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510(k) Data Aggregation

    K Number
    K962178
    Device Name
    BARD TIGER GUIDEWIRE MODEL 000540
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1996-10-29

    (145 days)

    Product Code
    OCY
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Bard@ Tiger™ guidewire is indicated for use with devices having a .035" guidewire compatible lumen. The Tiger guidewire is designed to guide and exchange endoscopic accessories into the G.I. Tract, including, but not limited to, the common bile, cystic, the right, and left hepatic and pancreatic ducts. It is not necessary to withdraw or remove the Tiger guidewire during sphincterotomy.

    Device Description

    The Bard@ Tiger™ guidewire is indicated for use with devices having a .035" guidewire compatible lumen. The Tiger guidewire is designed to guide and exchange endoscopic accessories into the G.I. Tract, including, but not limited to, the common bile, cystic, the right, and left hepatic and pancreatic ducts. It is not necessary to withdraw or remove the Tiger guidewire during sphincterotomy. The Tiger guidewire core material is a composite of Bisphenol A Epoxy and fibers, while the Zebra exchange and FlexFinder guidewires are constructed of Nitinol. The Tiger guidewire jacket material is polyethylene, while the Zebra exchange and FlexFinder quidewires are constructed out of the following plastics: Fluropolymer, Urethane, and polyester.

    AI/ML Overview

    The provided 510(k) summary for the TIGER™ GUIDEWIRE 6.0 does not contain information on acceptance criteria, device performance, or any studies with the specified details. The document focuses on establishing substantial equivalence to predicate devices based on design, materials, and intended use.

    Therefore, I cannot provide the requested information in the table format or answer the subsequent questions based solely on the given input.

    The document discusses:

    • Intended Use: Guiding and exchanging endoscopic accessories into the G.I. Tract.
    • Predicate Devices: Boston Scientific Zebra™ Exchange Guidewire, Flexmedics FlexFinder Guidewire, and Davol Laparoscopic Suction Irrigation Probe.
    • Similarities and Differences: Primarily material composition of the core and jacket. The TIGER™ guidewire uses Bisphenol A Epoxy and fibers for the core and polyethylene for the jacket, while predicate devices use Nitinol and other plastics.

    There is no mention of:

    1. Acceptance criteria or device performance numbers.
    2. Sample sizes for test sets, data provenance, or training sets.
    3. Number or qualifications of experts.
    4. Adjudication methods.
    5. MRMC studies or effect sizes.
    6. Standalone algorithm performance.
    7. Type of ground truth used.
    8. How ground truth was established.
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