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510(k) Data Aggregation

    K Number
    K170616
    Device Name
    van Andel Dilatation Catheter
    Manufacturer
    Cook Incorporated
    Date Cleared
    2017-04-28

    (58 days)

    Product Code
    DRE
    Regulation Number
    870.1310
    Type
    Traditional
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K123842,K153197
    Why did this record match?
    Device Name :

    van Andel Dilatation Catheter

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

    The van Andel Dilatation Catheter is intended to facilitate percutaneous introduction of guide wires, and other devices into the femoral, popliteal, and infrapopliteal arteries during diagnostic and interventional procedures.

    Device Description

    The van Andel Dilatation Catheter are intravascular dilation catheters comprised of polytetrafluoroethylene, designed for use in diagnostic and interventional procedures. The van Andel Dilatation Catheters are provided sterile and are meant for single use only. The van Andel Dilatation Catheter is available in 5.0, 6.3, 7.0, 8.0, and 9.0 French diameters and is manufactured in lengths of 60, 80, and 100 centimeters.

    AI/ML Overview

    The provided text describes the 510(k) summary for the van Andel Dilatation Catheter. This document focuses on demonstrating substantial equivalence to predicate devices through various performance tests, not through clinical studies involving human readers or AI. Therefore, numerous requested sections related to AI performance, reader studies, and ground truth establishment are not applicable.

    Here's the breakdown of the available information:

    1. Table of Acceptance Criteria and Reported Device Performance

    TestAcceptance CriteriaReported Device Performance
    Biocompatibility TestingPredetermined acceptance criteria as per ANSI AAMI ISO 10993-1:2009(R)2013 for cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, pyrogenicity, hemocompatibility, complement activation, and partial thromboplastin time.The device is biocompatible. The predetermined acceptance criteria were met.
    Tensile Testing of the Hub to Shaft BondWithstand peak load values specified in BS EN ISO 10555-1:2013 – Section 4.6 during proper clinical use.The hub-to-shaft connection is expected to withstand peak load values. The predetermined acceptance criterion was met.
    Liquid Leakage TestingNo liquid leakage during proper clinical use, as per BS EN ISO 10555-1:2013 - Section 4.7.1.There shall be no liquid leakage. The predetermined acceptance criterion was met.
    Dimensional Verification TestingOuter diameter, inner diameter, taper length, and overall length of the device are within a specified tolerance.The dimensions are within a specified tolerance. The predetermined acceptance criteria were met.
    Exterior Surface Condition Testing and Distal Tip InspectionExterior surface of the device is smooth and free from any process defects.The exterior surface was smooth and free from any process defects. The predetermined acceptance criteria were met.
    Radiopacity TestingDevice is visible under fluoroscopic imaging in simulated clinical conditions.The device would be visible under fluoroscopic imaging. The predetermined acceptance criterion was met.
    Kink Radius TestingDevice would not kink under clinical conditions.The device would not kink under clinical condition. The predetermined acceptance criteria were met.
    Simulated Use TestingPerformance parameters are acceptable for clinical use.The performance parameters were acceptable for clinical use. The predetermined acceptance criteria were met.

    2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • The document does not specify the sample sizes used for each of the listed tests.
    • The data provenance is not specified beyond being "applicable testing" conducted by the manufacturer, Cook Incorporated, in Bloomington, IN, USA. These are laboratory/bench tests, not clinical data.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not applicable. The tests conducted are physical and material property tests (e.g., tensile strength, leakage, dimensions, biocompatibility), not diagnostic interpretations requiring expert radiologists or similar medical professionals to establish ground truth.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not applicable. These are objective engineering and material tests, not subjective interpretations requiring adjudication.

    5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable. This is a medical device (catheter), not an AI-powered diagnostic or assistive tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not applicable. This is a medical device (catheter), not an AI algorithm.

    7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • The "ground truth" for the tests performed are established engineering and material standards and specifications (e.g., BS EN ISO 10555-1:2013, ANSI AAMI ISO 10993-1:2009(R)2013). These are objective criteria against which the device's physical properties and performance are measured.

    8. The sample size for the training set

    • Not applicable. This is a medical device, not a machine learning model; therefore, there is no "training set."

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

    • Not applicable. As there is no training set, this question is not relevant.
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