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 Description

The Barco Demetra BDEM-01 is designed to capture images of the skin and optimize the imaging and documentation workflow. The “Barco Demetra BDEM-01” consists of a hardware device and a software application. The hardware device is a portable, battery powered medical device for acquiring and visualizing images of the skin. The device acquires multispectral optical dermoscopic images in a contact mode (device in contact with the skin). In addition, the device can also acquire a clinical close-up image, when it is held at up to 10 to 15 cm from the skin, and a clinical overview image when it is held at a distance of approximately 35-55 cm from the skin. The stand-alone software application is cloud software with a related web application. The cloud software can generate reports containing white light dermoscopic images and clinical photographs of the skin to be reviewed by trained medical practitioners.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Demetra Dermatoscope BDEM-01 (K213957), which is a "Special 510(k)" submission. This typically means the device has minor changes from a previously cleared predicate device (K192829 in this case).

Crucially, the document does NOT contain information about a clinical study or performance testing that would typically establish acceptance criteria for an AI/ML medical device and prove its performance against those criteria.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device, specifically highlighting:

Identical Indications for Use: The current device has the same intended use as its predicate.
Minor modifications: The changes are related to the Multispectral Image Acquisition Workflow, micro-chip, supplier of camera, data acquisition/handling/display, and inclusion of an Analytics Toolkit (which itself was cleared via a separate 510(k), K201408).
Bench testing: The document states "bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device in the original 510(k) K192829." These tests are listed as "Functionality Tested" with a "PASS" criterion.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth, or MRMC studies, as the provided text pertains to a special 510(k) for a hardware and fixed software device based on substantial equivalence and bench testing, not an AI/ML algorithm requiring a comprehensive performance study as typically seen for novel AI claims.

If this were an AI/ML device with performance claims, such information would be mandatory. Since it is not present, it implies that the device (or at least this specific submission) is not an AI/ML algorithm making clinical claims that require such validation. The "Analytics Toolkit" mentioned is noted as "display of skin parameters map only, cleared via K201408," suggesting its AI component (if any) was addressed in a prior submission or is limited to visualization rather than diagnostic or prognostic output.

Summary

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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

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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 (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K213957

Device Name Demetra BDEM-01

Indications for Use (Describe)

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

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

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510(k) Summary (in accordance with 21 CFR 807.92)
1. Company	Barco N.V.Healthcare Division35 President Kennedypark8500 KortrijkBELGIUM
2. Contactperson	Imke StormRegulatory Affairs OfficerTel: +32 (0)470 189 293Imke.storm@barco.com
3. Date ofsubmission	November 29 2021
4. Deviceinformation	Trade name/model: Demetra BDEM-01Common name: DermatoscopeClassification name: Light Based Imaging - Surgical lampClassification code: PSNRegulation number: 878.4580
5. Predicatedevice	Demetra BDEM-01 - K192829
6. Devicedescription	The Barco Demetra BDEM-01 is designed to capture images of the skin and optimizethe imaging and documentation workflow.The “Barco Demetra BDEM-01” consists of a hardware device and a softwareapplication.The hardware device is a portable, battery powered medical device for acquiring andvisualizing images of the skin. The device acquires multispectral optical dermoscopicimages in a contact mode (device in contact with the skin). In addition, the device canalso acquire a clinical close-up image, when it is held at up to 10 to 15 cm from theskin, and a clinical overview image when it is held at a distance of approximately 35-55cm from the skin.The stand-alone software application is cloud software with a related web application.The cloud software can generate reports containing white light dermoscopic imagesand clinical photographs of the skin to be reviewed by trained medical practitioners.
7. Intended Useof the Device	The Barco Digital Dermatoscope is a non-invasive skin imaging system, which acquiresmultispectral and white light dermoscopic images and clinical photographs of the skin.These can be stored, retrieved, displayed and reviewed by trained medicalpractitioners.
8. Comparisonoftechnologicalcharacteristics	Trade Name/DeviceName	BDEM-01 (original K-192829)	BDEM-01 (this special 510(k))
	Product Code	PSN	PSN
Regulatory Class	II	II
Indications for use	The Barco DigitalDermatoscope is a non-invasive skin imagingsystem, which acquiresmultispectral and whitelight dermoscopic imagesand clinical photographsof the skin. These can bestored, retrieved,displayed and reviewedby trained medicalpractitioners.	The Barco DigitalDermatoscope is a non-invasive skin imaging system,which acquires multispectraland white light dermoscopicimages and clinicalphotographs of the skin.These can be stored,retrieved, displayed andreviewed by trained medicalpractitioners.
Illumination for	Skin	Skin
Intended users	Trained medicalpractitioners	Trained medical practitioners
Where used	Professional environment	Professional environment
Digital or Analog	Digital	Digital
Illumination	White light LEDs (for livepreview mode anddermoscopic images)Multispectral LEDs (fordermoscopic images)Amber Deep Red Green Cyan Blue Royal Blue Far Red Red-Orange (Only for acquisition andstorage, not for visualization inthe current intended use)	White light LEDs(for live previewmode anddermoscopicimages)MultispectralLEDs (fordermoscopicimages) Amber Deep Red Green Cyan Blue Royal Blue Far Red Red-Orange (Only for acquisition andstorage, not forvisualization in the currentintended use)
Magnification	10-50x fold(1 sensor pixel = 6.383umin contact)	10-50x fold(1 sensor pixel = 6.383um incontact)
Sensor resolution	3840 (H) × 2160 (V)CMOS sensor	3840 (H) × 2160 (V) CMOSsensor
	Design	Camera, software andintegrated AMOLEDcapacitive touchscreen	Camera, software and integratedAMOLED capacitive touchscreen
	Human factors	Handheld device	Handheld device
	Net weight scope	Without non-contactcone: 528 gWith non-contact cone:552 g	Without non-contact cone: 528 gWith non-contact cone: 552 g
	Biocompatibility	Biocompatible (ISO10993)	Biocompatible (ISO 10993)
	Data connection	Wireless communicationFCC compliant	Wireless communication FCCcompliant
	Compatibility with theenvironment and otherdevices	IEC 60601-1-2:2014 andEN 60601-1-2:2015compliant	IEC 60601-1-2:2014 and EN60601-1-2:2015 compliant
	Electrical Safety	IEC 60601 compliant	IEC 60601 compliant
9.Performancetesting	The bench tests mentioned below were performed to validate the devicecharacteristics that differ from the predicate device in the original 510(k)K192829.
	Modification to device	Test performed	Criteria
	Multispectral ImageAcquisition Workflow	Functionality Tested	PASS
	Micro-chip	Functionality Tested	PASS
	Supplier of the primaryand secondary camerachanged with identicalspecifications	Functionality Tested	PASS
	Data acquisition, handling,and display	Functionality Tested	PASS
	Inclusion of AnalyticsToolkit (display of skinparameters map only,cleared via K201408)	Functionality Tested	PASS
10.Conclusion	Demetra BDEM-01 was found to be substantially equivalent to the predicate device, due tothe following reasons:
	a)b)	Device and predicate device have the same intended useThe technological characteristics differences from the predicate device do not raisedifferent questions of safety or effectiveness

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	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.
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Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
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.(b)
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.