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    K Number
    K242033
    Device Name
    Access25™ Delivery Microcatheter
    Manufacturer
    Penumbra, Inc.
    Date Cleared
    2024-12-11

    (153 days)

    Product Code
    QJP,DQY
    Regulation Number
    870.1250
    Type
    Traditional
    Panel
    Neurology (NE)
    Reference & Predicate Devices
    K152840
    Why did this record match?
    Device Name :

    Access25™ Delivery Microcatheter

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

    The Access25 Delivery Microcatheter is indicated to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic devices, such as occlusion coils, to the peripheral and neuro vasculature.

    Device Description

    The Access25 Delivery Microcatheter (Access25) is a single lumen medical device designed to aid a physician in accessing distal vasculature when used in conjunction with a guide catheter and micro guidewire. The Access25 Delivery Microcatheter is supplied with annealed stainless steel mandrels that can be used to shape the distal tip as desired.

    AI/ML Overview

    This document pertains to the Access25™ Delivery Microcatheter by Penumbra, Inc. This is a medical device and not an AI/ML powered device, therefore some relevant sections of the query will not be applicable.

    Here's an analysis of the acceptance criteria and the study proving the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    TestAcceptance CriteriaReported Device Performance
    Dimensional/Visual Inspection TestCatheter outer diameter, inner diameter, length, and coating length meet specifications.Acceptance Criteria met
    Simulated Use TestDevice performs as intended under simulated use conditions in a clinically relevant anatomical model.The device performs as intended under simulated use conditions
    Tensile TestPeak tensile force meets ISO 10555-1 requirements after preconditioning in a simulated use model.Acceptance Criteria met
    Particulate TestParticulate generation during simulated use is comparable to the predicate device.Particulate generation was comparable to predicate device
    Burst Pressure TestUnits can withstand sufficient pressure per ISO 10555-1 after simulated use.Acceptance Criteria met
    Radiopacity TestMarkerband(s) are fluoroscopically visible.Acceptance Criteria met
    Flow Rate TestContrast media can be delivered through the catheter lumen.Acceptance Criteria met
    Friction TestUnits meet product specification related to friction.Friction results were comparable to the predicate
    Corrosion Resistance TestNo visible corrosion on units when tested per ISO 10555-1.Acceptance Criteria met
    Torque Strength TestDevice can withstand a specified number of catheter rotations until failure.Acceptance Criteria met
    Elongation TestUnits meet product specification related to elongation.Acceptance Criteria met
    Hub/Air TestUnits have no leaks when tested per ISO 10555-1.Acceptance Criteria met
    Distal Tip Stiffness TestMaximum compressive force to cause catheter tip buckling is comparable to the predicate.Distal tip stiffness was comparable to the predicate.
    Kink Resistance TestUnits have appropriate kink resistance.Acceptance Criteria met
    Liquid Leakage TestUnits can withstand sufficient pressure.Acceptance Criteria met
    Biocompatibility: CytotoxicityNon-cytotoxic (in accordance with ISO 10993-5).Pass: Non-cytotoxic
    Biocompatibility: SensitizationNon-sensitizing (in accordance with ISO 10993-10).Pass: Non-sensitizing
    Biocompatibility: IrritationNon-irritating (in accordance with ISO 10993-23).Pass: Non-irritating
    Biocompatibility: Systemic ToxicityNon-toxic (in accordance with ISO 10993-11).Pass: Non-toxic
    Biocompatibility: Material-Mediated PyrogenNon-pyrogenic (in accordance with USP ).Pass: Non-pyrogenic
    Biocompatibility: Hemolysis (direct contact)Non-hemolytic (in accordance with ISO 10993-4).Pass: Non-hemolytic
    Biocompatibility: Hemolysis (indirect contact)Non-hemolytic (in accordance with ISO 10993-4).Pass: Non-hemolytic
    Biocompatibility: In-vitro ThrombogenicityNon-thrombogenic (in accordance with ISO 10993-4).Pass: Non-thrombogenic
    Biocompatibility: Complement ActivationNon-activator of complement system (in accordance with ISO 10993-4).Pass: Non-activator of complement system
    Biocompatibility: Partial Thromboplastin Time (PTT)Hemocompatible (in accordance with ISO 10993-4).Pass: Hemocompatible
    SterilizationSterilized using a validated EO sterilization process in accordance with ISO 11135-1.Validated EO sterilization process per ISO 11135-1.
    PyrogenicityNon-pyrogenic, meeting and ANSI/AAMI ST72.Non-pyrogenic based on material mediated rabbit pyrogen biocompatibility testing per USP and LAL testing per ANSI/AAMI ST72 to meet , ANSI/AAMI ST72) and internal product specifications. These standards and specifications define what constitutes safe and effective performance for such a device.

    8. The sample size for the training set:

    Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.

    9. How the ground truth for the training set was established:

    Not applicable. As this is not an AI/ML algorithm, there is no training set or its associated ground truth establishment process. The "ground truth" in the device development context refers to the established performance requirements and standards against which the device is tested.

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