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510(k) Data Aggregation

    K Number
    K163444
    Device Name
    Spectre guidewire
    Manufacturer
    Vascular Solutions, Inc.
    Date Cleared
    2017-01-06

    (29 days)

    Product Code
    DQX
    Regulation Number
    870.1330
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K161702
    Predicate For
    K173532,K180128
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spectre guidewire is intended for use in percutaneous procedures to introduce and position cather interventional devices within the coronary and/or peripheral vasculature.

    Device Description

    The Spectre guidewire is a straight tip guidewire with a maximum outer diameter of 0.014" available in 190 cm and 300 cm lengths. The Spectre guidewire consists of a bi-metal stainless steel and nitinol core wire covered on the distal end by a radiopaque coil at the distal tip. The distal end of the Spectre guidewire has a hydrophilic coating (HPC) and the proximal end is coated with polytetrafluoroethylene (PTFE). The 190 cm length model is compatible with a guidewire extension.

    AI/ML Overview

    This document is a 510(k) premarket notification for a medical device called the "Spectre Guidewire." It's a review by the FDA determining substantial equivalence to a predicate device, not a study describing AI performance or complex acceptance criteria for an AI device.

    Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, MRMC study, training set details, ground truth for training) cannot be found in this document because it is not relevant to a typical 510(k) submission for a non-AI medical device.

    However, I can extract the acceptance criteria and study information that is present:

    1. A table of acceptance criteria and the reported device performance

    Acceptance Criteria / Performance AspectReported Device PerformanceStudy that proves the device meets the acceptance criteria
    Indications for UseIntended for use in percutaneous procedures to introduce and position catheters and other interventional devices within the coronary and/or peripheral vasculature.Substantial equivalence to predicate device (Endura Guidewire, K161702) based on comparison of specifications and bench tests.
    Anatomical LocationCoronary and peripheral vasculatureSubstantial equivalence to predicate device.
    DimensionsMaximum O.D.: 0.014", Length: 190 cm and 300 cmSubstantial equivalence to predicate device.
    Core Wire MaterialNitinol and Stainless SteelSubstantial equivalence to predicate device.
    Distal Tip3 cm radiopaque coilSubstantial equivalence to predicate device.
    Lubricious CoatingsHydrophilic (distal end) and PTFE (proximal end)Substantial equivalence to predicate device.
    SterilityEthylene Oxide (EO) – Sterility Assurance Level (SAL) 10-6Substantial equivalence to predicate device.
    Track ForceMet specified acceptance criteria.Bench tests
    Guidewire Support ProfileMet specified acceptance criteria.Bench tests

    Explanation for missing sections:

    • 2. Sample size used for the test set and the data provenance: Not applicable. This device is a guidewire, not an AI or diagnostic tool that uses a "test set" in the context of imagery or clinical data. The "test set" here refers to the guidewire samples used in bench testing. The document does not specify the number of guidewires tested for Track Force or Guidewire Support Profile.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a guidewire's physical properties (like track force) is established through physical measurement, not expert consensus.
    • 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for physical 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 not an AI-powered device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical tests like track force and guidewire support profile, the ground truth is based on engineering specifications and physical measurements.
    • 8. The sample size for the training set: Not applicable. This is not an AI-powered device.
    • 9. How the ground truth for the training set was established: Not applicable. This is not an AI-powered device.
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