Demetra BDEM-01 Dermatoscope

K192829 · Barco N.V. · PSN · Dec 13, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192829
• Device Name: Demetra BDEM-01 Dermatoscope
• Applicant: Barco N.V.
• Product Code: PSN · General, Plastic Surgery
• Decision Date: Dec 13, 2019
• Decision: SESE
• Submission Type: Traditional
• 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 portable, battery-powered handheld dermatoscope; captures multispectral and white light dermoscopic images, clinical close-ups (10-15 cm), and clinical overviews (35-55 cm). Device utilizes white light and multispectral LEDs (amber, red, green, cyan, blue, etc.) for image acquisition. Hardware includes an integrated AMOLED capacitive touchscreen for visualization. System integrates with cloud-based software and web applications for image storage, retrieval, and report generation. Used in professional clinical environments by medical practitioners; facilitates documentation and visualization of skin lesions. Benefits include improved imaging workflow and digital documentation of skin conditions.

Clinical Evidence

Bench testing only. Testing included IEC 62471 photobiological safety for multispectral LEDs, usability engineering for the handheld form factor, biocompatibility evaluation per ISO 10993, and review of sample images to validate acquisition performance. No clinical data provided.

Technological Characteristics

Handheld, battery-powered dermatoscope; 3840x2160 CMOS sensor; AMOLED capacitive touchscreen. Illumination: white light and multispectral LEDs (amber, deep red, green, cyan, blue, royal blue, far red, red-orange). Connectivity: wireless (FCC compliant). Biocompatibility: ISO 10993 compliant. Electrical safety: IEC 60601 compliant. Software: cloud-based with web application interface.

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

• Microderm (K040171)

Submission Summary (Full Text)

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December 13, 2019

Barco NV Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk, 8500 BE

Re: K192829

Trade/Device Name: Demetra BDEM-01 Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: PSN Dated: September 30, 2019 Received: October 2, 2019

Dear Julie Vandecandelaere:

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/cfdocs/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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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 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Purva Pandya Acting 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

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## Indications for Use

510(k) Number (if known) K192829

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="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:120%">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## K192829

| 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 | Julie Vandecandelaere<br>Regulatory Affairs Officer<br>Tel: [phone]<br>[e-mail] |
| 3. Date of<br>submission | September 30 2019 |
| 4. Device<br>information | Trade name/model: Demetra BDEM-01<br>Common name: Dermatoscope / Skin Analysis System<br>Classification name: Light Based Imaging – Surgical lamp<br>Classification code: PSN<br>Regulation number: 878.4580 |
| 5. Predicate<br>device | Microderm - K040171 |
| 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><br>The “Barco Demetra BDEM-01” consists of a hardware device and a software<br>application.<br><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><br>The stand-alone software application is cloud software with a related web application.<br>The cloud software can also generate one or more reports and feedback to the device. |
| 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.<br><br>This indication for use statement is equivalent to the one of the predicate device. The acquisition of<br>multispectral images is not a critical difference for the use of the device and does not affect the<br>safety or effectiveness of the device. |

| 8. Comparison of | |
|------------------------|---------------------|
| Trade Name/Device Name | BDEM-01 |
| | MicroDERM (K040171) |

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BAF

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| technological<br>characteristics | Product Code | PSN | PSN (originally filed as FSS) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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 light<br>dermoscopic images and<br>clinical photographs of the<br>skin. These can be stored,<br>retrieved, displayed and<br>reviewed by trained medical<br>practitioners. | MicroDERM is intended for<br>the acquisition and storage<br>of images of skin surfaces.<br>These images can then be<br>retrieved, printed,<br>reviewed and displayed. |
| | Illumination for | Skin | Skin |
| | Intended users | Trained medical practitioners | Physicians |
| | 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<br>• Deep Red<br>• Green<br>• Cyan<br>• Blue<br>• Royal Blue<br>• Far Red<br>• Red-Orange<br>(Only for acquisition and storage,<br>not for visualization in the current<br>intended use) | White light LEDs |
| | Magnification | 10-50x fold<br>(1 sensor pixel = 6.383um in<br>contact) | 15-50x fold |
| | Sensor resolution | 3840 (H) × 2160 (V) CMOS<br>sensor | 752 x 582 pixel CCD |
| | Design | Camera, software and<br>integrated AMOLED<br>capacitive touchscreen | Camera, software and<br>frame grabber card |
| | Human factors | Handheld device | Handheld device + card |
| | Net weight scope | Without non-contact cone:<br>528 g<br>With non-contact cone: 552<br>g | 2150 g |
| | Biocompatibility | Biocompatible (ISO 10993) | Unknown |
| | Data connection | Wireless communication<br>FCC compliant | Model or network card |
| | Compatibility with the<br>environment and other<br>devices | IEC 60601-1-2:2014 and EN<br>60601-1-2:2015 compliant | IEC 60601 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: | | |
| | Modification to device | Test performed | Criteria |
| | Multispectral LEDs<br>illumination | Per IEC 62471 | PASS |
| | Only hand-held and<br>device with less weight | Usability Engineering | PASS |
| | Biocompatibility | Biological Evaluation | PASS |
| | Image acquisition | Review of sample images | PASS |
| 10.<br>Conclusion | Demetra BDEM-01 was found to be substantially equivalent to the predicate device, due to<br>the following reasons:<br>a) Device and predicate device have the same intended use<br>b) The technological characteristics differences from the predicate device do not affect<br>safety or effectiveness<br>c) Bench testing showed that the device has similar characteristics compared to the<br>predicate device and did not reveal new issues of safety and performance. | | |

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