(165 days)
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No
The summary describes a fluorescence imaging device with a range finder and image capture capabilities, but there is no mention of AI or ML being used for image analysis, interpretation, or any other function.
No
The device is an imaging tool used for diagnosis and monitoring, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "allows clinicians diagnosing and treating skin wounds" to view and record images, indicating its role in the diagnostic process.
No
The device description explicitly states it is a "handheld, portable, and battery operated white light and fluorescence imaging tool" and details its hardware components like excitation light, range finder, and imaging modes, indicating it is a hardware device with integrated software.
Based on the provided information, the MolecuLight i:X is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The MolecuLight i:X is used to image the wound directly on the patient's skin. It does not involve the analysis of blood, tissue samples, or other bodily fluids in a laboratory setting.
- The device description focuses on imaging the wound surface. It captures standard white light images and fluorescence emitted from the wound itself, not from a processed sample.
- The intended use is for "viewing and digitally recording images of a wound" and "viewing and digitally recording images of fluorescence emitted from a wound." This describes an imaging tool for direct patient examination, not a diagnostic test performed on a specimen.
Therefore, the MolecuLight i:X falls under the category of an in vivo imaging device rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
QCR
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
White light and fluorescence imaging
Anatomical Site
Skin wounds
Indicated Patient Age Range
The device is not labeled for use in the pediatric population.
Intended User / Care Setting
Clinicians diagnosing and treating skin wounds, at the point of care.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was conducted to characterize the device performance.
Imaging field uniformity: Tested with green (fluorescein dye) and red (PpIX) fluorescent agents integrated into an optical tissue phantom. 2D intensity mapping was used to demonstrate spatial nonuniformity of illumination source and fluorescent imager.
Detection depth: A red fluorescent phantom was embedded at different depths inside a green fluorescent phantom. The results show the maximum detection depth of the device as 800um.
Detection limits, linearity, Signal-to-Noise Ratio (SNR): Different dilutions of green and red quantum dots were used to determine the minimum and maximum fluorescence detection limit, device linearity, and SNR for each spectral bandwidth.
Fluorescence Detection Depth: 0.8 mm
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
SNR at min limit of detection:
Green, Maximum: 2.2
Green, Minimum: 2.4
Red, Maximum: 1.2
Red, Minimum: 1.8
SNR at max limit of detection:
Green, Maximum: 8.5
Green, Minimum: 8.3
Red, Maximum: 7.8
Red, Minimum: 6.3
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
DE NOVO CLASSIFICATION REQUEST FOR MOLECULIGHT I:X
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Wound autofluorescence imaging device. 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.
NEW REGULATION NUMBER: 21 CFR 878.4165
CLASSIFICATION: Class I (Exempt from premarket notification, subject to the limitations in 21 CFR 878.9)
PRODUCT CODE: QCR
BACKGROUND
DEVICE NAME: MolecuLight i:X
SUBMISSION NUMBER: DEN180008
DATE OF DE NOVO: February 16, 2018
- MolecuLight Inc CONTACT: 101 College Street, Suite 200 Toronto. ON M5G 1L7 Canada
INDICATIONS FOR 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.
LIMITATIONS
The sale, distribution, and use of MolecuLight are restricted to prescription use in accordance with 21 CFR 801.109.
This device can detect fluorescence at maximum depth of 0.8mm in a wound.
1
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS, AND CONTRAINDICATIONS.
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.
Image /page/1/Picture/5 description: The image shows a blue handheld medical device with a screen displaying an image of what appears to be a wound or tissue sample. The device has a silver-colored top section with indicator lights and a screen in the middle. There is a silver button on the side and a triangular button at the bottom of the device.
Figure 1: MolecuLight i:X
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
There are no patient contacting components.
SHELF LIFE/STERILITY
No component of the MolecuLight i:X is provided sterile.
2
The life-time of the MolecuLight i:X has been evaluated to be at least (b) (4)
Shelf-life of the system is greater than 2 years and is determined by the shelf-life of the lithium batteries installed in the product that may slowly discharge into a nonrecoverable state. Other components, such as plastics and electronic printed circuit boards and other circuitry, are not anticipated to degrade in this time, and the device contains no electrolytic capacitors.
REPROCESSING
The subject device is multi-patient, reusable and is provided non-sterile to the end user. There are no patient contacting components. To mitigate the risk of cross-contamination through indirect patient transmission mechanisms, the subject device is intended to be cleaned and intermediate level disinfected in between uses. The cleaning instructions were validated using an artificial test soil to represent the worse-case constituents (i.e. bloods and protein) of patient material that may contact the device during use. After soiling, the sample was allowed to dry for one hour undisturbed at room temperature. Then the device was cleaned using worst case implementation of the instructions in the user manual. The acceptance criteria of