(458 days)
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.
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.
The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Shenzhen Beacon Display Technology Co., Ltd.'s 8MP Color LCD Displays (C811W, C811WT, PA27, PA27T).
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly derived from the "Test" column, and the reported device performance is presented in the "C811W", "C811WT", "PA27", and "PA27T" columns. The predicate device (Barco MDPC-8127) is also listed for comparison of technological characteristics.
| Acceptance Criteria (Derived from "Test") | Reported Device Performance (Example for C811W) |
|---|---|
| User Controls (Luminance, White Point, Color Space, 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 |
| Spatial resolution (MTF at Nyquist frequency) | Vertical and Horizontal MTFs are 0.861 and 0.862 at Nyquist frequency |
| Pixel defects (count and map) | Total number of bright and dark pixels <= 5 |
| Artifacts (Deviation) | Deviation <0.54% |
| Temporal response (Tmax, Tmin) | Tmax: 20.87ms, Tmin: 9.88ms |
| Maximum, minimum, and calibrated luminance | Maximum: 523.6 cd/m², Minimum: 0.501 cd/m² |
| Grayscale (Maximum deviation) | Maximum deviation: 5.94 % |
| Luminance uniformity and Mura test (Non-uniformity) | 11.16% non-uniformity on 100% video level |
| Stability of luminance and chromaticity response with temperature and lifetime (Deviation from target luminance, Variations for chromaticity) | Deviation from target luminance (500 cd/m²): 0.48%; Variations for chromaticity: < 0.55% |
| Bidirectional reflection function (Specular and Diffuse reflection coefficients) | Specular reflection coefficient: 4.4%, Diffuse reflection coefficient: 0.92% |
| Gray Tracking (Δu'v') | 0.0006 Δu'v' |
| Color scale (Maximum color error, Average color error) | Maximum color error: <2ΔE |
| Color gamut volume (2D color gamut overlapped with sRGB) | 2D color gamut overlapped with sRGB: 99.5% |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a sample size in terms of a number of distinct display units tested within each model group (C811W, C811WT, PA27, PA27T). The results are presented as single values for each model, implying that these are representative measurements from the tested devices.
The data provenance is from bench testing conducted on the newly submitted devices and compared against the specifications of a predicate device. Regarding country of origin, the manufacturer is Shenzhen, Guangdong, China. The testing itself would likely have been performed in a lab setting, possibly in China or by a certified testing facility collaborating with the manufacturer. The document does not specify if the data is retrospective or prospective, but as it's for a 510(k) submission, it would be considered prospective with respect to the regulatory approval process.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the study described is a technical performance assessment of display characteristics, not a clinical study involving human interpretation of medical images or ground truth established by medical experts. The "ground truth" for these tests are objective, measurable physical properties of the displays, governed by established test methods and standards (e.g., IDMS 1.03).
4. Adjudication method for the test set
This information is not applicable for the same reasons as #3. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where multiple human readers assess cases, and a process is needed to resolve discrepancies. This document describes objective bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, an MRMC comparative effectiveness study was not done. This study focuses on the technical performance of a medical display, not a clinical diagnostic aid involving AI or human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an LCD display, not an algorithm. Its "performance" is its ability to accurately render visual information, which is evaluated through the technical tests detailed.
7. The type of ground truth used
The ground truth used for this technical performance assessment is based on objective measurements of physical display characteristics as defined by industry standards, specifically the "TPA Guidance" and "IDMS 1.03" (International Display Measurement Standard). Examples include:
- Pre-defined target luminance (e.g., 500 cd/m²)
- Reference sRGB color space
- Calibrated measurement equipment to determine values like MTF, pixel defect counts, deviation percentages, and color errors against established benchmarks.
8. The sample size for the training set
This information is not applicable. The device is a hardware display, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as #8.
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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"
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(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).
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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
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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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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).
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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.
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7. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
7.1 Comparison table of Technological Characteristics
| Attributes | Proposed Device8MP Color LCDDisplay(C811WT, PA27T) | Predicate Device8MP Color LCDDisplayBarco MDPC-8127 | Explanation ofDifference |
|---|---|---|---|
| DisplayTechnology | TFT Color LCD Panel(AHVA) | TFT Color LCD Panel(IPS) | Both panels arefrom the samepanelmanufacturer andthe same IPS liketechnology. |
| 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 panelprovided by thesamemanufacturer |
| Pixel pitch | 0.15525 x 0.15525 mm | 0.155 x 0.155 mm | - |
| Backlight type | LED | LED | - |
| ColorCalibration | sRGB | sRGB | - |
| Calibratedluminance | 500 cd/m² | 450 cd/m² | Different displayprovided by thedifferentmanufacturer |
| ContrastRatio(typical) | 1000:1 | 1000:1 | - |
| DisplayInterface | DVI-D x 1,HDMI x 1,DisplayPort x 1 | DisplayPort x 2 | Different designscheme. |
| Ambientlightsensor | N/A | Yes | Different designscheme. |
| Touchscreentechnology | Capacitivetouchscreen | N/A | Different designscheme. |
| Calibrationtools | Front sensor;CalibrationFeedbackSystem | Front sensorQAWeb | Different designscheme. |
Table 2: General Comparison of C811WT, PA27T
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| Attributes | Proposed Device8MP Color LCDDisplay(C811W, PA27) | Predicate Device8MP Color LCDDisplayBarco MDPC-8127 | Explanation ofDifference |
|---|---|---|---|
| DisplayTechnology | TFT Color LCD Panel(AHVA) | TFT Color LCD Panel(IPS) | Both panels arefrom the samepanelmanufacturer andthe same IPS liketechnology. |
| 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 panelprovided by thesamemanufacturer |
| Pixel pitch | 0.15525 x 0.15525 mm | 0.155 x 0.155 mm | - |
| Backlight type | LED | LED | - |
| ColorCalibration | sRGB | sRGB | - |
| Calibratedluminance | 500 cd/m² | 450 cd/m² | Different displayprovided by thedifferentmanufacturer |
| Contrast Ratio(typical) | 1000:1 | 1000:1 | - |
| DisplayInterface | DVI-D x 1,HDMI x 1,DisplayPort x 1 | DisplayPort x 2 | Different designscheme. |
| Ambientlightsensor | N/A | Yes | Different designscheme. |
| Touchscreentechnology | N/A | N/A | - |
| Calibrationtools | Front sensor;Calibration FeedbackSystem | Front sensor;QAWeb | Different designscheme. |
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.
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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/ApplicableStandards | C811W | C811WT | PA27 | PA27T |
|---|---|---|---|---|---|
| 1.Usercontrols | 2.1 Modified-PerformanceModes, IDMS1.03. | Luminancetarget,Maximum: 500cd/m2 Displayfunction: sRGBWhite point: D65(6500K) Colorspace: sRGB30 minutes ofwarm-up time | Luminance target,Maximum: 500cd/m2 Displayfunction: sRGBWhite point: D65(6500K) Colorspace: sRGB30 minutes ofwarm-up time | Luminance target,Maximum: 500cd/m2 Displayfunction: sRGBWhite point: D65(6500K) Colorspace: sRGB30 minutes ofwarm-up time | Luminancetarget, Maximum:500 cd/m2Display function:sRGB Whitepoint: D65(6500K) Colorspace: sRGB30 minutes ofwarm-up time |
| 2.Spatialresolution | 7.7 EffectiveResolution,IDMS 1.03. | Vertical andHorizontal MTFsare 0.861 and0.862 at Nyquist | Vertical andHorizontal MTFsare 0.877 and0.885 at Nyquist | Vertical andHorizontal MTFsare 0.861 and0.862 at Nyquist | Vertical andHorizontal MTFsare 0.877 and0.885 at Nyquist |
| frequency | frequency | frequency | frequency | ||
| 3.Pixeldefects(count andmap) | 7.6 DefectivePixels, IDMS1.03. | Total number ofbright and darkpixels <= 5 | Total number ofbright and darkpixels <= 5 | Total number ofbright and darkpixels <= 5 | Total number ofbright and darkpixels <= 5 |
| 4. Artifacts | 10.4 ArtifactsandIrregularities,IDMS 1.03. | Deviation<0.54% | Deviation <0.62% | Deviation <0.34% | Deviation <0.68% |
| 5. Temporalresponse | 10.2.3 Gray-to-GrayResponseTime, IDMS1.03. | Tmax:20.87msTmin:9.88ms | Tmax:20.09msTmin:3.84ms | Tmax:22.87msTmin:6.11ms | Tmax:22.09msTmin:3.56ms |
| 6. Maximum,minimumluminanceandcalibratedluminance | 2.4 Vantage-Point Suite ofMeasurement,IDMS 1.03. | Maximum:523.6cd/m²Minimum:0.501cd/m² | Maximum:502.9cd/m²Minimum:0.4805cd/m² | Maximum:510cd/m²Minimum:0.499cd/m² | Maximum:502.6cd/m²Minimum:0.515cd/m² |
| 7. Grayscale | 6.1 Grayscale,IDMS 1.03. | Maximumdeviation:5.94 % | Maximumdeviation:5.33 % | Maximumdeviation:5.52% | Maximumdeviation:6.07 % |
| 8. Luminanceuniformityand Muratest | 8.1.2 SampledVantage-PointUniformity,IDMS 1.03. | 11.16% non-uniformity on100% video level | 6.89% non-uniformity on100% video level | 9% non-uniformityon 100% videolevel | 9.26% non-uniformity on100% video level |
| 9. Stability ofluminanceandchromaticityresponsewithtemperatureand lifetime | 10.1 Warm-uptime, IDMS1.03. | Deviation fromtarget luminance(500 cd/m²):0.48% Variationsfor chromaticity:< 0.55% | Deviation fromtarget luminance(500 cd/m²):0.66% Variationsfor luminanceand chromaticity:< 0.64% deviation | Deviation fromtarget luminance(500 cd/m²):0.66%, Variationsfor chromaticity: < 0.3% | Deviation fromtarget luminance(500 cd/m²):0.63% Variationsfor luminance andchromaticity:< 0.7% deviation |
| 10.Bidirection-al reflectionfunction | 11.12Diagnostic:CharacterizingHemisphereUniformity,IDMS 1.03. | Specularreflectioncoefficient:4.4%, Diffusereflectioncoefficient:0.92%: | Specularreflectioncoefficient:4.19%, Diffusereflectioncoefficient: 0.8%: | Specular reflectioncoefficient: 4.4%,Diffuse reflectioncoefficient: 0.92%: | Specular reflectioncoefficient:4.19%, Diffusereflectioncoefficient: 0.8%: |
| 11. GrayTracking | 6.15 Gray-scale ColorChanges,IDMS v1.03. | 0.0006 Δu'v' | 0.0016Δu'v': | 0.0006 Δu'v' | 0.0014Δu'v': |
| 12. Colorscale | 6. Gray- andColor-ScaleMeasurementand 5.4 Color-Signal White,IDMS 1.03. | Maximum colorerror:<2ΔE | Maximum colorerror:<2ΔΕAverage colorerror:<1ΔE | Maximum colorerror:<3ΔEAverage colorerror:<2ΔE | Maximum colorerror:<3ΔEAverage colorerror:<2ΔE |
| 13. Color gamut volume | 5.18 Volume-Color-ReproductionCapability,IDMS 1.03. | 2D color gamutoverlapped withsRGB:99.5% | 2D color gamutoverlapped withsRGB:99.6% | 2D color gamutoverlapped withsRGB:98.7% | 2D color gamutoverlapped withsRGB:99.6% |
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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.
No animal or clinical testing is needed for C811WT, PA27T, C811W, PA27.
8. Conclusion [21 CFR 807.92(b) (3)]
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Shenzhen Beacon Display Technology Co., Ltd. concludes that:
- Device and predicate device have the same intended use.
- The technological characteristic differences from predicate device do not affect the safety and effectiveness, no new risk is raised.
- Demonstrated by the bench tests, the display characteristics of 8MP Color LCD Displays are equivalent to the predicate device.
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:
- Aperio GT 450 DX with Aperio WebViewer DX, cleared under K232202
§ 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.