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    K Number
    DEN180008
    Device Name
    MolecuLight i:X
    Manufacturer
    MolecuLight Inc.
    Date Cleared
    2018-07-31

    (165 days)

    Product Code
    QCR
    Regulation Number
    878.4165
    Type
    Direct
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    QCR

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

    The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to

    • view and digitally record images of a wound, and (i)
    • view and digitally record images of fluorescence emitted from a wound (ii) when exposed to an excitation light.

    The MolecuLight i:X is for prescription use only.

    Device Description

    The MolecuLight i:X is a handheld, portable, and battery operated white light and fluorescence imaging tool. The MolecuLight i:X can (i) view and digitally record standard (ST) digital images of a wound.

    Standard digital images/video capture the appearance of the wound under illumination of broad band white light, like regular photography. This Standard Imaging Mode does not require contact with the patient and the distance between the device and wound is kept consistent (8 - 12 cm) between imaging sessions through the use of the built in range finder

    The MolecuLight i:X can also capture fluorescence features of wounds in real-time when used in Fluorescence Imaging Mode and it enables the user to document this fluorescence information. When the level of ambient light in the examination room is acceptable, an indicator light informs the user that fluorescence images (or videos) can be acquired. The distance between the device to the patient is maintained at 8 - 12 cm as guided by the range finder indicator light. The device has 450nm excitation light and is capable to detect fluorescence signals in 500-545 and 600-665nm wavelengths. The Moleculight i:X is not intended to quantify the fluorescence emitted from a wound.

    AI/ML Overview

    The MolecuLight i:X is a wound autofluorescence imaging device. The device is not intended to provide quantitative or diagnostic information, but rather to allow clinicians to view and digitally record images of wounds and fluorescence emitted from wounds.

    Here's an analysis of the acceptance criteria and the study proving the device meets them:

    1. A table of acceptance criteria and the reported device performance

    Acceptance CriteriaReported Device Performance
    Fluorescence Detection Depth0.8 mm (achieved)
    Linear range, green, maximum illumination intensity1-88% of Full Scale Image Sensor Range (0-125 nM Quantum Dots)
    Linear range, green, minimum illumination intensity0-94% of Full Scale Image Sensor Range (0-250 nM Quantum Dots)
    Linear range, red, maximum illumination intensity3-90% of Full Scale Image Sensor Range (0.5-5.6 nM Quantum Dots)
    Linear range, red, minimum illumination intensity2-95% of Full Scale Image Sensor Range (0.5-7.7 nM Quantum Dots)
    Limits of detection, green, maximum illumination intensity20-111 nM Quantum Dots
    Limits of detection, green, minimum illumination intensity20-182 nM Quantum Dots
    Limits of detection, red, maximum illumination intensity0.7-4.6 nM Quantum Dots
    Limits of detection, red, minimum illumination intensity0.5-5.6 nM Quantum Dots
    Excitation Source Intensity Variation100% to 52% at corners (met specification requirements for uniformity)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Green (Max Illumination, min limit of detection)2.2 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Green (Max Illumination, max limit of detection)8.5 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Green (Min Illumination, min limit of detection)2.4 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Green (Min Illumination, max limit of detection)8.3 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Red (Max Illumination, min limit of detection)1.2 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Red (Max Illumination, max limit of detection)7.8 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Red (Min Illumination, min limit of detection)1.8 (met)
    Fluorescence Imaging Signal-to-Noise Ratio (SNR) - Red (Min Illumination, max limit of detection)6.3 (met)
    BiocompatibilityNo patient-contacting components (addressed)
    Shelf LifeGreater than 2 years (evaluated and determined)
    Reprocessing (Cleaning)
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