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510(k) Data Aggregation

    K Number
    K964117
    Device Name
    NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
    Manufacturer
    KAWASUMI LABORATORIES CO., LTD.
    Date Cleared
    1997-03-14

    (150 days)

    Product Code
    LJT
    Regulation Number
    880.5965
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE

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

    ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.

    Device Description

    A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance evaluation. The document describes a medical device (KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE) and its performance data relates to biocompatibility and pyrogenicity tests, not AI/ML model performance.

    Therefore, I cannot populate the table or answer the questions related to AI/ML study design, sample sizes, expert ground truth, or adjudication methods based on the provided text.

    The only relevant information that can be extracted is about the performance data for the described medical device:

    Acceptance Criteria and Device Performance (Biocompatibility/Pyrogenicity)

    Acceptance CriteriaReported Device Performance
    Biocompatibility Tests (on body fluid contacting material portions)Device is suitable for its intended use.
    Limulus Amebocyte Lysate ("LAL") Test (described at "(85) BACTERIAL ENDOTOXINS TEST", USP XXII, PP 1493-1495)The device meets the LAL test.

    The text explicitly states: "The device meets all biocompatibility and pyrogenicity test requirements."

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