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510(k) Data Aggregation

    K Number
    K080901
    Date Cleared
    2008-10-02

    (185 days)

    Product Code
    Regulation Number
    870.5150
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    LBI EMBOLECTOMY SYSTEM

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

    The LBI Embolectomy System is indicated for use in removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.

    Device Description

    The system consists of a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529) and a fiber element on a 0.014" guide wire with attachable actuator tool. System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40um cell strainer cup.

    AI/ML Overview

    The provided text is a 510(k) premarket notification summary for the LBI Embolectomy System. It does not describe an AI/ML medical device, nor does it contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or comparative effectiveness with human readers.

    Therefore, I cannot fulfill your request for this specific document.

    The document discusses the substantial equivalence of the LBI Embolectomy System to legally marketed predicate devices, focusing on:

    • Intended Use: Removal of fresh, soft emboli and thrombi from vessels in the peripheral vasculature.
    • Device Description: A 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly and a fiber element on a 0.014" guidewire with an attachable actuator tool, along with accessories.
    • Safety & Performance: Demonstrated through comparison to predicate devices, biocompatibility testing, in vitro testing, and animal testing.

    No information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance metrics (e.g., sensitivity, specificity, AUC) is present.

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