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510(k) Data Aggregation

    K Number
    K160641
    Device Name
    Solitaire Platinum Revascularization Device, 6x40 mm
    Manufacturer
    Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
    Date Cleared
    2017-03-08

    (366 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K153071
    Why did this record match?
    Device Name :

    Solitaire Platinum Revascularization Device, 6x40 mm

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

    The Solitaire™ Platinum Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel 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.

    Device Description

    The subject 6-40-10 Solitaire™ Platinum Revascularization Device is designed to restore blood flow in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum Revascularization Device is designed for use in the neurovasculature such as the Internal Carotid Artery (ICA), M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal nitinol portion of the Solitaire™ Platinum Revascularization Device facilitates clot retrieval. The Solitaire™ Platinum Revascularization Device has Platinum Iridium radiopaque markers on the working cell length, proximal and distal ends. The subject Solitaire™ Platinum Revascularization Device is a portfolio expansion to the predicate Solitaire™ Platinum Revascularization Device (K153071).

    AI/ML Overview

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

    Device: Solitaire™ Platinum Revascularization Device (6x40 mm)

    1. Table of Acceptance Criteria and Reported Device Performance

    The provided document describes both biocompatibility testing and non-clinical bench testing. There is also clinical data leveraged from a registry.

    Biocompatibility Acceptance Criteria & Performance:

    Test CategoryTest DescriptionMethodAcceptance CriteriaReported Device Performance (Conclusion)
    CytotoxicityL929 MTT CytotoxicityISO 10993-5Viability is $\geq$ 70%.Acceptance criteria met
    SensitizationGuinea Pig Maximization SensitizationISO 10993-10Test article does not elicit a sensitization response.Acceptance criteria met
    IrritationIntracutaneous Irritation TestISO 10993-10Differences in the mean test and control scores of the extract dermal observations are $
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