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510(k) Data Aggregation

    K Number
    K961049
    Device Name
    FLEX NEEDLE
    Manufacturer
    LIGHTHOUSE MEDICAL, INC.
    Date Cleared
    1996-09-18

    (187 days)

    Product Code
    FPA
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The FlexNeedle™ allows transcutaneous cannulation of subdermally implanted venous access ports.

    Device Description

    The FlexNeedle™ is composed of a flexible catheter; a hub with elastomeric septum and side port; sideleg tubing with luer infusion fitting, cap, and pinch clamp; and an insertion stylet.

    AI/ML Overview

    The provided text is a 510(k) summary for a medical device called FlexNeedle™. It describes the device, its intended use, and its similarities to predicate devices. However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or statistical analyses (like MRMC studies or standalone performance).

    Therefore, I cannot fulfill your request for the detailed information outlined in points 1-9 based on the provided input. The input focuses solely on regulatory submission aspects rather than scientific study details.

    To answer your questions, I would need a different type of document, such as:

    • A clinical study report
    • A validation study report
    • A performance specification document
    • A scientific publication detailing the device's evaluation
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