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510(k) Data Aggregation

    K Number
    K972484
    Device Name
    ACS VIKING GUIDING CATHETER
    Manufacturer
    GUIDANT CORP.
    Date Cleared
    1997-09-26

    (86 days)

    Product Code
    DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K953987
    Why did this record match?
    Device Name :

    ACS VIKING GUIDING CATHETER

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

    The ACS VIKING TH Guiding Catheter is intended to provide a pathway through which therapeutic and diagnostic devices are introduced.

    Device Description

    The ACS VIKING™ Guiding Catheter is available in five diameters. The catheter has a standard length of 100 cm, but can be produced in lengths from 40 to 160 cm. The ACS VIKING™ Guiding Catheter is available in varying tip shapes. The guiding catheter has a radiopaque shaft, which varies in stiffness at the distal end. The catheter has a radiopaque soft tip and is available with or without side holes.

    AI/ML Overview

    The provided document is a 510(k) summary for the ACS VIKING™ Guiding Catheter. It focuses on demonstrating substantial equivalence to a predicate device (ACS TOURGUIDE™ Coronary Guiding Catheter, K953987) rather than providing detailed acceptance criteria and a study report proving the device meets those criteria.

    Therefore, the specific information requested about acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC, standalone performance, training set) is not available within this document.

    The document indicates that the substantial equivalence is based on:

    • Indications, methods and conditions of use, packaging, sterilization, and bench test results being identical to the predicate device.
    • Similar design to the predicate device.
    • Biocompatibility testing showing acceptability for clinical use.

    Since this submission is for a medical device that achieves regulatory approval through a 510(k) pathway, the primary "acceptance criterion" is demonstrating substantial equivalence to a legally marketed predicate device. The study that "proves" this is a comparison of various characteristics, largely through bench testing and material comparisons, against the predicate device.

    Without the specific study report, it's impossible to fill out the requested table and answer the detailed questions. The document only offers a high-level summary of the basis for equivalence.

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