8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

K233119 · Shenzhen Beacon Display Technology Co., Ltd. · PZZ · Dec 28, 2024 · Pathology

Device Facts

• Record ID: K233119
• Device Name: 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
• Applicant: Shenzhen Beacon Display Technology Co., Ltd.
• Product Code: PZZ · Pathology
• Decision Date: Dec 28, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.3700
• Device Class: Class 2

Indications for Use

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are 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. They are 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 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.

Device Story

Device consists of 27-inch 8MP color LCD monitors (models C811W, C811WT, PA27, PA27T) used in clinical pathology settings. Monitors receive digital image data from IVD-labeled whole-slide imaging scanners via DVI-D, HDMI, or DisplayPort interfaces. Displays utilize LED backlighting and built-in brightness stabilization control circuits to maintain consistent luminance. Models C811WT and PA27T include capacitive touch screens. Pathologists use these displays to view and interpret histopathology slides for primary diagnosis. Performance is maintained through front sensor calibration and feedback systems. Benefits include high-resolution visualization of digital pathology images, aiding diagnostic accuracy in clinical workflows.

Clinical Evidence

Bench testing only. Performance evaluated against IDMS 1.03 standards, including spatial resolution (MTF), pixel defects, temporal response, luminance uniformity, and color gamut volume. System-level testing performed with Leica GT450DX scanner using test targets and tissue sample images; results were acceptable.

Technological Characteristics

27-inch TFT Color LCD (AHVA) panel; LED backlight; 3840 x 2160 resolution; 500 cd/m² calibrated luminance; 1000:1 contrast ratio. Interfaces: DVI-D, HDMI, DisplayPort. Features: brightness stabilization control circuits, front sensor calibration, capacitive touch (select models). Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, AAPM TG18, IEC 62304, IDMS 1.03.

Indications for Use

Indicated for use by pathologists to review and interpret digital histopathology images 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

• Leica Aperio GT 450 DX (K232202)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K233119

B Applicant

Shenzhen Beacon Display Technology Co., Ltd.

C Proprietary and Established Names

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T

D Regulatory Information

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

## II Review Summary:

A Purpose for Submission:

New digital pathology displays as follows:

8MP Color LCD Display C811W

8MP Color LCD Display C811WT

8MP Color LCD Display PA27

8MP Color LCD Display PA27T

B Type of Test:

Digital pathology display monitors.

## 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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K233119 - Page 2 of 8

## B Indication(s) for Use:

8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are 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. They are 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 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T. The displays are 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 C811WT, C811WT, PA27 and PA27T are 8MP Color LCD displays, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners that have been validated for use with the display. The displays are equipped with a 27-inch color LCD panel with a fine pixel pitch and LED backlight panels. The built-in brightness stabilization control circuits enable the brightness of these displays are stable throughout the product life. Displays models C811WT and PA27T have capacitive touch screen and models C811W, PA27 do not have a capacitive touch screen.

### V Substantial Equivalence Information:

#### A Predicate Device Name(s):

Leica Aperio GT 450 DX

#### B Predicate 510(k) Number(s):

K232202

#### C Comparison with Predicate:

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K233119 - Page 3 of 8
| Device & Predicate
Device(s): | Device
K233119 | Predicate
K232202 |
| --- | --- | --- |
| Device Trade Name | Shenzhen Beacon 8MP Color LCD displays C811WT, PA27T, C811W and PA27 | Aperio GT 450 DX (Barco MDPC-8127 display component) |
| General Device
Characteristic
Similarities | | |
| Screen size | 684 mm (27") | 684 mm (27") |
| Backlight type | LED | LED |
| Color Calibration | sRGB | sRGB |
| Contrast Ratio (typical) | 1000:1 | 1000:1 |
| General Device
Characteristic
Differences | | |
| Display Technology | TFT Color LCD Panel (AHVA) | TFT Color LCD Panel (IPS) |
| Resolution | 3840 x 2160 @ 60 Hz (16:9 aspect ratio) | 3840 x 2160 @ 120 Hz (16:9 aspect ratio) |
| Pixel pitch | 0.15525 x 0.15525 mm | 0.155 x 0.155 mm |
| Calibrated luminance | 500 cd/m² | 450 cd/m² |
| Display Interface | DVI-D x 1
HDMI x 1
DisplayPort x 1 | DisplayPort x 2 |
| Ambient light sensor | N/A | Yes |
| Touch screen technology | Capacitive touch screen | N/A |
| Calibration tools | Front sensor;
Calibration Feedback system | Front sensor;
QAWeb |

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General Technological Characteristics Comparison of C811WT and PA27T

| Attributes | Proposed Device
8MP Color LCD Monitor
(C811WT, PA27T) | Predicate Device
8MP Color LCD Monitor
Barco MDPC-8127 |
| --- | --- | --- |
| Display Technology | TFT Color LCD Panel
(AHVA) | TFT Color LCD Panel (IPS) |
| Screen size | 684 mm (27") | 684 mm (27") |
| Resolution | 3840 x 2160 @ 60 Hz (16:9 aspect ratio) | 3840 x 2160 @ 120 Hz (16:9 aspect ratio) |
| Pixel pitch | 0.15525 x 0.15525 mm | 0.155 x 0.155 mm |
| Backlight type | LED | LED |
| Color Calibration | sRGB | sRGB |
| Calibrated luminance | 500 cd/m² | 450 cd/m² |
| Contrast Ratio
(typical) | 1000:1 | 1000:1 |
| Display Interface | DVI-D x 1,
HDMI x 1,
DisplayPort x 1 | DisplayPort x 2 |
| Ambient light sensor | N/A | Yes |
| Touch screen
technology | Capacitive touch screen | N/A |
| Calibration tools | Front sensor;
Calibration Feedback System | Front sensor
QAWeb |

General Technological Characteristics Comparison of C811W and PA27

| Attributes | Proposed Device
8MP Color LCD Monitor
(C811W, PA27) | Predicate Device
8MP Color LCD Monitor
Barco MDPC-8127 |
| --- | --- | --- |
| Display Technology | TFT Color LCD Panel
(AHVA) | TFT Color LCD Panel (IPS) |
| Screen size | 684 mm (27") | 684 mm (27") |
| Resolution | 3840 x 2160 @ 60 Hz (16:9 aspect ratio) | 3840 x 2160 @ 120 Hz (16:9 aspect ratio) |
| Pixel pitch | 0.15525 x 0.15525 mm | 0.155 x 0.155 mm |

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| Backlight type | LED | LED |
| --- | --- | --- |
| Color Calibration | sRGB | sRGB |
| Calibrated luminance | 500 cd/m² | 450 cd/m² |
| Contrast Ratio (typical) | 1000:1 | 1000:1 |
| Display Interface | DVI-D x 1,
HDMI x 1,
DisplayPort x 1 | DisplayPort x 2 |
| Ambient light sensor | N/A | Yes |
| Touch screen technology | N/A | N/A |
| Calibration tools | Front sensor;
Calibration Feedback System | Front sensor
QAWeb |

VI Standards/Guidance Documents Referenced:

- ANSI AAMI, ES60601-1:2005/R2012&A1:2012 C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]
- IEC, 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION
- AAPM, TG18 Assessment of Display Performance for Medical Imaging System, 2005
- IEC, TR 60601-4-2 Edition 1.0 2016-05
- ISO, 14971 Third Edition 2019-12
- IEC, 62563-1 Edition 1.2 2021-07
- ICDM, IDMS v1.03
- IEC, 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION

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

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5. Carry-Over:
Not applicable

B Other Supportive Instrument Performance Characteristics Data:

Technical performance testing for the displays was performed as specified in the Tables below:

Table: C811W, C811WT, PA27 and PA27T Test Results

| Test | Test Method/Applicable Standards | C811W | C811WT | PA27 | PA27T |
| --- | --- | --- | --- | --- | --- |
| 1.User controls | Modified-Performance Modes, IDMS 1.03, Section 2.1 | Luminance target, Maximum: 500 cd/m2 Display function: sRGB White point: D65 (6500K) Color space: sRGB 30 minutes of warm-up time | Luminance target, Maximum: 500 cd/m2 Display function: sRGB White point: D65 (500K) Color space: sRGB 30 minutes of warm-up time | Luminance target, Maximum: 500 cd/m2 Display function: sRGB White point: D65 (6500K) Color space: sRGB 30 minutes of warm-up time | Luminance target, Maximum: 500 cd/m2 Display function: sRGB White point: D65 (6500K) Color space: sRGB 30 minutes of warm-up time |
| 2.Spatial resolution | Effective Resolution, IDMS 1.03, Section 7.7 | Vertical and Horizontal MTFs are 0.861 and 0.862 at Nyquist frequency | Vertical and Horizontal MTFs are 0.877 and 0.885 at Nyquist frequency | Vertical and Horizontal MTFs are 0.861 and 0.862 at Nyquist frequency | Vertical and Horizontal MTFs are 0.877 and 0.885 at Nyquist frequency |
| 3.Pixel defects (count and map) | Defective Pixels, IDMS 1.03, Section 7.6 | Total number of bright and dark pixels <= 5 | Total number of bright and dark pixels <= 5 | Total number of bright and dark pixels <= 5 | Total number of bright and dark pixels <= 5 |
| 4. Artifacts | Artifacts and Irregularities, IDMS 1.03, Section 10.4 | Deviation <0.54% | Deviation <0.62% | Deviation <0.34% | Deviation <0.68% |
| 5. Temporal response | Gray-to-Gray Response Time, IDMS 1.03, Section 10.2.3 | Tmax: 20.87ms Tmin: 9.88ms | Tmax: 20.09ms Tmin: 3.84ms | Tmax: 22.87ms Tmin: 6.11ms | Tmax: 22.09ms Tmin: 3.56ms |
| 6. Maximum, minimum luminance and calibrated luminance | Vantage-Point Suite of Measurement, IDMS 1.03, Section 2.4 | Maximum: 523.6cd/m² Minimum: 0.501cd/m² | Maximum: 502.9cd/m² Minimum: 0.4805cd/m² | Maximum: 510cd/m² Minimum: 0.499cd/m² | Maximum: 502.6cd/m² Minimum: 0.515cd/m² |
| 7. Grayscale | Grayscale, IDMS 1.03, Section 6.1 | Maximum deviation:5.94 % | Maximum deviation:5.33 % | Maximum deviation:5.52% | Maximum deviation:6.07 % |

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| | | | | | |
| --- | --- | --- | --- | --- | --- |
| 8. Luminance uniformity and Mura test | Sampled Vantage-Point Uniformity, IDMS 1.03, Section 8.1.2 | 11.16% non-uniformity on 100% video level | 6.89% non-uniformity on 100% video level | 9% non-uniformity on 100% video level | 9.26% non-uniformity on 100% video level |
| 9. Stability of luminance and chromaticity response with temperature and lifetime | Warm-up time, IDMS 1.03, Section 10.1 | Deviation from target luminance (500 cd/m²): 0.48% Variations for chromaticity: < 0.55% | Deviation from target luminance (500 cd/m²): 0.66% Variations for luminance and chromaticity: < 0.64% deviation | Deviation from target luminance (500 cd/m²): 0.66%, Variations for chromaticity: < 0.3% | Deviation from target luminance (500 cd/m²): 0.63% Variations for luminance and chromaticity: < 0.7% deviation |
| 10. Bidirectional reflection distribution function | Diagnostic: Characterizing Hemisphere Uniformity, IDMS 1.03, Section 11.12 | Specular reflection coefficient: 4.4%, Diffuse reflection coefficient: 0.92% | Specular reflection coefficient: 4.19%, Diffuse reflection coefficient: 0.8% | Specular reflection coefficient: 4.4%, Diffuse reflection coefficient: 0.92% | Specular reflection coefficient: 4.19%, Diffuse reflection coefficient: 0.8% |
| 11. Gray Tracking | Gray-scale Color Changes IDMS v1.03, Section 6.15 | 0.0006 Δu'v' | 0.0016Δu'v': | 0.0006 Δu'v' | 0.0014Δu'v': |
| 12. Color scale | Gray- and Color-Scale Measurement and 5.4 Color-Signal White, IDMS 1.03, Section 6 | Maximum color error:<2ΔE Average color error:<1ΔE | Maximum color error:<2ΔE Average color error:<1ΔE | Maximum color error:<3ΔE Average color error:<2ΔE | Maximum color error:<3ΔE Average color error:<2ΔE |
| 13. Color gamut volume | Volume-Color-Reproduction Capability, IDMS 1.03, Section 5.18 | 2D color gamut overlapped with sRGB:99.5% | 2D color gamut overlapped with sRGB:99.6% | 2D color gamut overlapped with sRGB:98.7% | 2D color gamut overlapped with sRGB:99.6% |

System-level test was also performed to test the displays with the Leica GT450DX system by displaying a test target and multiple tissue sample images. The results were acceptable.

## VIII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

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IX Conclusion:

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

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