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510(k) Data Aggregation

    K Number
    K990713
    Device Name
    SPECTRANETICS LEAD LOCKING DEVICE (LLD) #1, #2, #3 LISTER
    Manufacturer
    SPECTRANETICS CORP.
    Date Cleared
    1999-10-22

    (232 days)

    Product Code
    DRB
    Regulation Number
    870.1380
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K970690
    Why did this record match?
    Reference Devices :

    K970690

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

    The Spectranetics Lead Locking Devices, LLD™, are intended for use in patients suitable for transvernous removal of chronically implanted pacing or defibrillator leads having an inner lumen and using a superior venous approach. The lead inner lumen must have an inner diameter (ID) range from 0.013 - 0.032 inches (0.33 - 0.81 mm) and a length less than 25.6 inches (65 cm).

    Device Description

    Lead Locking Devices are percutaneous wire stylets which are placed inside the central lumen of a pacemaker or defibrillator lead as a fixation mechanism to provide traction for the extraction of the lead.

    AI/ML Overview

    The provided text is a 510(k) summary for the Spectranetics Lead Locking Device (LLD™). It describes the device, its intended use, and claims substantial equivalence to a predicate device (Wilkoff Locking Stylet, K970690).

    However, the document does not contain the information requested regarding acceptance criteria and a detailed study proving the device meets those criteria. Specifically, the following information is not present:

    • A table of acceptance criteria and reported device performance.
    • Sample size used for the test set and data provenance.
    • Number of experts used to establish ground truth and their qualifications.
    • Adjudication method for the test set.
    • Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Information about a standalone (algorithm only) performance study.
    • The type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.

    The document states that a "Design validation protocols and the Design Failure Mode, Effect and Criticality Analysis (FMECA), addressed all known risks associated with the device including tensile strength, bond joints, tracking, locking and unlocking, visibility, trackability and biocompatibility. Testing performed for the Lead Locking Device provides reasonable assurance that the devices will perform in a safe and effective manner when used as indicated." This statement indicates that testing was performed, but it does not provide details on the specific acceptance criteria, test results, or study methodologies that would allow for a complete answer to your request.

    Therefore, I cannot provide the requested table or detailed study information based on the input text.

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