LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K231625
    Device Name
    VitalDetect
    Manufacturer
    Wellvii Inc
    Date Cleared
    2024-02-02

    (245 days)

    Product Code
    FLL,DQA,DXN
    Regulation Number
    880.2910
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K152905,K170047
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K152905

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 SignAcceptance Criteria (Standard)Reported Device Performance (Mean Difference/Bias & Standard Deviation)
    NIBP – SystolicCriterion 1: Mean difference: +/- 5 mmHg and STD:
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1