The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.

Device Description

The Stöckert APC System consists of the APC sensor module (Catalog Number: 23-45-22), 3-joint mast holder with fast clamp connectors for two bubble sensors, 420mm (Catalog Number: 23-26-96), bubble sensor for 3/8 inch tubing (Catalog Number: 23-07-50), and ultrasonic gel, bottle, 250 mL (Catalog Number: 96-06-10). All of these components are identical to those used with the Stöckert S5 System (K091008).

The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.

The Stöckert APC bubble trap is placed just before the venous bubble trap of the Synergy™/ECC.OTM. When bubble activity is sensed, the assigned roller pump on the heart lung machine console begins operation to remove a set tubing volume (as determined by tubing size and pump speed (RPM)) or to run for a set time (in seconds) at a perfusionist-selected flow rate. This fluid is pumped into an appropriate blood collection reservoir. The technology of the Stöckert APC is based on the technology of the Stöckert Air Purge Control System (K041558).

The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Stöckert Air Purge Control (APC) System:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a detailed "reported device performance" against specific metrics. Instead, it makes a general statement about the device fulfilling "prospectively defined functional acceptance test" criteria.

Acceptance Criterion (Implicit)	Reported Device Performance
Safety (electrical and mechanical)	Fulfills IEC60601-1 (with National Deviations)
Electromagnetic Compatibility (EMC)	Fulfills IEC60601-1-2
Functional Performance (air detection and removal)	Fulfills prospectively defined functional acceptance test and simulated use/in-use validation testing. The System performs in an identical manner as the System integrated with the Sorin C5 System. Meets user needs.
Substantial Equivalence with predicate device (K091007)	Identical hardware, firmware, electronics, and components. Performs the same function (detecting and removing air). Performance is unchanged when integrated with the heart lung machine.

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

The document does not specify a distinct "test set" in the sense of a dataset for evaluating an algorithm. The testing described is hardware and system validation.

Sample Size for Test Set: Not applicable as it's not a data-driven algorithmic evaluation. The testing involved the Stöckert APC System itself, integrated with a heart-lung machine.
Data Provenance: Not applicable. The testing was described as "non-clinical performance testing" and "simulated use/in-use validation testing" of the physical system, likely conducted internally by the manufacturer (Sorin Group Deutschland GmbH).

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

Not applicable. The ground truth for electrical safety, EMC, and functional performance would be established by engineering standards and internal testing protocols, not by expert consensus on a dataset.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human reader interpretation or diagnostic output that requires adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No. This device is a hardware system for detecting and removing air during cardiopulmonary bypass, not an AI or diagnostic imaging device that would involve human readers.

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

Yes, in a way. The "functional acceptance test and simulated use/in-use validation testing" evaluated the Stöckert APC System's performance in detecting air and initiating removal autonomously (which could be considered its "standalone" performance), even though it operates within the larger Stöckert S5 heart-lung machine system. The device's function is automated.

7. The Type of Ground Truth Used

The ground truth used for this type of device would be:

Engineering Standards: For electrical safety (IEC60601-1) and electromagnetic compatibility (IEC60601-1-2).
Physical Principles and Design Specifications: For the air detection and removal capabilities. The "prospectively defined functional acceptance test" would have protocols and metrics based on the expected physical behavior of the system (e.g., ability to reliably detect a certain volume of air, ability to remove air within a specified time).

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary

{0}------------------------------------------------

JAN 1 8 2011

510(k) Summary

for the Sorin Group Deutschland GmbH

Stöckert Air Purge Control (APC) System

(per 21 CFR 807.92 and Ittp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm)

1. SPONSOR/APPLICANT

Sorin Group Deutschland GmbH
Lindberghstrasse 25
80939 Munich
Germany
Telephone:	011-49 (0)89 323 01 152
Facsimile:	011-49(0)89 323 01 332
Contact:	Renate Goebert

Date prepared: January 13, 2010

2. DEVICE NAME

Proprietary Name:	Stöckert Air Purge Control (APC) System
Common/Usual Name:	Cardiopulmonary bypass bubble detector and sensor
Classification Name:	Cardiopulmonary bypass bubble detector (21 CFR 870.4205; Product Code: KRL)

3. PREDICATE DEVICES

Stöckert Air Purge Control (APC) System for S5 System Model 23-45-05 ● (K091007)
Stöckert Air Purge Control (APC) System (K041558) .

4. DEVICE DESCRIPTION

. Physical description

{1}------------------------------------------------

How the device functions .

The Stöckert APC can be operated automatically and manually using the APC displet of the heart lung machine.

Scientific concepts that form the basis for the device .

. Significant physical and performance characteristics of the device, such as device design, material used, and physical properties
The Stöckert APC is used for detecting air in the venous line and removing air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. Specifications are provided in the SCP Plus System/APC Operating Instructions.

5. INTENDED USE/INDICATION FOR USE

The Stöckert Air Purge Control (APC) System detects air in the venous line and removes air from the venous bubble trap of the Synergy™/ECC.O™ System tubing circuit. The Synergy™/ECC.O™ shall only be used in conjunction with the Stöckert S5 (or any compatible system using the S5 firmware versions of 3.0 or greater) and the SCP Plus System. The Stöckert S5 System is indicated for speed controlled pumping of blood through the cardiopulmonary bypass circuit for durations of six hours or less, left ventricular venting, cardiotomy suction and administration of cardioplegia solution.

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

The technological characteristics of the Stöckert APC System described in this Traditional 510(k) Premarket Notification are identical to that reviewed by the FDA in K091007. They use the same hardware, firmware, and electronics as well as components including the APC sensor module, the bubble sensors, and the 3-joint mast holder. Both Systems are used for detecting air in the venous line and removing it from the venous bubble trap of the Synergy/ECC.O System. The APC used with both heart lung machines is controlled via touchscreen and its performance is unchanged when integrated with the heart lung machine.

{2}------------------------------------------------

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 Air Purge Control (APC) System was tested in conjunction with the heart lung machine for safety in accordance with IEC60601-1 (with National Deviations), for electromagnetic compatibility in accordance with IEC60601-1-2, and performance according to a formal prospectively defined functional acceptance test and simulated use/in-use validation testing. Testing of the Stöckert Air Purge Control (APC) System (hardware, firmware, and performance) has demonstrated that the 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 Air Purge Control (APC) System has not been performed. Therefore, this section does not apply.

9. SUMMARY OF OTHER INFORMATION

No information other than that described was provided.

10. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTS

Based on the non-clinical testing provided in this premarket notification, the Stöckert Air Purge Control (APC) 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.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with stylized lines representing its wings and body. The image is in black and white.

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 1 8 201

Re: K103469

Trade/Device Name: Stöckert Air Purge Control (APC) System Regulation Number: 21 CFR 870.4205 Regulation Name: Cardiopulmonary bypass bubble detector Regulatory Class: II Product Code: KRL 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 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. Please note: CDRH does not evaluate information related to contract liability 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

{4}------------------------------------------------

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/About/DA/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/Resourcesfor You/Industry/default:htm.

Sincerely yours,

Bram D. Zuckerman, M.D.

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):

K103469

Device Name: Stöckert Air Purge Control System

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)

W.M.A.

510(k) Number K03469

Regulation Number and Section

§ 870.4205 Cardiopulmonary bypass bubble detector.

(a)
Identification. A cardiopulmonary bypass bubble detector is a device used to detect bubbles in the arterial return line of the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).