SnapshotGLO (KB100)

K242669 · Kent Imaging, Inc. · QJF · Mar 26, 2025 · General, Plastic Surgery

Device Facts

• Record ID: K242669
• Device Name: SnapshotGLO (KB100)
• Applicant: Kent Imaging, Inc.
• Product Code: QJF · General, Plastic Surgery
• Decision Date: Mar 26, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4550
• Device Class: Class 2

Intended Use

The SnapshotGLO 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 SnapshotGLO device should not be used to rule-out the presence of bacteria in a wound. The SnapshotGLO does not diagnose or treat skin wounds.

Device Story

Handheld, non-contact, point-of-care wound imaging device; operated by clinicians. Inputs: 395 nm LED excitation light and white LED light. Principle: Autofluorescence imaging; captures native fluorescence (400-700 nm) emitted by bacterial compounds; generates 2D color-coded bioburden maps. Also captures RGB clinical images and performs stickerless wound measurements (length, width, area). Output: Images and measurements displayed on integrated 7-inch touchscreen for clinical review/documentation. Use: Adjunct tool to clinical signs and symptoms (CSS) to identify wounds with high bacterial bioburden (>104 CFU/g). Benefit: Improved identification of bacterial presence compared to CSS alone; aids in wound monitoring and management.

Clinical Evidence

Retrospective clinical study (n=40 patients, 2 evaluators) compared SnapshotGLO and MolecuLightDX against clinical signs and symptoms (CSS) and culture results. SnapshotGLO + CSS showed >88% positive percent agreement and improved accuracy (75-82.5%) compared to MolecuLightDX (52.5-65%) when validated against culture. Bench testing confirmed equivalence in detecting red fluorescence from porphyrin-producing bacteria/biofilms and in manual wound measurement accuracy/repeatability.

Technological Characteristics

Handheld imaging device; 395 nm LED excitation; white LED (400-700 nm); 1 RGB camera (max 12 MP); 7-inch LCD touchscreen; 940 nm IR laser distance finder (17 mW). Non-patient contacting. Connectivity: Wireless networks. OS: Android 10Q.R8-based. Compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, IEC 60601-2-22.

Indications for Use

Indicated for adult patients with skin wounds to assist clinicians in visualizing bacterial bioburden via autofluorescence and measuring wound dimensions at the point of care. Not for ruling out bacterial presence or diagnosing/treating 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

• MolecuLightDX (K211901)

Submission Summary (Full Text)

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March 26, 2025

Kent Imaging Inc. Hitalo Arume Regulatory Affairs and Quality Assurance Manager Suite 300, 1210 8 Street SW Calgary, AB T2R 1L3 Canada

# Re: K242669

Trade/Device Name: SnapshotGLO (KB100) 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 17, 2025 Received: March 17, 2025

# Dear Hitalo Arume:

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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

Digitally signed by TANISHA - Digitally signed by Signed by L. HITHE - C Date: 2025.03.26
16:27:24 -04'00'

Tanisha Hithe 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) K242669

Device Name SnapshotGLO (KB100)

#### Indications for Use (Describe)

The SnapshotGLO 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 SnapshotGLO device should not be used to rule-out the presence of bacteria in a wound.

The SnapshotGLO does not diagnose or treat skin wounds.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image is a logo for Kent Imaging. The logo consists of a red square with a white stylized "K" inside, followed by the text "KENT" in large, bold, blue letters. Below the word "KENT" is the word "IMAGING" in smaller, gray letters.

# 510(k) Summary

## March 25, 2025

510(k) Number: K242669

Device Name: SnapshotGLO (KB100)

#### Submittal Information:

Post-approval contact: Hitalo Arume

Kent Imaging Inc. Suite 300, 1210 8 Street SW Calgary, AB CANADA T2R 1L3

Phone: [phone] Fax: [phone]

#### Name of the Device

SnapshotGLO

#### 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

## Legally Marketed Predicate Device

Device Name: MolecuLightDX

510(k) Number: K211901

#### SnapshotGLO (KB100) information

#### Indications for Use

The SnapshotGLO 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 SnapshotGLO device should not be used to rule-out the presence of bacteria in a wound.

The SnapshotGLO does not diagnose or treat skin wounds.

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Image /page/5/Picture/0 description: The image shows the logo for Kent Imaging. The logo consists of a red square with a white "K" inside, followed by the word "KENT" in blue, block letters. Below the word "KENT" is the word "IMAGING" in smaller, gray letters.

## Device Description

SnapshotGLO is a medical device that operates like a camera. It is a point-of-care, wound imaging device. This device is a non-contact imaging device wherein the wound images are captured from a height of ~12 cm using 395 nm LEDs and a white LED to produce a resultant fluorescence image that aids in visualising the bacteria on the wound and a colour-based "RGB" image or clinical image. Resultant images are viewed on the 7-inch touchscreen display.

SnapshotGLO is based on autofluorescence imaging technology and uses native fluorescence of bacteria to determine the presence of bacterial bioburden and displays a two-dimensional, colour-coded highlight of bioburden presence on the wounds.

SnapshotGLO is a handheld imaging tool that allows clinicians diagnosing, monitoring and treating skin wounds at the point of care with the help of the following features:

- . View and digitally record images of a wound,
- . 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 ● excitation light

SnapshotGLO consists of:

- SnapshotGLO device
- Medical grade adapter
- User Manual
- Quick Start Guide ●

SnapshotGLO is intended for wound care applications as an adjunct tool that uses autofluorescence to detect tissues or structures. 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 high bacteria bioburden compared to clinical symptoms alone. SnapshotGLO should not be used to rule-out the presence of bacteria in a wound. This device is not intended to provide a diagnosis.

## Fundamental Principles

SnapshotGLO operates using autofluorescence imaging technology. When exposed to 395 nm excitation light, naturally occurring bacterial compounds emit fluorescence in the visible spectrum (400-700 nm). This emitted light is captured by the device to generate fluorescence images that highlight areas of potential bacterial presence. When interpreted alongside clinical signs and symptoms, these images can assist clinicians in identifying wounds with high bacterial bioburden. The device also captures white light images and enables wound measurement, with results displayed on an integrated touchscreen for clinical review and documentation.

## Non-clinical study

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Image /page/6/Picture/0 description: The image is a logo for Kent Imaging. The logo consists of a red square with a white "K" inside, followed by the text "KENT IMAGING" in blue. The word "KENT" is in a larger, bolder font than the word "IMAGING", which is located directly below it.

## Culture Plate Bench Testing:

This nonclinical test aimed to evaluate the efficacy of the SnapshotGLO device in detecting bacterial fluorescence after ultraviolet excitation and compare it with the predicate device, MoleculightDX. The primary endpoints focused on detecting red fluorescence from porphyrin-producing bacteria, both in mono- and bi-microbial settings, as well as in bacterial biofilms. The secondary endpoints examined the time-series analysis of red fluorescence intensity.

The nonclinical test provided robust evidence that the SnapshotGLO device is substantially equivalent to the MoleculightDX in detecting bacterial fluorescence. The results support the device's effectiveness in clinical settings, confirming its potential for identifying porphyrin-producing bacteria and biofilms in wound care and infection management.

## Wound dimensions Testing:

This nonclinical testing discussed a comprehensive comparison of the SnapshotGLO device against the predicate device, MoleculightDX, to assess their equivalence in measuring wound dimensions. The purpose of these tests is to determine whether SnapshotGLO performs similarly to MoleculightDX, supporting a claim of substantial equivalence in the 510(k) submission.

This nonclinical test demonstrates that SnapshotGLO performs comparably to the predicate device, MoleculightDX, in manual wound detection modes. The strong agreement in measurement accuracy and repeatability between the two devices supports the claim of substantial equivalence.

## Clinical data

A retrospective clinical study involving 40 patients and two clinical evaluators was conducted to compare the performance of SnapshotGLO and MolecuLightDX, alongside clinical signs and symptoms (CSS). This blinded assessment demonstrated that SnapshotGLO, when used in conjunction with CSS, showed over 88% positive percent agreement and provided improved accuracy (75-82.5%) compared to MolecuLightDX (52.5-65%) when validated against culture results. These findings support the device's substantial equivalence and improved clinical performance.

## Substantial Equivalence

The SnapshotGLO (KB100) has the same regulatory information as the predicate device MolecuLightDX (K211901).

| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| Regulation Class | Class II | Class II | Same |
| Regulation<br>Number | QJF, FXN | QJF, FXN | Same |
| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
| Product<br>Classification | 21 CFR 878.4550<br>21 CFR 878.4160 | 21 CFR 878.4550<br>21 CFR 878.4160 | Same |
| Classification<br>Name | Autofluorescence detection<br>device for general surgery and<br>dermatological use | Autofluorescence detection<br>device for general surgery and<br>dermatological use | Same |
| Accessories | Dark drape/adapter/power cable | Drape/adapter/power cable | Same |
| Intended use | Intended for general surgery and<br>dermatological use as an adjunct<br>tool that uses autofluorescence to<br>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 to<br>detect tissues or structures. This<br>device is not intended to provide<br>a diagnosis. | Same |
| Indications for use | The MolecuLightDX is a<br>handheld imaging tool that<br>allows clinicians diagnosing and<br>treating skin wounds, at the point<br>of care, to<br>i)<br>View and digitally<br>record images of a<br>wound,<br>ii)<br>Measure and digitally<br>record the size of a<br>wound, and<br>iii)<br>View and digitally<br>record images of<br>fluorescence emitted<br>from a wound when<br>exposed to an excitation<br>light.<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 MolecuLightDX<br>device should not be used to | The SnapshotGLO is a handheld<br>imaging tool that allows<br>clinicians diagnosing and<br>treating skin wounds, at the point<br>of care, to<br>i)<br>View and digitally<br>record images of a<br>wound,<br>ii)<br>Measure and digitally<br>record the size of a<br>wound, and<br>iii)<br>View and digitally<br>record images of<br>fluorescence emitted<br>from a wound when<br>exposed to an excitation<br>light.<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 SnapshotGLO device<br>should not be used to rule-out | Same |
| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
| | rule-out the presence of bacteria in a wound. | the presence of bacteria in a wound. | |
| | The MolecuLightDX does not diagnose or treat skin wounds. | The SnapshotGLO does not diagnose or treat skin wounds. | |
| Target organ | Wounds | Wounds | Same |
| Patient population | Adult patients | Adult patients | Same |
| Operating modes | Standard and fluorescence imaging, video and image capture | Autofluorescence and white light imaging | Similar:<br>SnapshotGLO operates in white light and autofluorescence image capture mode only. |
| Excitation light | 405 nm light emitted from light emitting diodes (LED)s | 395 nm light emitted from light emitting diodes (LED)s | Similar. Small difference in excitation wavelength. |
| White LED | MoleculightDX has a white LED which is referred to as a torch. | White LED that covers the visible spectrum (~400-700 nm) | Similar, both devices use white light when capturing RGB images |
| Emission wavelength | 500-545 nm and 600-665 nm | 400-700 nm | Similar |
| Contrast agent | Not required - autofluorescence-based target | Not required - autofluorescence-based target | Same |
| Infrared Laser Distance Finder Wavelength | 940 nm | 940 nm | Same |
| Infrared Laser Distance Finder Peak Power Output | 17 mW | 17 mW | Same |
| Working distance | 8 - 12 cm (Fluorescence and Standard Imaging)<br>8 - 20 cm (Measurement Mode) | 11- 13 cm from the region of interest for both fluorescence and wound measurement modes | Similar. The slight difference in the imaging distance does not affect the performance of the device. |
| Optical head | 3 camera system | 1 RGB camera | Different.<br>Only 1 camera required for autofluorescence and wound dimension measurement. |
| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
| Resolution (focal<br>plane) | 8 megapixels | Maximum 12 MP for RGB<br>camera | Similar. |
| Maximum Frame<br>Rate | 30 images/sec | 30 images/sec | Same |
| Camera Bit Depth | 8 bits | 8 bits for RGB camera | Same |
| Image size (pixels) | 3264 x 2448 pixels | 1200x1200 pixels | Similar |
| Image format | JPEG | JPEG | Same |
| Software operating<br>system (OS)<br>compatibility | Android 9.1 | A customized OS provided by<br>the module manufacturer<br>(Quectel) based on the AOSP of<br>Android 10Q.R8. | Similar. Both devices use an<br>Android-based OS. |
| Measurement<br>Functionality | Stickerless Wound<br>Measurement: Wound length,<br>width, and area measurements | Stickerless Wound<br>Measurement: Length, Width,<br>and Area measurements | Same |
| Power Supply | Battery and Wall | Battery and Wall | Same |
| Display | 5.5" AMOLED display | 7" LCD display | Similar. |
| Patient Contacting<br>Materials | Non-patient contacting device | Non-patient contacting device | Same |
| Sterility | Device non-sterile | Device non-sterile | Same |
| Electrical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | Same |
| Mechanical Safety | Compliance to IEC 60601-1 | Compliance to IEC 60601-1 | Same…