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510(k) Data Aggregation

    K Number
    K123482

    Validate with FDA (Live)

    Device Name
    REFLOW ASPIRATION CATHETER
    Manufacturer
    VOLCANO CORPORATION
    Date Cleared
    2013-04-29

    (167 days)

    Product Code
    QEZ,DXE
    Regulation Number
    870.5150
    Type
    Traditional
    Panel
    Cardiovascular
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The ReFLOW Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the coronary, carotid and peripheral vasculature.

    Device Description

    The ReFLOW Aspiration Catheter is an embolectomy catheter comprised of a catheter shaft and hub. It is 150cm long and is available in 6F and 7F diameters.

    AI/ML Overview

    The provided text describes the 510(k) summary for the ReFLOW Aspiration Catheter, which includes performance data derived from non-clinical testing. It does not contain information about acceptance criteria or a study with specific performance metrics such as sensitivity, specificity, or AUC, which are typically used for AI/ML-based device performance evaluations. The data provided focuses on physical and biological characteristics of the device, not a comparative clinical study or AI algorithm performance.

    Therefore, many of the requested categories cannot be filled as the information is not present in the provided document.

    Here's a breakdown of the available information and what's missing:

    1. Table of Acceptance Criteria and Reported Device Performance

    Test TypeAcceptance Criteria (Not explicitly stated in the document)Reported Device Performance
    Non-clinical Device TestingNot explicitly stated as acceptance criteria, but implied to meet "known standards or product specifications"
    Dimensional VerificationSuccessfully completed
    Visual InspectionSuccessfully completed
    Particulate EvaluationSuccessfully completed
    Tube to Stopcock Tensile StrengthSuccessfully completed
    Tube to Luer Tensile StrengthSuccessfully completed
    RX Notch Tensile Strength (if applicable)Successfully completed
    Hub to Shaft Tensile StrengthSuccessfully completed
    Loading Tool Tensile StrengthSuccessfully completed
    Liquid Leak Pressure TestSuccessfully completed
    Wall Integrity TestSuccessfully completed
    Guidewire Loading TestSuccessfully completed
    Torque StrengthSuccessfully completed
    Coating Adhesion TestSuccessfully completed
    Kink ResistanceSuccessfully completed
    Liquid Aspiration Leak TestSuccessfully completed
    Aspiration Flow RateSuccessfully completed
    Thromboemboli Aspiration Simulated Use TestingSuccessfully completed
    Biocompatibility Testing
    CytotoxicitySuccessfully completed
    IntracutaneousSuccessfully completed
    Systemic ToxicitySuccessfully completed
    Maximum SensitizationSuccessfully completed
    Material Mediated PyrogenSuccessfully completed
    ASTM HemolysisSuccessfully completed
    In Vitro HemolysisSuccessfully completed
    C3a Complement ActivationSuccessfully completed
    SC5-b Complement ActivationSuccessfully completed
    Partial Thromboplastin TimeSuccessfully completed
    In vivo ThromboresistenceSuccessfully completed
    Limulus Amebocyte LysateSuccessfully completed

    2. Sample size used for the test set and the data provenance

    The document describes non-clinical bench and biocompatibility testing. It does not refer to a "test set" in the context of clinical data, AI/ML performance evaluation, or patient-specific samples. The tests were performed on the device itself. Therefore, sample size and data provenance as requested are not applicable in this context.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

    Not applicable. This is not a study that uses expert-established ground truth for a test set. The "ground truth" for the non-clinical tests would be the established scientific methods and pass/fail criteria for each specific test (e.g., a certain tensile strength must be achieved, or a certain level of cytotoxicity must not be exceeded).

    4. Adjudication method for the test set

    Not applicable. There is no test set in the clinical evaluation sense that would require 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 not an AI/ML-based device and no MRMC study is described.

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

    Not applicable. This is not an AI/ML-based device.

    7. The type of ground truth used

    For the non-clinical and biocompatibility tests, the ground truth is based on established industry standards, scientific methodologies, and product specifications. For example, tensile strength tests have defined failure points, and biocompatibility tests have defined acceptable limits for various biological responses.

    8. The sample size for the training set

    Not applicable. There is no training set mentioned as this is not an AI/ML-based device.

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

    Not applicable. There is no training set mentioned as this is not an AI/ML-based device.

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