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510(k) Data Aggregation

    K Number
    K071915
    Device Name
    CPAP MASK
    Manufacturer
    ARCIMED LABORATORIES LLC
    Date Cleared
    2008-05-14

    (308 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K063122,K950771,K002465
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    A patient interface, face mask, for use with CPAP and bi-level systems used in the treatment of adult (>30 kg) OSA and / or ventilatory support. Two styles (with exhalation port and without exhalation port). Single use only

    Device Description

    The proposed patient interface face mask incorporates a number of features, which are designed to maximize seal and comfort, and maintain the mask in the correct position throughout use. Adhesive foam to seal to the patient face. One size - medium. Models with and without Integral fixed leak (exhalation) port.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study information based on the provided text, categorized as requested:

    1. Table of Acceptance Criteria and Reported Device Performance

    Feature/MetricAcceptance Criterion (Predicate Device Performance)Reported Device Performance (ARCimed CPAP mask)
    Exhaust Flow RangePressure / Flow (lpm)
    3 cm H2O / 17.8 lpm
    10 cm H2O / 31.5 lpm
    20 cm H2O / 42.6 lpm
    30 cm H2O / 51.7 lpm
    40 cm H2O / 60.1 lpm
    (Based on ResMed Quattro K063122)Pressure / Flow (lpm)
    3 cm H2O / 19.9 lpm
    10 cm H2O / 33.3 lpm
    20 cm H2O / 47.1 lpm
    30 cm H2O / 58.0 lpm
    40 cm H2O / 67.8 lpm
    Pass / fail +/- 15% (Implied acceptance within this range of predicate)
    Pressure Drop (Resistance to Flow)ResMed – K063122
    0.59 cm H2O @ 50 lpm
    1.2 cm H2O @ 100 lpm0.35 cm H2O @ 50 lpm
    0.81 cm H2O @ 100 lpm
    CO2 RebreathingResMed – K063122
    0.25% EtCO2 (Measured change from baseline)0.06% EtCO2 (Measured change from baseline)
    Adhesive SealAdvanced Warming – K950771
    Offers a tight seal
    No performance requirements other than it will remain attached to patient's faceWe are claiming no performance requirements other than the mask will seal and remain attached to the patient's face.
    Vented/Non-vented models (Anti-Asphyxia Valve compatibility)Yes – ResMed – K063122
    Offer a mask with optional anti-asphyxia valveVented and Non-vented models requires attachment to a circuit with anti-asphyxia valve incorporated demonstrated to activate AAV valve equivalent to predicates. Should be used with AAV with minimum opening pressures of
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