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510(k) Data Aggregation

    K Number
    K213451
    Device Name
    Spartan MC 0165
    Manufacturer
    Spartan Micro
    Date Cleared
    2021-11-22

    (27 days)

    Product Code
    QJP,DQY,KRA
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K151638
    Predicate For
    K201141
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Spartan MC 0165™ is intended for the introduction of interventional devices or infusion of diagnostic agents into the neuro, peripheral and coronary vasculatures.

    Device Description

    The Spartan MC 0165™ is a sterile single-use microcatheter device. On the proximal end is a Luer connector for infusion of diagnostic agents. The microcatheter has a single lumen of 0.0165" ID, has a flexible and variable stiffness composite body, and 2 radiopaque marker bands on the distal tip for visualization under fluoroscopy. It comes with a sterile stainless steel shaping mandrel to shape the distal portion of the catheter.

    AI/ML Overview

    The Spartan MC 0165™ is a microcatheter device. The provided text describes several performance studies conducted to demonstrate its substantial equivalence to a predicate device.

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance Criteria (Implied)Reported Device Performance
    Coating Lubricity (Friction Force)Acceptable friction force under simulated use conditions similar to the predicate device.The Spartan MC 0165™ was found to have acceptable friction force under simulated use conditions similar to the predicate device.
    Hub Functional & DimensionalMeet ISO 594-1:1986-06-15 and ISO 594-2:1998-09-01 requirements.The Spartan MC 0165™ met the acceptance criteria for hub functional and dimensional requirements.
    Torque StrengthAcceptable torsional strength similar to the predicate device during simulated use.The Spartan MC 0165™ exhibited acceptable torsional strength similar to the predicate device.
    TensileMeet ISO 10555-1:2013 Annex B requirements.The Spartan MC 0165™ met the acceptance criteria for tensile strength.
    Air AspirationMeet ISO 10555-1:2013(E) Annex D requirements for air leakage.The Spartan MC 0165™ met the acceptance criteria for air aspiration.
    Liquid LeakMeet ISO 10555-1:2013(E) Annex C requirements for liquid leakage.The Spartan MC 0165™ met the acceptance criteria for liquid leakage.
    Particulate and Coating IntegrityMeet acceptance criteria for particulate generation and coating integrity, and be substantially equivalent to the predicate.The Spartan MC 0165™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate.
    Tip ShapeRetain steam-shaped tip shape and be substantially equivalent to the predicate device.The Spartan MC 0165™ met the acceptance criteria for tip shapeability and was found substantially equivalent to the predicate.
    StiffnessMeet acceptance criteria for catheter stiffness and be substantially equivalent to the predicate.The Spartan MC 0165™ met the acceptance criteria for catheter stiffness and was found substantially equivalent to the predicate.
    Kink ResistanceWithstand bends and be substantially equivalent to the predicate.The Spartan MC 0165™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate.
    RadiopacityBe visible under fluoroscopy and be substantially equivalent to the predicate device.The Spartan MC 0165™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate.
    CorrosionMeet ISO 10555-1:2013(E) Annex A requirements.The Spartan MC 0165™ met the acceptance criteria for corrosion resistance.
    Static Burst PressureMeet ISO 10555-1:2013(E) Annex F requirements.The Spartan MC 0165™ met the acceptance criteria for static burst pressure.
    Torque ResponseMeet acceptance criteria for torque response and be substantially equivalent to the predicate.The Spartan MC 0165™ met the acceptance criteria for torque response and was found substantially equivalent to the predicate.
    BucklingMeet acceptance criteria for tip deflection and buckling, and be substantially equivalent to the predicate.The Spartan MC 0165™ met the acceptance criteria for tip deflection and buckling, and was found substantially equivalent to the predicate.
    Design ValidationMeet requirements for which it was designed and tested in a challenging use setting.The Spartan MC 0165™ met the requirements for which it was designed and tested.
    Dimensional TestingMeet device specifications.The Spartan MC 0165™ met the dimensional requirements.
    Visual InspectionMeet visual inspection requirements.The Spartan MC 0165™ met the visual inspection requirements.
    Dead Space VolumeDead space volume to be measured and reported in labeling.The Spartan MC 0165™ dead space volume was measured and is reported in the labeling.
    Pressure Flow Testing with Contrast MediaFlow rates and pressures for various solutions to be evaluated and reported in labeling.The Spartan MC 0165™TM pressure-flow performance was evaluated, and flow rates and pressures of various saline and contrast media solutions are reported in the labeling.
    Sensitization (Kligman Maximization Test)Classified as a non-sensitizer (0% sensitization).Spartan MC 0165 elicited no reaction at the challenge (0% sensitization), classified as a non-sensitizer.
    Genotoxicity (Mouse Lymphoma Mutagenesis Assay)Non-mutagenic (IMF of Test Article
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