(51 days)
20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
CDL2009A has a multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200. This is also compliant with VESA standard display mode.
This document describes the 510(k) premarket notification for the TOTOKU 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204). It is important to note that this is a submission for a display device, not an Artificial Intelligence (AI) enabled device. Therefore, many of the requested categories related to AI performance, ground truth, and expert evaluation are not applicable.
Here's an analysis of the provided information:
1. A table of acceptance criteria and the reported device performance
For a medical display device, acceptance criteria typically revolve around image quality, luminance, uniformity, resolution, and adherence to display standards for diagnostic viewing. The provided document, being a 510(k) summary, does not detail specific acceptance criteria values or a direct side-by-side comparison with reported performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
However, based on the nature of the device (a color LCD monitor for medical image display), the following are implied or commonly expected performance aspects for such a device. The "Reported Device Performance" column indicates what the summary states about the device's capabilities, rather than specific measured values against a numerical criterion.
| Acceptance Criteria (Implied/Standard for Medical Displays) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Displaying medical images for diagnosis | "to be used in displaying and viewing medical images for diagnosis by trained medical practitioners." |
| Contrast and Resolution suitable for diagnostic viewing | "multi-displaying function corresponding to the resolution from VGA 640 x 480 to UXGA 1600 x 1200." |
| Compliance with industry display standards (e.g., DICOM Part 14 Grayscale Standard Display Function for grayscale; color calibration for color) | "compliant with VESA standard display mode." (While VESA is a standard, DICOM Part 14 is generally more critical for medical image display but not explicitly mentioned here.) |
| Luminance and Uniformity | Not explicitly stated in the provided summary, but implied by substantial equivalence to a predicate medical display. |
| Color Accuracy | Not explicitly stated, but critical for color displays for medical use. |
| Absence of artifacts or defects | Implied by the need to be suitable for diagnostic viewing. |
| Power consumption and safety (electrical, emissions) | Implied by regulatory submission and general device requirements. |
2. Sample size used for the test set and the data provenance
For a medical display device, there isn't typically a "test set" of images in the same way an AI algorithm is tested. Instead, performance testing involves:
- Physical measurements: Using calibration tools and specialized equipment to measure luminance, contrast, uniformity, resolution, color accuracy, and other display characteristics.
- Observer studies (human factors): In some cases, human observers (e.g., radiologists) might evaluate the display for ergonomic factors, clarity, and image quality, though this is less common for substantial equivalence submissions for monitors if the technical specifications are benchmarked.
The provided 510(k) summary does not specify a sample size for image quality evaluation (as it's not an AI model). The evaluation of the device features and performance would have been based on technical specifications, engineering tests, and possibly human factors evaluations against predefined technical standards and predicate device performance.
Data provenance: Not applicable in the context of image data for an AI model. The "data" here refers to the device's technical specifications and measurement results.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" for a display device is established by objective, measurable technical specifications and industry standards for display performance (e.g., luminance, contrast ratios, color gamut). It does not involve expert medical readers establishing ground truth on cases.
4. Adjudication method for the test set
Not applicable. There is no "test set" of medical cases requiring adjudication for a display device.
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 is a display device, not an AI-enabled system or a diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display device, not an algorithm.
7. The type of ground truth used
The "ground truth" for a medical display is its physical and optical performance characteristics measured against established industry standards (e.g., DICOM Part 14 for grayscale, various color calibration standards, VESA display modes) and the specifications of an identified predicate device. These are objective engineering measurements rather than subjective expert consensus or pathology results.
8. The sample size for the training set
Not applicable. This is a hardware device, not an AI model. There is no "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or "ground truth for a training set" for this device.
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K06106/
TOTOKU
JUN - 7 2006
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan |
|---|---|
| Contact Person: | Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548 |
| Date Prepared: | April 17, 2006 |
| Device Name: | 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) |
| Common Name: | CDL2009A, CCL204 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | CCL202 (Flat Panel Display, ME and CCL Series, K021738) |
| Device Description: | CDL2009A has a multi-displaying function corresponding to theresolution from VGA 640 x 480 to UXGA 1600 x 1200. This is alsocompliant with VESA standard display mode. |
| Indended Use: | 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) is to beused in displaying and viewing medical images for diagnosis bytrained medical practitioners. It is not meant to be used for digitalmammography. |
| Substantial Equivalence: | CDL2009A shares the same characteristics with our predicatedevice CCL202 (Flat Panel Display, ME and CCL Series, K021738)except for the panel, inverter, and main board. |
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CDL2009A Premarket Notification
:
・・・・・・
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 7 2006
Mikio Hasagawa General Manager TOTOKU ELECTRIC CO., INC. 300 Oya, Ueda Nagano 386-0192 JAPAN
Re: K061061
Trade/Device Name: 20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 17, 2006 Received: April 17, 2006
Dear Mr. Hasagawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.
Protecting and Promoting Public Health
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Page 2 -
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely vours.
Nancy C Hodgdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 20.1-inch (51cm) Color ECD Monitor CDL2009A (CCL204) Indications for Use:
20.1-inch (51cm) Color LCD Monitor CDL2009A (CCL204) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Beradon
and Rac 510(k) Numb
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§ 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).