(266 days)
The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as:
ECG: Heartrate, Asystolic Time, Respiration Rate
Invasive Blood Pressure: systolic, distolic and mean pressure
Temperature: temperature and AT
Non Invasive Blood Pressure: systolic, distolic and mean pressure
CO2, etCO2 and CO2ins
SpO2: SpO2 and pulse rate
on humans and for the evaluation of Resting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments.
The system comprises the Parameter Box PB-1000 and the Visualisation Unit ARGUS PRO. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.
The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.
The system is inteded for use in the Intensive Care Unit, in the Recovery Room, in the Operation Room and during hospital internal transport.
The Monitoring System ARGUS PB-1000 is for the monitoring of vital parameters such as:
ECG: Heartrate, Asystolic Time, Respiration Rate
Invasive Blood Pressure: systolic, distolic and mean pressure
Temperature: temperature and AT
Non Invasive Blood Pressure: systolic, distolic and mean pressure
CO2, etCO2 and CO2ins
SpO2: SpO2 and pulse rate
on humans and for the evaluation of Resting ECG, Arrhythmias, ST-Segments and Cardiac Output. There is alarm handling for all parameters except ST-Segments.
The system comprises the Parameter Box PB-1000 and the Visualisation Unit ARGUS PRO. The two units are connected via a serial interface.
All vital parameters and evaluations are registered and calculated in the PB-1000. This data is then transmitted to the visualisation unit ARGUS PRO or another generally used PC via the serial interface. All data can be shown and monitored on the ARGUS PRO.
The PB-1000 operated using an internal battery and an external power input (RS 232/12V), which is, like the data transmission, completely separate from the visualisation unit. The ARGUS PRO is powered via the normal mains connection 230V/110V.
The provided 510(k) summary for the SCHILLER AG Argus PB-1000 System primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Cardiovit CS-200 K970879) through non-clinical testing for safety and effectiveness.
Here’s a breakdown of the information requested, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on compliance with specific international
standards for electrical safety and electromagnetic compatibility, and the device performance is reported as meeting these standards. Because this is a 510(k) submission, the device performance is primarily judged in comparison to the predicate device.
| Acceptance Criteria (from EN Standards/Predicate Comparison) | Reported Device Performance |
|---|---|
| Electrical Safety: | |
| EN 60601-1:1990 (General requirements) | Passed |
| EN 60601-1-1:1993 (Medical electrical systems) | Passed |
| EN 60601-1-4:1996 (Programmable electrical medical systems) | Passed |
| EN60601-2-25:1996 (Safety of electrocardiographs) | Passed |
| EN 60601-2-27:1996 (Safety of ECG monitoring equipment) | Passed |
| EN 60601-2-30:1995 (Safety of automatic cycling indirect blood pressure monitoring equipment) | Passed |
| Electromagnetic Compatibility (EMC): | |
| EN 60601-1-2 (General EMC standard) | Passed |
| ESD: Fully functional below 4 kV (Open Air) | Passed (same as predicate) |
| ESD: No damage below 8 kV (Open Air) | Passed (same as predicate) |
| Radiated Emissions: Less than 30 dB Microvolts | Passed (same as predicate) |
| Radiated Immunity: Less than 3 Volts per meter | Passed (same as predicate) |
| Environmental Conditions: | |
| Operating temperature: +10° - 40° C | Same as predicate |
| Storage temperature: -10° - +50° C | Same as predicate |
| Relative humidity: 25% - 95% (non condensing) | Same as predicate |
| Software Quality: | Reviewed according to "reviewer guidance for computer controlled medical devices undergoing 510 (k) review," with requirements, structure, development, revision, identification, verification, validation, and testing described in attached data. |
| Equivalence to Predicate Device (Cardiovit CS-200 K970879): | "We consider the submitted device to be as safe and effective as the Predicate Cardiovit CS-200 (K970879) device." (Based on non-clinical tests and comparison of technical specifications, with no safety-relevant differences identified). |
Study Information:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not describe a clinical test set or data provenance for performance evaluation. The testing described is non-clinical (electrical safety, EMC, software quality).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. There is no mention of a test set requiring expert ground truth establishment for clinical performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a test set requiring adjudication.
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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 device is a monitoring system, not an AI-assisted diagnostic tool, and no MRMC study is mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document implies standalone testing of various electrical and EMC parameters as per the standards listed. However, "standalone" in the context of an "algorithm only" performance study typically refers to diagnostic accuracy of an AI model, which is not relevant here. The device itself (PB-1000) performs the parameter measurements and calculations, and these are presumably tested for accuracy and reliability as part of the standards compliance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" is adherence to the specified engineering and safety standards (e.g., standard electrical safety limits, electromagnetic compatibility thresholds, expected physical behavior of components).
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The sample size for the training set:
- Not applicable. This document describes a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "software quality" section refers to software development and verification processes, not statistical training of an AI model.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI model. The software quality assurance processes adhere to established guidelines and involve verification and validation against requirements.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.