Demetra Dermatoscope BDEM-01

K213957 · Barco N.V. · PSN · Mar 11, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K213957
• Device Name: Demetra Dermatoscope BDEM-01
• Applicant: Barco N.V.
• Product Code: PSN · General, Plastic Surgery
• Decision Date: Mar 11, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

Device Story

Demetra BDEM-01 is a handheld, battery-powered digital dermatoscope; captures multispectral and white light dermoscopic images (contact mode) and clinical photographs (non-contact, 10-55 cm distance). Device features integrated AMOLED capacitive touchscreen; transmits data via wireless connection to cloud-based software. Used by trained medical practitioners in professional clinical environments. Software application manages imaging workflow, stores images, and generates reports for review. Analytics toolkit displays skin parameter maps. Device aids documentation and visualization of skin lesions; supports clinical decision-making by providing high-resolution, multispectral visual data for dermatological assessment.

Clinical Evidence

Bench testing only. Functional testing performed on multispectral image acquisition, micro-chip, camera components, data handling/display, and analytics toolkit. All tests passed.

Technological Characteristics

Handheld dermatoscope; CMOS sensor (3840x2160); white light and multispectral LEDs (Amber, Deep Red, Green, Cyan, Blue, Royal Blue, Far Red, Red-Orange). Magnification 10-50x. Biocompatible (ISO 10993). Wireless connectivity. IEC 60601-1-2 and IEC 60601 compliant. Integrated AMOLED capacitive touchscreen.

Indications for Use

Indicated for trained medical practitioners to acquire, store, retrieve, display, and review non-invasive multispectral and white light dermoscopic images and clinical photographs of the skin.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Demetra BDEM-01 (K192829)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION".

Barco NV Imke Storm Regulatory Affairs Officer President Kennedypark 35 Kortrijk, W-LV 8500 Belgium

March 11, 2022

Re: K213957

Trade/Device Name: Demetra Dermatoscope BDEM-01 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: PSN Dated: February 10, 2022 Received: February 17, 2022

Dear Imke Storm:

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/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.

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

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Neil R.P. Ogden, MS Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K213957

Device Name Demetra BDEM-01

Indications for Use (Describe)

The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin. These can be stored, retrieved, displayed and reviewed by trained medical practitioners.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b></b></span> | <span style="text-decoration: underline;"><b></b></span> |
| <div style="display:inline-block;"><div><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div></div> | <div style="display:inline-block;"><div><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div></div> |

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

| 510(k) Summary (in accordance with 21 CFR 807.92) | | | |
|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>8500 Kortrijk<br>BELGIUM | | |
| 2. Contact<br>person | Imke Storm<br>Regulatory Affairs Officer<br>Tel: [phone]<br>[e-mail] | | |
| 3. Date of<br>submission | November 29 2021 | | |
| 4. Device<br>information | Trade name/model: Demetra BDEM-01<br>Common name: Dermatoscope<br>Classification name: Light Based Imaging - Surgical lamp<br>Classification code: PSN<br>Regulation number: 878.4580 | | |
| 5. Predicate<br>device | Demetra BDEM-01 - K192829 | | |
| 6. Device<br>description | The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize<br>the imaging and documentation workflow.<br>The “Barco Demetra BDEM-01” consists of a hardware device and a software<br>application.<br>The hardware device is a portable, battery powered medical device for acquiring and<br>visualizing images of the skin. The device acquires multispectral optical dermoscopic<br>images in a contact mode (device in contact with the skin). In addition, the device can<br>also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the<br>skin, and a clinical overview image when it is held at a distance of approximately 35-55<br>cm from the skin.<br>The stand-alone software application is cloud software with a related web application.<br>The cloud software can generate reports containing white light dermoscopic images<br>and clinical photographs of the skin to be reviewed by trained medical practitioners. | | |
| 7. Intended Use<br>of the Device | The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquires<br>multispectral and white light dermoscopic images and clinical photographs of the skin.<br>These can be stored, retrieved, displayed and reviewed by trained medical<br>practitioners. | | |
| 8. Comparison<br>of<br>technological<br>characteristics | Trade Name/Device<br>Name | BDEM-01 (original K-<br>192829) | BDEM-01 (this special 510(k)) |
| | Product Code | PSN | PSN |
| Regulatory Class | II | II | |
| Indications for use | The Barco Digital<br>Dermatoscope is a non-<br>invasive skin imaging<br>system, which acquires<br>multispectral and white<br>light dermoscopic images<br>and clinical photographs<br>of the skin. These can be<br>stored, retrieved,<br>displayed and reviewed<br>by trained medical<br>practitioners. | The Barco Digital<br>Dermatoscope is a non-<br>invasive skin imaging system,<br>which acquires multispectral<br>and white light dermoscopic<br>images and clinical<br>photographs of the skin.<br>These can be stored,<br>retrieved, displayed and<br>reviewed by trained medical<br>practitioners. | |
| Illumination for | Skin | Skin | |
| Intended users | Trained medical<br>practitioners | Trained medical practitioners | |
| Where used | Professional environment | Professional environment | |
| Digital or Analog | Digital | Digital | |
| Illumination | White light LEDs (for live<br>preview mode and<br>dermoscopic images)<br>Multispectral LEDs (for<br>dermoscopic images)<br>Amber Deep Red Green Cyan Blue Royal Blue Far Red Red-Orange (Only for acquisition and<br>storage, not for visualization in<br>the current intended use) | White light LEDs<br>(for live preview<br>mode and<br>dermoscopic<br>images)<br>Multispectral<br>LEDs (for<br>dermoscopic<br>images) Amber Deep Red Green Cyan Blue Royal Blue Far Red Red-Orange (Only for acquisition and<br>storage, not for<br>visualization in the current<br>intended use) | |
| Magnification | 10-50x fold<br>(1 sensor pixel = 6.383um<br>in contact) | 10-50x fold<br>(1 sensor pixel = 6.383um in<br>contact) | |
| Sensor resolution | 3840 (H) × 2160 (V)<br>CMOS sensor | 3840 (H) × 2160 (V) CMOS<br>sensor | |
| | Design | Camera, software and<br>integrated AMOLED<br>capacitive touchscreen | Camera, software and integrated<br>AMOLED capacitive touchscreen |
| | Human factors | Handheld device | Handheld device |
| | Net weight scope | Without non-contact<br>cone: 528 g<br>With non-contact cone:<br>552 g | Without non-contact cone: 528 g<br>With non-contact cone: 552 g |
| | Biocompatibility | Biocompatible (ISO<br>10993) | Biocompatible (ISO 10993) |
| | Data connection | Wireless communication<br>FCC compliant | Wireless communication FCC<br>compliant |
| | Compatibility with the<br>environment and other<br>devices | IEC 60601-1-2:2014 and<br>EN 60601-1-2:2015<br>compliant | IEC 60601-1-2:2014 and EN<br>60601-1-2:2015 compliant |
| | Electrical Safety | IEC 60601 compliant | IEC 60601 compliant |
| 9.<br>Performance<br>testing | The bench tests mentioned below were performed to validate the device<br>characteristics that differ from the predicate device in the original 510(k)<br>K192829. | | |
| | Modification to device | Test performed | Criteria |
| | Multispectral Image<br>Acquisition Workflow | Functionality Tested | PASS |
| | Micro-chip | Functionality Tested | PASS |
| | Supplier of the primary<br>and secondary camera<br>changed with identical<br>specifications | Functionality Tested | PASS |
| | Data acquisition, handling,<br>and display | Functionality Tested | PASS |
| | Inclusion of Analytics<br>Toolkit (display of skin<br>parameters map only,<br>cleared via K201408) | Functionality Tested | PASS |
| 10.<br>Conclusion | Demetra BDEM-01 was found to be substantially equivalent to the predicate device, due to<br>the following reasons: | | |
| | a)<br>b) | Device and predicate device have the same intended use<br>The technological characteristics differences from the predicate device do not raise<br>different questions of safety or effectiveness | |

Image /page/3/Picture/5 description: The image shows the word "BARCO" in white letters against a red background. The letters are bold and sans-serif. The "O" in BARCO is stylized with a circle and two short lines extending from either side.

{4}------------------------------------------------

#### P 2 / 4

$$\mathbf{Bool}$$

{5}------------------------------------------------

{6}------------------------------------------------

| | c) All hardware and software tests were performed since the first traditional 510(K) for BDEM-01 to make sure that all features work as intended. No safety or performance issues were reported. |
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|--|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|

Image /page/6/Picture/3 description: The image features the word "BARCO" in a bold, sans-serif font. The text is white and is set against a solid red background. The logo has a stylized design element to the right of the word.