(127 days)
Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age.
This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently.
This VITALS360® device is intended for use in a clinical or home environment.
This VITALS360® device is a reusable device following thorough cleaning between uses.
The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal.
The Vitals360® capabilities include storing, displaying measuring data.
This document describes the regulatory submission for the Vitals360® Multi-Vitals Mobile Monitor (K210086). The device is intended for measuring, displaying, reviewing, and storing non-invasive blood pressure (NIBP), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), and ECG in adults 18 years of age and older.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present a single table of acceptance criteria and specific reported device performance in a dedicated section with pass/fail outcomes. Instead, it describes performance characteristics and accuracies within the "Comparison to the Predicate Device" section and lists the standards to which clinical studies were conducted under "Performance Data."
Based on the information provided, we can infer the acceptance criteria for individual parameters from the device's specifications and the adherence to relevant ISO standards for medical devices. The "reported device performance" is essentially the device's stated specifications and accuracies.
| Parameter | Acceptance Criteria (Implied from stated device performance and predicate comparison) | Reported Device Performance (Vitals360®) |
|---|---|---|
| SpO2 Accuracy | Should be comparable to or better than predicate (±3% for 70%-100% range) | Displayed range: 70% |
| Pulse Rate Range | Comparable to predicate (30 bpm-240 bpm) | 30 to 150 bpm |
| Pulse Rate Accuracy | Comparable to predicate (±2bpm or ±2%, whichever is greater) | ±2bpm or ±2%, whichever is greater |
| NIBP Accuracy | Mean deviation values: ±5 mmHg. Standard deviation |
§ 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).