MolecuLightDX

K211901 · MolecuLight, Inc. · QJF · Jul 21, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K211901
• Device Name: MolecuLightDX
• Applicant: MolecuLight, Inc.
• Product Code: QJF · General, Plastic Surgery
• Decision Date: Jul 21, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4550
• Device Class: Class 2

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 tool; uses 405nm LED excitation light to induce autofluorescence in wounds; captures standard and fluorescence images via 3-camera system; displays images on 5.5" AMOLED screen. Operated by clinicians at point of care. Provides visual feedback on bacterial presence (>10^4 CFU/g) when combined with clinical assessment; aids in wound management decisions. Benefits include improved identification of high bacterial loads compared to clinical signs alone. Features stickerless wound measurement functionality.

Clinical Evidence

No new clinical data provided. Substantial equivalence supported by non-clinical bench testing, including software verification/validation, system V&V, accuracy/variability testing of wound measurement, and compliance with electrical/mechanical/thermal safety and EMC standards.

Technological Characteristics

Handheld imaging device; 405nm LED excitation; 3-camera system; 8MP resolution; 5.5" AMOLED display; Android 9.1 OS. Non-patient contacting (8-20cm working distance). Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, and IEC 62471. No sterile components.

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 fluorescence emitted from wounds under excitation light. Used as an adjunct to clinical signs/symptoms to identify wounds with bacterial loads >10^4 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

• MolecuLight i:X (K191371)

Submission Summary (Full Text)

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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.

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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 ([e-mail]) or phone [phone] 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) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="white-space: nowrap;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span style="white-space: nowrap;"> <span style="font-size: 16px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 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: [phone] 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.

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## 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)
- 2) Software Verification and Validation
- 3) System Verification and Validation
- 4) 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.
- 2. 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

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| | MolecuLightDX<br>SUBJECT DEVICE | MolecuLight i:X<br>PREDICATE DEVICE |
|--------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | MolecuLightDX | MolecuLight i:X |
| Manufacturer | MolecuLight Inc. | MolecuLight Inc. |
| 510(k) Number | - | K191371 |
| Regulatory Class | Class II | Class II |
| Regulation<br>Number | QJF | QJF |
| Product<br>Classification | 21 CFR 878.4550 | 21 CFR 878.4550 |
| Classification<br>Name | Autofluorescence detection device for<br>general surgery and dermatological use | Autofluorescence detection device for<br>general surgery and dermatological use |
| Intended Use | Intended for general surgery and<br>dermatological use as an adjunct tool that<br>uses autofluorescence to detect tissues or<br>structures. This device is not intended to<br>provide a diagnosis. | Intended for general surgery and<br>dermatological use as an adjunct tool<br>that uses autofluorescence to detect<br>tissues or structures. This device is not<br>intended to provide a diagnosis. |
| Indications for<br>Use | The MolecuLightDX is a handheld imaging<br>tool that allows clinicians diagnosing and<br>treating skin wounds, at the point of care, to | The MolecuLight i:X is a handheld<br>imaging tool that allows clinicians<br>diagnosing and treating skin wounds, at<br>the point of care, to |
| | i) View and digitally record images of a<br>wound,<br>ii) Measure and digitally record the size of<br>a wound, and<br>iii) View and digitally record images of<br>fluorescence emitted from a wound when<br>exposed to an excitation light. | i) View and digitally record images of<br>a wound,<br>ii) Measure and digitally record the<br>size of a wound, and<br>iii) View and digitally record images<br>of fluorescence emitted from a wound<br>when exposed to an excitation light. |
| | The fluorescence image, when used in<br>combination with clinical signs and<br>symptoms, has been shown to increase the<br>likelihood that clinicians can identify<br>wounds containing bacterial loads >104<br>CFU per gram as compared to examination<br>of clinical signs and symptoms alone. The<br>MolecuLightDX device should not be used<br>to rule-out the presence of bacteria in a<br>wound.<br>The MolecuLightDX does not diagnose or<br>treat skin wounds. | The fluorescence image, when used in<br>combination with clinical signs and<br>symptoms, has been shown to increase<br>the likelihood that clinicians can identify<br>wounds containing bacterial loads >104<br>CFU per gram as compared to<br>examination of clinical signs and<br>symptoms alone. The MolecuLight i:X<br>device should not be used to rule-out the<br>presence of bacteria in a wound. |
| | | The MolecuLight i:X does not diagnose<br>or treat skin wounds. |
| Target Organ | Wounds | Wounds |
| | MolecuLightDX<br>SUBJECT DEVICE | MolecuLight i:X<br>PREDICATE DEVICE |
| Patient<br>Population | Adult Patients | Adult Patients |
| Operating Modes | Standard and fluorescence imaging, video<br>and image capture | Standard and fluorescence imaging, video and image capture |
| Excitation Light | 405nm light emitted from light emitting<br>diodes (LEDs) | 405nm light emitted from light emitting<br>diodes (LEDs) |
| Laser Power<br>Density | N/A | N/A |
| Infrared LED | N/A | N/A |
| White LED | N/A | N/A |
| Emission<br>Wavelength | 500-545nm and 600-665nm | 500-545nm and 600-665nm |
| Contrast Agent | Not required - autofluorescent target | Not required - autofluorescent target |
| Infrared Laser<br>Distance Finder<br>Wavelength | 940nm | 850nm |
| Infrared Laser<br>Distance Finder<br>Peak Power Output | 17mW | 14mW |
| Working<br>Distance | 8 – 12 cm (Fluorescence and Standard<br>Imaging)<br>8 – 20 cm (Measurement Mode) | 8-12cm (All imaging modes) |
| Torch | Yes | No |
| Optical head | 3 Camera System | 1 Camera |
| Resolution (focal<br>plane) | 8 megapixels | 5 megapixels |
| Magnification | N/A | N/A |
| Maximum Frame<br>Rate | 30 images/sec | 30 images/sec |
| Camera Bit<br>Depth | 8 bits | 8 bits |
| Image Size<br>(Pixels) | 3264 x 2448 pixels | 1135 x 640 pixels |
| Image Format | JPEG | JPEG |
| Video Format | MOV | MOV |
| Software<br>Operating System<br>(OS) | Android 9.1 | Apple iOS 9.3.5 |
| Compatibility | | |
| Measurement<br>Functionality | Stickerless Wound Measurement: Wound<br>length, width, and area measurements | Wound length, width, and area<br>measurements |
| Shelf-Life | 2 Years | 2 Years |
| Power Supply | Battery and wall | Battery and wall |
| Display | 5.5" AMOLED | 4" LCD |
| | MolecuLightDX<br>SUBJECT DEVICE | MolecuLight i:X<br>PREDICATE DEVICE |
| Patient<br>Contacting<br>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<br>which the Device<br>complies | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 62471 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-57<br>IEC 62471 |

# Table 1: Comparison of Technological Characteristics for Fluorescence Imaging

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## 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).