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    K Number
    K180902
    Device Name
    MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
    Manufacturer
    MediPines Corporation
    Date Cleared
    2019-01-11

    (280 days)

    Product Code
    CCK,BZL,CCL,DQA
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K093080,K094012
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    Device Name :

    MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

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

    The MediPines Gas Exchange Monitor (GEM) is a non-invasive, multi-parameter respiratory monitoring device that provides spot-check respiratory gas measurements of oxygen (PO2, ETO2) and carbon dioxide (PCO2, ETCO2) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices.

    At-rest patient measurements are obtained in a spot-check measurement session lasting approximately two minutes, using specified accessories which include a single patient use breathing gas mouthpiece, a single patient use nose clip, and a reusable pulse oximeter finger sensor.

    The device is indicated for use by qualified medical personnel in professional healthcare facilities on conscious and cooperative patients who are eighteen (18) years and older. The GEM is not to be utilized simultaneously with supplemental Oxygen nor with other respiratory gases or agents.

    The MediPines Gas Exchange Monitor (GEM) is not intended to be used as the sole basis for making diagnosis or treatment decisions related to patient gas exchange; it is intended to be used in conjunction with additional methods of assessing clinical signs and symptoms. It is not intended to replace arterial blood gas sampling for treatment purposes.

    Device Description

    The Gas Exchange Monitor (GEM) is a non-invasive multi-parameter respiratory monitoring system that uses at-rest spot check breath samples to provide respiratory measurements of oxygen (PO₂, ETO₂) and carbon dioxide (PCO₂, ETCO₂) from breathing, respiration rate (RR), functional saturation of arterial hemoglobin (SpO2), pulse rate (PR), and a range of other calculated indices to assess a patient's respiratory status.

    The device utilizes a single patient use disposable mouthpiece attached to the monitor via a tubing system and an attached pulse oximetry probe. A nose clip is used during the measurement session and real-time tracing of breath samples are displayed on the device screen and may be exported as PDF and image files.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the MediPines Gas Exchange Monitor (GEM), based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document provides specific accuracy criteria for CO2 and O2 measurements, and SpO2/Pulse rate.

    ParameterAcceptance CriteriaReported Device Performance
    CO2 Measurement± 2 mmHg from 0 - 38 mmHg (at ATPS) ± 5% of actual from 39 - 76 mmHg (at ATPS) ± 8% of actual from 77 - 99 mmHg (at ATPS)Met current gas monitoring standard accuracy requirements. This performance matches the acceptance criteria explicitly stated.
    O2 Measurement
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