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510(k) Data Aggregation

    K Number
    K250787
    Device Name
    Liberant Thrombectomy System
    Manufacturer
    Medtronic, Ireland
    Date Cleared
    2025-06-11

    (89 days)

    Product Code
    QEW
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K142870,K192981,K193244
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Liberant Thrombectomy System is indicated for the removal of fresh, soft emboli or thrombi from the vessels of the peripheral arterial and venous systems.

    Device Description

    The Liberant Thrombectomy System consists of the Liberant Thrombectomy Set (catheter, clotbuster, dilator, aspiration tubing and hemostasis valve), Liberant Blood Conservation Unit (BCU), Riptide Aspiration Pump and Riptide Collection Canister with intermediate tubing. The Liberant Thrombectomy Set is single use and provided sterile.

    The Liberant BCU and Riptide Pump are provided separately from the Liberant Thrombectomy Set as non-sterile capital units. The single use, non-sterile Riptide Collection Canister is provided separately to the pump.

    AI/ML Overview

    The provided FDA 510(k) clearance letter pertains to a thrombectomy system, which is a physical medical device (catheter-based system) used for removing blood clots. It is not an AI/ML device. Therefore, the request for acceptance criteria and study details relevant to AI/ML devices, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone performance, cannot be answered from the provided text.

    The document focuses on the substantial equivalence of the Liberant Thrombectomy System to a predicate device (Penumbra Indigo Aspiration System) based on:

    • Indications for Use: Both systems are indicated for the removal of fresh, soft emboli or thrombi from peripheral arterial and venous systems.
    • Operating Principle/Technological Design: Both utilize continuous aspiration and fragmentation tools (clotbuster/separator).
    • Catheter Specifications: Similar sizes, lengths, and guidewire compatibility.
    • Non-Clinical Data: Extensive performance, biocompatibility, shelf-life, sterilization, packaging, software validation (for the pump control), and electrical/EMC testing were performed. This type of "software validation" typically refers to embedded software controlling the pump mechanics, not an AI/ML diagnostic or predictive algorithm.

    Therefore, I cannot provide the requested information regarding AI/ML device acceptance criteria and study details because the provided document describes a non-AI medical device.

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