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510(k) Data Aggregation

    K Number
    K033393
    Device Name
    ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
    Manufacturer
    GUIDANT CORP.
    Date Cleared
    2003-11-10

    (18 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Type
    Special
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K014184,K021898,K982346,K020052,K030638
    Why did this record match?
    Reference Devices :

    K014184,H020002,K021898,K982346,K020052,K030638

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

    The ABSOLUTE™ .035 Biliary Self-Expanding Stent System is intended for palliation of malignant strictures in the biliary tree.

    Device Description

    The ABSOLUTE™ Biliary Self-Expanding Stent System is comprised of the ABSOLUTE™ stent pre-mounted on an over-the-wire delivery system. The delivery catheter consists of three coaxial members (an inner member, a retractable outer member, and an outer, outer member), a guide wire lumen, a distal soft tip and a proximal handle with retraction and locking features. The distal section of the outer member constrains the stent on the inner member. Deployment of the ABSOLUTE™ stent occurs when the outer member is retracted by activating the retraction features in the handle.

    AI/ML Overview

    The provided text is a 510(k) Summary for the Guidant ABSOLUTE™ .035 Biliary Self-Expanding Stent System. It declares substantial equivalence to predicate devices based on technological characteristics and performance data. However, it does not contain the detailed information required to fill out the requested table and study details.

    Specifically, the document states:

    • "The results of the in vitro bench tests and analyses demonstrated the safety and effectiveness of the ABSOLUTE™ .035 Biliary Self-Expanding Stent System."

    This is a general statement and does not provide:

    1. A table of specific acceptance criteria.
    2. Reported device performance against those criteria (e.g., specific measurements, thresholds, or statistical results).
    3. Details about the study design (sample sizes, data provenance, ground truth establishment, expert qualifications, etc.).
    4. Information on MRMC studies or standalone algorithm performance.

    Therefore, I cannot extract the requested information from the provided text. The document focuses on demonstrating substantial equivalence through a summary of technological characteristics and a general assertion of safety and effectiveness from bench tests, rather than providing the detailed clinical or performance study data one would expect for an AI/device performance study with specific acceptance criteria.

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