MolecuLight i:X

K191371 · MolecuLight, Inc. · QJF · Dec 4, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191371
• Device Name: MolecuLight i:X
• Applicant: MolecuLight, Inc.
• Product Code: QJF · General, Plastic Surgery
• Decision Date: Dec 4, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4550
• Device Class: Class 2

Intended 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 >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.

Device Story

Handheld imaging device; utilizes 405 nm LED excitation light to induce tissue autofluorescence; captures standard digital and fluorescence images via integrated CCD camera; displays images on high-resolution color LCD touch screen. Used by clinicians at point-of-care for wound assessment. Device measures wound length, width, and area. Fluorescence output, combined with clinical signs and symptoms (CSS), assists clinicians in identifying wounds with bacterial loads >104 CFU/g. Does not provide automated diagnosis; output serves as adjunct to clinical judgment. Benefits include improved identification of high bacterial load compared to CSS alone, aiding clinical decision-making regarding wound management.

Clinical Evidence

Prospective clinical study (n=350) evaluated identification of wounds with >104 CFU/g bacteria. Compared clinician assessment using CSS alone vs. CSS + MolecuLight i:X fluorescence. Results: CSS+iX sensitivity 60.98%, specificity 84.13%; CSS alone sensitivity 15.33%, specificity 93.65%. Study demonstrated increased likelihood of identifying high bacterial load with device usage. No device-attributable adverse events reported.

Technological Characteristics

Handheld imaging device; 405 nm LED excitation source; CCD camera; 5-megapixel resolution; 8-bit depth; 8-12 cm working distance. Non-patient contacting. Battery/wall powered. Software-based wound measurement (length, width, area). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, and ISO 10993-1.

Indications for Use

Indicated for adult patients with skin wounds. Used by clinicians at the point of care to view/record wound images, measure wound size, and view/record wound fluorescence to assist in identifying bacterial loads >104 CFU/g. Not for ruling out bacteria; does not diagnose or treat wounds.

Regulatory Classification

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

• Fluobeam 800 Clinic Imaging Device (DEN170092)
• WoundVision Scout

Reference Devices

• MolecuLight i:X (DEN180008)

Submission Summary (Full Text)

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December 4, 2019

MolecuLight Inc. % Joel Ironstone President Ironstone Product Development Suite 222, 276 Carlaw Avenue Toronto, M4M 3L1 Canada

Re: K191371

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: OJF, FXN Dated: October 28, 2019 Received: October 29, 2019

Dear Joel Ironstone:

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

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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya 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

Enclosure

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| Indications for Use | | | |
|-----------------------------------------|--|--|--|
| Food and Druq Administration | | | |
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | | | |

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K191371

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

- 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 an excitation light. (iii)

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.

Type of Use (Select one or both, as applicable)

ال Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801

Subpart C)

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# K191371 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: [phone] Contact Person: Tyler Chackowicz

Date Prepared: December 3, 2019

#### 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

Fluobeam 800 Clinic Imaging Device (DEN170092, Predicate Device) WoundVision Scout (Class I, Predicate Device) MolecuLight i:X (DEN180008, Reference Device)

### 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)

(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.

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### 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.

# Clinical Testing

Clinical testing was performed to evaluate the potential increase in the identification of wounds containing >104 CFU per gram of bacteria when the MolecuLight i:X is added to a clinician's evaluation of a subject's clinical signs and symptoms (CSS). In the study, the clinician's interpretation of the MolecuLight i:X fluorescence image and CSS were compared to quantitative microbiological analysis.

The baseline demographics of the study population is provided in the Table 1 below.

| Characteristic | Measure | All patients<br>(n = 350) | Microbiology<br>Positive (n=287) | Microbiology<br>Negative (n=63) |
|-------------------------------|------------------------------|---------------------------|----------------------------------|---------------------------------|
| Age (years) | Mean<br>(SD) | 60.19 (12.44) | 59.95 (12.11) | 61.27 (13.87) |
| | Median<br>(Minimum, Maximum) | 59.76<br>(27.83, 96.03) | 59.72<br>(27.83, 94.76) | 60.27<br>(28.47, 96.03) |
| Sex (Female) | | 125 (35.71) | 87 (30.31) | 38 (60.32) |
| Systemic Antibiotic Use (Yes) | | 90 (25.71) | 56 (19.51) | 34 (53.97) |
| Fitzpatrick Score | | | | |
| Light (I or II) | Count (%) | 224 (64) | 179 (62.37) | 45 (71.43) |
| Medium (III or IV) | | 83 (23.71) | 74 (25.78) | 9 (14.29) |
| Dark (V or VI) | | 43 (12.29) | 34 (11.85) | 9 (14.29) |

### Table 1 Baseline demographics of study population

The clinical testing demonstrated that the fluorescence image, when used in combination with clinical signs and symptoms (CSS), increased the likelihood that clinicians could identify wounds containing bacterial loads >104 CFU per gram as compared to examination of CSS alone. The use of the MolecuLight i:X in combination with clinical signs and symptoms resulted in a <10% increase as compared to CSS alone in the rate in wounds that were incorrectly identified as having bacterial load >104 CFU/g, whose resulting bacterial load determined by conventional microbiological analysis was <104 CFU/q.

| Measure | Total (%)<br>n= 350 | |
|---------|---------------------|-------------|
| | Sensitivity | Specificity |
| CSS+iX | 60.98 | 84.13 |
| CSS | 15.33 | 93.65 |

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No device attributable adverse events were recorded in the study. These study results demonstrated that the MolecuLight i:X increased the likelihood that clinicians can identify wounds containing wounds containing bacterial loads >104 CFU per gram as compared to examination of clinical signs and symptoms alone . The fluorescence output of the device is not ground truth regarding wound bacterial load >104 CFU/g and must be used in combination with CSS and other confirmatory methods such as bacterial culture, to make a determination of bacterial load.

# Non-Clinical Testing

Nonclinical testing included the following on the subject device:

- 1) Standards Compliance Testing
- 2) Software Verification and Validation
- 3) System Verification and Validation
- 4) Cleaning and Disinfection Validation
- 5) Accuracy and Inter/Intra Reader Variability Testing of Wound Measurement Function
- 6) Bioburden Testing for the DarkDrape Accessory
- Biocompatibility according to ISO 10993-1 including Cytotoxicity, Sensitization, 7) Acute Systemic Toxicity for the DarkDrape and Wound Stickers.
- Packaging and Transport validation 8)

# Compliance with Special Controls of 21 CFR 878.4550

The device complies with the all applicable special controls as per 21 CFR 878.4550 as follows:

- 1. A clinical study has been conducted that evaluates the device's performance under anticipated use conditions.
- 2. Patient Contact Materials have been demonstrated to be biocompatible.
- 3. Performance testing demonstrated the electromagnetic compatibility and electrical, mechanical and thermal safety of the device.
- 4. Software verification and validation has been completed.
- 5. LED light safety testing has been demonstrated according to IEC 60601-2-57:2011.
- 6. Labeling is provided that includes instructions for use as well as the performance of the device when used as intended.

Note: There are no components labeled as sterile included with this product.

### Standards Compliance

MolecuLight i:X 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 ●

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- LED Testing per IEC 60601-2-57:2011 and IEC 62471:2006 ●
- Biocompatibility according to ISO 10993-1 ●

## 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

The intended use for both the subject device, MolecuLight i:X, and predicate device, Fluobeam 800 Clinic Imaging Device (DEN170092), are the same. Both the subject and predicate devices illuminate target tissues or structures and detect a resulting autofluorescence image using a charge-coupled device (CCD) camera. Additionally, the subject device's wound measurement feature is similar in indication and technical characteristics to the second predicate device, WoundVision Scout. Table 2 below compares the characteristics of the subject device (MolecuLight i:X), the predicate device (Fluobeam 800 Clinic Imaging Device, DEN170092), and the reference device (MoleouLight i.X, DEN180008). Table 3 below compares the wound measurement characteristics of the subject device (MolecuLight i:X) and the predicate device (WoundVision Scout).

The subject device and the predicate devices have different technological characteristics. The submitted information, including both Non-Clinical testing establish that the MolecuLight i:X device is at least as safe and effective as the predicate devices. Both devices operate on the principle of tissue autofluorescence, which is the property of fluorescent molecules (fluorophores) absorbing a wavelength of light and then emitting a longer wavelength of light. However, while the predicate device uses a laser for illumination, the subject device uses non-coherent light-emitting diodes (LEDs) as an excitation light source. These differences do not raise different questions of safety or effectiveness.

| | SUBJECT DEVICE<br>'Modified' MolecuLight i:X | PREDICATE DEVICE<br>Fluobeam 800 Clinic Imaging<br>Device (DEN170092) | REFERENCE DEVICE<br>Granted<br>MolecuLight i:X<br>(DEN180008) |
|---------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Device Name | MolecuLight i:X | Fluobeam 800 Clinic Imaging<br>Device | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | Fluoptics | MolecuLight Inc. |
| 510(k)<br>Number | - | DEN170092 | DEN180008 |
| Regulatory<br>Class | Class II | Class II | Class I |
| Regulation<br>Number | QJF | QDG | QCR |
| Product<br>Classification | 21 CFR 878.4550 | 21 CFR 878.4550 | 21 CFR 878.4165 |
| Classification<br>Name | Autofluorescence<br>detection<br>device for general surgery and<br>dermatological use | Autofluorescence<br>detection<br>device for general surgery and<br>dermatological use | Wound Autofluorescence Imaging<br>Device |

| | | Table 2: Comparison of Technological Characteristics for Fluorescence Imaging | |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Intended for general surgery and<br>dermatological use as an adjunct<br>tool that uses autofluorescence<br>to detect tissues or structures.<br>This device is not intended to<br>provide a diagnosis. | Intended for general surgery and<br>dermatological use as an adjunct<br>tool that uses autofluorescence<br>to detect tissues or structures.<br>This device is not intended to<br>provide a diagnosis. | A wound autofluorescence<br>imaging device is a tool to view<br>autofluorescence images from<br>skin wounds that are exposed to<br>an excitation light. The device is<br>not intended to provide<br>quantitative or diagnostic<br>information. |
| Indications<br>for Use | The MolecuLight i:X is a<br>handheld imaging tool that<br>allows clinicians diagnosing and<br>treating skin wounds, at the<br>point of care, to<br>(i) View and digitally<br>record images of a wound,<br>(ii) Measure and digitally<br>record the size of a wound, and<br>(iii) View and digitally<br>record images of fluorescence<br>emitted from a wound when<br>exposed to an excitation light.<br><br>The fluorescence image, when<br>used in combination with clinical<br>signs and symptoms, has been<br>shown to increase the likelihood<br>that clinicians can identify<br>wounds containing bacterial<br>loads >104 CFU per gram as<br>compared to examination of<br>clinical signs and symptoms<br>alone. The MolecuLight i:X<br>device should not be used to<br>rule-out the presence of bacteria<br>in a wound.<br><br>The MolecuLight i:X does not<br>diagnose or treat skin wounds. | The Fluoptics Fluobeam®<br>Imaging system is intended to<br>provide real-time near infrared<br>(NIR) fluorescence imaging of<br>tissue during surgical<br>procedures. The Fluoptics<br>Fluobeam® Imaging system is<br>indicated for use in capturing and<br>viewing fluorescent images for<br>the visual assessment of blood<br>flow in adults as an adjunctive<br>method for the evaluation of<br>tissue perfusion, perfused<br>organs, and related tissue-<br>transfer circulation in tissue and<br>free flaps used in plastic, micro-<br>and reconstructive and organ<br>transplant surgeries.<br><br>The Fluoptics Fluobeam®<br>Imaging system can also be<br>used to assist in the imaging of<br>parathyroid<br>glands and can be used as an<br>adjunctive method to assist in the<br>location of parathyroid glands<br>due to the auto-fluorescence of<br>this tissue.<br><br>Use of the Fluobeam® device is<br>intended to assist, not replace,<br>experienced visual assessment,<br>and biopsy with conventional<br>histopathological confirmation<br>per standard of care. The system<br>is not to be used to confirm the<br>absence of parathyroid tissue or<br>glands and is only to be used to<br>assist in locating visually<br>identified gland/tissues. | The MolecuLight i:X is a handheld<br>imaging tool that allows clinicians<br>diagnosing and treating skin<br>wounds, at the point of care, to<br>(i) view and digitally<br>record images of a<br>wound, and<br>(ii) view and digitally<br>record images of<br>fluorescence<br>emitted from a<br>wound when<br>exposed to an<br>excitation light.<br>The MolecuLight i:X is for<br>prescription use only. |
| Target Organ | Wounds | Tissue during surgical<br>procedures | Wounds |
| Patient<br>Population | Adult patients | Adult patients | Adult patients |
| Operating<br>Modes | Standard and fluorescence<br>imaging, video and image<br>capture | Fluorescence imaging | Standard and fluorescent<br>imaging, video and image capture |
| Excitation<br>Light | 405 nm light emitted from light<br>emitting diodes (LED)s | 750 nm emitted from a laser<br>diode | 405 nm light emitted from light<br>emitting diodes (LED)s |
| Laser Power<br>Density | N/A | $5 \pm 1$ mW/cm² | N/A |
| Infrared LED | N/A | Unknown | N/A |
| White LED | N/A | Broadband LEDs with normal<br>illumination | N/A |
| | | | |
| Emission<br>Wavelength | 500-545 nm and 600-665 nm | >800 nm | 500-545 nm and 600-665 nm |
| Contrast | Not required – autofluorescent | Autofluorescent target or | Not required – autofluorescent |
| agent | target | Indocyanine green (ICG) | target |
| | | | |
| Working | 8-12 cm | 20-30 cm | 8-12 cm |
| Distance | | | |
| Resolution | 5 megapixels | 300 µm to 50 µm depending on<br>magnification | 5 megapixels |
| (focal plane) | | | |
| Magnification | N/A | X10 zoom | N/A |
| Maximum | 30 images/sec | 25 images/sec | 30 images/sec |
| Frame Rate | | | |
| Camera<br>Bit | 8 bits | 8 bits | 8 bits |
| Depth |…