(19 days)
The Vital Signs Monitors models VSM-300 and VSM-300A (hereinafter called monitor) are intended to be used for non-invasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature).
The monitors are intended to be used only under regular supervision of clinical personnel. It is applicable to adult, pediatric, and neonatal usage in hospitals, hospital type facilities and intra-hospital moves.
The monitors are equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
VSM-300 & VSM-300A Vital Signs Monitors are patient monitoring devices providing the patient with a continuous vital physiological monitoring of noninvasive continuous monitoring of SpO2 (oxygen saturation of the blood), NIBP (non-invasive blood pressure) and TEMP (temperature) in a hospital, hospital type facilities environment and intra-hospital moves. The following lists the detailed features of the subject device.
- · LCD or LED display
- · SpO2, Pulse Rate NIBP and TEMP measurement
- · Nellcor or EDAN SpO2 module
- · Display numeric and waveform information simultaneously
- · Nurse call feature
- · Built-in Lithium-ion Battery
- · Suitable for adult, pediatric and neonate patients
- · Visual and audible alarm
This 510(k) submission for the VSM-300 & VSM-300A Vital Signs Monitors does not contain the information requested in your prompt.
Here's a breakdown of why and what information is missing:
The provided text focuses on:
- Administrative details: Device name, classification, submitter information, date prepared, 510(k) number.
- Device description: What the device measures (SpO2, NIBP, TEMP), display type, features, and patient populations (adult, pediatric, neonate).
- Intended Use: Reinforces the measurements and settings of use.
- Non-clinical tests: Lists general categories like "Software testing," "Safety testing," "Performance testing," "Risk analysis," and "Final validation."
- Predicate device comparison: States that the device is similar in technology and intended use to the predicate.
- FDA correspondence: The official letter from the FDA determining substantial equivalence.
Crucially, it is missing all the detailed study information you requested, such as:
- Specific acceptance criteria: The document only mentions "Performance testing" without detailing the specific thresholds or metrics being evaluated for NIBP, SpO2, or TEMP.
- Reported device performance: There are no actual performance data (e.g., accuracy, bias, precision values) presented for any of the measured parameters.
- Study design details:
- No mention of sample sizes for any test sets.
- No data provenance information (country, retrospective/prospective).
- No information on ground truth establishment (number of experts, qualifications, adjudication method, type of ground truth).
- No details about MRMC studies.
- No details about standalone algorithm performance (as this is a hardware device, not an AI/ML algorithm).
- No training set sample size or how its ground truth was established, as this is not an AI/ML device.
To answer your prompt, I would need a different type of document, typically a detailed test report or clinical study summary, that is often referenced or included as an appendix in a 510(k) submission, but is not present in the provided text.
Therefore, I cannot populate the table or answer the specific questions based on the input given.
This 510(k) summary is extremely high-level and does not delve into the granular details of performance validation studies.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).