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510(k) Data Aggregation

    K Number
    K192230
    Device Name
    MF SAFECATH
    Manufacturer
    MediFirst Co., Ltd.
    Date Cleared
    2020-04-23

    (251 days)

    Product Code
    FOZ
    Regulation Number
    880.5200
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K013800
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MF SAFECATH, an intravascular catheter is a device that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. These catheters may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.

    Device Description

    This medical device is a disposable intravascular tube catheter composed of cap, cannula, catheter tube, catheter hub, gasket, g-holder, cannula hub, plug, filter. This device has a passive needlestick safety feature that prevents the cannula from escaping forward during the use. MF SAFECATH are available in 16G, 18G, 20G, 22G, and 24G and various lengths.

    AI/ML Overview

    I'm sorry, but the provided text does not contain the specific information required to answer your request in the specified format. The document describes a 510(k) premarket notification for a medical device (MF SAFECATH Intravascular Catheter) and details its indications for use, device description, comparison to a predicate device, and a summary of performance and other tests conducted.

    However, it does not include:

    1. A table of specific acceptance criteria and reported device performance metrics in numerical or qualitative terms for the device to meet those criteria.
    2. Details about sample sizes specifically for test sets, data provenance, or information on training sets for any AI/algorithm-based component.
    3. Information regarding the number and qualifications of experts for establishing ground truth or the adjudication methods used.
    4. Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
    5. A standalone (algorithm only) performance study.
    6. The type of ground truth used (e.g., pathology, outcomes data).

    The document mentions "Simulated Clinical Use Study" and that "the safety function has been activated correctly" but does not provide specific acceptance criterion or quantitative results from this study. It primarily focuses on demonstrating substantial equivalence to a predicate device through conformity to international standards and biocompatibility testing, rather than reporting on specific performance metrics against defined acceptance criteria in the context of an AI/algorithm.

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