The Siemens Servo Ventilator 300 is intended for general and critical ventilatory care for use with neonatal, infant, pediatric, and adult patients The unit is designed to be used at the bedside and for in-hospital transport. It is not intended for transport use in ambulances or helicopters in the U.S. market.

The intended use of the Computer Interface Board Version 2 is the same as for the Computer Interface Board Version 1. The CI board stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces.

Device Description

The Servo Ventilator 300 and Computer Interface Version 2 is a modification of the Servo Ventilator 300 and Computer Interface Version 1 which was found Substantially Equivalent on June 26, 1991 (Premarket Notification K902859). These modifications are being made to update the hardware design and to make additional software features available, while retaining the original functionality.

The Servo Ventilator 300 Alarm and Monitoring Module has been modified to eliminate false or otherwise unnecessary alarms by eliminating the "Leakage Alarm" feature, and miscellaneous minor improvements to other alarm functions. This improves ease of use, and has the additional benefit of improving user vigilance when real alarms occur.

The Computer Interface, CI, is an accessory circuit board that interfaces the ventilator to an external information-gathering system, such as a personal computer, via asynchronous serial lines. Information, such as trend data, real time parameter values, and technical information, is transferred to the external system via different commands. The modifications in the Version 2 hardware improve reliability and manufacturing efficiency. The modifications in the Version 2 software allow the user to select from a wider variety of data channels and add the transmission of checksums to ensure data integrity.

AI/ML Overview

This 510(k) summary describes a ventilator and computer interface, not an AI/ML device, therefore, the requested information elements related to AI/ML device performance (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the study proving the device meets them for this traditional medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Safety	1. No reduction in patient safety due to alarm logic modifications (specifically, removal of "Leakage Alarm").2. Reduced risk of ventilator shutdown due to component failures on the Computer Interface Board.	1. The two circumstances triggering the predicate device's leakage alarm (gross leaks, malfunctioning flow transducer) will also trigger the expired minute volume alarm, thus "no reduction in patient safety from removing this alarm function."2. Hardware improvements to the Computer Interface Board "affect the safety and effectiveness of the Servo Ventilator 300 by reducing the risk of ventilator shutdown as a result of component failures on the Computer Interface Board."
Effectiveness/Functionality	1. Retain original functionality despite hardware/software modifications.2. Improve ease of use (related to alarm logic).3. Computer Interface to store and transmit information about the ventilator to external digital devices.4. Computer Interface to provide an expanded list of data items.	1. Modifications made "while retaining the original functionality."2. Alarm logic modifications "improves ease of use."3. Computer Interface (CI) "stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces."4. Software modifications "introduce new functions which provide the external data gathering system with an expanded list of data items that can be queried from the Servo Ventilator."
Performance (Technical)	1. Reliability improvements for both Servo Ventilator 300 and Computer Interface.2. Manufacturing efficiency improvements.3. Immunity to interference (for CI).4. Data integrity (for CI, via checksums).5. All alarm conditions simulated and output channels tested; tests passed according to criteria equal to or more stringent than predicate device.	1. Servo Ventilator 300 hardware modifications "improve reliability." CI hardware design changes "improve reliability."2. CI hardware design changes "simplify manufacturing."3. CI hardware design changes "increase immunity to interference."4. CI software modifications "add the transmission of checksums to ensure data integrity."5. "All alarm conditions were simulated and all output channels were tested... All tests were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device."
Substantial Equivalence	Device is "as safe and effective, and performs as well as or better than the predicate device."	"Analysis and testing have shown that... the modified device is as safe and effective, and performs as well as or better than the predicate device."

Study Proving Device Meets Acceptance Criteria

The study described is a non-clinical verification and validation study of the modified device, performed at the unit, integration, and system levels.

Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML device. For this traditional device, the "test set" consisted of various operational states and parameters of the ventilator itself. The data provenance refers to the simulated conditions and outputs generated within a controlled test environment.
- Data Provenance: The tests involved simulating "all alarm conditions" and a "range of ventilator operating states." This indicates a controlled, artificial generation of conditions within a lab setting to test the device's responses.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The "ground truth" for a mechanical/electronic device like a ventilator is its designed functionality and expected operational responses per engineering specifications, alarm thresholds, and data transmission protocols. These are established by engineering design and regulatory standards, not by expert consensus in the diagnostic sense.
Adjudication method for the test set: Not applicable. The testing described is objective and based on comparison of actual device outputs/behavior against predefined engineering specifications and the predicate device's performance.
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: Not applicable. This is a traditional medical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a ventilator, a physical system interacting with a patient, with software components. "Standalone performance" in the AI sense is not relevant. The "standalone" performance here refers to the device's inherent functionality without external systems, which was tested.
The type of ground truth used:
- Engineering Specifications/Design Requirements: The primary ground truth was the device's design specifications for functionality (e.g., alarm logic, data transmission), safety (e.g., no reduction in patient safety), and performance (e.g., reliability, immunity to interference, data integrity via checksums).
- Predicate Device Performance: The predicate device served as a baseline for "as safe and effective, and performs as well as or better than." The criteria for passing new tests were "equal or more stringent than the test criteria which were applied to the predicate device."
The sample size for the training set: Not applicable. This is a traditional medical device, not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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K 960010

OCT 25 1996 510(k) Summary for SERVO VENTILATOR 300 AND COMPUTER INTERFACE BOARD

DATE THIS SUMMARY WAS PREPARED: September 24, 1996 1.

2. SUBMITTER'S NAME AND ADDRESS

Siemens-Elema AB Röntgenvägen 2 S-171 95 Solna Sweden

3. CONTACT PERSON

Mr. Anders Lodin

Telephone 011-46 8 730 7228 Telefax 011-46 8 98 63 05

4. DEVICE NAME

Trade/Proprietary Name:	Servo Ventilator 300 and Computer Interface BoardVersion 2
Common Name:	Ventilator
Classification Name:	Ventilator, Continuous (Respirator)

5. PREDICATE DEVICES

The legally marketed devices to which equivalence is being claimed are:

Servo Ventilator 300 and Computer Interface Board Version 1, marketed . by Siemens-Elema.

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6. DEVICE DESCRIPTION

7. INTENDED USE

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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS 8.

The hardware modifications to the Servo Ventilator 300 consist of minor changes to circuit design to improve reliability and to facilitate changes in the alarm logic. The redundant nature of the Alarm and Monitoring subsystem requires that both hardware and software be modified simultaneously in order to implement a change to the alarm logic.

The software changes to the Servo Ventilator Alarm and Monitoring Module implement the removal of the "Leakage Alarm" feature, and minor adjustments in other alarm functions. The two circumstances that can trigger the leakage alarm in the predicate device, gross leaks in the breathing circuit and a malfunctioning flow transducer, will also trigger the expired minute volume alarm, so there is no reduction in patient safety from removing this alarm function.

The Servo Ventilator 300 Computer Interface Version 2 is a hardware and software modification to the Servo Ventilator 300 Computer Interface Version 1, which is an accessory to the Servo Ventilator 300 which was found substantially equivalent on June 26, 1991 (Premarket Notification K902859). The hardware design changes improve reliability, increase immunity to interference, and simplify manufacturing by updating the circuit design and incorporating state-of-the-art electronic components. The only hardware modification that affects the hardware requirements specification is the addition of "jumpers" in series with the external control inputs which are used for product test procedures. These jumpers are removed when the device is manufactured to disable functions that are not intended to be available to the user. The software modifications add the transmission of checksums to ensure data integrity and introduce new functions which provide the external data gathering system with an expanded list of data items that can be queried from the Servo Ventilator.

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9. NON-CLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The design of the modified Servo Ventilator 300 and Computer Interface Board Version 2 has been thoroughly validated at the unit, integration and system level. Non-clinical tests were conducted of the complete Servo Ventilator 300 with the Computer Interface installed. All alarm conditions were simulated and all output channels were tested by simulating a range of ventilator operating states and noting the outputs from the serial ports using both MS-Windows Terminal program, Version 3.1 and a proprietary program for displaying ventilator parameters (Servo Graphics, Version 1.0). All tests were passed according to criteria that are equal or more stringent than the test criteria which were applied to the predicate device.

CONCLUSION 10.

Analysis and testing have shown that the modifications to the Servo Ventilator 300 alarm logic improves the ease of use of the device without adversely affecting patient safety.

Updating the hardware design and expanding the list of data items that can be requested from the Computer Interface Board are changes that are not critical to the intended therapeutic use of the Servo Ventilator 300 and do not adversely affect the safety and effectiveness of the device when used as labeled. The hardware improvements affect the safety and effectiveness of the Servo Ventilator 300 by reducing the risk of ventilator shutdown as a result of component failures on the Computer Interface Board.

Therefore, we conclude that the requirements specifications and validation testing show that the modified device is as safe and effective, and performs as well as or better than the predicate device.

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).