(202 days)
No
The description focuses on autofluorescence imaging and image capture/display, with no mention of AI or ML algorithms for image analysis or interpretation. The performance studies compare the device's ability to visualize bacteria and measure wounds, not the performance of an AI/ML model.
No
The device is described as an imaging tool that aids in diagnosis and monitoring, specifically stating it "does not diagnose or treat skin wounds" and "is not intended to provide a diagnosis."
No
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state: "The SnapshotGLO does not diagnose or treat skin wounds" and "This device is not intended to provide a diagnosis." It is presented as an adjunct tool to aid clinicians, not to make a diagnosis itself.
No
The device description explicitly states that SnapshotGLO "consists of: - SnapshotGLO device - Medical grade adapter - User Manual - Quick Start Guide". The "SnapshotGLO device" is described as a handheld imaging tool with LEDs, a touchscreen display, and operates like a camera, indicating it is a hardware component, not solely software.
Based on the provided information, the SnapshotGLO device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The SnapshotGLO directly images the wound on the patient's skin. It does not analyze a sample taken from the body.
- The device description and intended use clearly state it is a handheld imaging tool for use at the point of care. This indicates direct interaction with the patient's wound, not laboratory analysis of a specimen.
- The device uses autofluorescence imaging and white light imaging. These are imaging modalities applied directly to the wound surface.
- The performance studies involve imaging patients' wounds and comparing results to culture results (which are IVD tests), but the device itself is not performing the culture.
While the device aids in identifying wounds likely to contain high bacterial loads, and this information is used in conjunction with clinical signs and symptoms to inform diagnosis and treatment decisions, the device itself is not performing a diagnostic test on a biological specimen. It is a tool that provides visual information about the wound.
N/A
Intended Use / 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.
Product codes
QJF, FXN
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical imaging (autofluorescence imaging, white light imaging)
Anatomical Site
Wounds
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
clinicians, at the point of care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Non-clinical study:
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.
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.
Key Metrics
Positive Percent Agreement (PPA) > 88%
Accuracy (75-82.5%)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4550 Autofluorescence detection device for general surgery and dermatological use.
(a)
Identification. An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) In vivo testing under anticipated conditions of use must characterize the ability of the device to detect autofluorescent signals from tissues or structures consistent with the indications for use.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate the electromagnetic compatibility and electrical, mechanical, and thermal safety of the device.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Performance testing must demonstrate the sterility of patient-contacting components of the device.
(6) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(7) Performance testing must demonstrate laser and light safety for eye, tissue, and skin.
(8) Labeling must include the following:
(i) Instructions for use;
(ii) The detection performance characteristics of the device when used as intended; and
(iii) A shelf life for any sterile components.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and consists of the letters "FDA" stacked on top of the words "U.S. FOOD & DRUG ADMINISTRATION".
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.
1
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.
2
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,
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
3
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: 403-455-7610 Fax: 877-664-5450
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 | |||
| Number | QJF, FXN | QJF, FXN | Same |
| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
| Product | |||
| Classification | 21 CFR 878.4550 | ||
| 21 CFR 878.4160 | 21 CFR 878.4550 | ||
| 21 CFR 878.4160 | Same | ||
| Classification | |||
| Name | Autofluorescence detection | ||
| device for general surgery and | |||
| dermatological use | Autofluorescence detection | ||
| device for general surgery and | |||
| dermatological use | Same | ||
| Accessories | Dark drape/adapter/power cable | Drape/adapter/power cable | Same |
| 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. | Same | ||
| Indications for use | 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 | 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 | 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: |
| 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) | ||
| 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. |
| Only 1 camera required for autofluorescence and wound dimension measurement. | |||
| Description | MoleculightDX (Predicate) | SnapshotGLO (Subject) | Notes |
| Resolution (focal | |||
| plane) | 8 megapixels | Maximum 12 MP for RGB | |
| camera | Similar. | ||
| Maximum Frame | |||
| 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 | |||
| system (OS) | |||
| compatibility | Android 9.1 | A customized OS provided by | |
| the module manufacturer | |||
| (Quectel) based on the AOSP of | |||
| Android 10Q.R8. | Similar. Both devices use an | ||
| Android-based OS. | |||
| Measurement | |||
| Functionality | Stickerless Wound | ||
| Measurement: Wound length, | |||
| width, and area measurements | Stickerless Wound | ||
| Measurement: Length, Width, | |||
| and Area measurements | Same | ||
| Power Supply | Battery and Wall | Battery and Wall | Same |
| Display | 5.5" AMOLED display | 7" LCD display | Similar. |
| Patient Contacting | |||
| 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 |
| Chemical Safety | No chemical delivered or used as | ||
| part of the system | No chemical delivered or used as | ||
| part of the system | Same | ||
| Standards with | |||
| which the Device | |||
| complies | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-57 | |||
| IEC 62471 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 60601-2-57 | |||
| IEC 62471 | |||
| IEC 60601-2-22 | Similar. The laser module in | ||
| the ranging sensor is IEC | |||
| 60601-2-22 certified. | |||
| Connectivity | Can be connected to wireless | ||
| networks | Can be connected to wireless | ||
| networks | Same |
Detailed Comparative Features between Devices.
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Image /page/7/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 words "KENT" in blue, and "IMAGING" in gray underneath. The "K" in the square is stylized with a curved line extending from the top left corner to the bottom right corner.
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Image /page/9/Picture/0 description: The image shows the logo for Kent Imaging. The logo consists of a red square with a white stylized "K" inside, followed by the word "KENT" in large, bold, blue letters. Below the word "KENT" is the word "IMAGING" in smaller, black letters.
Conclusion
The SnapshotGLO (KB100) has the same intended use, indications for use, and fundamental technological characteristics as the predicate device, MolecuLightDX (K211901). Minor differences in design, such as
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Image /page/10/Picture/0 description: The image shows the logo for Kent Imaging. The logo consists of a red square with a white stylized "K" inside, followed by the word "KENT" in large, bold, blue letters. Below the word "KENT" is the word "IMAGING" in smaller, gray letters. The logo is simple and modern, and the colors are eye-catching.
excitation wavelength and imaging hardware, do not raise new questions of safety or effectiveness. Nonclinical and clinical performance data support that SnapshotGLO is substantially equivalent to the predicate device for its intended purpose in wound imaging and bacterial fluorescence detection.