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510(k) Data Aggregation

    K Number
    K032170
    Device Name
    TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000
    Manufacturer
    MEDICAL INDUSTRIES AMERICA, INC.
    Date Cleared
    2004-05-28

    (317 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K914836,K963924,K021443
    Why did this record match?
    Device Name :

    TRANSNEB COMPRESSOR W/NEBULIZER, MODEL 5000

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

    The TransNeb compressor/nebulizer includes a DC powered air compressor that provides a source of compressed air for home health care use. The compressor is used with a venturi (pneumatic nebulizer) to convert certain inhaled drugs into an acrosol form for inhalation by a patient. The device can be used with adult or pediatric patients.

    Device Description

    The TransNeb system consists of a nebulizer and a DC powered piston-type compressor that generates compressed air. Small, lightweight and designed for convenience, the TransNeb device offers the user a choice of running off of AC power via a universal adapter or DC power via an option 12 volt auto adapter or an optional rechargeable battery pack. The device consists of a motor driven piston compressor, a printed circuit board and a switch. The circuit board does not incorporate a microprocessor but serves as a means to prevent double feed of power. The circuit board is not a part of the charging circuit for the battery pack. The nebulizer, which employs a venturi effect to convert the medication into a fine aerosol mist, is used cither snapped directly onto the compressor outlet barb or with an extension tube. Providing a connection between the compressor outlet barb and the nebulizer bottom, the extension tube allows the user to place the compressor on a sturdy surface and to simply hold onto the nebulizer. The nebulizer is designed for single patient and is reusable. The nebulizer with or without its tubing adapter is designed specifically for use only with the TransNeb compressor.

    AI/ML Overview

    This document describes the TransNeb System, a nebulizer compressor intended for home health care use. It provides general information about the device's function, design, and a comparison to predicate devices, but it does not contain information about a study that tests or proves acceptance criteria for an AI/ML powered device.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance as the provided text pertains to a traditional medical device (nebulizer compressor), not an AI/ML-powered device. The document is a 510(k) summary for a Nebulizer Compressor.

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