(266 days)
No
The summary describes image processing and visualization tools, but there is no mention of AI, ML, or any learning algorithms being used to generate the maps or perform analysis. The clinical studies focus on validating the visualization capabilities and comparing them to a predicate device, not on evaluating the performance of an AI/ML model.
No
The device is a non-invasive skin analysis system intended to complement dermoscopy by providing maps of blood and pigment and highlighting surface contours; it does not treat or cure any condition.
No
The device is described as a "non-invasive skin analysis system" intended "only to complement dermoscopy" and to provide "additional information to dermoscopy by highlighting surface contours" and aiding the user in "visualizing blood and pigment patterns in the skin." It is not specifically stated as providing a diagnosis, only aiding in analysis and visualization.
No
The device is described as a software application that supports analysis of images captured by a specific hardware dermatoscope (K192829). The performance studies also include integration testing with this hardware device.
Based on the provided information, the Barco Demetra Analytics Toolkit is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is a "non-invasive skin analysis system" and is "intended only to complement dermoscopy." IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device analyzes the skin in situ.
- Device Description: The description reinforces that it analyzes dermoscopic images of the skin and provides maps to visualize blood and pigment patterns in the skin.
- Lack of Specimen Analysis: There is no mention of analyzing any biological specimens or samples taken from the patient.
While the device provides information that can be used by medical practitioners to aid in diagnosis, it does so by analyzing images of the skin directly, not by performing tests on biological samples. This aligns with the definition of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.
Product codes
PSN
Device Description
The Barco Demetra Analytics Toolkit is a software application used to support analysis of dermoscopic images captured with the Barco Demetra BDEM-01 dermatoscope (K192829). The system is intended for use by medical practitioners. Scatter Contrast Maps provide additional information to dermoscopy by highlighting surface contours. The Skin Parameter Maps Tool provides images generated from multispectral image sets and aids the user in visualizing blood and pigment patterns in the skin. The output of the Skin Parameter Maps is shown to the user as grayscale two-dimensional maps. The maps are intended only to complement dermoscopy.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multispectral image sets
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical practitioners.
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 following performance data were provided in support of the substantial equivalence determination.
Test performed:
Software Verification Testing - PASS
Usability Engineering Testing - PASS
Design Validation, which includes integration testing with BDEM-01 device - PASS
The Demetra Analytics Toolkit software has a moderate level of concern.
Several clinical validation activities have been performed to support safety and effectiveness of the device. This included:
- A retrospective clinical study "Clinical validation of Demetra Skin Parameter Maps". This retrospective reader study was performed by four board certified dermatologists from different sites in the USA. The selected dataset contains a mix of 28 cases, representing various dermatology conditions for which a dermatologist can use a dermatoscope during evaluation, with a focus on skin lesions suspicious for skin cancer. For each of the cases, all readers provided a subjective rating of the skin parameter maps corresponding to these cases. Statistical analysis was performed on the collected ratings. In addition qualitative feedback from the readers was also collected.
- A retrospective study "SIAScans vs. Barco Analytics Toolkit" performed by a board certified dermatologist from OHSU Dermatology Clinic, Portland. This study compared performance of the Barco skin parameter maps with performance of the predicate device (Siascope) for a representative set of specific types of cases. Contribution of 'other' signals to the maps (for both Siascope and Barco) was also included in the performance comparison.
- A prospective clinical study performed by a board certified dermatologist from Washington DC; and a dermato pathologist from Maryland. The study "Correlation of structures visualized in the Skin Parameter Maps with pathology findings" directly compared skin parameter maps with pathology H&E images for collected 15 cases. Subjective rating as well as qualitative case analysis was performed. Statistical analysis was performed on the collected ratings.
- A clinical study performed by a dermatologist from University Hospital Leuven in Belgium. This study "Validation of skin structures imaged in the Skin Parameter Maps" included 15 cases for which a dermatologist would typically use the skin parameter maps. Subjective rating as well as qualitative case analysis was performed. Statistical analysis was performed on the collected ratings.
- A clinical study performed at Charité Universitätsmedizin Berlin, Germany; and at a dermatology practice in Oregon, USA. Four observers participated in this retrospective reader study. 28 representative cases were collected from an existing database. Purpose of this study was to validate the skin parameter maps, and more specifically also to validate the device when used with and without liquid interface. All observers provided subjective ratings for every case. Statistical analysis was performed on the collected ratings.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SIAscope V - Astron Clinica Limited - K062736
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of 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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Barco NV Julie Vandecandelaere Regulatory Affairs Officer President Kennedypark 35 Kortrijk. W-VL 8500 Belgium
February 18, 2021
Re: K201408
Trade/Device Name: Demetra Analytics Toolkit Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical Lamp Regulatory Class: Class II Product Code: PSN Dated: January 18, 2021 Received: January 21, 2021
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.
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
1
- 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, M.S. 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) K201408
Device Name Demetra Analytics Toolkit
Indications for Use (Describe)
The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco Demetra Skin Parameter Maps Tool provides maps that show the relative location of blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to complement dermoscopy.
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 | |
|---|---|
| 1. Company | Barco N.V. |
| Healthcare Division | |
| 35 President Kennedypark | |
| 8500 Kortrijk | |
| BELGIUM | |
| 2. Contact | |
| person | Julie Vandecandelaere |
| Regulatory Affairs Officer | |
| Tel: +32 (0)56 26 13 19 | |
| julie.vandecandelaere@barco.com | |
| 3. Date of | |
| submission | February 17 2021 |
| 4. Device | |
| information | Trade name/model: Demetra Analytics Toolkit |
| Common name: Light Based Imaging | |
| Classification name: Surgical Lamp | |
| Classification code: PSN | |
| Regulation number: 878.4580 | |
| Regulatory class: 2 | |
| 5. Predicate | |
| device | SIAscope V - Astron Clinica Limited - K062736 |
| 6. Device | |
| description | The Barco Demetra Analytics Toolkit is a software application used to support analysis of |
| dermoscopic images captured with the Barco Demetra BDEM-01 dermatoscope | |
| (K192829). The system is intended for use by medical practitioners. | |
| Scatter Contrast Maps provide additional information to dermoscopy by highlighting | |
| surface contours. The Skin Parameter Maps Tool provides images generated from | |
| multispectral image sets and aids the user in visualizing blood and pigment patterns in the | |
| skin. The output of the Skin Parameter Maps is shown to the user as grayscale two- | |
| dimensional maps. The maps are intended only to complement dermoscopy. | |
| 7. Indications | |
| for Use of the | |
| Device | The Barco Demetra Analytics Toolkit is a non-invasive skin analysis system. The Barco |
| Demetra Skin Parameter Maps Tool provides maps that show the relative location of | |
| blood and pigment. The Barco Demetra Skin Parameter Maps Tool is intended only to | |
| complement dermoscopy. |
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 a line extending from it.
4
K201408
| 8. Comparison | Trade Name/Device Name | Analytics Toolkit | SIAscope V |
|---|---|---|---|
| of technological | Product Code | PSN | PSN |
| characteristics | Regulatory Class | II | II |
| Indications for use | The Barco Demetra Analytics | ||
| Toolkit is a non-invasive skin | |||
| analysis system. The Barco | |||
| Demetra Skin Parameter Maps | |||
| Tool provides maps that show the | |||
| relative location of blood and | |||
| pigment. The Barco Demetra | |||
| Skin Parameter Maps Tool is | |||
| intended only to complement | |||
| dermoscopy. | The SIAscope is a non- | ||
| invasive skin analysis | |||
| system, which provides | |||
| color bitmaps called | |||
| 'SIAscans' that show the | |||
| relative location of blood, | |||
| collagen and pigment | |||
| Functionality | The Skin Parameter Maps are | ||
| generated from multispectral | |||
| image sets and aid the user in | |||
| visualizing blood and pigment | |||
| patterns in the skin. The output of | |||
| the Skin Parameter Maps is | |||
| shown to the user as grayscale | |||
| two-dimensional maps. | SIAscans show the relative | ||
| location of blood, collagen | |||
| and pigment | |||
| Operating principle | Measuring intensity of remitted | ||
| light based on Beer-Lambert | |||
| principle | Measuring intensity of | ||
| remitted light, based on | |||
| Kubelka-Munk skin model | |||
| Analysis of images of | Skin | Skin | |
| Where used | Professional environment | Professional environment | |
| Digital or Analog images | Digital | Digital | |
| Illumination of the | |||
| compatible dermatoscope | White light LEDs (for live preview | ||
| mode and dermoscopic images) | LEDs both visible and | ||
| near-infrared | |||
| Multispectral LEDs (for | |||
| dermoscopic images) | |||
| • Amber | |||
| • Deep Red | |||
| • Green | |||
| • Cyan | |||
| • Blue | |||
| • Royal Blue | |||
| • Far Red | |||
| • Red-Orange | |||
| Design | Only software, compatible with | ||
| Barco's Demetra BDEM-01 | |||
| dermatoscope (K192830) | Hardware dermatoscope + | ||
| software (Dermetrics) |
BAR
5
| 9.
Performance
testing | The following performance data were provided in support of the substantial equivalence
determination. | |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| | Test performed | Result |
| | Software Verification
Testing | PASS |
| | Usability Engineering
Testing | PASS |
| | Design Validation, which
includes integration testing
with BDEM-01 device | |
| | The Demetra Analytics Toolkit software has a moderate level of concern. | |
| | Several clinical validation activities have been performed to support safety and
effectiveness of the device. This included: | |
| | - A retrospective clinical study "Clinical validation of Demetra Skin Parameter Maps".
This retrospective reader study was performed by four board certified
dermatologists from different sites in the USA. The selected dataset contains a mix
of 28 cases, representing various dermatology conditions for which a dermatologist
can use a dermatoscope during evaluation, with a focus on skin lesions suspicious
for skin cancer. For each of the cases, all readers provided a subjective rating of
the skin parameter maps corresponding to these cases. Statistical analysis was
performed on the collected ratings. In addition qualitative feedback from the readers
was also collected. | |
| | - A retrospective study "SIAScans vs. Barco Analytics Toolkit" performed by a board
certified dermatologist from OHSU Dermatology Clinic, Portland. This study
compared performance of the Barco skin parameter maps with performance of the
predicate device (Siascope) for a representative set of specific types of cases.
Contribution of 'other' signals to the maps (for both Siascope and Barco) was also
included in the performance comparison. | |
| | - A prospective clinical study performed by a board certified dermatologist from
Washington DC; and a dermato pathologist from Maryland. The study "Correlation
of structures visualized in the Skin Parameter Maps with pathology findings" directly
compared skin parameter maps with pathology H&E images for collected 15 cases.
Subjective rating as well as qualitative case analysis was performed. Statistical
analysis was performed on the collected ratings. | |
| | - A clinical study performed by a dermatologist from University Hospital Leuven in
Belgium. This study "Validation of skin structures imaged in the Skin Parameter
Maps" included 15 cases for which a dermatologist would typically use the skin
parameter maps. Subjective rating as well as qualitative case analysis was
performed. Statistical analysis was performed on the collected ratings. | |
| | - A clinical study performed at Charité Universitätsmedizin Berlin, Germany; and at a
dermatology practice in Oregon, USA. Four observers participated in this
retrospective reader study. 28 representative cases were collected from an existing
database. Purpose of this study was to validate the skin parameter maps, and more
specifically also to validate the device when used with and without liquid interface.
All observers provided subjective ratings for every case. Statistical analysis was
performed on the collected ratings. | |
| 10.
Conclusion | Demetra Analytics Toolkit was found to be as safe, as effective, and performs as well as the legally marketed predicate device, due to the following reasons:
a) Device and predicate device have a similar intended use
b) The technological characteristics differences from the predicate device do not affect safety or effectiveness
c) Bench testing showed that the device has similar characteristics compared to the predicate device and did not reveal new issues of safety and performance. | |
P 3 / 4
BAI
6
K201408
Image /page/6/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 horizontal lines extending from either side.