Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a device for acquiring, storing, and displaying images. It mentions an "Analytics Toolkit" but explicitly states it only displays a "skin parameters map," which was cleared via a previous K number (K201408). There is no mention of AI, ML, or any form of automated image analysis or interpretation beyond simple display. The performance studies focus on hardware and workflow validation, not algorithmic performance.

Therapeutic

No
The device is described as a non-invasive skin imaging system that acquires, stores, retrieves, displays, and reviews images of the skin. Its purpose is to optimize imaging and documentation workflow for trained medical practitioners, not to treat a disease or condition.

Diagnostic

No

The device acquires, stores, retrieves, displays, and reviews images but does not provide a diagnosis or analysis of the images. Its function is to support trained medical practitioners in their review.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the "Barco Demetra BDEM-01" consists of a hardware device and a software application.

IVD (In Vitro Diagnostic)

Based on the provided information, the Barco Digital Dermatoscope is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Barco Digital Dermatoscope acquires images directly from the skin surface using non-invasive methods (dermoscopy and clinical photography). It does not analyze biological samples taken from the body.
Intended Use: The intended use is to acquire, store, retrieve, display, and review images of the skin for trained medical practitioners. This is an imaging and documentation tool, not a device that performs tests on biological specimens.

Therefore, the Barco Digital Dermatoscope falls under the category of a medical imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

PSN

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

multispectral and white light dermoscopic images and clinical photographs

Anatomical Site

Skin

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained medical practitioners, Professional environment

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

The bench tests mentioned below were performed to validate the device characteristics that differ from the predicate device in the original 510(k) K192829.

Modification to device	Test performed	Criteria
Multispectral Image Acquisition Workflow	Functionality Tested	PASS
Micro-chip	Functionality Tested	PASS
Supplier of the primary and secondary camera changed with identical specifications	Functionality Tested	PASS
Data acquisition, handling, and display	Functionality Tested	PASS
Inclusion of Analytics Toolkit (display of skin parameters map only, cleared via K201408)	Functionality Tested	PASS

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Demetra BDEM-01 - K192829

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K201408

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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

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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)

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)

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 Division
35 President Kennedypark
8500 Kortrijk
BELGIUM
2. Contact
person	Imke Storm
Regulatory Affairs Officer
Tel: +32 (0)470 189 293
Imke.storm@barco.com
3. Date of
submission	November 29 2021
4. Device
information	Trade name/model: Demetra BDEM-01
Common name: Dermatoscope
Classification name: Light Based Imaging - Surgical lamp
Classification code: PSN
Regulation number: 878.4580
5. Predicate
device	Demetra BDEM-01 - K192829
6. 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.
7. Intended Use
of the Device	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.
8. Comparison
of
technological
characteristics	Trade Name/Device
Name	BDEM-01 (original K-

                                                                                                                                                                                                                                                                | BDEM-01 (this special 510(k))                                    |

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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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