← Product Code [QJF](/submissions/SU/subpart-e%E2%80%94surgical-devices/QJF) · K210882 # MolecuLight I:X (K210882) _MolecuLight, Inc. · QJF · Jun 22, 2021 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QJF/K210882 ## Device Facts - **Applicant:** MolecuLight, Inc. - **Product Code:** [QJF](/submissions/SU/subpart-e%E2%80%94surgical-devices/QJF.md) - **Decision Date:** Jun 22, 2021 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4550 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery ## 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. ## Device Story Handheld imaging device; features high-resolution color LCD, touch screen, optical/microelectronic components. Operates by exposing wounds to 405 nm LED excitation light; captures standard digital images and fluorescence images (500-545 nm and 600-665 nm emission). Used by clinicians at point of care for wound assessment. Device displays images on integrated screen; no remote display. Clinicians use fluorescence signatures (red/cyan) alongside clinical signs to identify bacterial presence (>10^4 CFU/g). Cyan fluorescence specifically indicates increased likelihood of Pseudomonas aeruginosa. Device does not diagnose/treat; aids clinical decision-making regarding wound management. ## Clinical Evidence Retrospective analysis of 350 patients. Evaluated effectiveness of cyan fluorescence in identifying Pseudomonas aeruginosa at bacterial loads ≥ 10^4 CFU/g. Results: Sensitivity 43.75% (95% CI: 26.26, 62.34), Specificity 94.97% (95% CI: 91.96, 97.10), PPV 46.67%, NPV 94.38%, Likelihood Ratio 8.70. Additional analyses provided for Total Bacterial Load (TBL) detection. ## Technological Characteristics Handheld imaging device; 405 nm LED excitation; 500-545 nm and 600-665 nm emission filters. 5-megapixel resolution; 8-bit depth; 1136 x 640 pixel JPEG/MOV output. Non-patient contacting (8-12 cm working distance). Battery/wall powered. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471. No chemical agents used. ## Regulatory 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. ## Special Controls In combination with the general controls of the FD&C Act, the autofluorescence detection device for general surgery and dermatological use is subject to the following special controls: *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. ## Predicate Devices - MolecuLight i:X ([K191371](/device/K191371.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 22, 2021 MolecuLight Inc. Jordan John Director, Quality Assurance & Regulatory Affairs Suite 700, 425 University Avenue Toronto, Ontario M5G 1T6 Canada Re: K210882 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 Dated: March 24, 2021 Received: March 25, 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) #### 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. Measure and digitally record the size of a wound, and (ii) 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 grams 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) Subpart C) □ Over-The-Counter Use (21 CFR 801 #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff > > PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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: June 22, 2021 #### Name of Device MolecuLight i:X ### Device Classification and Product Code Autofluorescence detection device, 21 CFR 878.4550, Class II, QJF Tape, Camera, Surqical, 21 CFR 878.4160, Class I, FXN ### Predicate Devices MolecuLight i:X (K191371) #### 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) - Measure and digitally record the size of a wound, and (ii) - View and digitally record images of fluorescence emitted from a wound when exposed to (iii) 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. {4}------------------------------------------------ ## 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 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 identical to the previously cleared MolecuLight i:X. The only difference between the subject and predicate device is an additional statement in the device's labeling clarifying the relationship between the presence of a cyan fluorescence signature and the increased likelihood that wound contains Pseudomonas aeruqinosa. This statement does 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
MolecuLight i:X | Predicate Device
MolecuLight i:X (K191371) | |---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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,
(ii) Measure and digitally
record the size of a wound, and | 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 | | | Table 1: Comparison of Technological Characteristics for Fluorescence Imaging | | |--|-------------------------------------------------------------------------------|--| | | | | {5}------------------------------------------------ | (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. | (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. | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------| | Labelled relationship between Cyan fluorescence and Pseudomonas aeruginosa | Yes | No | | 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 | | 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) | Apple iOS 9.3.5 | Apple iOS 9.3.5 | | Compatibility 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 | | 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 | {6}------------------------------------------------ In summary, the modified MolecuLight i:X with the additional labeling statement 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 statement does 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 statement. Thus, the MolecuLight i:X is substantially equivalent to the previously cleared MolecuLight i:X. # Non-Clinical Testing No non-clinical performance testing was performed for this 510(k) submission. # Clinical Performance Testing Data from 350 patients were retrospectively analyzed to evaluate the effectiveness of MolecuLight i:X to identify wounds with Pseudomonas aeruginosa at bacterial loads ≥ 104 CFU/g based on sensitivity, specificity, PPV, NPV, and likelihood ratio. {7}------------------------------------------------ # Table 2: Cyan Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q | Fluorescence
Signature | Sensitivity
(95% CI)ª
n=32 | Specificity
(95% CI)ª
n=318 | PPVb
(95% CI)ª
n=30 | NPVb
(95% CI)ª
n=320 | Likelihood
Ratio
(95% CI)
N=30 | |---------------------------|----------------------------------|-----------------------------------|-----------------------------|-----------------------------|-----------------------------------------| | Cyan | 43.75%
(26.26,
62.34) | 94.97%
(91.96,
97.10) | 46.67%
(28.34,
65.67) | 94.38%
(91.26,
96.63) | 8.70
(4.69, 16.14) | o aTwo-sided 95% Clopper Pearson Confidence Intervals. o bThe PPV and NPV are computed for the study prevalence of 9.14%. - o Likelihood ratio is the probability of a wound with Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence divided by the probability of a wound that does not have Pseudomonas aeruginosa at Specific Levels ≥ 104 CFU/q being positive for cyan fluorescence. Detailed retrospective analysis included assessment for the presence of any i:X fluorescence signature (red and/or cyan), presence of cyan fluorescence, presence of red fluorescence, and total bacterial load (TBL; CFU/g; sum of all species). Results for three separate analyses of the diagnostic parameters are presented below: - Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ i. 104 CFU/g - Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g ii. - iii. Fluorescence in the Detection Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g in Absence of Pseudomonas aeruginosa | Test | | | Post.Test.Risk (PPV) | | | Likelihood | |-------------------|---------|--------|----------------------|------------------------------|------------------------------|------------| | Output | Pa.High | Pa.Low | Post.Test.Risk | Lower
Confidence
Limit | Upper
Confidence
Limit | Ratio | | Cyan FL | 14 | 16 | 0.467 | 0.283 | 0.657 | 8.695 | | Red FL | 14 | 145 | 0.088 | 0.049 | 0.143 | 0.959 | | Red or
Cyan FL | 25 | 150 | 0.143 | 0.095 | 0.204 | 1.656 | | Total | 32 | 318 | 0.091 | 0.063 | 0.127 | 1.000 | ### Table 3: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Pseudomonas aeruginosa at Species Specific Levels ≥ 104 CFU/g {8}------------------------------------------------ Table 4: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g | | | | Post.Test.Risk (PPV) | | | | |-------------------|----------|---------|----------------------|------------------------------|------------------------------|---------------------| | Test
Output | TBL.High | TBL.Low | Post.Test.Risk | Lower
Confidence
Limit | Upper
Confidence
Limit | Likelihood
Ratio | | Cyan FL | 29 | 1 | 0.967 | 0.828 | 0.999 | 6.366 | | Red FL | 152 | 7 | 0.956 | 0.911 | 0.982 | 4.767 | | Red or
Cyan FL | 168 | 7 | 0.960 | 0.919 | 0.984 | 5.268 | | Total | 287 | 63 | 0.820 | 0.776 | 0.859 | 1.000 | Table 5: Cyan, Red, and Cyan or Red Fluorescence in the Detection of Wounds with Total Bacterial Load (TBL) at Levels ≥ 104 CFU/g negative for Pseudomonas aeruginosa | Test
Output | TBL
(Absent
PA).High | TBL
(Absent
PA).Low | Post.Test.Risk (PPV) | | | Likelihood
Ratio | |----------------------|----------------------------|---------------------------|----------------------|------------------------------|------------------------------|---------------------| | | | | Post.Test.Risk | Lower
Confidence
Limit | Upper
Confidence
Limit | | | Cyan
FL | 15 | 1 | 0.938 | 0.698 | 0.998 | 3.706 | | Red FL | 138 | 7 | 0.952 | 0.903 | 0.980 | 4.871 | | Red or
Cyan
FL | 143 | 7 | 0.953 | 0.906 | 0.981 | 5.047 | | Total | 255 | 63 | 0.802 | 0.754 | 0.844 | 1.000 | # Conclusion The modified MolecuLight i:X is substantially equivalent to the cleared MolecuLight i:X. --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QJF/K210882](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/QJF/K210882) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com