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

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 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)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

INSTRUMENT ONLY

## I Background Information:

A 510(k) Number

K203364

B Applicant

Barco NV

C Proprietary and Established Names

MDPC-8127

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| PZZ | Class II | 21 CFR 864.3700 - Whole Slide Imaging System | PA - Pathology |

## II Submission/Device Overview:

A Purpose for Submission:

New digital pathology display

B Type of Test:

Digital Pathology Display

## III Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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## B Indication(s) 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 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.

## C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

## IV Device/System Characteristics:

### A Device Description:

The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of digital images of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software. The MDPC-8127 consists of a high-resolution 27-inch color LCD-panel and can be calibrated to the sRGB color gamut or other broader color spaces. The display uses built-in techniques to ensure constant accuracy over time. The display characteristics and specifications are provided in the Table below.

| Display Characteristics | |
| --- | --- |
| Screen technology | IPS LCD with LED backlighting |
| Active screen size (diagonal) | 684 mm (27") |
| Active screen size (H x V) | 569 x 335 mm (22.4 x 13.2") |
| Aspect ratio (H:V) | 16:9 |
| Resolution | 8MP (3840 x 2160 pixels @ 120 Hz) |
| Pixel pitch | 0.155 mm |
| Color imaging | Yes |
| Gray imaging | Yes |
| Color depth | 30 bit (1.07 billion possible colors) |
| Viewing angle (H, V) | 178° |
| Screen surface treatment | Anti-Glare coating |
| Uniformity Technology | PPU |

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| Display Characteristics | |
| --- | --- |
| Color calibration | sRGB, DICOM GSDF, |
| Color gamut NTSC | 115% (typical) |
| Color gamut sRGB | 132% (typical), 137.1% (measured) |
| Color gamut DCI-P3 | 105% (typical) |
| Ambient light presets | Yes, reading room selection |
| Ambient light sensor | Yes |
| Front sensor | Yes, I-Guard |
| Maximum luminance (panel typical) | 850 cd/m² |
| Calibrated luminance | 450 cd/m² |
| Contrast ratio (panel typical) | 1000:1 |
| sRGB Delta E2000 (typical) | < 1 (average)
< 3 (maximum) |
| Response time [(Tr + Tf)/2)] (typical) | 8 ms (typical), 5.01 ms (measured) |
| Housing color | Black / White |
| Video input signals | 2x DisplayPort 1.2 |
| USB ports | 1x USB 2.0 upstream (endpoint) 2x USB 2.0 downstream |
| Power rating | 100-240 Vac, 50/60 Hz, 3.6-1.6 A |
| Power consumption | 75 W (nominal) @ calibrated luminance of 450 cd/m²
< 0.5 W (hibernate)
< 0.5 W (standby) |

B Instrument Description Information:

1. Instrument Name:
MDPC-8127

2. Specimen Identification:
The FFPE tissue specimen is identified on the scanned images by patient-specific barcodes and/or patient identifying information present on the glass slides.

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3. Specimen Sampling and Handling:

Specimen sampling, which includes FFPE tissues, is performed by clinicians. Biopsy specimens are processed and FFPE slides are scanned by trained healthcare professionals to generate a digital image.

4. Calibration:

Calibrated color spaces: DICOM GSDF and sRGB

5. Quality Control:

Image quality is checked by the user for acceptability. In addition, quality checks for the display are initiated by the QAWeb quality assurance software and performed as a background activity.

V Substantial Equivalence Information:

A Predicate Device Name(s):

Philips IntelliSite Pathology Solution

B Predicate 510(k) Number(s):

K192259

C Comparison with Predicate:

| | Device
K203364 | Predicate
K192259 |
| --- | --- | --- |
| Device Trade Name | Barco MDPC-8127 | Philips Intellisite Pathology Solution
MMPC-4227F1 (PP27QHD) |
| Device Characteristics - Similarities | | |
| Screen Technology | In-Plane Switching (IPS) Liquid Crystal Display (LCD) | Same |
| Display Calibration | Standard Red Green Blue (sRGB), Digital Imaging and Communication in Medicine (DICOM) | Same |
| Aspect ratio (H:V) | 16:9 | Same |
| Device Characteristics - Differences | | |
| Resolution | 8MP (3840 x 2160 pixels) | 3.6MP (2560 x1440 pixels) |

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| Uniformity Technology | Color Per Pixel Uniformity (PPU) | None |
| --- | --- | --- |

VI Standards/Guidance Documents Referenced:

1. FDA Guidance document: Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices. Guidance for Industry and Food and Drug Administration Staff. April 20, 2016 (TPA Guidance).
2. ANSI/AAMI ES60601- 1:2005/(R)2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD)
3. IEC 62304 Edition 1.1 2015-06 Medical Device Software - Software Life Cycle Processes
4. ISO 15223-1 Third Edition 2016- 11-01 Medical Devices - Symbols To Be Used With Medical Device Labels, Labelling, And Information To Be Supplied - Part 1: General Requirements
5. ISO 14971 Second edition 2007-03-01(5-40) Medical devices - application of risk management to medical devices.

VII Performance Characteristics (if/when applicable):

A Analytical Performance:

1. Precision/Reproducibility: Not applicable.
2. Linearity: Not applicable.
3. Analytical Specificity/Interference: Not applicable.
4. Accuracy (Instrument): Not applicable.
5. Carry-Over: Not applicable.

B Other Supportive Instrument Performance Characteristics Data:

Technical performance testing for Barco MDPC-8127 display was performed according to the TPA guidance (section IV(A)(11)(b). Bench testing included assessment of the following performance characteristics:

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| 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 <= 5 with a minimum distance greater than 15 mm. | Total number of bright and dark pixels <= 3 within a circle of 10 mm. diameter |
| Artifacts | Image retention after 1 hour | < 0.65% | < 0.65% |
| Temporal response | 10.2.3 Gray-to-Gray Response Time, IDMS v1.03b | The response time ranges from 3.1 ms to 6.2 ms with an average of 5.01 ms. | The response time is maximum 15 ms and typical 8 ms. |
| Maximum and minimum luminance | 5 Fundamental Measurements, IDMS v1.03b | The maximum and minimum achievable luminance values are 678.6 and 0.633 cd/m², respectively.
The calibrated luminance target is 450 cd/m².
The contrast ratio is greater than 1000:1. | The maximum and minimum achievable luminance values are 550 and 0.3 cd/m², respectively.
The calibrated luminance target is 350 cd/m².
The contrast ratio is 1000:1. |
| Grayscale | Contrast response deviation, AAPM TG-18 | Maximum error calculated = 1.4% | Maximum error calculated = 2.1% |
| Luminance uniformity and Mura test | 8 Uniformity Measurements, IDMS v1.03b | <10% non-uniformity on 80% video level | 21% non-uniformity on 80% video level |

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| Test | Test Method | Results | |
| --- | --- | --- | --- |
| | | MDPC-8127 | Predicate device |
| Stability of luminance and chromaticity response | Luminance and chromaticity characteristics of the display measured with temperature and time | Deviation from target luminance (450 cd/m²): ±0.44%
Variations for luminance and chromaticity: < 5% deviation | Deviation from target luminance (350 cd/m²): ±0.2%
Variations for luminance and chromaticity: < 2% deviation |
| Bidirectional reflection distribution function | 11. Reflection Measurements, IDMS v1.03b | Specular reflection coefficient: 1.90%
Diffuse reflection coefficient: 2.87% | Specular reflection coefficient: 1.69%
Diffuse reflection coefficient: 2.21% |
| Gray tracking | 6.15 Gray-scale Color Changes, IDMS v1.03b | +/- 0.01 Δu’v’
White point at D65: +/- 0.01 Δu’v’ | +/- 0.002 Δu’v’
White point at D65: +/- 0.002 Δu’v’ |
| Color scale | 6. Gray- and Color-Scale Measurement, IDMS v1.03b | Average color error < 1 ΔE00
Maximum color error < 3 ΔE00 | Average color error < 2 ΔE00
Maximum color error < 5 ΔE00 |
| Color gamut volume | 5.18.1 Relative Gamut Area, IDMS v1.03b | 2D color gamut wrt sRGB: 137.1%
2D color gamut overlapped with sRGB: 99.6% | 2D color gamut wrt sRGB: 99.4%
2D color gamut overlapped with sRGB: 98.4% |

VIII Proposed Labeling:

The labeling is sufficient, and it satisfies the requirements of 21 CFR Parts 801 and 809, as applicable, and the special controls for this device type, as applicable.

IX Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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