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510(k) Data Aggregation

    K Number
    K980119
    Device Name
    ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIRE
    Manufacturer
    GUIDANT CORP.
    Date Cleared
    1998-03-20

    (66 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K852123,K861765,K915554,K942382
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is intended to facilitate the placement and exchange of diagnostic and therapeutic devices during intravascular procedures. It is not intended for use in the cerebral vasculature.

    Device Description

    The ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire is a steerable guide wire with a nominal diameter of 0.035 inches and three lengths: a 145, a 190 cm and a 300 cm exchange length.

    AI/ML Overview

    The provided text describes a 510(k) submission for a medical device, the ACS HI-TORQUE WHOLEY SUPRA CORE™ Guide Wire, and thus does not contain information about software or AI. Therefore, most of the requested fields related to AI/software performance studies are not applicable.

    Here's the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Distal Tip Pull TestMaintain performance similar to predicate deviceMet acceptance criteria, performed similar to predicate device
    Turns-to-Failure TestMaintain performance similar to predicate deviceMet acceptance criteria, performed similar to predicate device
    Rotational Accuracy TestMaintain performance similar to predicate deviceMet acceptance criteria, performed similar to predicate device
    Tip Flexibility TestMaintain performance similar to predicate deviceMet acceptance criteria, performed similar to predicate device

    Note: The document states that the new device "met the acceptance criteria and performed similar to the predicate Wholey Hi-Torque Standard® Guide Wire" for all listed tests, implying that the acceptance criteria were set based on the performance of the predicate device. Specific numerical acceptance values or performance metrics are not provided in this summary.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
    Not applicable. This was bench testing, not a clinical study involving human data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
    Not applicable. Ground truth for bench tests is based on engineering specifications and physical measurements, not expert human assessment.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
    Not applicable. This was bench testing.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
    Not applicable. This is a physical medical device (catheter guide wire), not an AI/software device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
    Not applicable. This is a physical medical device.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
    For bench tests, the ground truth is established by engineering standards, physical measurements, and comparison to the predicate device's known performance.

    8. The sample size for the training set
    Not applicable. This is a physical medical device.

    9. How the ground truth for the training set was established
    Not applicable. This is a physical medical device.

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