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510(k) Data Aggregation

    K Number
    K050156
    Device Name
    WHS-1000 WOUND HEALING SYSTEM
    Manufacturer
    IYIA TECHNOLOGIES, INC.
    Date Cleared
    2005-06-17

    (144 days)

    Product Code
    KPJ
    Regulation Number
    878.5650
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K022028
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Misty™ Wound Treatment System provides humidified hyperbaric oxygen to open, chronic wounds as an adjunct therapy in wound management and treatment. In addition, the device can also provide heat, gentle massage, moisture, and infrared and ultraviolet light therapy. The device is intended for the treatment of the following kinds of wounds: - skin ulcerations due to diabetes, venous stasis, and post surgical infections - gangrenous lesions, - decubitus ulcers . - amputations/infected stumps . - . skin grafts - . burns - frostbite ♥ Caution: Federal law restricts this device to use by or on the order of a physician or podiatrist.

    Device Description

    The Wound Treatment System is composed of a rectangular, rigid plastic shell that is of sufficient size to accommodate the patient's foot. There are four fittings on the chamber: one for oxygen tubing that fills the chamber, one for a pressure sensor, one to allow the mist to enter the chamber and one for water transfer. The front panel control consists of a plastic panel with switches, indicators and timer controls; these connect to the Wound Treatment System via a cable. The system plugs into an AC wall outlet.

    AI/ML Overview

    This 510(k) summary for the WHS-1000 Wound Treatment System (Misty™) does not contain information about acceptance criteria or a study proving the device meets said criteria. The document explicitly states "Performance Data: N/A" and "Clinical Data: N/A".

    The 510(k) clearance for this device was based on a demonstration of substantial equivalence to an existing legally marketed device (the VX-400 Topical Hyperbaric Oxygen Chamber). This means that the FDA determined the new device has the same intended use and technological characteristics as the predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

    Therefore, the requested information cannot be extracted from the provided text. The document does not describe a study involving human or AI performance, ground truth establishment, or multi-reader studies.

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