(72 days)
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.
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 also generate one or more reports and feedback to the device.
The provided text is a Premarket Notification (510(k)) summary for the Demetra BDEM-01 device, a non-invasive skin imaging system. It focuses on demonstrating substantial equivalence to a predicate device (Microderm - K040171) rather than presenting a performance study against specific acceptance criteria for an AI/algorithm-driven device.
Therefore, this document does not contain the information required to describe acceptance criteria and a study that proves a device meets them in the context of an AI-driven medical device, as it describes a non-algorithm-driven imaging system.
Here's why and what information is missing:
- No AI/Algorithm: The device description clearly states "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." There is no mention of any artificial intelligence, machine learning, or algorithm that processes these images beyond storage, retrieval, display, and review by trained medical practitioners. The "multispectral images" are acquired, but there's no indication of AI interpretation of these multispectral data for diagnosis or risk assessment.
- No Diagnostic Aid Claim (for AI): The Indications for Use state "These can be stored, retrieved, displayed and reviewed by trained medical practitioners." This implies a tool for human review, not an autonomous diagnostic or assistive AI.
- Performance Testing Focus: The "Performance testing" section (9) focuses on bench tests validating differences from the predicate device related to hardware modifications (Multispectral LEDs illumination, hand-held design, biocompatibility) and basic image acquisition review, not on the performance of a diagnostic algorithm. The criteria listed are simply "PASS," indicating compliance with safety and engineering standards.
To answer your request, if this were an AI-driven device, the following information would typically be found in a 510(k) summary or an associated clinical study report for an AI/ML product:
- A table of acceptance criteria and the reported device performance: This would list metrics like sensitivity, specificity, AUC, F1-score, accuracy, etc., along with the target values and the achieved values from the study.
- Sample sizes used for the test set and the data provenance: Details on the number of cases/images used for testing, where the data came from (e.g., specific hospitals, geographical regions), and whether it was retrospectively collected or prospectively gathered.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Information on the number of clinicians (e.g., dermatologists, radiologists) who provided the reference standard for the test data, and their relevant experience and certifications.
- Adjudication method for the test set: How disagreements among the experts establishing ground truth were resolved (e.g., majority vote, third expert review, consensus meeting).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: For AI-assisted reading, this study would compare human performance with and without AI assistance, quantifying the improvement (effect size) in diagnostic accuracy, efficiency, or other relevant metrics.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Often, an initial study evaluates the AI's performance independently against the ground truth.
- The type of ground truth used: Whether ground truth was established by expert consensus, biopsy/pathology results, long-term patient outcomes, or a combination.
- The sample size for the training set: The number of cases/images used to train the AI model.
- How the ground truth for the training set was established: Similar to the test set, but for the data used during model development.
Because the provided document pertains to a primary imaging device, and not an AI/ML diagnostic aid, it lacks the specific study design elements and performance metrics that would be associated with an AI product's acceptance criteria.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ 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.Healthcare Division35 President Kennedypark8500 KortrijkBELGIUM |
| 2. Contactperson | Julie VandecandelaereRegulatory Affairs OfficerTel: +32 (0)56 26 13 19julie.vandecandelaere@barco.com |
| 3. Date ofsubmission | September 30 2019 |
| 4. Deviceinformation | Trade name/model: Demetra BDEM-01Common name: Dermatoscope / Skin Analysis SystemClassification name: Light Based Imaging – Surgical lampClassification code: PSNRegulation number: 878.4580 |
| 5. Predicatedevice | Microderm - K040171 |
| 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 also generate one or more reports and feedback to the device. |
| 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.This indication for use statement is equivalent to the one of the predicate device. The acquisition ofmultispectral images is not a critical difference for the use of the device and does not affect thesafety 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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| technologicalcharacteristics | Product Code | PSN | PSN (originally filed as FSS) |
|---|---|---|---|
| Regulatory Class | II | II | |
| Indications for use | The Barco DigitalDermatoscope is a non-invasive skin imagingsystem, which acquiresmultispectral and white lightdermoscopic images andclinical photographs of theskin. These can be stored,retrieved, displayed andreviewed by trained medicalpractitioners. | MicroDERM is intended forthe acquisition and storageof images of skin surfaces.These images can then beretrieved, printed,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 livepreview mode anddermoscopic images)Multispectral LEDs (fordermoscopic images)• Amber• Deep Red• Green• Cyan• Blue• Royal Blue• Far Red• Red-Orange(Only for acquisition and storage,not for visualization in the currentintended use) | White light LEDs | |
| Magnification | 10-50x fold(1 sensor pixel = 6.383um incontact) | 15-50x fold | |
| Sensor resolution | 3840 (H) × 2160 (V) CMOSsensor | 752 x 582 pixel CCD | |
| Design | Camera, software andintegrated AMOLEDcapacitive touchscreen | Camera, software andframe grabber card | |
| Human factors | Handheld device | Handheld device + card | |
| Net weight scope | Without non-contact cone:528 gWith non-contact cone: 552g | 2150 g | |
| Biocompatibility | Biocompatible (ISO 10993) | Unknown | |
| Data connection | Wireless communicationFCC compliant | Model or network card | |
| Compatibility with theenvironment and otherdevices | IEC 60601-1-2:2014 and EN60601-1-2:2015 compliant | IEC 60601 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: | ||
| Modification to device | Test performed | Criteria | |
| Multispectral LEDsillumination | Per IEC 62471 | PASS | |
| Only hand-held anddevice with less weight | Usability Engineering | PASS | |
| Biocompatibility | Biological Evaluation | PASS | |
| Image acquisition | Review of sample images | PASS | |
| 10.Conclusion | Demetra BDEM-01 was found to be substantially equivalent to the predicate device, due tothe following reasons:a) Device and predicate device have the same intended useb) The technological characteristics differences from the predicate device do not affectsafety or effectivenessc) Bench testing showed that the device has similar characteristics compared to thepredicate device and did not reveal new issues of safety and performance. |
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§ 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.