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510(k) Data Aggregation

    K Number
    K060357
    Device Name
    TREK S NEBULIZER COMPRESSOR
    Manufacturer
    PARI INNOVATIVE MANUFACTURERS, INC.
    Date Cleared
    2006-04-05

    (51 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K960675,K002862
    Why did this record match?
    Device Name :

    TREK S NEBULIZER COMPRESSOR

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

    The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek S is intended for adult and pediatric patients.

    Device Description

    The Trek S nebulizer compressor is a portable, DC-powered air compressor intended to provide a source of compressed air for use with jet nebulizers. The Trek™ S is intended for adult and pediatric patients. The device is non-sterile, prescription-use only, intended for use in hospital, clinic, or home environments.

    AI/ML Overview

    The provided document, K060357, describes a 510(k) submission for the PARI Trek™ S nebulizer compressor. This device is a nebulizer compressor, which is a mechanical device, not an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as ground truth, expert adjudication, MRMC studies, training set, etc.) are not applicable in this context.

    The submission focuses on demonstrating substantial equivalence to predicate devices through technological characteristics and non-clinical performance summaries.

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Measured Performance)Reported Device Performance (PARI Trek™ S)
    Total Output Rate (TOR)Comparable to predicate devices
    Mass Median Diameter (MMD)Comparable to predicate devices
    Volume %
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