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510(k) Data Aggregation

    K Number
    K031197
    Device Name
    MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
    Manufacturer
    CORDIS CORP.
    Date Cleared
    2003-06-16

    (61 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K021898,K023217
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

    Device Description

    The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows:
    6 French stent delivery system profile;
    Stent material - Nickel Titanium alloy and tantalum micromarkers;
    Expanded stent diameters 9, and 10 mm
    Stent lengths: 100 mm;
    Stent delivery system usable length 80 and 120 cm; and
    Guidewire lumen 0.035".
    Proximal Deployment handle

    AI/ML Overview

    I am sorry, but the provided text describes a medical device (a biliary stent) and its regulatory clearance (510(k) submission). It does not contain information about studies or acceptance criteria that would allow me to populate the requested table and answer the questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or human reader performance with AI assistance. The document is primarily a regulatory summary stating substantial equivalence to predicate devices based on pre-clinical testing, rather than a clinical study report.

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