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510(k) Data Aggregation

    K Number
    K220716
    Device Name
    Spartan SC 069
    Manufacturer
    Spartan Micro, Inc.
    Date Cleared
    2022-05-05

    (55 days)

    Product Code
    DQY,QJP
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K150107,K180715
    Why did this record match?
    Device Name :

    Spartan SC 069

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

    The Spartan SC 069TM is indicated for the introduction of interventional devices into the peripheral and neuro vasculature.

    Device Description

    The Spartan SC 069™ is a support catheter designed for the introduction of interventional devices into the peripheral and neuro vasculature. The SC 069™ is a single lumen, flexible, variable stiffness composite catheter with a Nitinol structure. A radiopaque marker band on the distal tip of the device is used for visualization under fluoroscopy. The distal section of the catheter is coated with a hydrophilic coating to reduce the overall frictional force during intravascular use. The device is supplied sterile and intended for single use only.

    AI/ML Overview

    The provided text describes the performance data for the Spartan SC 069™ support catheter. This device appears to be a medical device, and the information presented is from a 510(k) premarket notification to the FDA, which focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study evaluating the device's diagnostic performance. Therefore, many of the requested fields regarding diagnostic acceptance criteria, multi-reader multi-case studies, and human-in-the-loop performance are not applicable.

    Here's the information extracted from the document:

    1. A table of acceptance criteria and the reported device performance

    The document lists various non-clinical bench tests and biocompatibility tests, with each test summary implying a pass/fail acceptance criterion. The results consistently state that the Spartan SC 069™ "met the acceptance criteria" or showed "acceptable" performance, or similar to the predicate device.

    TestTest Method Summary (Implied Criteria)Reported Device Performance
    Coating Lubricity (Friction Force)Acceptable friction force under simulated use conditions similar to predicate.The Spartan SC 069™ 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 SC 069™ met the acceptance criteria for hub functional and dimensional requirements.
    Torque StrengthAcceptable torsional strength similar to predicate in simulated path model.The Spartan SC 069™ exhibited acceptable torsional strength similar to the predicate device.
    TensileMeet ISO 10555-1:2013 Annex B.The Spartan SC 069™ met the acceptance criteria for tensile strength.
    Air AspirationMeet ISO 10555-1:2013(E) Annex D for air leakage.The Spartan SC 069™ met the acceptance criteria for air aspiration.
    Liquid LeakMeet ISO 10555-1:2013(E) Annex C.The Spartan SC 069™ met the acceptance criteria for liquid leakage.
    Particulate and Coating IntegrityAcceptable particulate generation and coating integrity, substantially equivalent to predicate.The Spartan SC 069™ met the acceptance criteria for particulate generation and coating integrity, and was found substantially equivalent to the predicate.
    StiffnessMeet acceptance criteria for catheter stiffness, substantially equivalent to predicate.The Spartan SC 069™ met the acceptance criteria for catheter stiffness and found substantially equivalent to the predicate.
    Kink ResistanceMeet acceptance criteria for kink resistance, substantially equivalent to predicate.The Spartan SC 069™ met the acceptance criteria for kink resistance and was found substantially equivalent to the predicate.
    RadiopacityMeet acceptance criteria for radiopacity, substantially equivalent to predicate.The Spartan SC 069™ met the acceptance criteria for radiopacity and was found substantially equivalent to the predicate.
    CorrosionMeet ISO 10555-1:2013(E) Annex A.The Spartan SC 069™ met the acceptance criteria for corrosion resistance.
    Static Burst PressureMeet ISO 10555-1:2013(E) Annex F for burst pressure.The Spartan SC 069™ met the acceptance criteria for static burst pressure.
    BucklingMeet acceptance criteria for tip deflection and buckling, substantially equivalent to predicate.The Spartan SC 069™ met the acceptance criteria for tip deflection and buckling and was found substantially equivalent to the predicate.
    Design ValidationMeet requirements for interventional device introduction, trackability, stability, guidewire interaction, and overall device integrity in a challenging use setting.The Spartan SC 069™ met the requirements for which it was designed and tested.
    Dimensional TestingMeet device specifications.The Spartan SC 069™ met the dimensional requirements.
    Visual InspectionMeet acceptance criteria.The Spartan SC 069™ met the visual inspection requirements.
    Dead Space VolumeMeasured and reported in labeling.The Spartan SC 069™ dead space volume was measured. The dead space volume is reported in the labeling.
    Pressure Flow Testing with Contrast MediaEvaluated flow rates and pressures of various solutions; reported in labeling.The Spartan SC 069™ pressure-flow performance was evaluated. Flow rates and pressures of various saline and contrast media solutions are reported in the labeling.
    Biocompatibility Tests
    Sensitization (Guinea Pig)No reaction at challenge; classified as non-sensitizer per ISO 10993-10.Non-sensitizer.
    Genotoxicity (Mouse Lymphoma)IMF of Test Article
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