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510(k) Data Aggregation

    K Number
    K213863
    Device Name
    Everion+ System
    Date Cleared
    2023-02-23

    (440 days)

    Product Code
    Regulation Number
    870.2300
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    Everion+ System

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

    Everion+ provides continuous monitoring of the following vital signs in adults, 18 years of age or older, when at rest:

    • Pulse rate
    • Respiration rate
    • Movement
      The data from Everion+ is intended to be used in a hospital or home environment in order to support monitoring of wearers under the care of a trained healthcare professional. Everion+ is not intended for use in a critical care environment such as an ICU or operating room. The device information should not be the sole basis for clinical decisions.
    Device Description

    The Everion+ is a wireless multi-parameter vital-signs monitoring system. The Everion+ was includes an Application Programming Interface (API), which is intended to allow development of user interface applications that enable clinicians and medically-qualified personnel to access recorded vital signs information for active patient monitoring.
    The system is comprised of the following components:

    • Wearable device with multiple sensors
    • Secure cloud environment with an API .
    • Charger with accessories .
    • Armband .
      The Everion+ wearable is battery-operated with integrated sensors and wireless transceiver. The wearable is worn on the upper arm via the adjustable armband that snaps to it. The armband is made of a stretchy material and has an adjustable clip to enable fitting to most adults. The wearable continuously gathers multi-parameter vital signs data from the person being monitored and securely transmits the data to the server component of the system, via cellular communication, when in range of a third-party receiver.
    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Everion+ System, based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    ParameterAcceptance Criteria (Objective)Reported Device Performance (Result)
    Pulse Rate (PR)RMSE ≤ 3 bpmRMSE ≤ 3 bpm (met)
    Respiration Rate (RR)RMSE
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