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    K Number
    K192488
    Device Name
    CO2 Sidestream Module
    Manufacturer
    Beijing Kingst Commercial & Trade Co.,Ltd.
    Date Cleared
    2020-05-22

    (254 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K170820,K053174
    Why did this record match?
    Device Name :

    CO2 Sidestream Module

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

    The CO2 Sidestream Module is designed to provide carbon dioxide monitoring system during anesthesia / recovery, in the intensive care unit (ICU), and in Respiratory care. The CO2 Sidestream Module is used for adult patients.

    Device Description

    The CO2 Sidestream module is a non-dispersive infrared gas analyzer with an autozero adjustment system and gain control. The operation of the CO2 Sidestream module is based on CO2 energy absorption rates. CO2 molecules absorb infrared light energy of specific wavelengths, with the amount of energy absorbed being directly related to the CO2 concentration. When an IR light beam is passed through a gas sample containing CO2, the electronic signal from the infrared sensor (which measures the remaining light energy), can be obtained. This signal is then compared to the energy of the IR source, and calibrated to reflect CO2 concentration in the sample accurately. Calibration is performed using the infrared sensor's response to a known concentration of CO2 stored in the Module's memory. As the sample gas passes through a three-way valve, with the change of temperature and time, the valve leading to the pure air will close for 3-4 seconds to adjust the zero point. The circuit module retains the atmospheric absolute pressure sensors and control of the pressure sensor. Modules can measure atmospheric pressure, and atmospheric can compensate for the calculation for the concentrations of carbon dioxide, which improves the design accuracy. The Module then determines CO2 concentration in the breathing gases by measuring the amount of light absorbed by these gases. EtCO2 displays a numerical value in millimeters of mercury (mmHg), percent (%), or kilopascals (kPa). Respiration rate is calculated by measuring the time interval between detected breaths.

    AI/ML Overview

    The provided text describes the acceptance criteria and a study demonstrating the device's compliance.

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    EtCO2 Measurement Range0-150 mmHg, 0-19.7%, 0-20 kPa
    EtCO2 Accuracy0-40 mmHg: ±2 mmHg
    41-70 mmHg: ±5% of reading
    71-100 mmHg: ±8% of reading
    101-150 mmHg: ±10% of reading
    Respiration Rate Measurement Range3 - 150 breaths/minute (RPM)
    Respiration Rate Accuracy±1% of reading or ±1 breaths/min, whichever is greater
    In Vitro CytotoxicityViability%: 87.9% (No toxicity)
    Skin Sensitization0% skin sensitization rate (No evidence of sensitization)
    Skin IrritationPrimary irritation index: 0 (Negligible)
    Emissions of Particulate MatterParticulate Matter: $3.2 \times 10^{-3}$ µg/m3 (Particle size ≤2.5 μm)
    $3.2 \times 10^{-3}$ µg/m3 (Particle size ≤10 μm) (Qualified)
    Emissions of Volatile Organic CompoundsEach VOC
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