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510(k) Data Aggregation

    K Number
    K970844
    Device Name
    ATOMISOR
    Manufacturer
    MEDICAL CONSULTING SERVICE, INC.
    Date Cleared
    1997-11-13

    (251 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ATOMISOR AL + NL9 NEBULIZER is an aerosol generator for the delivery of aerosol to the airways. Because they have been designed to be operated together, the ATOMISOR NL9 nebulizer and the ATOMISOR AL compressor should never be used separately.

    Device Description

    The ATOMISOR AL is a small and easy to use portable compressor for jet nebulizer aerosol generator. The pump inside is a diaphragm pump and the casing of the compressor is made of metal with a plastic carrying handle on top. In order to ease its' transportation, in case of rental for example, the ATOMISOR AL can be sold with a PVC carrying case in which both the compressor and the nebulizer can be placed. When used, the compressor is removed from the carrying-case.

    AI/ML Overview

    The provided information describes a Premarket Notification [510(k)] for the ATOMISOR AL + NL9 NEBULIZER. This is a submission to demonstrate substantial equivalence to a predicate device, not a study performing a rigorous evaluation against acceptance criteria as outlined in your request for new medical imaging AI/ML devices.

    Therefore, this document does not contain the information needed to answer your questions regarding:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size used for the test set and data provenance.
    3. Number of experts used to establish ground truth and their qualifications.
    4. Adjudication method for the test set.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
    6. Standalone (algorithm only) performance.
    7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
    8. Sample size for the training set.
    9. How the ground truth for the training set was established.

    Instead, the provided text focuses on the device's description, intended use, and a comparison of its physical and performance specifications (e.g., size, weight, nebulization rate, particle size) to a legally marketed predicate device (PRONEB). The "study" mentioned is implicitly the comparison of these specifications to determine "substantial equivalence" for a nebulizer, which is a mechanical device, not an AI/ML diagnostic.

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