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The ViSi Mobile Monitoring System is intended for use by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of adult patients. It is indicated for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP) in hospital-based facilities; including general medical-surgical floors, intermediate care floors, and emergency departments.

The ViSi Mobile Monitoring System may be used as standalone devices or networked to a central station through wireless 802.11 communication.

The ViSi Mobile Monitoring System is a lightweight, portable patient vital signs monitor featuring a high resolution, full color touch screen display, with visual and audible alarms and alerts. The ViSi Mobile Monitor is body-worn and designed to continuously measure ECG, heart rate, SpO2, pulse rate, respiration rate, and temperature. The ECG, SpO2, and Respiration waveforms are viewable on demand. NIBP can be measured as a onetime measurement, or it can be measured automatically at predefined intervals.

The provided document (510(k) Summary for the ViSi Mobile Monitoring System) does not contain detailed information about specific acceptance criteria, a comprehensive study outline proving these criteria, or specific performance metrics with sample sizes, ground truth establishment, or expert qualifications for the device's various parameters.

The document primarily focuses on describing the device, its indications for use, and a general statement about its safety and effectiveness based on compliance with recognized standards and similarities to predicate devices. It also mentions "verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection." However, it does not provide the specifics of these verification and validation activities in terms of acceptance criteria and study details.

Therefore, I cannot populate the requested table and answer the specific questions about the study design, sample sizes, ground truth, and expert involvement based solely on the provided text.

The information that is available from the document is:

• Device Name: ViSi Mobile Monitoring System
• Intended Use: Single or multi-parameter vital signs monitoring of adult patients in hospital-based facilities (general medical-surgical floors, intermediate care floors, and emergency departments) for ECG (3 or 5 leadwire), respiration rate (RESP), heart rate (HR), non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), and skin temperature (TEMP).
• General Claim: "The ViSi System has been tested and complies with recognized performance, safety, and electromagnetic compatibility standards for medical devices. The verification and validation activities performed based on the FDA's draft guidance on Radio-Frequency Wireless Technology in Medical Devices provides assurance of a more reliable wireless connection. These results demonstrate that the ViSi System is safe, as effective, and based on the similarities with the predicate devices, substantially equivalent."

To answer your request, a more detailed study report or clinical trial summary would be necessary, which is typically a separate document from the 510(k) summary itself.

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