LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K091272
    Device Name
    BESMED JET NEBULIZER BOTTLE SET
    Manufacturer
    BESMED HEALTH BUSINESS CORP.
    Date Cleared
    2009-11-10

    (194 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K052811
    Why did this record match?
    Device Name :

    BESMED JET NEBULIZER BOTTLE SET

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

    The BESMED Jet Nebulizer Bottle Set is used to administer various aerosol treatments to adult and pediatric patients in both the homecare and hospital settings. Its use is indicated whenever a physician or healthcare professional administers or prescribes medical aerosol products to a patient using a Small Volume Nebulizer.

    Device Description

    The MAXHEALTH Air Nebulizer is intended to spray liquid medications in aerosol fonn into gases that re directly delivered to the patient.

    AI/ML Overview

    The information provided describes the acceptance criteria and a study to demonstrate substantial equivalence for the BESMED Jet Nebulizer Bottle Set, Model PN-1128E, as part of a 510(k) submission.

    This is a device for administering aerosol treatments. The studies conducted are primarily performance and biocompatibility tests, rather than studies involving human readers or AI algorithms for diagnostic purposes. Therefore, some of the requested information (like MRMC studies, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets in the context of AI) is not applicable to this type of device and submission.

    Here's a breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document doesn't explicitly list "acceptance criteria" in a quantitative table format for performance beyond what's compared with the predicate device. However, it indicates conformity to relevant standards and a comparative analysis.

    AspectAcceptance Criteria (Implied by equivalence to predicate & standards)Reported Device Performance
    Intended UseAdminister aerosol treatments to adult/pediatric patients; home/hospital. Used with FDA approved drugs as prescribed.SAME as predicate device (HSINER Jet Nebulizer, K052811)
    PrincipleAerosolizes liquid into aerosol form by compressing air.SAME as predicate device
    Capacity of Medication Cup6 mlSAME as predicate device (6 ml)
    Particle Size
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1