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510(k) Data Aggregation

    K Number
    K132127
    Device Name
    TRANSCEND AUTO
    Manufacturer
    SOMNETICS INTERNATIONAL, INC.
    Date Cleared
    2013-10-17

    (99 days)

    Product Code
    BZD
    Regulation Number
    868.5905
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K100121,K041010
    Why did this record match?
    Device Name :

    TRANSCEND AUTO

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

    The Transcend Auto provides positive airway pressure for treatment of obstructive sleep apnea (OSA) in adults weighing over 66 pounds (30 kg). The device is intended for home and hospital/institutional use.

    Device Description

    The Transcend Auto is a microprocessor-controlled, blower-based system that generates positive airway pressure to support treatment of obstructive sleep apnea. It utilizes a differential pressure sensor connected to an internal pneumotach positioned in the airstream to determine flow levels. This flow signal, coupled with pressure sensing, is used to monitor breathing and adjust pressure. When interfaced with a mask, the system provides pressure from 4 to 20 cmHzO above the ambient atmospheric pressure to a patient's oral/nasal airway.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Transcend Auto device, based on the provided text:

    Acceptance Criteria and Reported Device Performance

    CriteriaAcceptance Criteria (Predicate Device)Reported Device Performance (Transcend Auto)
    Pneumatic Performance:
    Therapy Pressure (cm H2O)4-204-20
    Pressure RegulationTranscend CPAP: ±1 cm H2O or 10%, whichever is greater
    REMstar Auto CPAP:
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