(30 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the device description focuses on standard imaging and measurement functionalities.
No
The device explicitly states, "The MolecuLightDX does not diagnose or treat skin wounds," indicating it is not a therapeutic device.
No
The "Intended Use / Indications for Use" section explicitly states, "The MolecuLightDX does not diagnose or treat skin wounds."
No
The device description explicitly states it is a "handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components," indicating it is a hardware device with integrated software.
Based on the provided information, the MolecuLightDX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MolecuLightDX Function: The MolecuLightDX is a handheld imaging tool that directly images the wound on the patient's body. It does not analyze a specimen taken from the body.
- Intended Use: The intended use describes the device as a tool to view and record images of the wound and view and record fluorescence emitted from the wound. While the fluorescence is related to the presence of bacteria, the device itself is not performing a test on a biological sample. It's providing visual information about the wound surface.
- No Specimen Analysis: There is no mention of collecting or analyzing any biological specimen in the device description or intended use.
The device is a medical imaging device used in vivo (on the living body) rather than in vitro (in a test tube or lab setting).
N/A
Intended Use / Indications for Use
The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to
- (i) View and digitally record images of a wound,
- (ii) Measure and digitally record the size of a wound, and
- (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
The MolecuLightDX does not diagnose or treat skin wounds.
Product codes
QJF, FXN
Device Description
The MolecuLightDX Imaging Device is a handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLightDX uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluorescence Imaging, Standard Digital Imaging
Anatomical Site
Skin wounds and surrounding healthy skin
Indicated Patient Age Range
Adult Patients
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical testing included the following on the subject device:
- Standards Compliance Testing
- Software Verification and Validation
- System Verification and Validation
- Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
- Packaging and Transport validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 21, 2021
MolecuLight Inc. Jordan John Director, Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K211901
Trade/Device Name: MolecuLightDX Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence Detection Device For General Surgery And Dermatological Use Regulatory Class: Class II Product Code: QJF, FXN Dated: June 21, 2021 Received: June 21, 2021
Dear Jordan John:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211901
Device Name
MolecuLightDX
Indications for Use (Describe)
The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to
- (i) View and digitally record images of a wound,
- (ii) Measure and digitally record the size of a wound, and
- (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
The MolecuLightDX does not diagnose or treat skin wounds.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K211901
510(k) SUMMARY
MolecuLightDX
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 416-542-5522 Contact Person: Jordan John
Date Prepared: July 19, 2021
Name of Device
MolecuLightDX
Device Classification and Product Code
Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surgical, 21 CFR 878.4160, Class I, FXN
Predicate Devices
MolecuLight i:X K191371
Indications for Use
The MolecuLightDX 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, (i)
Measure and digitally record the size of a wound, and (ii)
(iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light.
The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
The MolecuLightDX does not diagnose or treat skin wounds.
4
Device Description
The MolecuLightDX Imaging Device is a handheld medical imaging device comprised of a high-resolution color AMOLED display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLightDX uses its patented technology to enable real-time standard digital imaging and fluorescence imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
Non-Clinical Testing
Nonclinical testing included the following on the subject device:
- Standards Compliance Testing 1)
-
- Software Verification and Validation
-
- System Verification and Validation
-
- Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
- ર) Packaging and Transport validation
Compliance with Special Controls of 21 CFR 878.4550
The device complies with the following applicable special controls as per 21 CFR 878.4550 as follows:
- Patient Contact Materials have been assessed to be biocompatible. 1.
-
- Performance testing demonstrated the electromagnetic compatibility and electrical, mechanical and thermal safety of the device.
- Software verification and validation has been completed. 3.
- ব LED light safety testing has been demonstrated according to IEC 60601-2-57:2011.
- Labeling is provided that includes instructions for use as well as the performance of the device when 5. used as intended.
Note: There are no components labeled as sterile included with this product.
Standards Compliance
MolecuLightDX has been tested to comply with the following FDA recognized standards:
- . Safety Testing per IEC 60601-1:2005+A1:2012& US National Differences per ANSI/AAMI ES 60601-1:2005/A1:2012
- EMC Testing per IEC 60601-1-2:2014 4th Edition ●
- LED Testing per IEC 60601-2-57:2011 and IEC 62471:2006 ●
Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device
5
| | MolecuLightDX
SUBJECT DEVICE | MolecuLight i:X
PREDICATE DEVICE |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MolecuLightDX | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | MolecuLight Inc. |
| 510(k) Number | - | K191371 |
| Regulatory Class | Class II | Class II |
| Regulation
Number | QJF | QJF |
| Product
Classification | 21 CFR 878.4550 | 21 CFR 878.4550 |
| Classification
Name | Autofluorescence detection device for
general surgery and dermatological use | Autofluorescence detection device for
general surgery and dermatological use |
| Intended Use | Intended for general surgery and
dermatological use as an adjunct tool that
uses autofluorescence to detect tissues or
structures. This device is not intended to
provide a diagnosis. | Intended for general surgery and
dermatological use as an adjunct tool
that uses autofluorescence to detect
tissues or structures. This device is not
intended to provide a diagnosis. |
| Indications for
Use | The MolecuLightDX is a handheld imaging
tool that allows clinicians diagnosing and
treating skin wounds, at the point of care, to | The MolecuLight i:X is a handheld
imaging tool that allows clinicians
diagnosing and treating skin wounds, at
the point of care, to |
| | i) View and digitally record images of a
wound,
ii) Measure and digitally record the size of
a wound, and
iii) View and digitally record images of
fluorescence emitted from a wound when
exposed to an excitation light. | i) View and digitally record images of
a wound,
ii) Measure and digitally record the
size of a wound, and
iii) View and digitally record images
of fluorescence emitted from a wound
when exposed to an excitation light. |
| | The fluorescence image, when used in
combination with clinical signs and
symptoms, has been shown to increase the
likelihood that clinicians can identify
wounds containing bacterial loads >104
CFU per gram as compared to examination
of clinical signs and symptoms alone. The
MolecuLightDX device should not be used
to rule-out the presence of bacteria in a
wound.
The MolecuLightDX does not diagnose or
treat skin wounds. | The fluorescence image, when used in
combination with clinical signs and
symptoms, has been shown to increase
the likelihood that clinicians can identify
wounds containing bacterial loads >104
CFU per gram as compared to
examination of clinical signs and
symptoms alone. The MolecuLight i:X
device should not be used to rule-out the
presence of bacteria in a wound. |
| | | The MolecuLight i:X does not diagnose
or treat skin wounds. |
| Target Organ | Wounds | Wounds |
| | MolecuLightDX
SUBJECT DEVICE | MolecuLight i:X
PREDICATE DEVICE |
| Patient
Population | Adult Patients | Adult Patients |
| Operating Modes | Standard and fluorescence imaging, video
and image capture | Standard and fluorescence imaging, video and image capture |
| Excitation Light | 405nm light emitted from light emitting
diodes (LEDs) | 405nm light emitted from light emitting
diodes (LEDs) |
| Laser Power
Density | N/A | N/A |
| Infrared LED | N/A | N/A |
| White LED | N/A | N/A |
| Emission
Wavelength | 500-545nm and 600-665nm | 500-545nm and 600-665nm |
| Contrast Agent | Not required - autofluorescent target | Not required - autofluorescent target |
| Infrared Laser
Distance Finder
Wavelength | 940nm | 850nm |
| Infrared Laser
Distance Finder
Peak Power Output | 17mW | 14mW |
| Working
Distance | 8 – 12 cm (Fluorescence and Standard
Imaging)
8 – 20 cm (Measurement Mode) | 8-12cm (All imaging modes) |
| Torch | Yes | No |
| Optical head | 3 Camera System | 1 Camera |
| Resolution (focal
plane) | 8 megapixels | 5 megapixels |
| Magnification | N/A | N/A |
| Maximum Frame
Rate | 30 images/sec | 30 images/sec |
| Camera Bit
Depth | 8 bits | 8 bits |
| Image Size
(Pixels) | 3264 x 2448 pixels | 1135 x 640 pixels |
| Image Format | JPEG | JPEG |
| Video Format | MOV | MOV |
| Software
Operating System
(OS) | Android 9.1 | Apple iOS 9.3.5 |
| Compatibility | | |
| Measurement
Functionality | Stickerless Wound Measurement: Wound
length, width, and area measurements | Wound length, width, and area
measurements |
| Shelf-Life | 2 Years | 2 Years |
| Power Supply | Battery and wall | Battery and wall |
| Display | 5.5" AMOLED | 4" LCD |
| | MolecuLightDX
SUBJECT DEVICE | MolecuLight i:X
PREDICATE DEVICE |
| Patient
Contacting
Materials | Non-patient contacting device (held 8-20cm from skin) | Non-patient contacting device (held 8-12cm from skin) |
| Sterility | Used non-sterile | Used non-sterile |
| Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| Mechanical safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 |
| Chemical Safety | No chemical delivered or used as part of the system | No chemical delivered or used as part of the system |
| Standards with
which the Device
complies | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 | IEC 60601-1
IEC 60601-1-2
IEC 60601-2-57
IEC 62471 |
Table 1: Comparison of Technological Characteristics for Fluorescence Imaging
6
7
Conclusion
The performance tsting conducted on the MolecuLightDX demonstrates that the device can be used safely and effectively for the indications for use stated above. The MolecuLightDX's technological characteristics are similar to the technological characteristics of the predicate device (K191371) and does not raise new types of questions regarding safety and technology. The proposed MolecuLightDX is considered to be substantially equivalent to the MolecuLight i:X predicate device (K191371).