(270 days)
The monitoring system ARGUS PB-2200 is for the monitoring of vital parameters such as:
Invasive blood pressure: systolic, diastolic and mean pressure
s and controller Brings and/or sidestream Invasive blood pressure. Systems, main and/or sidestream FIO2
lt will extend the functionality of the existing Argus PB-1000 system (K0122Z6).
The function and the promoter her PB-1000 and the visualisation unit AR It will extend the functionality of the existing Algust PB-1000 (PB-100) (PB-100)
The system comprises the parameter box PB-1000 and the visualisation unit ARGUS
(PBS) and th
The system compilses the parcined via a serial interface. PRO. The two units are connected via a serial intenated and calculated in the PB-2200. This All vital parameters and evaluations are registered and calouaced manager generally used
data is then transmitted to the visualisation unit ARGUS PRO or another generally us data is then transmitted to the visuallsation und monitored on the ARGUS PRO.
PC via the serial interface. All data can be shown and monitored on the ARGUS PRO. PC via the serial interface. All data can be snown and monecessed power input (RS
The PB-2200 is operated using an internal battery and an external power input (RS
e and the The PB-2200 is operated using an internal battery alle an and the manate from the 232/12V), which is, like the data transmission, completely sop
visualisation unit. The ARGUS PRO is powered via the normal mains connection
230V/110V.
The system is intended for use in the intensive care unit, in the recovery room, in the The system is intended for ass internal transports.
The system comprises the Parameter Box PB-1000 and the Visualisation Unit AR-GUS 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 ARGUS PB-2200 Monitoring System indicates that no specific acceptance criteria or a dedicated study proving performance against such criteria were explicitly presented in the document. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (ARGUS PB-1000 System, K012226) by showing that the ARGUS PB-2200 meets or exceeds various established safety and electromagnetic compatibility standards.
The key takeaway is that for this device, the "acceptance criteria" are the compliance with recognized medical device standards, and the "study" is the non-clinical testing performed against those standards.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Electrical Safety: | |
| EN 60601-1:1990 (General Safety) | All tests passed. |
| EN 60601-1-1:1993 (Medical Electrical Systems Safety) | All tests passed. |
| EN 60601-1-4:1996 (Programmable Medical Systems Safety) | All tests passed. |
| Electromagnetic Compatibility (EMC): | |
| EN 60601-1-2 (EMC Test) | All tests passed. |
| - Electrostatic Discharge (ESD) | Fully functional below 4 kV (Open Air), No damage below 8 kV (Open Air) |
| - Radiated Emissions | Less than 30 dB Microvolts |
| - Radiated Immunity | Less than 3 Volts per meter |
| Specific Safety (Blood Pressure Monitoring): | |
| EN 60601-2-34:1995 (Blood Pressure Monitoring Equipment Safety) | All tests passed. |
| Software Quality: | Reviewed according to "reviewer guidance for computer controlled medical devices undergoing 510 (k) review." Device software requirements, structure, development, revision, identification, verification, validation, and testing are described in attached data. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document relates to non-clinical testing of the device against standards. There is no mention of a "test set" in the context of patient data or clinical performance. Therefore, sample size for a test set is not applicable (N/A) for this type of submission. The data provenance is related to in-house or contracted laboratory testing for compliance with international standards, likely performed in Switzerland (country of origin of SCHILLER AG). The testing is prospective in the sense that the device was actively tested against the standards.
3. 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. This submission focuses on engineering and safety standards compliance, not on clinical performance evaluated by medical experts establishing ground truth from patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" in the context of clinical data requiring adjudication.
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 MRMC comparative effectiveness study was done. This device is a vital signs monitor, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a monitoring system for vital parameters. Its "performance" is its ability to accurately measure and display these parameters and comply with safety standards. The non-clinical tests described are essentially "standalone" performance evaluations against specified engineering and safety criteria. There is no mention of an algorithm in the sense of a diagnostic or interpretive AI, therefore, no standalone algorithm performance study as typically understood in AI/ML medical devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" is established by the defined parameters and tolerances within the referenced international standards (e.g., specific voltage levels for ESD, frequency ranges for emitted radiation, and safety requirements for medical electrical equipment). The device's performance is compared directly against these established standard requirements.
8. The sample size for the training set
The document does not describe a "training set" as it is commonly understood for AI/ML models. This device is a hardware monitoring system, not an AI/ML product that undergoes a training phase with a dataset.
9. How the ground truth for the training set was established
Not applicable. No training set for an AI/ML model was used or described.
§ 870.1110 Blood pressure computer.
(a)
Identification. A blood pressure computer is a device that accepts the electrical signal from a blood pressure transducer amplifier and indicates the systolic, diastolic, or mean pressure based on the input signal.(b)
Classification. Class II (performance standards).