንስ Mi

D-80939 Munich
Germany
Contact Person:	Renate Goebert
Telephone:	011 +49 (0)89 323 01 153

Date Prepared: January 17, 2011

2. DEVICE NAME

Proprietary Name:	Stöckert Centrifugal Pump (SCP) Plus System
Common/Usual Name:	Cardiopulmonary bypass centrifugal pump
Classification Name:	Cardiopulmonary bypass speed control device (21 CFR 870.4380: Product Code: DWA)

3. PREDICATE DEVICE/S

Stöckert Centrifugal Pump (SCP) Plus System K091008 ●

4. DEVICE DESCRIPTION

Physical description .

How the device functions .

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Scientific concepts that form the basis for the device .

The SCP Plus System with the loaded single use and disposable centrifugal pump recirculates the contents of the extracorporeal circuit during cardiopulmonary bypass.

Significant physical and performance characteristics of the device, such as . device design, material used, and physical properties The design, materials, and physical properties of the SCP Plus are unchanged from that already cleared by the FDA.

5. INTENDED USE/INDICATION FOR USE

The Stöckert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy™/ECC.OTM for speed controlled pumping through a cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the $5 firmware versions of 3.0. or greater) and the Stöckert Air Purge Control (APC) System.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE/S

The technological characteristics of the Stöckert Centrifugal Pump (SCP) Plus System described in this Traditional 510(k) Premarket Notification are identical to that reviewed by the FDA in K091008. They use the same hardware, firmware, and electronics as well as the same components including the drive unit, control panel, flow probe, emergency drive unit, flexible drive shaft, and connection cables.

7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

No comparative non-clinical testing served as the basis for substantial equivalence.

The Stöckert Centrifugal Pump (SCP) Plus System was tested in conjunction with the heart lung machine for safety in accordance with IEC60601-1 (with National

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Deviations), for electromagnetic compatibility in accordance with IEC60601-1-2, and performance according to a formal prospectively defined functional acceptance test. Testing of the Stöckert Centrifugal Pump (SCP) Plus System (hardware, firmware, and performance) has demonstrated that the Stöckert Centrifugal Pump (SCP) Plus System fulfills prospectively defined performance criteria and that the System meets user needs.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Formal clinical testing of the Stöckert Centrifugal Pump (SCP) Plus System has not been performed. Therefore, this section does not apply.

9. SUMMARY OF OTHER INFORMATION

No information other than that described was included in this 510(k).

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the non-clinical testing provided in this premarket notification, the Stöckert Centrifugal Pump (SCP) Plus System integrated with the Stöckert S5 performs in an identical manner as the System integrated with the Sorin C5 System, thus demonstrating that there are no differences and that the devices are substantially equivalent and perform in accordance with specifications and meets user needs.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a human figure or a bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sorin Group Deutschland GmbH c/o Ms. Rosina Robinson Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

JAN 2 0 201

Re: K103468

Trade/Device Name: Stöckert Centrifugal Pump (SCP) Plus System (SCP Plus) Regulation Number: 21 CFR 870.4380 Regulation Name: Cardiopulmonary bypass pump speed control Regulatory Class: II Product Code: DWA Dated: November 24, 2010 Received: November 24, 2010

Dear Ms. Robinson:

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 includions for use stated in the enclosure) to legally marketed predicate devices marked 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, Dr to 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, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract lightlity warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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Page 2 -- Ms. Rosina Robinson

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutlFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

una R. b. Auner

^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 Statement

510(k) Number (if known): K103468

Stöckert Centrifugal Pump (SCP) Plus System Device Name:

Indications for Use:

The Stockert Centrifugal Pump System is a cardiopulmonary bypass speed control device (21CFR 870.4380) that is indicated for use with the Cobe Revolution® Pump Head/Dideco Synergy™/ECC.OTM for for speed controlled pumping through ଥ cardiopulmonary bypass circuit for typical durations of six hours or less. The SCP Plus is intended for use as a component part of or optional accessory to the S3 and S5 System (or any compatible system using the SS firmware versions of 3.0. or greater) and the Stöckert Air Purge Control (APC) System.

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)

uma R. V. hner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K103468

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).