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510(k) Data Aggregation

    K Number
    K050183
    Device Name
    SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
    Manufacturer
    SILVESTRIN FABRIS S.R.L.
    Date Cleared
    2005-08-16

    (201 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 SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc

    Device Description

    The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (a compressor/nebulizer). It confirms that the device is substantially equivalent to a legally marketed predicate device.

    This type of document does not contain information about:

    • Acceptance criteria or reported device performance in a clinical study. 510(k)s often rely on demonstrating equivalence to existing devices, and detailed clinical study results with specific performance metrics are not typically included in the summary of a clearance letter.
    • Sample sizes, data provenance, ground truth establishment, or expert qualifications for performance studies.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • Training set details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

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