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    K Number
    K122350
    Device Name
    TAP PAP NASAL PILLOW MASK
    Manufacturer
    AIRWAY MANAGEMENT, INC.
    Date Cleared
    2012-11-01

    (90 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TAP PAP NASAL PILLOW MASK

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

    The TAP PAP Nasal Pillow Mask is intended to be used by individuals who have been diagnosed by a Physician as requiring CPAP or Bi-Level ventilator treatment. The TAP PAP Nasal Pillow Mask is intended for single patient adult (>66lb/30kg) use in the home, hospital or other clinical setting.

    Device Description

    The TAP PAP Nasal Pillow Mask consists of a boil & bite type dental appliance. A small bracket that extends beyond the lips to attach the mask frame (Mask - Upper Mouth Piece Adjustment Joint). Two soft silicone nasal pillows are located on the mask frame to seal against the nostrils. The nasal pillows come in three sizes and can be individually rotated to align with the user's nares. A corrugated flexible tube extends upwards from the mask frame to a 22 mm connector which connects to a breathing tube of a CPAP or bi-level device. The mask frame has exhalation vents (bias holes) that allow exhaled gases to be continually flushed.

    AI/ML Overview

    Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: TAP PAP Nasal Pillow Mask

    1. Table of Acceptance Criteria and Reported Device Performance

    Test/AttributeAcceptance CriteriaReported Device Performance
    Pressure DropNo pass/fail criteria, reportable values only. (Implied: must be low enough for CPAP machines to supply required flow, and patient exhalation through mouth should have no resistance).50 lpm: 0.2 cm H₂O
    100 lpm: 0.6 cm H₂O
    Bias (vent) Flow / Exhaust FlowNo pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher leak rate indicates greater CO2 washout and is not clinically significant).6 cm H₂O: 23 lpm
    10 cm H₂O: 30 lpm
    20 cm H₂O: 42 lpm
    Dead SpaceNo pass/fail criteria, reportable values only. Should be comparable to the predicate. (Implied: Higher reported value is acceptable if CO2 washout demonstrates effectiveness).95 ml
    CO2 Washout (per ISO 17510-2)Changes in CO2 at various pressures to be
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