(458 days)
MDPC-8127
Not Found
No
The document describes a medical display monitor and its technical specifications. There is no mention of AI or ML being used in the device's functionality or image processing.
No
The device is a display for viewing digital images of histopathology slides, aiding pathologists in diagnosis. It does not directly provide therapy or therapeutic interventions.
No
The device is an 8MP Color LCD Display that acts as an "aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis." It displays images acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software. The device itself is not performing the diagnosis; it is a display tool used by a human pathologist for diagnostic purposes.
No
The device description explicitly states that the device is an "8MP Color LCD Display" and details hardware components like the LCD panel, LED backlight panels, and touch screen. It is a physical display device, not software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The "Intended Use / Indications for Use" section clearly states: "8MP Color LCD Displays C811W, C811WT, PA27 and PA27T are intended for in vitro diagnostic use..."
- Role in the Diagnostic Process: The text describes the displays as an "aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis." This places the device directly within the diagnostic workflow.
- Requirement for IVD-labeled Inputs: The device is intended for use with "digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed using IVD-labeled digital pathology image viewing software." This further reinforces its role in an IVD ecosystem.
Therefore, the device is explicitly intended and described as being used for in vitro diagnostic purposes.
N/A
Intended Use / 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.
Product codes
PZZ
Device Description
The C811WT. PA27T. C811W. PA27 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. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.
For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.
C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.
The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
pathologist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- User Controls
- Spatial Resolution
- Pixel defects
- Artifacts
- Temporal response
- Max and Min Luminance
- Grayscale
- Luminance Uniformity and Mura Test
- Stability of Luminance and Chromaticity with Temperature and Lifetime
- Bidirectional Reflection Distribution
- Gray Tracking
- Color Scale
- Color Gamut Volume
The test results showed that C811WT, PA27T, C811W, PA27 displays have equivalent characteristics and performance to the predicate device, MDPC-8127 except some items, which do not affect the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below.
Shenzhen Beacon Display Technology Co., Ltd. Li Yafei Official Correspondent 15F, Building 6, Hengda Shishang Huigu (East) Fulong Road, Dalang Subdistrict, Longhua Shenzhen, Guangdong 518109 China
December 28, 2024
Re: K233119
Trade/Device Name: 8MP Color LCD Displays C811W, C811WT, PA27, PA27T Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: PZZ Dated: September 27, 2023 Received: September 27, 2023
Dear Li Yafei:
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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrb/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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
Sincerely,
Shyam Kalavar -S
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233119
Device Name
8MP Color LCD Displays C811W, C811WT, PA27 and PA27T
Indications for Use (Describe)
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.
| 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)
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4
510(k) Summary
1. Date Prepared [21 CFR807.92 (a) (1)]
Dec. 27, 2024
2. Submitter's Information [21 CFR807.92 (a) (1)]
| Name of Sponsor: | Shenzhen Beacon Display Technology Co., Ltd. |
|---|---|
| Address: | 15F, Building 6, Hengda Shishang Huigu (East), Fulong Road, |
| Dalang Subdistrict, Longhua, Shenzhen, 518109 China | |
| Contact Name: | Li Yafei |
| Telephone No.: | +86-024-88087610 |
| Fax No.: | +86-024-88087629 |
| Email Address: | liyf@beacon-display.cn |
3. Trade Name, Common Name, Classification [21 CFR807.92 (a) (2)]
- Trade Name/Model: 8MP Color LCD Displays C811W, C811WT, PA27 and PA27T ●
- Common Name: 8MP Color LCD Display
- Classification Name: Digital Pathology Display
- Regulation Number: 21 CFR 864.3700
- Product code: PZZ
- Classification Panel: Pathology
- Device Class: ll ●
- 510(k) Number: K233119
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
The identified predicate within this submission is as follows: Barco MDPC-8127, display used in Aperio GT 450 DX, referenced in 510(k) No. K232202 (Decision Date -07/25/2023).
5
5. Description of the Device [21 CFR 807.92(a) (4)]
The C811WT. PA27T. C811W. PA27 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. They use the latest generation of LED backlight panels. The built-in brightness stabilization control circuits make sure the brightness of these displays is stable in their life, so the products meet the demands of high precision medical imaging.
For C811WT. PA27T. C811W. PA27. the only difference is the capacitive touch screen.
C811WT, PA27T have the same capacitive touch screen. C811W, PA27 don't have a capacitive touch screen.
The difference between C811WT and PA27T is only different customers which results in the two models. The difference between C811W and PA27 is only different customers which results in the two models.
| Model | Touch screen |
|---|---|
| C811WT | With touch screen |
| PA27T | With touch screen |
| C811W | Without touch screen |
| PA27 | Without touch screen |
Table 1: Differences between models
6. Intended Use [21 CFR 807.92(a)(5)]
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.
6
7. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
7.1 Comparison table of Technological Characteristics
| Attributes | Proposed Device
8MP Color LCD
Display
(C811WT, PA27T) | Predicate Device
8MP Color LCD
Display
Barco MDPC-8127 | Explanation of
Difference |
|--------------------------------|----------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Display
Technology | TFT Color LCD Panel
(AHVA) | TFT Color LCD Panel
(IPS) | Both panels are
from the same
panel
manufacturer and
the same IPS like
technology. |
| 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) | Different panel
provided by the
same
manufacturer |
| 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 | Different display
provided by the
different
manufacturer |
| Contrast
Ratio
(typical) | 1000:1 | 1000:1 | - |
| Display
Interface | DVI-D x 1,
HDMI x 1,
DisplayPort x 1 | DisplayPort x 2 | Different design
scheme. |
| Ambient
light
sensor | N/A | Yes | Different design
scheme. |
| Touch
screen
technology | Capacitive
touch
screen | N/A | Different design
scheme. |
| Calibration
tools | Front sensor;
Calibration
Feedback
System | Front sensor
QAWeb | Different design
scheme. |
Table 2: General Comparison of C811WT, PA27T
7
| Attributes | Proposed Device
8MP Color LCD
Display
(C811W, PA27) | Predicate Device
8MP Color LCD
Display
Barco MDPC-8127 | Explanation of
Difference |
|-------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| Display
Technology | TFT Color LCD Panel
(AHVA) | TFT Color LCD Panel
(IPS) | Both panels are
from the same
panel
manufacturer and
the same IPS like
technology. |
| 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) | Different panel
provided by the
same
manufacturer |
| 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 | Different display
provided by the
different
manufacturer |
| Contrast Ratio
(typical) | 1000:1 | 1000:1 | - |
| Display
Interface | DVI-D x 1,
HDMI x 1,
DisplayPort x 1 | DisplayPort x 2 | Different design
scheme. |
| Ambient
light
sensor | N/A | Yes | Different design
scheme. |
| Touch
screen
technology | N/A | N/A | - |
| Calibration
tools | Front sensor;
Calibration Feedback
System | Front sensor;
QAWeb | Different design
scheme. |
Table 3: General Comparison of C811W, PA27
The technological characteristic differences discussed above do not affect the safety and the effectiveness of the C811WT, PA27T, C811W, PA27.
8
7.2 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:
- User Controls
- Spatial Resolution
- Pixel defects
- Artifacts
- Temporal response ●
- Max and Min Luminance ●
- Grayscale
- Luminance Uniformity and Mura Test
- Stability of Luminance and Chromaticity with Temperature and Lifetime
- Bidirectional Reflection Distribution
- Gray Tracking
- Color Scale ●
- Color Gamut Volume
Test results are provided in the table below:
Table 4: C811W, C811WT, PA27 and PA27T Test Results
| Test | Test Method/
Applicable
Standards | C811W | C811WT | PA27 | PA27T |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.User
controls | 2.1 Modified-
Performance
Modes, IDMS
1.03. | 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 | 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 | 7.7 Effective
Resolution,
IDMS 1.03. | Vertical and
Horizontal MTFs
are 0.861 and
0.862 at Nyquist | Vertical and
Horizontal MTFs
are 0.877 and
0.885 at Nyquist | Vertical and
Horizontal MTFs
are 0.861 and
0.862 at Nyquist | Vertical and
Horizontal MTFs
are 0.877 and
0.885 at Nyquist |
| | | frequency | frequency | frequency | frequency |
| 3.Pixel
defects
(count and
map) | 7.6 Defective
Pixels, IDMS
1.03. | Total number of
bright and dark
pixels