(283 days)
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No
The document describes a real-time ventilatory monitor system that displays and trends data from ventilators. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies. The device appears to be a data display and trending system, not an analytical or predictive system using AI/ML.
No.
The device is a monitor designed to display information from a ventilator, not to provide therapy itself.
No
The device is described as a real-time ventilatory monitor system that displays information from ventilators. Its intended use is to aid clinicians in reviewing the operating state of the ventilator and the ventilatory status of the patient by displaying parameters. It does not perform a diagnosis itself but rather provides information for the clinician.
No
The device description explicitly states it consists of a "small, compact computer unit" and a "flat screen display unit," along with a support arm and an interface module (SCM 990) for one of the ventilators. These are physical hardware components, not just software.
Based on the provided information, the Servo Screen 390 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display parameter information from a ventilator to aid clinicians in reviewing the ventilator's operating state and the patient's ventilatory status. This is a monitoring and display function, not a diagnostic test performed on biological samples in vitro.
- Device Description: The device is described as a real-time ventilatory monitor system that reads and calculates parameters from ventilators and displays this information. It's an interface and display unit for existing medical devices (ventilators).
- Lack of IVD Characteristics: There is no mention of the device being used with biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on the analysis of these samples.
The device's function is to present data from a life-support device (a ventilator) to a clinician, which falls under the category of patient monitoring and display, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the clinician to verify critical settings and measurements on the ventilator control panel and to obtain appropriate additional data from other sources before initiating changes in therapy.
The Servo Screen 390 does not control the ventilator, nor does it recommend specific changes in therapy or provide a diagnosis. It is a device for the formatting and display of data.
Product codes
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Device Description
The Servo Screen 390 is a real time ventilatory monitor system that continuously reads and makes calculations from parameters measured or calculated by Servo Ventilators. It displays this information in a clear and logically organized manner. Parameters are listed in a numerical format and/or as waveforms and loops. All displayed parameters are trended in 3, 6, 12, or 24 hour intervals.
The device consists of a small, compact computer unit suitable for use in the clinical environment designed specifically for integration with existing ventilators Servo Ventilator 300 and Servo Ventilator 900. The flexible support arm makes it easy to place the screen in a wide array of positions; on the ventilator, on a cart, or even on a wall rail for maximum visibility. The front panel has an electro-luminescence monochromatic display screen and a single operator control in the form of a control-knob, which is simply turned or pressed.
The flat screen display unit measures 252 x 330 x 88 mm (not including control knob) and a flexible support arm. Weight including the support arm is 4.3 kg. When used with the Servo Ventilator 900, the Servo Computer Module 990 is required to interface the two devices. This interface mounts under the ventilator, adding 2.7 kg to the weight and 4.0 cm to the height.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Clinician
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted of the Siemens Model 390 Servo Screen, interfaced to both the Servo Ventilator 900 and Servo Ventilator 300. These tests demonstrated that the data displayed by the servo screen is in agreement with the ventilator display when ventilator operation is simulated over the operating range of key ventilator parameters. The Servo Screen 390 and the SCM 990 have been tested and do meet the requirements for immunity to electromagnetic interference and emissions of electromagnetic energy as defined by EN60601-1-2.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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OCT 2 5 1996
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510(k) Summary for Siemens Servo Screen 390
DATE THIS SUMMARY WAS PREPARED 1.
January 11, 1996
SUBMITTER'S NAME AND ADDRESS 2.
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 Screen 390 and Servo Computer Module 990 |
|---|---|
| Common Name: | Ventilator Monitoring System |
| Classification Name: | (Accessories to) Ventilator, Continuous (Respirator) |
5. PREDICATE DEVICES
The legally marketed devices to which equivalence is being claimed are:
- · LEONARDO Patient Data Manager Hamilton Medical P.O. Box 30008 Reno, NV 89520
1/11/96
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- 7202 DISPLAY OPTION MODULE Puritan-Bennett International, Inc. P.O. Box 25905 Overland Park, KS 66225
- EVITA Ventilator Dräger 4101 Pleasant Valley Road Suite 100 Chantilly, VA 22021
DEVICE DESCRIPTION 6.
The Servo Screen 390 is a real time ventilatory monitor system that continuously reads and makes calculations from parameters measured or calculated by Servo Ventilators. It displays this information in a clear and logically organized manner. Parameters are listed in a numerical format and/or as waveforms and loops. All displayed parameters are trended in 3, 6, 12, or 24 hour intervals.
The device consists of a small, compact computer unit suitable for use in the clinical environment designed specifically for integration with existing ventilators Servo Ventilator 300 and Servo Ventilator 900. The flexible support arm makes it easy to place the screen in a wide array of positions; on the ventilator, on a cart, or even on a wall rail for maximum visibility. The front panel has an electro-luminescence monochromatic display screen and a single operator control in the form of a control-knob, which is simply turned or pressed.
The flat screen display unit measures 252 x 330 x 88 mm (not including control knob) and a flexible support arm. Weight including the support arm is 4.3 kg. When used with the Servo Ventilator 900, the Servo Computer Module 990 is required to interface the two devices. This interface mounts under the ventilator, adding 2.7 kg to the weight and 4.0 cm to the height.
INTENDED USE 7.
The intended use of the Servo Screen 390 is to provide a central bedside location for the display of all parameter information from the ventilator in order to aid the clinician in quickly and accurately reviewing the operating state of the ventilator and the ventilatory
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status of the patient. When review of the tabular or graphical data displayed on the Servo Ventilator 300 indicate that intervention may be required, it is the responsibility of the clinician to verify critical settings and measurements on the ventilator control panel and to obtain appropriate additional data from other sources before initiating changes in therapy.
The Servo Screen 390 does not control the ventilator, nor does it recommend specific changes in therapy or provide a diagnosis. It is a device for the formatting and display of data.
8. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The Servo Screen, Leonardo, 7202 Display Option Module, and Evita all provide for storage, trending, and graphing of data retrieved from the ventilator. All provide a video screen at the ventilator where the user can choose to view in real time a subset of the available parameters as tables, waveforms over time, or X-Y "loop" plots. Differences in the set of parameters available are due to differences in the ventilators, not the ventilatory monitoring system itself. Of the thirty parameters and graphs that can be displayed on the Servo Screen, fifteen are also available on the Leonardo. Of the fifteen not found on the Leonardo, three are found on the Puritan-Bennett 7202 Display Option Module (minute volume, tidal volume, and dynamic compliance), and one on the Dräger Evita (CO2 concentration). The remaining twelve parameters represent unique capabilities of the Siemens Servo Ventilators, rather than a substantial difference in the monitoring systems.
Servo screen uses an Intel 80486SX microprocessor, MS-DOS operating system, and displays data on an electroluminescent flat-panel display. The hardware and software are designed, manufactured, and maintained under GMP controls. The Leonardo system is an application program that runs on an IBM compatible personal computer and displays data on a CRT display. The Puritan-Bennett 7202 Display Module displays data on an electroluminescent display. The details of the processor hardware are not known to this applicant. The Dräger Evita includes the equivalent functionality as an integral part of the ventilator and displays data on an LCD display.
The differences in user interface, size & weight, and data formatting among the four systems reflect differing implementations of systems with the common goal of providing the convenient and user-friendly presentation for the user. While some clinicians may
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prefer one implementation over the others, we do not believe that these subjective differences have a significant effect on the clinical efficacy of the devices.
The SCM 990 Version 2 is a firmware upgrade to enable the data interface to provide a larger selection of ventilator parameters for display on the Servo Screen. The expanded list of available parameters is equivalent to the parameters which can be displayed on the predicate devices.
9. NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The design of the Siemens Model 390 Servo Screen has been thoroughly validated at the unit, integration and system level. Non-clinical tests were conducted of the Siemens Model 390 Servo Screen, interfaced to both the Servo Ventilator 900 and Servo Ventilator 300. These tests demonstrated that the data displayed by the servo screen is in agreement with the ventilator display when ventilator operation is simulated over the operating range of key ventilator parameters. The Servo Screen 390 and the SCM 990 have been tested and do meet the requirements for immunity to electromagnetic interference and emissions of electromagnetic energy as defined by EN60601-1-2
10. CONCLUSIONS FROM NONCLINICAL TESTING
Based on inspection of the Servo Screen and Servo Computer Module Requirements Specifications and review of the testing that demonstrates that these requirements are met, we conclude that the Servo Screen 390 and the SCM 990 are substantially equivalent to the predicate devices cited above.