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510(k) Data Aggregation

    K Number
    K243534
    Device Name
    Micro Catheter
    Manufacturer
    Suzhou Zenith Vascular SciTech Limited
    Date Cleared
    2025-07-30

    (257 days)

    Product Code
    KRA
    Regulation Number
    870.1210
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    K210114
    Why did this record match?
    Applicant Name (Manufacturer) :

    Suzhou Zenith Vascular SciTech Limited

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

    The Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.

    Device Description

    The Micro Catheter is a sterile, single-use, single lumen, variable stiffness, composite catheter. The Micro Catheter is available in three inner diameters (0.017″, 0.021″ and 0.027″), and two working lengths (150cm and 155cm). All models are designed with a straight tip, and are steam shapeable by the user. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated with a hydrophilic coating to increase lubricity. The proximal end of Micro Catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter body has a semi-rigid proximal end which transitions into the flexible distal end to facilitate the advancement of the catheter in the tortuous vasculature. The Micro Catheter is compatible with ≤ 0.014″ guidewires and 5F or larger guide catheters.

    AI/ML Overview

    The provided 510(k) clearance letter pertains to a Micro Catheter and describes its performance and testing to demonstrate substantial equivalence to a predicate device. This document does not discuss an AI/ML powered device, nor does it present data from a study involving human readers or the establishment of ground truth for AI model training or testing. Therefore, I cannot address most of your specific questions related to AI device evaluation.

    However, I can extract the acceptance criteria and performance data for the Micro Catheter based on the provided text.

    Acceptance Criteria and Device Performance for Micro Catheter

    The document describes the testing performed on the Micro Catheter to demonstrate its substantial equivalence to a predicate device. The "acceptance criteria" are implied by the "Results" column in the tables, indicating whether the device met the required performance standards for each test.

    1. Table of Acceptance Criteria and Reported Device Performance

    Note: The FDA 510(k) summary for a medical device like a micro catheter focuses on engineering and biocompatibility performance rather than AI-specific metrics. The "acceptance criteria" are implicitly met if the "Results" indicate compliance, comparability to a predicate, or "met the acceptance criteria."

    Test (Category)Specific Test Method SummaryAcceptance Criteria (Implied by Results)Reported Device Performance
    Bench Performance Testing
    Dimensional VerificationMeasured inner/outer diameter, effective length.Met specified dimensions.Micro Catheter and accessories met the acceptance criteria.
    RadiopacityVisualized under fluoroscopy.Equivalent to predicate device.Micro Catheter and the predicate device were imaged showing equivalence in terms of radiopacity.
    Surface InspectionVisual inspection under microscopy.Met visual quality standards.Micro Catheter met the acceptance criteria.
    Corrosion ResistanceISO 10555-1, Annex A.No signs of corrosion.Micro Catheter showed no signs of corrosion.
    Peak Tensile Force/Bond StrengthEvaluated full system tensile force/bond strength.Met minimum tensile strength requirement.Micro Catheter met the acceptance criteria.
    Liquid LeakageISO 10555-1, Annex C.No leakage.Micro Catheter showed no leakage.
    Air LeakageISO 10555-1, Annex I.No leakage.Micro Catheter showed no leakage.
    Hub TestingISO 80369-20.Met hub standards.Micro Catheter hub met the acceptance criteria.
    Flowrate at Maximum Rated Infusion PressureMeasured flow rate with saline, saline:contrast, contrast.Met flow rate criteria; comparable to predicate.Micro Catheter met the acceptance criteria. The mean flow rate values for the subject device and predicate device are comparable for the injectate media tested.
    Dynamic Burst PressureISO 10555-1, Annex G.Met burst pressure criteria.Micro Catheter met the acceptance criteria.
    Static Burst PressureISO 10555-1, Annex F.Met burst pressure criteria.Micro Catheter met the acceptance criteria.
    Simulated UseEvaluated in anatomical model for preparation, assembly, compatibility, trackability, lubricity, durability, kink resistance.Met performance in simulated use.Micro Catheter met the acceptance criteria.
    Flexibility and Kink TestEvaluated resistance to kinking in bends.Met kink resistance criteria.Micro Catheter met the acceptance criteria.
    Torque StrengthRotated in anatomical model with distal tip fixed; recorded rotations to failure.Similar rotations to failure as cleared comparator.Micro Catheter and a cleared comparator showed a similar number of rotations to failure.
    Coating IntegrityInspected pre- and post-simulated use.Met coating integrity standards.Micro Catheter met the acceptance criteria.
    Coating LubricityEvaluated frictional forces on universal testing machine.Similar frictional forces to predicate.Micro Catheter and the predicate showed similar frictional forces.
    Particulate EvaluationEvaluated particulate generation during simulated use.Similar particle numbers to predicate.Micro Catheter and the predicate showed similar particle numbers.
    Tip StiffnessDistal tip deflected on universal testing machine.Similar tip stiffness to cleared comparator.Micro Catheter and a cleared comparator showed a similar tip stiffness.
    Distal Tip InspectionInspected for defects.Met defect criteria.Distal tip met the acceptance criteria.
    Tip ShapeabilityShaped using shaping mandrel.Met shapeability criteria.Distal tip met the acceptance criteria.
    Lumen CollapseMeasured force to collapse catheter.Similar forces to collapse catheter as predicate.Micro Catheter and the predicate showed similar forces to collapse the catheter.
    Compatibility testsInspected for damage post-simulated use with compatible interventional devices.Met compatibility criteria.Micro Catheter met the acceptance criteria.
    Biocompatibility Testing
    ISO MEM Elution TestISO 10993-5Reactivity grade ≤2.Non-cytotoxic (reactivity grade of ≤2).
    ISO Guinea Pig Maximization Sensitization TestISO 10993-10No evidence of delayed dermal contact sensitization.Non-sensitizer.
    Intracutaneous Reactivity Test in RabbitsISO 10993-23Differences between test and control mean scores
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