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510(k) Data Aggregation

    K Number
    K070411
    Device Name
    AMSURE NEBULIZER
    Manufacturer
    AMSINO INTERNATIONAL, INC.
    Date Cleared
    2007-10-01

    (231 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K930525
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The AMSURE® Nebulizer is intended for the administration of various aerosol treatments in both the homecare and hospital settings. This device is intended for use only with FDA-approved drugs for nebulization, under the direction of a physician. It can be used for both pediatric and adult patient populations.

    Device Description

    The AMSure ® Nebulizer is a single-use patient device, which is filled with fluid, typically respiratory medication and connected to a source of compressed via flexible tubing. The nebulizer delivers aerosolized fluids for patient inhalation in the respirable range of approximately 1.0µm to 5.0µm. It operates on a compressed gas source which draws liquids from a refillable cup by the Venturi Principle and aerosolizes it by impaction and baffling.

    AI/ML Overview

    The AMSure® Nebulizer 510(K) Submission (K070411) identifies "Non-Clinical Testing" as the study proving the device meets acceptance criteria. The submission states, "Performance and biocompatibility testing has demonstrated that the AMSure® Nebulizer is safe and effective for its intended use."

    However, the provided text does not contain specific acceptance criteria or detailed reported device performance metrics in a table. It also lacks information regarding sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or the specific type and establishment of ground truth for either training or testing sets.

    The information provided only broadly states that the device's performance and biocompatibility testing support its safety and effectiveness relative to its predicate device (Hudson RCI Micro Mist® (K930525)). The comparison to the predicate device emphasizes operational principle, materials, design, technical characteristics, and intended use, stating that "Any differences do not affect the intended use or the safety and effectiveness of the device."

    Therefore, based solely on the provided text, a comprehensive answer to your request is not possible beyond the high-level statement about non-clinical testing. The document does not offer the granular detail typically associated with acceptance criteria and detailed study results for a medical device.

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