LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K040439
    Device Name
    MDI TRIGGER GUARD
    Manufacturer
    NORTH AMERICAN TECHNICAL SERVICES (NATS) CORP.
    Date Cleared
    2004-07-08

    (140 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 MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation. Intended for use by entire patient population for which metered dose inhalers are approved, excluding children under the age of 8. Device is not reusable. Device is to be used for the life of the metered dose inhaler, then discarded.

    Device Description

    The MDI Trigger Guard serves as a mechanical stop intended to be used with FDA approved metered dose inhalers. The MDI Trigger Guard is an accessory to a metered dose inhaler to prevent accidental actuation.

    AI/ML Overview

    I am sorry, but the provided text from the FDA 510(k) summary for the "MDI Trigger Guard" (K040439) does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

    This document is a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices, and an "Indications for Use" statement. It explicitly mentions that the FDA's determination of substantial equivalence does not mean the device complies with other requirements, including those related to performance studies.

    Therefore, I cannot provide:

    1. A table of acceptance criteria and reported device performance: This information is not present in the document.
    2. Sample size used for the test set and data provenance: Not available.
    3. Number of experts used to establish ground truth and their qualifications: Not available.
    4. Adjudication method for the test set: Not available.
    5. Multi-reader multi-case (MRMC) comparative effectiveness study details: Not available. The device is a mechanical accessory, not an AI or imaging device that would typically involve such studies.
    6. Standalone performance study details: Not available.
    7. Type of ground truth used: Not available.
    8. Sample size for the training set: This refers to AI algorithms, which is not applicable here.
    9. How ground truth for the training set was established: Not applicable.

    The document focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with specific acceptance criteria as you've described for AI/diagnostic devices.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1