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510(k) Data Aggregation

    K Number
    K962688
    Device Name
    MONTGOMERY RADIOPAQUE SALIVARY BYPASS TUBE
    Manufacturer
    BOSTON MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-07-25

    (14 days)

    Product Code
    KCF
    Regulation Number
    874.4420
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    KCF

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

    1. Treatment of pharyngocutaneous fistulas following laryngectorny or laryngoesophagectorny.

    2. Management of cervical esophageal and hypopharyngeal strictures and fistulas resulting from a variety of causes including surgery, radiation, advanced malignancy, trauma, and ingestion of caustic agents.

    Device Description

    The Montgomery Salivary Bypass Tube is a silicone tube with a funnel-shaped end for use in treating esophageal strictures and fistulas. The tube is available is sizes 8mm, 10mm, 12mm, 14mm, 16mm, 18mm, and 20mm (outside diameter).

    AI/ML Overview

    This document is a 510(k) summary for a medical device called the "Montgomery Radiopaque Salivary Bypass Tube." It describes the product, its intended use, and indicates that it passed cytotoxicity testing.

    However, the provided text does not contain any information regarding acceptance criteria, device performance metrics (like sensitivity, specificity, accuracy), or any details about a study evaluating its effectiveness or a comparative effectiveness study involving AI or human readers.

    Therefore, I cannot fulfill your request for information about acceptance criteria, device performance, study details, expert involvement, or ground truth establishment based on the provided input. This document focuses on the regulatory submission aspects for a traditional medical device, not a diagnostic or AI-driven system that would typically have such performance metrics reported.

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