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510(k) Data Aggregation

    K Number
    K203019
    Device Name
    LF900
    Manufacturer
    DaeSung Maref Co., Ltd
    Date Cleared
    2021-06-22

    (264 days)

    Product Code
    IRP
    Regulation Number
    890.5650
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    K113275
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    LF900 is intended for use by medical professionals and patients at home, who are under medical supervision, in treating many conditions, such as: Primary lymphedema, Edema following trauma and sport injuries, Postimmobilization edema, Venous insufficiencies, Lymphedema.

    Device Description

    This product is an Intermittent Pneumatic Compression system to improve the blood circulation of the human body. The operating principle is that the air from the device will be delivered to the sleeve with 4 air chambers and the air pressurizes sequentially the chambers from 1st to 4th.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a medical device called LF900, a powered inflatable tube massager. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML algorithm or diagnostic accuracy.

    The text focuses on demonstrating substantial equivalence to a predicate device (POWER-Q1000 Premium) based on:

    • Intended Use: Both devices are for treating conditions like lymphedema, edema, and venous insufficiencies.
    • Technological Characteristics: Comparison of physical specifications like power source, time, pressure, and number of chambers. Small differences in these parameters are justified as not raising new safety or effectiveness concerns.
    • Non-Clinical Testing: Compliance with electrical safety (IEC 60601 series) and device performance tests (pressure, time, sleeve durability).
    • Clinical Testing: The document explicitly states, "Clinical testing was not required to demonstrate the substantial equivalence of the LF900 to its predicate device."

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance, ground truth, expert adjudication, or MRMC studies. The device described in this FDA clearance is a physical medical device, not an AI/ML diagnostic or assistive tool.

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