LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K974132
    Device Name
    VOICE MASTER PROSTHESIS
    Manufacturer
    E. BENSON HOOD LAB, INC.
    Date Cleared
    1998-02-25

    (114 days)

    Product Code
    EWL
    Regulation Number
    874.3730
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VOICE MASTER PROSTHESIS

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

    The VoiceMaster is to be used in patients after a Laryngectomy who would like to restore their vocal abilities.

    Device Description

    This device is an indwelling voice prosthesis, with a one-way ball valve, designed to fit into a tracheo-esophageal fistula.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria. The document is a 510(k) summary for a medical device (VoiceMaster Prosthesis) and the FDA's clearance letter for it.

    The 510(k) summary:

    • Identifies the product (VoiceMaster Prosthesis) and its intended use (restoring vocal abilities after a laryngectomy).
    • Compares it to predicate devices (Groningen Voice Prosthesis, Panje Voice Prosthesis, Provox Voice Prosthesis), highlighting similarities in body design and material, and a difference in valve design (ball valve vs. slit/flap valves).

    The FDA clearance letter:

    • Confirms the device is substantially equivalent to legally marketed predicate devices.
    • States that the device can be marketed.

    Therefore, I cannot provide the requested information in the table format or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement, as this information is not present in the provided text.

    To answer your request, a different type of document (e.g., a clinical study report, a detailed performance testing protocol, or a more comprehensive premarket submission) would be required.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1