(165 days)
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.
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.
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 Criteria | Reported Device Performance |
|---|---|
| Fluorescence Detection Depth | 0.8 mm (achieved) |
| Linear range, green, maximum illumination intensity | 1-88% of Full Scale Image Sensor Range (0-125 nM Quantum Dots) |
| Linear range, green, minimum illumination intensity | 0-94% of Full Scale Image Sensor Range (0-250 nM Quantum Dots) |
| Linear range, red, maximum illumination intensity | 3-90% of Full Scale Image Sensor Range (0.5-5.6 nM Quantum Dots) |
| Linear range, red, minimum illumination intensity | 2-95% of Full Scale Image Sensor Range (0.5-7.7 nM Quantum Dots) |
| Limits of detection, green, maximum illumination intensity | 20-111 nM Quantum Dots |
| Limits of detection, green, minimum illumination intensity | 20-182 nM Quantum Dots |
| Limits of detection, red, maximum illumination intensity | 0.7-4.6 nM Quantum Dots |
| Limits of detection, red, minimum illumination intensity | 0.5-5.6 nM Quantum Dots |
| Excitation Source Intensity Variation | 100% 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) |
| Biocompatibility | No patient-contacting components (addressed) |
| Shelf Life | Greater than 2 years (evaluated and determined) |
| Reprocessing (Cleaning) |
§ 878.4165 Wound autofluorescence imaging device.
(a)
Identification. A wound autofluorescence imaging device is a tool to view autofluorescence images from skin wounds that are exposed to an excitation light. The device is not intended to provide quantitative or diagnostic information.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.