The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview of all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation, and are not intended for making clinical decisions for diagnosis.

Device Description

The Stöckert Interface Module IDDD is an addition to the Stöckert S3 heart lung machine (K950990) and the SC heart lung system (K982014), which were both previously cleared for marketing. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The Interface Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.

AI/ML Overview

The provided text describes the Stöckert Instrumente Interface Module IDDD, an accessory to cardiopulmonary bypass heart-lung machines. The document focuses on its substantial equivalence to predicate devices and testing performed to ensure its safety and functionality.

Here's an analysis of the acceptance criteria and study information contained in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical Safety (IEC 60601-1)	Performed using both SC and S3 Systems with IDDD installed.
Functional Safety (IEC 60601-1)	Performed using both SC and S3 Systems with IDDD installed.
Electromagnetic Compatibility (Emissions and Immunity)	Conducted on the STÖCKERT S3 Perfusion System with all components and accessories, including IDDD, during operation in no-load and full-load states.
EMI/EMC Pass Criteria:
No pump stops	Met
No pump runaway	Met
No sensor alarms	Met
Stable displayed values	Met
Correctly functioning IDDD after testing	Met
Impact on SC and S3 heart-lung system functions (safety critical pump functions)	Tested to show correct functioning with the IDDD Module in place.
CAN message acceptance (Code Inspection of CAN receivers)	Code inspection showed that CAN messages from the IDDD are only accepted by the CDM (set messages) and by IDDD modules themselves (data messages). IDDD messages are not accepted by other CAN receivers.

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

The document does not explicitly state a "sample size" in the conventional sense for a test set of data. Instead, the testing involved:

Physical Devices: Stöckert S3 System, SC heart-lung system, and an Interface Module IDDD installed in each.
Operating Conditions: No-load and full-load states for EMI/EMC testing, with pump heads running at 100 RPM.

The data provenance is not specified, but given the manufacturer (Stöckert Instrumente GmbH, Munich, Germany) and the testing descriptions, it can be inferred that the testing was conducted prospectively by the manufacturer. No information regarding country of origin of "data" is provided, as the "data" being evaluated is the device's operational performance, not clinical or diagnostic data.

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

This information is not provided in the document. The testing described is primarily engineering and safety testing, not diagnostic performance evaluation requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided in the document. Adjudication methods are typically used in clinical studies where disagreement among experts needs resolution to establish ground truth for classification or diagnostic tasks. The described tests are objective pass/fail criteria based on device functionality and safety 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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices that assist human readers. The Interface Module IDDD is an accessory for data output and documentation, not an interpretive or diagnostic AI tool.

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

Yes, in essence, standalone testing was performed. The described electrical safety, functional safety, and EMI/EMC tests evaluate the device's performance independently of human interaction beyond setting up and operating the system for the test. The "algorithm" here refers to the device's internal logic for data transfer and processing. The tests establish that the device operates correctly on its own and does not interfere with the primary heart-lung machine functions.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is primarily engineering specifications, safety standards (IEC 60601-1), and functional requirements. For example:

Electrical Safety: Compliance with IEC 60601-1.
Functional Safety: Correct operation of safety-critical pump functions.
EMI/EMC: No pump stops, no pump runaway, no sensor alarms, stable displayed values, and correctly functioning IDDD.
CAN Message Acceptance: Only specified messages are accepted by respective modules.

These are objective, measurable outcomes directly related to the device's design and intended function, rather than subjective interpretations like pathology results or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

This information is not applicable and therefore not provided. The Interface Module IDDD is a hardware accessory for data transfer, not an AI or machine learning model that requires a "training set" of data.

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

This information is not applicable and therefore not provided, as there is no training set for this type of device.

Summary

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DEC 2 0 1999

K992635

Special 510(k) Summary Stöckert Instrumente Interface Module IDDD

SPONSOR/APPLICANT NAME, ADDRESS, TELEPHONE NUMBER 1.

Stöckert Instrumente GmbH Lilienthalalee 5-7 D-80939 Munich Germany

Contact Person: Helmut Höfl

August 5, 1999 Date of Summary Preparation:

2. DEVICE NAME

Proprietary Name:	Interface Module IDDD
Common/Usual Name:	Interface Module
Classification Name:	Accessory to Cardiopulmonary bypass heart lung machine

3. IDENTIFICATION OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) TO WHICH EQUIVALENCE IS BEING CLAIMED

Stöckert S3 Heart Lung Machine (K950990) Stöckert SC Heart Lung System (K982014) Stöckert-Shiley HLM Interface Module (K983541)

4. DEVICE DESCRIPTION

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Module IDDD is installed into the Electronics and Power Supply Pack (E/P) of the S3 or the Sensor Module Rack of the SC. A CAN bus system manages the data transfer.

5. INTENDED USE

The Stöckert S3 heart lung machine and the SC heart lung system are integrated heart lung machines for cardiopulmonary bypass. The Interface Module IDDD provides serial data output from the Stöckert S3 and SC Heart Lung Machines for recording data on an external PC or other recording devices. Serial output information from external devices like blood gas analyzers or patient monitors can also be input to the Interface Module IDDD to be passed through to the serial output. The output protocol provides a complete overview on all relevant data obtained from the heart lung machine as well as from external devices. The serial output data are intended for procedure documentation and are not intended for making clinical decisions for diagnosis.

A STATEMENT OF HOW THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE 6. COMPARE TO THOSE OF THE PREDICATE OR LEGALLY MARKETED DEVICE(S) CITED

The S3 and SC Interface Module IDDD is substantially equivalent to the HLM Interface Module of the Stöckert-Shiley CAPS System, in that they are both intended to link a heart lung machine to user-selected, peripheral instruments, allowing data to be displayed on the DMS software or recorded and displayed on a user-selected PC (not provided).

The STÖCKERT Interface Module IDDD and the HLM Interface Module of the Stöckert-Shiley CAPS System both feature a module that gathers and processes data delivered not only from the heart lung machine module but also from other instruments such as patient monitors or blood gas analyzers. Using the DMS Software or in the case of the CAPS machine, specially designed perfusion software, the perfusionist can record the course of perfusion.

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7. TESTING:

All electrical testing, including electrical safety and electromagnetic compatibility was conducted on the Stöckert S3 System with an Interface Module IDDD installed.

Testing for electrical safety and functional safety (according to IEC 60601-1) was performed using both SC and S3 Systems with an Interface Module IDDD installed. Testing for electromagnetic compatibility (emissions and immunity) was conducted on the STÖCKERT S3 Perfusion System with all S3 System components and accessories in place on the console including the Interface Module IDDD, during operation in no-load and full-load states.

During EMI/EMC testing, all pump heads were running at 100 RPM. The S3 System was connected to the AC line. The Interface Module IDDD passed the EMI/EMC testing. The pass criteria consisted of no pump stops, no pump runaway, no sensor alarms, stable displayed values and a correctly functioning IDDD after testing.

Testing was performed to determine if the functions of the SC and S3 heart-lung systems are affected by the addition of the Interface Module IDDD. The testing was performed, in part, to show that the safety critical pump functions worked correctly with the IDDD Module in place. The second part of the test consisted of a code inspection of all CAN receivers to determine that the filters only accept the CAN messages specified for the respective module. The code inspection showed that CAN messages from the IDDD are only accepted by the CDM (set messages) and by IDDD modules themselves (data messages). IDDD messages are not accepted by other CAN receivers.

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Image /page/3/Picture/1 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 a stylized symbol of three human profiles facing right, with three horizontal lines above them, representing the concept of health and human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 20 1999

Stockert Instrumente C/O MDCI 49 Plain Street 02760 North Attleboro, MA Attn: Mary McNamara-Cullinane

K992635 Re: Interface Module IDDD Requlatory Class: II (two) Product Code: KRI, DTQ Dated: December 3, 1999 Received: December 6, 1999

Dear Ms. McNamara-Cullinane:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Paqe 2 - Ms. Mary McNamara-Cullinane

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

sincerely yours,

Carl Bute & Campbell

Celia M. Witten, Ph.D., M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K 992635

Device Name: Stöckert Instrument Interface Module IDDD

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 Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number __ 19921

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

Regulation Number and Section

§ 870.4200 Cardiopulmonary bypass accessory equipment.

(a)
Identification. Cardiopulmonary bypass accessory equipment is a device that has no contact with blood and that is used in the cardiopulmonary bypass circuit to support, adjoin, or connect components, or to aid in the setup of the extracorporeal line, e.g., an oxygenator mounting bracket or system-priming equipment.(b)
Classification. (1) Class I. The device is classified as class I if it does not involve an electrical connection to the patient. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.(2) Class II (special controls). The device is classified as class II if it involves an electrical connection to the patient. The special controls are as follows:
(i) The performance standard under part 898 of this chapter, and
(ii) The guidance document entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 870.9.