(30 days)
The Trio™ monitor is intended for use in healthcare settings under the direct supervision of a licensed healthcare practitioner. The intended use of the monitor is to monitor physiologic parameter data on adult and pediatric patients. Physiologic data includes: electrocardiogram, invasive blood pressure, non-invasive blood pressure (NIBP), pulse oximetry, heart rate (derived from ECG, SpO2 or NIBP), respiration and temperature as summarized in the operating instructions manual. The information can be displayed, stored, trended and printed. The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor
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This document is a marketing authorization from the FDA for a medical device called "Trio Monitor." It does not contain information about the device's acceptance criteria or the study that proves the device meets those criteria. The provided text is purely regulatory and addresses the substantial equivalence of the device to legally marketed predicate devices, allowing it to proceed to market. It does not include performance data, test designs, or information about ground truth establishment.
Therefore, I cannot extract the requested information as it is not present in the provided document.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).