(90 days)
CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
30 inch Color LCD Monitor 3280 x 2080 (landscape)
High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display.
Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable.
Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor.
Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
The provided text describes a 510(k) premarket notification for a medical LCD monitor (JVCKENWOOD 6MP Color LCD Monitor CL-S600). Since this is a submission for a display device, the acceptance criteria and study information provided are related to the technical performance of the monitor itself, rather than the performance of an AI algorithm or diagnostic accuracy.
Therefore, the response below will focus on the device's technical specifications and the tests conducted to demonstrate compliance and substantial equivalence to a predicate device, as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance test items in the guidance (which can be inferred as acceptance criteria for this type of device) and the methods used to verify compliance. The actual numerical performance results are not explicitly stated in this high-level summary but are implied to have met the relevant standards.
| Acceptance Criteria (Performance Test Item in Guidance) | Test Method(s) | Compliance / Reported Performance (Implied) |
|---|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital camera equipped with a macro lens. The MTF is calculated with the captured data. | Met (implied by conclusion) |
| b. Pixel defects (maximum counts, allowed defect types, and locations) | ISO 13406-2; IDMS 1.03, 7.6 DEFECTIVE PIXELS; Pixel defects are counted based on the ISO13406-2, 3.4.13 table 3. | Met (implied by conclusion) |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous Tests; IDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES. | Met (implied by conclusion) |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIME; Rise and fall time constants at four grayscale intervals (0-100%, 5-95%, 10-90%, 40-60%) are provided by the panel manufacturer. | Met (implied by conclusion) |
| e. Luminance (maximum, minimum, achievable, and recommended) | $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed. | Met (implied by conclusion) |
| f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance Response; Luminance response for 256 levels are measured. | Met (implied by conclusion) |
| m. Color tracking (primary colors and color gamut) | Color scale: IDMS 1.03, 6. Gray- and Color-Scale Measurement; IDMS 1.03, 5.4 Color-Signal White; Color gamut volume: IDMS 1.03, 5.31 Volume-Color-Reproduction Capability. | Met (implied by conclusion) |
| n. Gray tracking (gray shades and white point) | AAPM-TG196 Gray Tracking; IEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscale chromaticity evaluation. | Met (implied by conclusion) |
Note: Items g, h, i, j, k, l are marked "N/A" as they are "For mammography displays," and the device is explicitly stated as "not meant to be used in digital mammography." The compliance is "implied" because the document concludes that "The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device."
2. Sample Size Used for the Test Set and the Data Provenance
The document describes physical laboratory tests on the device itself. Thus, the "sample size" is the single device (JVCKENWOOD 6MP Color LCD Monitor CL-S600) undergoing testing. There isn't a "test set" of patient data in the context of an AI algorithm evaluation. The provenance of the data is the physical testing conducted by the manufacturer, JVCKENWOOD Corporation, in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable for a medical display device's technical performance testing. Ground truth for display performance is established by objective physical measurements against established industry standards (e.g., ISO, AAPM-TG18, IDMS, IEC).
4. Adjudication Method for the Test Set
Not applicable for technical performance testing of a physical device. Objective measurements are used.
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
Not applicable. This device is a medical display monitor, not an AI algorithm for diagnostic interpretation. Therefore, no MRMC study or AI assistance evaluation was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical display monitor, not an AI algorithm. Its performance is inherent in its hardware and firmware capabilities to accurately display images.
7. The Type of Ground Truth Used
The "ground truth" for the device's technical performance is defined by established international and industry standards for medical displays, such as:
- ISO 13406-2 for pixel defects
- AAPM-TG18 for luminance response and artifacts
- IDMS 1.03 (Information Display Measurements Standard) for various display characteristics
- AAPM-TG196 for gray tracking
- IEC 62563-1 for greyscale chromaticity evaluation
- DICOM GSDF (Grayscale Standard Display Function) for luminance characteristics.
These standards provide objective, quantifiable benchmarks for display performance.
8. The Sample Size for the Training Set
No "training set" is applicable for this device. This is a display monitor, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
No "training set" or corresponding ground truth establishment is applicable for this device.
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Image /page/0/Picture/0 description: The image contains 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 features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
JVCKENWOOD Corporation % Hideki Tengeiji Senior Manager 3-12, Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa 221-0022 JAPAN
December 16, 2021
Re: K212985
Trade/Device Name: 6MP Color LCD Monitor CL-S600 Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: September 27, 2021 Received: September 30, 2021
Dear Hideki Tengeiji:
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. 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 located at https://www.accessdata.fda.gov/scripts/cdrh/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.
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K212985
Device Name 6MP Color LCD Monitor CL-S600
Indications for Use (Describe)
CL-S600 is intended to be used in displaying and viewing medical images for trained medical practitioners or certified personnel. It is not meant to be used in digital mammography.
| 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
Submitted Information: JVCKENWOOD Corporation 3-12, Moriya-cho, Kanagawa-ku, Yokohama-shi, Kanagawa, 221-0022 Japan Contact Person: Hideki Tengeiji, Senior Manager Email: tengeiji.hideki@jvckenwood.com Tel: +81-45-450-2715 Fax: +81-45-450-1926 Date Prepared: September 14, 2021 6MP Color LCD Monitor CL-S600 Device Name: Common Name: display, diagnostic radiology Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Medical Image Management and Processing System 30 inch (76.8cm) Color LCD Monitor CCL650i2 Predicate Device: (CL30650/ K140214) Device Description: 30 inch Color LCD Monitor 3280 x 2080 (landscape) ■ High-luminance color LCD panel, which has wide view angle, is used for this product. It is designed for medical image display. ■ Luminance stabilization function composed with luminance sensor and luminance control circuit always observes the luminance and makes it stable. ■ Images are faithfully displayed along grayscale characteristics (DICOM GSDF) based on the calibrated data stored to the lookup table of the monitor. ■ Luminance and the color mura correction functions will help achieve uniformity on the whole screen.
JVCKENWOOD Corporation
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JVCKENWOOD
| Cybersecurity: | FDA guidance located athttps://www.fda.gov/media/86174/download, is followed forcybersecurity concerns. |
|---|---|
| Intended Use: | CL-S600 is intended to be used in displaying and viewing medicalimages for diagnosis by trained medical practitioners or certifiedpersonnel. It is not meant to be used in digital mammography. |
| Substantial Equivalence: | CL-S600 shares the same technical characteristics, application,and intended use as our predicate device CCL650i2(CL30650/ K140214) |
JVCKENWOOD Corporation
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Device Description & Substantial Equivalence Comparison
| Predicate deviceLCD Monitor CL30650 | Proposed deviceLCD Monitor CL-S600 | Explanation ofDifferences | |
|---|---|---|---|
| 510(k) Number | K140214 | - | - |
| Indication for use | CL30650 is intended to be used indisplaying and viewing medical images fordiagnosis by trained Medical practitioners.It is not meant to be used in digitalmammography. | CL-S600 is intended to be used indisplaying and viewing medical images fordiagnosis by trained medical practitionersor certified personnel. It is not meant to beused in digital mammography. | - |
| Display Technology | IPS LCD panel with TFT active-matrixarray with LED backlight | IPS LCD panel with TFT active-matrixarray with LED backlight | - |
| Screen size | Diagonal: 30"Aspect ratio: 16:9.99 | Diagonal: 30"Aspect ratio: 16:10.15 | The display area of the proposed device iswider than the predicate device.Compared to the predicate device, theproposed device has a larger display area. |
| Backlight type | LED | LED | - |
| Frame rate and refreshrate | 60Hz | 60Hz | - |
| Resolution / Pixel array | 6MP (3280 x 2048) | 6MP (3280 × 2080) | The resolution of the proposed device islarger than that of the predicate device. |
| Pixel Pitch | Horizontal: 0.197mmVertical: 0.197mm | Horizontal: 0.197mmVertical: 0.197mm | - |
| Subpixel pattern | Stripe RGB | Stripe RGB | - |
| Pixel aperture ratio | 43.0% | 46.5 % | Almost the same. |
| Subpixel driving (spatialand temporal dithering) | N/A | N/A | - |
| Display Interface | Input:DVI-D x2DisplayPort x2Output:N/A | Input:DisplayPort x2Output:DisplayPort x1 | The proposed device is not equipped witha DVI-D input, but this is not a problemsince graphics cards are no longerequipped with a DIV-D output. |
| Video bandwidth | Dot clock: 443.52 MHz | Dot clock: 443.52 MHz | - |
| Predicate deviceLCD Monitor CL30650 | Proposed deviceLCD Monitor CL-S600 | Explanation ofDifferences | |
| User controls | Input signal switchEDID switchDynamic gammaAUTO TEXTTest patternConfiguration switch,INPUT SOURCE AUTO SCANNING | Input signal switchDynamic gammaAUTO TEXTTest patternConfiguration switchPixel EnhancerTurbo LuminanceDynamic Range ExtensionAuto Config SelectHuman Presence SensorReading LightUSB Power | The functions in the predicate device arealso available in the proposed device.Regarding "EDID switch", the proposeddevice can automatically switch EDID. |
| Ambient light sensing | Built-in Sensor (For correction duringcalibration) | Built-in Sensor (For correction duringcalibration) | - |
| Touch-screentechnology | N/A | N/A | - |
| Luminance calibrationtools / Quality-controlprocedures | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor / Medivisor NXFCAL | Hardware:Integrated sensorExternal sensorSoftware:QA Medivisor AgentFCAL | - |
| AdditionalSoftware/Firmware | N/A | N/A | - |
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Physical Laboratory Tests
| Performance test items in the guidance | Test method(s) |
|---|---|
| a. Spatial resolution | The bar pattern is displayed and captured by a digital cameraequipped with a macro lens. The MTF is calculated with thecaptured data. |
| b. Pixel defects (maximum counts, alloweddefect types, and locations) | ISO 13406-2IDMS 1.03, 7.6 DEFECTIVE PIXELSPixel defects are counted based on the ISO13406-2, 3.4.13table 3. |
| c. Artifacts | AAPM-TG18, 4.9 Miscellaneous TestsIDMS 1.03, 4.6 ARTIFACTS & IRREGULARITIES |
| d. Temporal response | IDMS 1.03, 10.2.3 GRAY-TO-GRAY RESPONSE TIMERise and fall time constants at four grayscale intervals (0-100%,5-95%, 10-90%, 40-60%) are provided by the panelmanufacturer. |
| e. Luminance(maximum, minimum, achievable, andrecommended) | $L_{min}$ and $L_{max}$ on the calibrated luminance are confirmed. |
| f. Conformance to a grayscale-to-luminance function (e.g., DICOM GSDF) | AAPM-TG18, 4.3.5 Advanced Luminance ResponseLuminance response for 256 levels are measured. |
| (For mammography displays)g. Luminance at 30° and 45° in diagonal,horizontal, and vertical directions at centerand four corners | N/A |
| (For mammography displays)h. Luminance uniformity or Mura test | N/A |
| (For mammography displays)i. Stability of luminance and chromaticityresponse with temperature and time ofoperation or on-time | N/A |
| (For mammography displays)j. Spatial noise | N/A |
| (For mammography displays)k. Reflection coefficient | N/A |
| (For mammography displays)l. Veiling glare or small-spot contrast | N/A |
| (For color displays)m. Color tracking (primary colors and colorgamut) | Color scale:IDMS 1.03, 6. Gray- and Color-Scale MeasurementIDMS 1.03, 5.4 Color-Signal WhiteColor gamut volume:IDMS 1.03, 5.31 Volume-Color-Reproduction Capability |
| (For color displays)n. Gray tracking (gray shades and whitepoint) | AAPM-TG196 Gray TrackingIEC 62563-1: 2009 + AMD1: 2016 CSV, 7.4.9 Greyscalechromaticity evaluation |
Conclusion
As shown above, the intended use of the subject and predicate devices are identical, the technical characteristics are similar, and any differences between the characteristics do not affect the device safety or effectiveness. The results of the performance testing and the verification demonstrate that the subject device is substantially equivalent to the currently marketed predicate device.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).