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    K Number
    K203219
    Device Name
    Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever
    Manufacturer
    Stryker Neurovascular
    Date Cleared
    2020-12-29

    (57 days)

    Product Code
    POL,NRY
    Regulation Number
    882.5600
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K190779,K200117
    Why did this record match?
    Device Name :

    Trevo XP ProVue Retriever and Trevo NXT™ ProVue Retriever

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
    2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
    3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-MI segments with smaller core infarcts (0-50 cc for age
    Device Description

    The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

    AI/ML Overview

    This document describes the Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever, neurovascular mechanical thrombectomy devices reviewed under K203219. The submission confirms substantial equivalence to previous devices (K190779 and K200117) made by the same manufacturer. The core argument for substantial equivalence relies on the fact that the indications for use, materials, manufacturing processes, design, technology, biocompatibility, packaging, and sterilization methods remain the same, with the only change being a modification to the core wire dimension.

    Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

    1. Table of Acceptance Criteria and Reported Device Performance

    The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it provides a summary of various bench tests and their "Conclusions," stating that "Device integrity met acceptance criteria," "Deliverability force met acceptance criteria," etc. The specific quantitative acceptance values are not detailed.

    TestTest Method SummaryConclusions (Reported Device Performance)
    Insertion Tool Use, DimensionsEvaluate device integrity after use of insertion tool. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.Device integrity met acceptance criteria.
    Retriever / Microcatheter Deliverability (Track Test- First Push)Measure the force required to track a retriever through a microcatheter placed in a clinically relevant vasculature model.Deliverability force met acceptance criteria.
    Retriever In-Vivo ResheathabilityEvaluate device integrity after re-sheathing into microcatheter. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.Device integrity met acceptance criteria.
    Retractability of Retriever into Balloon Guide CatheterEvaluate device integrity after retracting retriever into Balloon Guide Catheter. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.Device integrity met acceptance criteria.
    Retriever Shaft Kink ResistanceEvaluate device integrity after tracking through a tortuous anatomy. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.Device integrity met acceptance criteria.
    Reloadability into Insertion ToolEvaluate device integrity after reloading retriever into insertion tool. Device prepared per IFU, inspected, subjected to 3 runs of simulated use in a clinically relevant vasculature model, and inspected after each run.Device integrity met acceptance criteria.
    Retriever Shaped Section Torque/Tensile DurabilityDetermine durability of shaped section after multiple torque and tensile loading cycles. Apply two clockwise (CW) or counter clockwise (CCW) revolutions and load proximal 50% of exposed shaped section to 1.7 lbf five times, then pull to failure. Acceptance: Device shall withstand six cycles at 1.7 lbf before fracture.Torque/tensile durability met acceptance criteria.
    Retriever Proximal Curl ResistanceDetermine if curl formation is present after the required revolutions. Apply 5 clockwise (CW) or 5 counter clockwise (CCW) revolutions. Acceptance: Core wire shall not form a curl or fracture.Curl resistance met acceptance criteria.
    Retriever Mid Joint Tensile StrengthDetermine mid joint tensile strength. Identify mid solder joint(s) and subject to tensile testing. Acceptance: Device shall withstand 1.7 lbf minimum before wire or solder joint failure.Mid Joint Tensile met acceptance criteria.
    Retriever platinum wire and joint durabilityDetermine durability of platinum wire weaves and solder joints. Identify Mid-Joint, position tubing with Retriever inside, wrap tubing containing shaped section around Dowel Pin (one layer) until entire shaped section is wrapped around pin, unwrap and repeat for 6 times. Unsheath and examine.Platinum wire and joint met acceptance criteria.
    Retriever platinum wire joint tensile strengthDetermine platinum wire solder joint tensile strength. Free Platinum wires, unweave from Nitinol struts. Subject joint to tensile testing. Acceptance: Joint shall withstand 0.1 lbf minimum before wire or solder joint failure.Platinum wire solder joint met acceptance criteria.
    ISO FractureTesting for fracture based on EN ISO 11070:2014, Annex F. Retriever wire wound around a cylindrical former (
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