(150 days)
No
The device is a medical display and the description focuses on its technical specifications for displaying images, not on image analysis or processing using AI/ML.
No
The device is a medical display intended for viewing diagnostic images, not for providing a therapeutic effect.
Yes
This device is intended for in vitro diagnostic use to display digital images of histopathology slides, aiding pathologists in reviewing and interpreting these images for primary diagnosis.
No
The device description explicitly states it is a "medical, color-calibrated display" and consists of an "8 mega-pixel, 27-inch color LCD-panel with internal electronics platform," indicating it is a hardware device.
Based on the provided information, the Barco MDPC-8127 device is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- Intended Use: The intended use states it is "intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device." It acts as a display for images generated by IVD devices (the scanners and software).
- Device Description: The description reinforces this, calling it a "medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software."
- Role in the Workflow: The device's role is to present the images for interpretation by a pathologist. The diagnostic process itself is performed by the pathologist using the displayed images, which were generated by other IVD devices.
- Predicate and Reference Devices: The predicate and reference devices listed are either displays used in IVD systems or the IVD systems themselves (scanners and viewing software). This further indicates that the Barco MDPC-8127 is a component within a larger IVD system, rather than an IVD device on its own.
In summary, the Barco MDPC-8127 is a display device designed to be used in conjunction with IVD-labeled whole-slide imaging scanners and digital pathology image viewing software for in vitro diagnostic purposes. It is a critical component of the diagnostic workflow, but it does not perform the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
Product codes
PZZ
Device Description
The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software that have been validated for use with the display.
The use of the MDPC-8127 display with scanners and viewing software is determined by using verified test methods to establish the display's capability to meet or exceed the performance specifications and the intended color space specified by the IVD-labeled whole-slide imaging scanners and digital pathology image viewing software.
The display uses built-in techniques and technology to ensure constant accuracy over time.
The MDPC-8127 consists of an 8 mega-pixel, 27-inch color LCD-panel with internal electronics platform. It is calibrated to defined color spaces for whole-slide imaging and is compatible with digital pathology viewing software that utilizes defined color spaces to ensure images are displayed in intended colors.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pathologist
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
Non-clinical bench tests were performed according to FDA Guidance document "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: April 20, 2016" (TPA Guidance), Chapter IV (A) (11) on the proposed device and the predicate device to verify that the technical characteristics and performance of the proposed display are equivalent to the predicate device. Tests performed include Spatial Resolution, Pixel defects, Artefacts, Temporal response, Max and Min Luminance, Grayscale, Luminance Uniformity and Mura Test, Stability of Luminance and Chromaticity with Temperature and Lifetime, Bidirectional Reflection Distribution, Chromaticity and Gray Tracking, Color Scale, and Color Gamut Volume. Other non-clinical tests were performed on the proposed device to demonstrate compliance with IEC 60601-1:2005 Edition 3 + A1:2012 (Electrical safety), ANSI AAMI 60601-1:2005/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 (Electrical safety), IEC 60601-1-2:2014 (EMC), and IEC 62304:2006 / A1:2015 (Software lifecycle process). System Integration tests were performed to test the performance of the proposed device with its software accessories.
The non-clinical bench tests demonstrated that the proposed device has equivalent or higher performance and technical characteristics compared to the predicate device and performs according to the requirements for displays used in Digital Pathology Whole Slide Imaging Devices following the corresponding TPA guidance and display requirements from FDA cleared IVD-labeled whole-slide imaging scanners and/or digital pathology image viewing software platforms. Additional bench tests demonstrated that the proposed device complies with applicable international and FDA-recognized standards and can be used safely with its software accessories.
Key Metrics
| Test | MDPC-8127 | Predicate device |
|---|---|---|
| User controls - Luminance target, maximum | 450 cd/m² | 350 cd/m2 |
| User controls - Display function | sRGB | sRGB |
| User controls - White point | 6500K | 6500K |
| User controls - Color space | sRGB | sRGB |
| User controls - Warm-up time | 10 minutes | 10 minutes |
| Spatial resolution - MTFs | Both horizontal and vertical MTFs are greater than 85% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| Pixel defects - Total number of bright and dark pixels |
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 15, 2021
Barco NV Lieven De Wandel Regulatory Affairs Officer President Kennedypark 35 Kortrijk, W-VL 8500 Belgium
Re: K203364
Trade/Device Name: MDPC-8127 Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PZZ Dated: February 12, 2021 Received: February 22, 2021
Dear Lieven De Wandel:
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
1
801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing 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,
Soma Ghosh, Ph.D. Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203364
Device Name MDPC-8127
Indications for Use (Describe)
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
MDPC-8127
Company
Barco N.V. Healthcare Division 35 President Kennedypark 8500 Kortrijk BELGIUM
Contact person
Lieven De Wandel Requlatory Affairs Officer Tel: +32 (0)56 233459 lieven.dewandel@barco.com
Date of submission
February 12, 2021
Device information
| Trade name/model: | MDPC-8127 |
|---|---|
| Common name: | Digital Pathology Display |
| Classification name: | Digital Pathology Display |
| Classification code: | PZZ |
| Regulation number: | 21 CFR §864.3700 |
Predicate device
MMPC-4227F1 (PP27QHD), Display used in Philips Intellisite Pathology Solution, referenced in 510(k) - K192259 (Philips Intellisite Pathology Solution)
Device description
The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software that have been validated for use with the display.
The use of the MDPC-8127 display with scanners and viewing software is determined by using verified test methods to establish the display's capability to meet or exceed the performance specifications and the intended color space specified by the IVD-labeled whole-slide imaging scanners and digital pathology image viewing software.
The display uses built-in techniques and technology to ensure constant accuracy over time.
The MDPC-8127 consists of an 8 mega-pixel, 27-inch color LCD-panel with internal electronics platform. It is calibrated to defined color spaces for whole-slide imaging and is compatible with digital pathology viewinq software that utilizes defined color spaces to ensure images are displayed in intended colors.
P 1 / 5
Image /page/3/Picture/19 description: The image shows the Barco logo. The word "BARCO" is written in white letters on a red background. The "O" in Barco is stylized to look like a circle with two lines extending from either side.
4
The display is available with the following software accessories:
- Intuitive Workflow Tools (When paired with a Barco MXRT display controller graphics card and driver ● software)
| Test | Test Method | Results | |
|---|---|---|---|
| MDPC-8127 | Predicate device | ||
| User controls | Out-of-the-box settings | Luminance target, maximum: 450 cd/m² | |
| Display function: sRGB | |||
| White point: 6500K | |||
| Color space: sRGB | |||
| 10 minutes of warm-up time | Luminance target, maximum: | ||
| 350 cd/m2 | |||
| Display function: sRGB | |||
| White point: 6500K | |||
| Color space: sRGB | |||
| 10 minutes of warm-up time | |||
| Spatial | |||
| resolution | Roehrig, Hans, et al. "In- | ||
| field evaluation of the | |||
| modulation transfer function | |||
| of electronic display | |||
| devices." Medical Imaging | |||
| 2004: Visualization, Image- | |||
| Guided Procedures, and | |||
| Display. Vol. 5367. | |||
| International Society for | |||
| Optics and Photonics, 2004 | Both horizontal and vertical | ||
| MTFs are greater than 85% | |||
| at Nyquist frequency | Both horizontal and vertical | ||
| MTFs are greater than 75% at | |||
| Nyquist frequency | |||
| Pixel defects | 7.6 Defective Pixels, IDMS | ||
| v1.03b | Total number of bright and | ||
| dark pixels |