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510(k) Data Aggregation

    K Number
    K173452
    Device Name
    EmboTrap ll Revascularization Device
    Manufacturer
    Neuravi Ltd.
    Date Cleared
    2018-05-09

    (184 days)

    Product Code
    NRY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K122478,K113455
    Predicate For
    K193063,K211338,K212908
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The EmboTrap® II Revascularization Device 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.

    Device Description

    The EmboTrap® II Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EmboTrap® II Revascularization Device is supplied sterile, and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke. It is indicated for patients who are ineligible for intravenous tissue plasogen activator (IV t-PA) or who fail IV t-PA therapy.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

    Acceptance Criteria and Device Performance

    Criteria CategoryAcceptance CriteriaReported Device Performance and Conclusion
    BiocompatibilityAll biocompatibility tests (MTT Cytotoxicity, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, ISO Systemic Toxicity, USP Rabbit Pyrogen, ASTM Hemolysis, Complement Activation Assay) must meet pre-assigned acceptance criteria.All biocompatibility tests completed met the pre-assigned acceptance criteria. The device was found to be non-cytotoxic, not a sensitizer, not an irritant, non-toxic, non-pyrogenic, non-hemolytic, and had acceptable levels of C3a and SC5b-9.
    SterilizationDevice must be EO-sterilized to achieve a minimum SAL of 10-6.The sterilization process was successfully validated and process monitoring controls assure a minimum SAL of 10-6.
    Shelf LifeShelf life studies must establish that the product and packaging remain functional and sterile for a period of 3 years.Shelf life studies established that the product and packaging remain functional and sterile for a 3-year shelf life.
    In Vitro (Bench) TestingDevice must fulfill all pre-determined product performance specification requirements for: Dimensional Testing (Radial Force, Outer Cage Recovery, Device Durability/Integrity, Joint Strength), Flexibility & Kink Resistance Testing (Torque Durability, Corrosion Resistance, Radiopacity, Tip Flexibility, Re-sheathing Force), Simulated Use/Performance Testing (Coating Integrity, Particulate Evaluation). Performance must be comparable to predicate devices.The device fulfilled all pre-determined product performance specifications. Side-by-side bench testing showed the EmboTrap® II to be comparable or superior to its predicate devices in terms of performance and functionality for all tested characteristics (System Dimensions, Tip Flexibility, Re-sheathing force, Delivery and re-sheathing force during simulated use, Durability Testing, System Kink Resistance, Kink Resistance - Deployed Shaped Section, Distal Coil Tensile Testing, System Tensile Testing, Torque Testing in a Microcatheter, Torque Strength Testing, Radial Force Testing, Radiopacity, Clot retrieval and performance, and Physician usability testing).
    In Vivo (Animal) StudiesUsability, effectiveness, and safety must be assessed in a swine model compared to predicate devices. Local and end organ tissue response must be comparable to predicate devices.Acute performance on Day 0 showed equivalent usability and performance to the predicate device. Histological evaluation after 3 and 28 days demonstrated comparable local and end organ tissue response between the EmboTrap® II and predicate devices.
    Clinical Efficacy (Primary Endpoint)Revascularization rate (mTICI 2b or greater in the target vessel following 3 or less passes of the EmboTrap® device without rescue therapy) must be statistically significantly greater than a performance goal (NL) of 0.56 (56%). Null Hypothesis (H0: PEmboTrap ≤ 0.56) should be rejected in favor of the Alternative Hypothesis (H1: PEmboTrap > 0.56) at a one-sided Exact test for a binomial proportion at the 5% significance level.The successful revascularization rate was 72% (137/191) with a 95% confidence interval of [65%, 78%]. The p-value was
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