(245 days)
The Wellvii VitalDetect™ is a device designed for spot measurements with recorded results of non-invasive blood pressure (NIBP), pulse rate (PR), and temperature (TMP).
This device uses an infra-red sensor for non-contact temperature measurement at the forehead. All other measurements use finger-based technology.
The VitalDetectTM is applicable for prescription home use by individuals 18 years of age or older for monitoring.
The device is not intended for continuous monitoring.
VitalDetect is a Bluetooth® connected, hand-held, portable vital sign monitor for prescription home use. The monitoring device can read physiological parameters, including: Pulse Rate (PR), Non-Invasive Blood Pressure (NIBP), and Body Temperature (TEMP).
The device uses a lithium-polymer battery which is rechargeable by the User. The battery is replaceable only by service personnel.
The VitalDetect monitoring system consists of a measurement device with inflatable finger-cuff, 5 finger shims, USB charging cord, and a downloadable application (APP) for use on a mobile device.
Here's a breakdown of the acceptance criteria and study details for the Wellvii VitalDetect device, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the VitalDetect device are primarily based on clinical accuracy, aligning with relevant ISO standards for blood pressure, pulse rate, and temperature measurement.
Table of Acceptance Criteria and Reported Device Performance:
| Vital Sign | Acceptance Criteria (Standard) | Reported Device Performance (Mean Difference/Bias & Standard Deviation) |
|---|---|---|
| NIBP – Systolic | Criterion 1: Mean difference: +/- 5 mmHg and STD: |
§ 880.2910 Clinical electronic thermometer.
(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.