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510(k) Data Aggregation

    K Number
    K100135
    Device Name
    GDS-DC12
    Manufacturer
    GUIDED DELIVERY SYSTEMS
    Date Cleared
    2010-04-16

    (87 days)

    Product Code
    DQY,DOY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K091367,K043489
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    GDS-DC12 is intended to facilitate the intracardiac placement of interventional devices such as guidewires.

    Device Description

    GDS-DC12 is a polymeric, single use, sterile, non-pyrogenic, disposable intracardiac catheter of various sizes and curvatures with a deflectable tip and hemostasis valve.

    AI/ML Overview

    The provided text describes a GDS-DC12 Cardiac Introducer Sheath and its 510(k) premarket notification for FDA clearance, not an AI device. Therefore, the questions related to AI studies (sample size, experts, adjudication, MRMC, standalone performance, training set details) are not applicable.

    However, I can extract the acceptance criteria and the summary of the study showing the device meets these criteria, which are primarily bench testing and biocompatibility assessments for a medical device.

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Performance Characteristic)Reported Device Performance (Summary)
    Dimensional measurements (OD, ID, Lengths)In compliance with design input requirements.
    Torsional ResponseIn compliance with design input requirements.
    Pull Wire MovementIn compliance with design input requirements.
    Corrosion ResistanceIn compliance with design input requirements.
    Shaft to Hub TensileIn compliance with design input requirements.
    Shaft TensileIn compliance with design input requirements.
    Pull Wire TensionIn compliance with design input requirements.
    Tip TensileIn compliance with design input requirements.
    Torque TestIn compliance with design input requirements.
    Shaft Leak Under PressureIn compliance with design input requirements.
    Shaft Leak Under VacuumIn compliance with design input requirements.
    Catheter Flexibility/Kink ResistanceIn compliance with design input requirements.
    Catheter Turns To FailureIn compliance with design input requirements.
    RadiopacityLeveraged from predicate device GDS-DC6 (K091367).
    BiocompatibilityComplies with ISO 10993.
    SterilizationDevice is sterile.
    PackagingPackaging is robust and maintains a sterile barrier.
    Shelf lifeMaintains a sterile barrier for the stated expiration time.

    Study Details:

    1. Sample size used for the test set and the data provenance: Not explicitly stated for each test, but the studies were bench testing, sterilization/packaging/shelf life testing, and biocompatibility testing. This indicates the data provenance is from laboratory tests, not human data, and thus is prospective from a manufacturing/testing standpoint. The country of origin of the testing is not specified, but the sponsor is a US company (Guided Delivery Systems, Inc., Santa Clara, CA).

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For engineering performance tests, ground truth is established by meeting predefined specifications and standards, not by expert consensus on observational data. Biocompatibility follows ISO 10993.

    3. Adjudication method: Not applicable. Performance is measured against objective engineering specifications and international standards (e.g., ISO 10993 for biocompatibility), not through adjudication of expert opinions.

    4. 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, as this is not an AI device.

    5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

    6. The type of ground truth used:

      • For performance characteristics: Engineering specifications/design input requirements and industry expectations/product labeling.
      • For biocompatibility: ISO 10993 standards.
      • For radiopacity: Leveraged from predicate device (K091367), indicating its ground truth was established during the predicate's clearance.

    7. The sample size for the training set: Not applicable, as this is not an AI device.

    8. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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