LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033497
    Device Name
    BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2004-02-04

    (91 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K020682
    Predicate For
    K063532,K082093
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is indicated for use in the treatment of biliary strictures resulting from malignant neoplasms.

    Device Description

    The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is a stenting device, designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes a self-expanding Bard® LUMINEXX™ 3 biliary stent pre-loaded on a flexible delivery system. Highly radiopaque markers on the ends of the stent facilitate stent placement. The Bard® LUMINEXX™ 3 Biliary Stent and Delivery System is available in several diameters and lengths.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria, device performance metrics, or a study demonstrating that the device meets such criteria. The document is a 510(k) premarket notification letter for the Bard® LUMINEXX™ 3 Biliary Stent and Delivery System, which focuses on establishing substantial equivalence to a predicate device.

    Therefore, I cannot provide the requested information. The text does not include details on:

    1. A table of acceptance criteria and reported device performance.
    2. Sample size for the test set or data provenance.
    3. Number of experts used to establish ground truth or their qualifications.
    4. Adjudication method for the test set.
    5. A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. Sample size for the training set.
    9. How ground truth for the training set was established.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1