(297 days)
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.
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.
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"). |
- 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."
- 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. - Improve ease of use (related to alarm logic).
- Computer Interface to store and transmit information about the ventilator to external digital devices.
- Computer Interface to provide an expanded list of data items. | 1. Modifications made "while retaining the original functionality."
- Alarm logic modifications "improves ease of use."
- Computer Interface (CI) "stores and transmits information about the ventilator to external digital devices via optically isolated serial interfaces."
- 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. - Manufacturing efficiency improvements.
- Immunity to interference (for CI).
- Data integrity (for CI, via checksums).
- 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."
- CI hardware design changes "simplify manufacturing."
- CI hardware design changes "increase immunity to interference."
- CI software modifications "add the transmission of checksums to ensure data integrity."
- "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.
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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.
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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.
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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.
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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.
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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.
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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."
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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.
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How the ground truth for the training set was established: Not applicable.
§ 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).