(160 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related terms. The device description focuses on optical and microelectronic components for imaging and measurement. The performance studies evaluate the effectiveness of fluorescence-guided sampling compared to standard sampling, not an AI/ML algorithm's performance.
No.
The device is an imaging tool used for diagnosis and monitoring, and the intended use explicitly states it "does not diagnose or treat skin wounds."
No
The "Intended Use / Indications for Use" section explicitly states, "The MolecuLight i:X does not diagnose or treat skin wounds." While it aids in identifying wounds containing bacterial loads, this information is meant to be used in combination with clinical signs and symptoms, and it does not make a diagnosis itself.
No
The device description explicitly states it is comprised of a handheld device with integrated optical and microelectronic components, indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, the MolecuLight i:X is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens taken from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- MolecuLight i:X Function: The MolecuLight i:X is a handheld imaging tool that directly images the wound on the patient's body (in vivo). It uses fluorescence imaging to visualize bacteria in the wound.
- Intended Use: The intended use clearly states it's a "handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to... View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light." It explicitly states it "does not diagnose or treat skin wounds."
- No Specimen Analysis: The device does not analyze a sample taken from the patient. It images the wound directly.
While the device provides information that can assist clinicians in identifying wounds with high bacterial loads, this information is obtained through in vivo imaging and is used in conjunction with clinical signs and symptoms. It does not perform an in vitro analysis of a biological specimen.
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
(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 >10^4 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.
Product codes (comma separated list FDA assigned to the subject device)
QJF, FXN
Device Description
The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence (FL) 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
Wounds (skin)
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Clinicians, 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
Data from post hoc retrospective analysis of 78 patients were analyzed to evaluate the effectiveness of MolecuLight i:X to guide wound sampling to detect bacterial burden, including pathogens of interest, as defined by the CDC, compared to the Standard of Care (SoC) method of sampling, which is collected from the center of the wound.
Data from all wounds that had two samples obtained in the study were analyzed (N = 78).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Testing: Data from post hoc retrospective analysis of 78 patients were analyzed to evaluate the effectiveness of MolecuLight i:X to guide wound sampling to detect bacterial burden, including pathogens of interest, as defined by the CDC, compared to the Standard of Care (SoC) method of sampling, which is collected from the center of the wound. Samples targeted to the brightest location of fluorescence (FL-guided) were more likely to contain elevated bacterial load (≥ 10^4 CFU/g) compared to SoC-guided sampling at the center of the wound. Fluorescence-guided biopsies detected a higher number of species and pathogens of interest compared to SoC-guided biopsies.
Non-Clinical Testing: Species listed produced red fluorescence that was detectable through fluorescence imaging with the MolecuLight i:X. All species were sub-cultured from frozen isolated on commercially available Porphyrin Test Agar (PTA). Aerobic bacterial species were cultured and imaged at 24 and 40 hours, while slower growing anaerobic bacterial species were cultured and imaged at 40 and 120 hours. Negative controls were included and imaged at all time points. The fluorescence images taken with the MolecuLight i:X of each bacterial species were analyzed to determine the presence of red fluorescence using a custom algorithm.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (SoC-guided sample): 87.2% (95% CI: 77.7%, 93.7%)
Sensitivity (FL-guided sample): 98.7% (95% CI: 93.06%, 99.97%)
P-value (Sensitivity): P = 0.012
Mean difference in number of pathogens (FL Biopsy # - SoC Biopsy #): 0.795 (SD 1.804)
P-value (paired t-test for number of species): P
§ 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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 20, 2022
MolecuLight, Inc. Jordan John Director. Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K213840
Trade/Device Name: MolecuLight I:X 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
Dear Jordan John:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 18, 2022. Specifically, FDA is updating this SE Letter as an administrative correction for an inappropriate product code that does not categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Office of Surgical and Infection Control Devices at 301-796-7674 Jianting Wang, or Jianting.wang(@fda.hhs.gov.
Sincerely,
Digitally signed by Jianting Wang
Jianting Wang -S
Date: 2022.07.20 11:11:28 -04'00'
Jianting Wang Acting 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
1
Image /page/1/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 18, 2022
MolecuLight, Inc. Jordan John Director. Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada
Re: K213840
Trade/Device Name: MolecuLight i:X Regulation Number: 21 CFR 878.4550 Regulation Name: Autofluorescence Detection Device For General Surgery And Dermatological Use Regulatory Class: Class II Product Code: QDG, QJF Dated: April 13, 2022 Received: April 20, 2022
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 mav, 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.
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
2
Page 2
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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 U. Pandya -S
Purva Pandya, D.Eng. 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
3
Indications for Use
510(k) Number (if known) K213840
Device Name MolecuLight i:X
Indications for Use (Describe)
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.
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 >10^4 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.
| 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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4
510(k) SUMMARY
MolecuLight i:X
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
MolecuLight Inc. Suite 700, 425 University Avenue Toronto, ON, Canada M5G 1T6 Phone: 647-362-4684 Contact Person: Jordan John
Date Prepared: May 13, 2022
Name of Device
MolecuLight i:X
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 (K210882)
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, (i)
(ii) Measure and digitally record the size of a wound, and
View and digitally record images of fluorescence emitted from a wound when exposed to an (iii) 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 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.
5
Device Description
The MolecuLight i:X Imaging Device is a handheld medical imaging device comprised of a high-resolution color LCD display and touch-sensitive screen with integrated optical and microelectronic components. MolecuLight i:X uses its patented technology to enable real-time standard digital imaging and fluorescence (FL) imaging in wounds and surrounding healthy skin of patients as well as wound area measurements.
Comparison of Intended Use, Indications for Use and Technological Characteristics with the Predicate Device
- The intended use and technological characteristics of the subject MolecuLight i:X are I. identical to the previously cleared MolecuLight i.X. The only difference between the subject and predicate device are additional statements in the device's labeling clarifying: i) that the fluorescence in a region of a wound corresponds to the presence of elevated bacterial loads (>104 CFU/g); ii) that fluorescence in a region of a wound corresponds to the presence of more bacterial species and bacterial species of interest; iii) that species that produce red fluorescence is detectable by the MolecuLight i.X in vitro; iv) that Gram(+), Gram(-), aerobic and anaerobic species produce fluorescence detected by the MolecuLight i:X.
These statements do not change the indications for use of the device, and does not raise any new questions of safety or efficacy. The statement is supported by additional analysis of the clinical study reported in support of K191371.
| SUBJECT DEVICE | Predicate Device | |
|---|---|---|
| MolecuLight i:X | MolecuLight i:X (K210882) | |
| Device Name | MolecuLight i:X | 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 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. | 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. |
| Table 1: Comparison of Technological Characteristics for Fluorescence Imaging | ||||||
|---|---|---|---|---|---|---|
6
| | SUBJECT DEVICE
MolecuLight i:X | Predicate Device
MolecuLight i:X (K210882) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (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. | (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 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. | 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. |
| Labelled relationship
between Cyan
fluorescence and
Pseudomonas
aeruginosa | Yes | Yes |
| Labelled relationship
between region of a
wound and presence of
elevated bacterial
loads (>104 CFU/g) | Yes | No |
| Labelled relationship
between fluorescence
in a region of a wound
and the presence of
more bacterial species
and bacterial species of
interest | Yes | No |
| Labelled relationship
between species that
produce red
fluorescence and red
fluorescence signature | Yes | No |
| Labelled relationship
between fluorescence
imaging and
identifying wounds
with elevated bacterial
load including Gram | Yes | No |
| | SUBJECT DEVICE
MolecuLight i:X | Predicate Device
MolecuLight i:X (K210882) |
| (+) Gram (-), aerobic
and anaerobic species. | | |
| Target Organ | Wounds | Wounds |
| 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 | 405 nm light emitted from light emitting diodes (LED)s | 405 nm light emitted from light emitting diodes (LED)s |
| Laser Power Density | N/A | N/A |
| Infrared LED | N/A | N/A |
| White LED | N/A | N/A |
| Emission Wavelength | 500-545 nm and 600-665 nm | 500-545 nm and 600-665 nm |
| Contrast agent | Not required - autofluorescent target | Not required - autofluorescent target |
| Working Distance | 8-12 cm | 8-12 cm |
| Resolution (focal plane) | 5 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) | 1136 x 640 pixels | 1136 x 640 pixels |
| Image Format | JPEG | JPEG |
| Video Format | MOV | MOV |
| Software Operating System (OS)
Compatibility | Apple iOS 9.3.5 | Apple iOS 9.3.5 |
| Measurement Functionality | Wound length, width, and area measurements | Wound length, width, and area measurements |
| Power Supply | Battery and Wall | Battery and Wall |
| Display | Handheld device; no remote display | Handheld device; no remote display |
| Shelf-Life | 2 Years | 2 Years |
| Lifetime | 5 Years | 5 Years |
| Patient Contacting Materials | Non-patient contacting device (held 8-12 cm from skin) | Non-patient contacting device (held 8-12 cm 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 60601-1-2
IEC 60601-1
IEC 60601-2-57
IEC 62471 | IEC 60601-1-2
IEC 60601-1
IEC 60601-2-57
IEC 62471 |
7
8
In summary, the modified MolecuLight i:X with the additional labeling statements is substantially equivalent to the legally marketed MolecuLight i:X. The intended use of the i:X device is the same as the predicate, and there are no differences in technological characteristics. The additional labeling statements do not raise different questions of safety or efficacy. Retrospective analysis has demonstrated the safety and effectiveness of MolecuLight i:X with regards to the additional labeling statements. Thus, the MolecuLight i:X is substantially equivalent to the previously cleared MolecuLight i:X.
Non-Clinical Testing
Each species listed produced red fluorescence that was detectable through fluorescence imaging with the MolecuLight i:X. To demonstrate this, all species were sub-cultured from frozen isolated on commercially available Porphyrin Test Agar (PTA). Porphyrins fluoresce red under violet light illumination. Aerobic bacterial species were cultured and imaged at 24 and 40 hours, while slower growing anaerobic bacterial species were cultured and imaged at 40 and 120 hours. Negative controls were included and imaged at all time points. The fluorescence images taken with the MolecuLight i:X of each bacterial species were analyzed to determine the presence of red fluorescence using a custom algorithm.
Clinical Performance Testing
Data from post hoc retrospective analysis of 78 patients were analyzed to evaluate the effectiveness of MolecuLight i:X to guide wound sampling to detect bacterial burden, including pathogens of interest, as defined by the CDC, compared to the Standard of Care (SoC) method of sampling, which is collected from the center of the wound.
Data from all wounds that had two samples obtained in the study were analyzed (N = 78). Samples targeted to the brightest location of fluorescence (FL-guided) were more likely to contain elevated bacterial load (≥ 10ª CFU/g) compared to SoC-guided sampling at the center of the wound (See Table 2).
Table 2: Sensitivity of Soc-Guided Biopsy and FL-Guided Biopsy to Detect Any Species at Levels ≥ 104 CFU/G in Patients with Two Biopsies Obtained
| SoC-guided sample | FL-guided sample | P-value | |
|---|---|---|---|
| Sensitivity | 87.2% | ||
| (95% CI: 77.7%, 93.7%) | 98.7% | ||
| (95% CI: 93.06%, 99.97%) | P = 0.012 |
Fluorescence-guided biopsies detected a higher number of species compared to SoC-guided biopsies as described in Table 3.
9
| | Number of Species
by FL-guided Biopsy
(N=78) | Number of Species
by SoC-guided
Biopsy
(N=78) | Difference
in
Number
of
Pathogens
(FL
Biopsy # -
SoC
Biopsy #) | P-value
(paired t-
test) | 95%
Confidence
Interval |
|-------------------|----------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------|-------------------------------|
| Mean (SD) | 3.026 (1.667) | 2.231 (1.528) | 0.795
(1.804) | P