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510(k) Data Aggregation

    K Number
    K032849
    Device Name
    AERONEB GO NEBULIZER, MODEL AG-AG2000
    Manufacturer
    AEROGEN, INC.
    Date Cleared
    2003-11-21

    (70 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology (AN)
    Reference & Predicate Devices
    K963924,K923024
    Why did this record match?
    Device Name :

    AERONEB GO NEBULIZER, MODEL AG-AG2000

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

    The Aeroneb Go nebulizer, for use by pediatric and adult patients, is intended to aerosolize physician-prescribed solutions for inhalation that are approved for use with a general-purpose nebulizer.

    Device Description

    The Aeroneb Go nebulizer uses the OnQ™ Aerosol Generator, which is comprised of a unique dome shaped aperture plate containing over 1,000 precision-formed tapered holes surrounded by a vibrational element. When energy is applied, the aperture plate vibrates approximately 100,000 times per second. This rapid vibration causes each aperture to act as a micropump, drawing liquid through the holes to form consistently sized droplets. The Aeroneb Go nebulizer is lightweight, compact and silent. The device can be powered with the AC Power Controller or with the Battery Powered Controller that uses three "AA" disposable batteries.

    AI/ML Overview

    Here's an analysis of the provided text regarding the Aeroneb Go Nebulizer, matching the requested criteria:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided 510(k) summary does not explicitly list "acceptance criteria" with specific quantitative thresholds. Instead, it states that performance evaluations were conducted and demonstrated "substantial equivalence" to predicate devices. The performance evaluations focused on "nebulizer delivery characterization, electrical, mechanical, and EMC safety."

    Acceptance Criteria (Implied)Reported Device Performance
    Nebulizer delivery characterization meets standards of predicate devices.The Aeroneb Go nebulizer was found to be "substantially equivalent to the other legally marketed devices in performance" after non-clinical performance tests comparing it to the Aeroneb Portable Nebulizer System, the Pari LC Star, and the Omron MicroAir.
    Electrical safety meets relevant standards."Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with electrical safety, as it was a stated evaluation area).
    Mechanical safety meets relevant standards."Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with mechanical safety, as it was a stated evaluation area).
    EMC safety meets relevant standards."Successful tests demonstrated the device consistently performed within its design parameters." (Implies compliance with EMC safety, as it was a stated evaluation area).
    Consistent performance within design parameters."The successful tests demonstrated the device consistently performed within its design parameters."

    2. Sample Size Used for the Test Set and Data Provenance

    The document refers to "non-clinical performance tests." It does not specify a sample size for the test set. It also does not provide information about the data provenance (e.g., country of origin, retrospective/prospective), as these were non-clinical, likely bench tests.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

    This section is not applicable. The verification did not involve human interpretation or expert-established ground truth in the way a diagnostic imaging study would. The performance was assessed against technical specifications and comparison to predicate devices.

    4. Adjudication Method for the Test Set

    This section is not applicable. There was no need for adjudication as the testing involved objective measurements and comparisons to predicate device performance.

    5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    This section is not applicable. The device is a nebulizer, not an AI-assisted diagnostic tool.

    6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

    This section is applicable in the sense that the device's performance was assessed independently of human interaction for its core function (aerosolizing solutions). The "standalone" performance is the focus of the non-clinical tests.

    7. The Type of Ground Truth Used

    The "ground truth" for the performance evaluation was established by:

    • Technical specifications/design parameters: The device was tested to ensure it performed consistently within its intended design.
    • Comparison to predicate devices: The performance metrics (likely particle size distribution, nebulization rate, etc.) were compared against those of already-approved predicate nebulizers. The FDA guidance for nebulizers (October 1, 1993) also likely served as a reference for expected performance characteristics.

    8. The Sample Size for the Training Set

    This section is not applicable as this is not an AI/machine learning device that requires a training set.

    9. How the Ground Truth for the Training Set Was Established

    This section is not applicable as this is not an AI/machine learning device that requires a training set.

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