MDPC-8127

K203364 · Barco N.V. · PSY · Apr 15, 2021 · Pathology

Device Facts

• Record ID: K203364
• Device Name: MDPC-8127
• Applicant: Barco N.V.
• Product Code: PSY · Pathology
• Decision Date: Apr 15, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Intended 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 using IVD-labeled 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.

Device Story

Medical, color-calibrated 27-inch IPS LCD display; used by pathologists in clinical settings to review digital histopathology images. Inputs digital signals from IVD-labeled whole-slide imaging scanners via DisplayPort; processes images for high-resolution (8MP) visualization. Features built-in PPU (Color Per Pixel Uniformity) technology and I-Guard front sensor for constant accuracy. Output viewed by pathologist to aid primary diagnosis. Benefits include high-fidelity color and grayscale reproduction, ensuring consistent image quality for diagnostic interpretation.

Clinical Evidence

Bench testing only. Performance verified against FDA TPA guidance, including spatial resolution, pixel defects, artifacts, temporal response, luminance/chromaticity stability, and color gamut. Testing demonstrated MDPC-8127 meets or exceeds predicate performance. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and IEC 62304 (software lifecycle) confirmed. System integration testing performed with validated WSI scanners and viewing software.

Technological Characteristics

27-inch IPS LCD with LED backlighting; 8MP resolution (3840x2160); 16:9 aspect ratio. Calibrated to sRGB and DICOM GSDF. Features: PPU (Color Per Pixel Uniformity), I-Guard front sensor, ambient light sensor. Connectivity: 2x DisplayPort 1.2, USB 2.0. Power: 100-240 Vac. Anti-glare coating. Standards: IEC 60601-1, IEC 62304, ISO 15223-1, ISO 14971.

Indications for Use

Indicated for use by pathologists to review and interpret digital images of FFPE histopathology slides for primary diagnosis. Not for use with frozen section, cytology, or non-FFPE hematopathology specimens.

Regulatory Classification

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.

Special Controls

A whole slide imaging system must comply with the following special controls: (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; (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: (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 factors 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: The intended use statement must include the information described in paragraph (i) (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 paragraph (1)(ii) and (1)(iii) of this section, as appropriate. (iii) A description of the performance studies and the summary of results, including those that relate to paragraph (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.

*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.

Predicate Devices

• Philips IntelliSite Pathology Solution (K192259)

Submission Summary (Full Text)

{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 ([e-mail]) or phone [phone] 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: [phone] [e-mail]

#### 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<br>Display function: sRGB<br>White point: 6500K<br>Color space: sRGB<br>10 minutes of warm-up time | Luminance target, maximum:<br>350 cd/m2<br>Display function: sRGB<br>White point: 6500K<br>Color space: sRGB<br>10 minutes of warm-up time |
| Spatial<br>resolution | Roehrig, Hans, et al. "In-<br>field evaluation of the<br>modulation transfer function<br>of electronic display<br>devices." Medical Imaging<br>2004: Visualization, Image-<br>Guided Procedures, and<br>Display. Vol. 5367.<br>International Society for<br>Optics and Photonics, 2004 | Both horizontal and vertical<br>MTFs are greater than 85%<br>at Nyquist frequency | Both horizontal and vertical<br>MTFs are greater than 75% at<br>Nyquist frequency |
| Pixel defects | 7.6 Defective Pixels, IDMS<br>v1.03b | Total number of bright and<br>dark pixels <= 5 with a<br>minimum distance greater<br>than 15 mm. | Total number of bright and<br>dark pixels <= 3 within a<br>circle of 10 mm. diameter |
| Artifacts | Image retention after 1 hour | < 0.65% | < 0.65% |
| Temporal<br>response | 10.2.3 Gray-to-Gray<br>Response Time, IDMS<br>v1.03b | The response time ranges<br>from 3.1 ms to 6.2 ms with<br>an average of 5.01 ms. | The response time is<br>maximum 15 ms and typical<br>8 ms. |
| Maximum<br>and<br>minimum<br>luminance | 5 Fundamental<br>Measurements, IDMS<br>v1.03b | The maximum and<br>minimum achievable<br>luminance values are 678.6<br>and 0.633 cd/m²,<br>respectively.<br>The calibrated luminance<br>target is 450 cd/m².<br>The contrast ratio is greater<br>than 1000: 1. | The maximum and minimum<br>achievable luminance values<br>are 550 and 0.3 cd/m2,<br>respectively.<br>The calibrated luminance<br>target is 350 cd/m2.<br>The contrast ratio is 1000: 1. |
| Grayscale | Contrast response deviation,<br>AAPM TG-18 | Maximum error calculated =<br>1.4% | Maximum error calculated =<br>2.1% |
| Luminance<br>uniformity<br>and Mura | 8 Uniformity Measurements,<br>IDMS v1.03b | <10% non-uniformity on<br>80% video level | 21% non-uniformity on 80%<br>video level |
| Stability of<br>luminance<br>and<br>chromaticity<br>response | Luminance and chromaticity<br>characteristics of the display<br>measured with temperature<br>and time | Deviation from target<br>luminance (450 cd/m²):<br>$\pm$ 0.44%<br>Variations for luminance<br>and chromaticity: < 5%<br>deviation | Deviation from target<br>luminance (350 cd/m2):<br>$\pm$ 0.2%<br>Variations for luminance and<br>chromaticity: < 2% deviation |
| Bidirectional<br>reflection<br>distribution<br>function | 11. Reflection<br>Measurements, IDMS<br>v1.03b | Specular reflection<br>coefficient: 1.90%<br>Diffuse reflection<br>coefficient: 2.87% | Specular reflection<br>coefficient: 1.69%<br>Diffuse reflection coefficient:<br>2.21% |
| Gray<br>tracking | 6.15 Gray-scale Color<br>Changes, IDMS v1.03b | $\pm$ 0.01 Δu'v'<br>White point at D65: $\pm$<br>0.01 Δu'v' | $\pm$ 0.002 Δu'v'<br>White point at D65: $\pm$ 0.002<br>Δu'v' |
| Color scale | 6. Gray- and Color-Scale<br>Measurement, IDMS v1.03b | Average color error < 1<br>ΔE₀₀<br>Maximum color error < 3<br>ΔE₀₀ | Average color error<br>< 2 ΔE₀₀<br>Maximum color error < 5<br>ΔE₀₀ |
| Color gamut<br>volume | 5.18.1 Relative Gamut Area,<br>IDMS v1.03b | 2D color gamut wrt sRGB:<br>137.1%<br>2D color gamut overlapped<br>with sRGB: 99.6% | 2D color gamut wrt<br>sRGB: 99.4%<br>2D color gamut overlapped<br>with sRGB: 98.4% |

Table 1: Relevant performance specifications with verified test methods

#### P 2 / 5

Image /page/4/Picture/7 description: The image shows the word "BARCO" in white letters on a red background. The letters are bold and sans-serif. To the right of the word "BARCO" is a white symbol that looks like a stylized circuit diagram. The red background is a solid color and appears to be a rectangle.

{5}------------------------------------------------

#### Intended 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 using IVD-labeled 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.

#### Table 2: Comparison of technological characteristics

| Item | Proposed Device<br>MDPC-8127 | Predicate device<br>MMPC-4227F1 (PP27QHD) |
|---------------------------------------------------|------------------------------|-------------------------------------------|
| Screen technology | IPS | Same |
| Active screen size (diagonal) | 684 mm (27") | Same |
| Dimensions (W x H x D) | 651 x 482~582 x 238 mm | 648.5 x 473~573 x 235 mm |
| Resolution | 8MP (3840 x 2160 pixels) | 3.6MP (2560 x1440 pixels) |
| Color bit depth (internal) | 10 bit color | 8 bit color |
| Calibrated luminance | 450 cd/m² | 350 cd/m² |
| Contrast ratio | 1000: 1 | 1000: 1 |
| Uniformity Technology | Color PPU | None |
| Color Calibration | sRGB and DICOM GSDF modes | sRGB and DICOM GSDF modes |
| Front sensor for stabilization and<br>calibration | Yes, I-Guard™ | Front sensor |

P 3 / 5

ENABLING BRIGHT OUTCOMES

Barco nv | Beneluxpark 21 | B-8500 Kortrijk | Belgium Registered office: President Kennedypark 35 | B-8500 Kortrijk | Belgium IBAN BE49 3850 5234 2071 BBRUBEBB | VAT BE 0473.191.041 | RPR Gent, Section Kortrijk www.barco.com

Image /page/5/Picture/8 description: The image shows the word "BARCO" in white letters on a red background. The letters are bold and sans-serif. The "O" in BARCO is stylized with a circle inside a circle and two horizontal lines extending from the outer circle.

{6}------------------------------------------------

#### Performance testing

According to FDA Guidance document titled "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), the below-mentioned tests were performed 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:

- 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
- . Color Gamut Volume

Other non-clinical tests were performed on the proposed device to demonstrate that the proposed device complies with the following international and FDA-recognized standards:

- 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)
- IEC 62304:2006 / A1:2015 (Software lifecycle process) .

Finally, to test the performance of the proposed device in use with its software accessories, System Integration tests have been performed.

The non-clinical bench tests have 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 quidance and display reguirements from FDA cleared IVD-labeled whole-slide imaging scanners and/or digital pathology image viewing software platforms.

Additional bench tests have demonstrated that the proposed device complicable international and FDA-recognized standards and can be used safely with its software accessories.

#### Conclusion

The proposed device MDPC-8127 is substantially equivalent with the predicate device in terms of intended use, technological characteristics, performance, safety and effectiveness.

Non-clinical tests according to the TPA guidance have been performed to assess the technical characteristics of the display for its intended use and have demonstrated that the MDPC-8127 has equivalent or better

P 4 / 5

Image /page/6/Picture/27 description: The image contains the words "ENABLING BRIGHT OUTCON" in red font. The words are stacked on top of each other. The background is white.

Image /page/6/Picture/28 description: The image shows the Barco logo. The logo consists of the word "BARCO" in white, with a stylized "O" that resembles a circuit board. The background is a solid red color.

{7}------------------------------------------------

performance than the other devices under test; as well as compatible with FDA cleared IVD-labeled whole-slide imaging scanners and/or digital pathology image viewing software platforms.

The tests have demonstrated that the proposed device is as safe and effective as the predicate device. Additionally, it has been demonstrated that the proposed device may be used for primary diagnosis in the following validated FDA-cleared WSI systems and digital pathology viewing software:

- Philips Intellisite Pathology Solution with Philips Image Management System viewing software, cleared . under K192259
- . Philips Intellisite Pathology Solution with Paige.AI Inc. FullFocus DX viewing software, cleared under K201005
- . Leica Aperio AT2 DX System with ImageScope DX viewing software, cleared under K190332
- Leica Aperio AT2 DX scanner with Sectra Digital Pathology Module, cleared under K193054 .

Image /page/7/Picture/8 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 inside a circle and two horizontal lines extending from either side of the outer circle.

ENABLING BRIGHT OU