MMPC-4127F1

K172922 · Barco N.V. · PZZ · Dec 21, 2017 · Pathology

Device Facts

• Record ID: K172922
• Device Name: MMPC-4127F1
• Applicant: Barco N.V.
• Product Code: PZZ · Pathology
• Decision Date: Dec 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Intended Use

The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. 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

MMPC-4127F1 (PP27QHD) is a 27-inch color-calibrated IPS LCD display system for viewing digital histopathology slides. Device receives digital image data from validated IVD-labeled whole-slide imaging scanners; displays images for pathologist review and interpretation in clinical settings. System includes QAWeb quality assurance software for calibration and luminance stabilization via front sensor. Output allows pathologists to perform diagnostic interpretation of tissue samples. Benefits include standardized, color-accurate visualization of digital pathology slides to support clinical decision-making.

Clinical Evidence

Bench testing only. Performance validated via spatial resolution, pixel defect, artifact, temporal response, luminance/chromaticity stability, grayscale tracking, and noise power spectrum testing. Results demonstrate performance equivalent to predicate device.

Technological Characteristics

27-inch IPS LCD panel; 2560x1440 resolution; 10-bit/sub-pixel LUT; 1000:1 contrast ratio; 500 cd/m² max luminance. Features front-sensor luminance stabilization. Connectivity via DisplayPort/USB. Calibration software: MediCal QAWeb. Operating temperature 10-40°C.

Indications for Use

Indicated for pathologists to review and interpret digital images of histopathology slides (FFPE) acquired from validated IVD-labeled whole-slide imaging scanners. Not indicated for 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 (PIPS) - PP27QHD display (K172174)

Submission Summary (Full Text)

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December 21, 2017

Barco N.V. Lieven De Wandel Regulatory Officer 35 President Kennedypark 8500 Kortrijk, Belgium

Re: K172922

Trade/Device Name: MMPC-4127F1 (PP27QHD) Regulation Number: 21 CFR 864.3700 Regulation Name: Whole Slide Imaging System Regulatory Class: Class II Product Code: PZZ Dated: September 22, 2017 Received: September 25, 2017

Dear Mr. 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. 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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Reena Philip -S

Reena Philip, Ph.D. Director Division of Molecular Genetics and Pathology Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K172922

Device Name MMPC-4127F1

## Indications for Use (Describe)

The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners that have been validated for use with this device, for review and interpretation by pathologists. 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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| 510(k) Summary (in accordance with 21 CFR 807.92) | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>8500 Kortrijk<br>BELGIUM |
| 2. Contact<br>person | Lieven De Wandel<br>Regulatory Affairs Officer |
| 3. Date of<br>submission | September 22 2017 |
| 4. Device<br>information | Trade name/model: MMPC-4127F1<br>Common name: MMPC-4127F1<br>Classification name: Whole Slide Imaging System<br>Classification code: PSY<br>Regulation number: 864.3700 |
| 5. Predicate<br>device | MMPC-4127 (PP27QHDCR), display component of<br>Philips IntelliSite Pathology Solution, cleared under DeNovo no. DEN160056 |
| 6. Device<br>description | The MMPC-4127F1, also marketed as the PP27QHD, is a stabilized, color-calibrated<br>display system designed to review and interpret digital images of surgical pathology<br>slides.<br><br>The display is equipped with a 27-inch color LCD panel with a fine pixel pitch that can be<br>calibrated to the sRGB gamut.<br><br>Accessories:<br>- QAWeb quality assurance software<br>- DisplayPort cable<br>- USB cable<br>- AC power cord cables |
| 7. Intended Use<br>of the Device | The Barco MMPC-4127F1 (PP27QHD) device is intended for in vitro diagnostic use to<br>display digital images of histopathology slides acquired from IVD-labeled whole-slide<br>imaging scanners that have been validated for use with this device, for review and<br>interpretation by pathologists. The display is not intended for use with digital images from<br>frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE)<br>hematopathology specimens. |

Image /page/3/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. To the right of the "O" is a symbol that looks like a circle with a horizontal line through the middle, and two smaller circles on either side of the line.

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| 8. Comparison<br>of technological<br>characteristics | Parameter | New Device<br>MMPC-4127F1<br>(PP27QHD) | Predicate Device<br>MMPC-4127<br>(PP27QHDCR),<br>Display<br>component of<br>Philips IntelliSite<br>Pathology Solution |
|------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|
| | Display Optical Performance | | |
| | Display technology | IPS LCD | IPS LCD |
| | Native Resolution | 2560 x1440 | 2560 x1440 |
| | Display LUT | ≥ 10 bit / sub-pixel | ≥ 10 bit / sub-pixel |
| | Pixel Pitch (Horizontal) (mm) | 0.2331 | 0.2331 |
| | Pixel pitch (Verical) (mm) | 0.2331 | 0.2331 |
| | Active screen (Diagonal) (mm / inch) | 685.8 / 27.0 | 685.8 / 27.0 |
| | Active screen (Width) (mm) | 596.74 | 596.74 |
| | Active screen (Height) (mm) | 335.66 | 335.66 |
| | Contrast Ratio - (typical) | 1000:1 | 1000:1 |
| | Luminance stabilization | +2% / -2%<br>front sensor | +2% / -2% backlight<br>sensor |
| | Maximum Luminance (typical) (cd/m²) | 500 | 500 |
| | DICOM Calibrated Luminance (Typical)<br>(cd/m²) | 350 | 350 |
| | Luminance non-uniformity (per DIN6868-<br>157), diagnostic room class | <25% on 9 points,<br>10%/80% luminance | <25% on 9 points,<br>10%/80% luminance |
| | Response Time (typical) (ms) | 12 | 12 |
| | Response Time (max) (ms) | 24 | 24 |
| | Calibration Performance | | |
| | Supported color spaces | sRGB, DICOM,<br>native | sRGB |
| | Average dE2000 deviation from sRGB | <2 on 6x6x6 grid | <2 on 6x6x6 grid |
| | Maximum dE2000 deviation from sRGB | <5 on 6x6x6 grid | <5 on 6x6x6 grid |
| | White point chromaticity stabilization | +/-0.01 u'v' | +/-0.01 u'v' |
| | Gray tracking (per IEC 62563) | +/-0.01 u'v' | +/-0.01 u'v' |
| | Grayscale transfer function deviation | <10% on 18 points | <10% on 18 points |
| | Calibration Software | MediCal QAWeb | Nucleus Software |
| | Environmental Specifications | | |
| | Operational Temperature (min/max) (°C) | 10 / 40 | 10 / 40 |
| | Within specification temperature<br>(min/max) (°C) | 10 / 35 | 10 / 35 |
| | Power Consumption (@ 100-240VAC<br>typical) (W) | 120 | 85 |
| 9. Performance<br>testing | The bench tests mentioned below were performed to validate the device characteristics<br>that differ from the predicate device: | | |
| | Spatial resolution | | |
| | Pixel defects | | |
| | Artifacts | | |
| | Temporal response | | |
| | Maximum and minimum luminance | | |
| | Grayscale | | |

BARCO

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| | Intrinsic bit-depth of panel |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | True output bit depth by performing visual test with gradient test pattern |
| | Mapping of image values (DDL) to luminance (cd/m²) |
| | Luminance uniformity and Mura |
| | Stability of luminance and chromaticity |
| | Stability of calibrated luminance over temperature |
| | Stability of calibrated luminance over time |
| | Specular and diffuse coefficients |
| | Gray Tracking |
| | Color scale |
| | Color gamut |
| | Angular dependency of the luminance |
| | Noise |
| | RMS (image variance) for multiple video levels |
| | NPS (Noise Power Spectrum) |
| | Veiling glare |
| | The tests showed that the device has similar characteristics compared to the predicate<br>device and did not reveal new issues of safety and performance. |
| | Animal testing has not been performed. |
| 10. Conclusion | The MMPC-4127F1 display was found to be substantially equivalent to the predicate<br>device, due to the following reasons: |
| a) | Device and predicate device have the same intended use |
| b) | The technological characteristics differences from the predicate device do not<br>affect safety or effectiveness |
| c) | Bench testing showed that the device has similar characteristics compared to the<br>predicate device and did not reveal new issues of safety and performance. |

Image /page/5/Picture/2 description: The image shows the word "BARCO" in a bold, sans-serif font. The letters are white against a black background. The "O" in "BARCO" has a small extension on the upper right side, resembling a stylized electronic component.