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510(k) Data Aggregation

    K Number
    K180023
    Device Name
    WIRION
    Manufacturer
    Gardia Medical Ltd.
    Date Cleared
    2018-03-21

    (77 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Cardiovascular (CV)
    Reference & Predicate Devices
    K143570,K111010
    Why did this record match?
    Applicant Name (Manufacturer) :

    Gardia Medical Ltd.

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

    WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.

    The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

    Device Description

    WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.

    AI/ML Overview

    The document describes the acceptance criteria and study findings for the WIRION™ Embolic Protection System (EPS).

    Here's the breakdown of the requested information:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance CriteriaReported Device Performance
    Primary Study Endpoint: Freedom from Major Adverse Events (MAE) to 30 days post-procedure. Historic controls average MAE rate: 10.6%. Performance Goal (PG) for WIRION™ was not explicitly stated as a numerical value but the study aimed to show superiority/non-inferiority to the historical control.MAE Rate: 1.9% (2 out of 103 patients). The P-value obtained (
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