(273 days)
The Halo vital signs monitor is a prescription device intended to be used as an adult patient monitor. It is indicated as a single- or multi-parameter vital signs monitor for SpO2 - pulse oximetry, pulse rate, respiratory rate, core body temperature, and skin temperature for spot-check measurements and continuous monitoring from the back of the cavum concha and the neck.
The Halo monitor may be used in hospitals, healthcare facilities, emergency medical transport, home healthcare settings, and other healthcare applications to include medical military settings in the field. The monitor is intended to be used in trauma scenarios, triage, motion, low perfusion, general monitoring, and telemedicine settings. It is reusable, transportable, and for use in all types of ambulances.
The Halo monitor uses wired or wireless communications to transmit vital signs data to a handheld or personal computer. The monitor is intended to be used by trained healthcare providers who are trained to interpret the vital signs readings and make appropriate medical interventions or patients who are und guidance of a medical professional or doctor. Alarms can be set with user-defined thresholds.
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The provided text is a 510(k) clearance letter from the FDA for the "Sempulse Halo Vital Signs Monitor." This document focuses on the regulatory clearance process and does not contain the detailed technical study information (acceptance criteria, test set, ground truth, training set, etc.) that would prove the device meets specific performance criteria.
Therefore, I cannot provide the requested information from the given text.
The typical content of a 510(k) summary (which is a separate document often submitted for public review after clearance) or a detailed performance validation study would include such information. This letter simply confirms that the device has been found "substantially equivalent" to legally marketed predicate devices.
§ 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).