(51 days)
21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.
This document describes the 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A). This submission establishes substantial equivalence to a predicate device and does not detail a study proving the device meets specific acceptance criteria in the sense of a clinical performance study with defined metrics like sensitivity, specificity, or reader agreement.
The device is a medical image display monitor. For such devices, acceptance criteria typically relate to technical performance specifications (e.g., luminance, contrast, resolution, uniformity, color accuracy) rather than diagnostic performance in a clinical study. The provided text does not include a table of acceptance criteria or a study proving the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on shared characteristics.
Therefore, many of the requested details, such as sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training/test sets, are not applicable or not provided in this regulatory submission for a display monitor.
Here's a response based on the information provided in the input:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary does not include a table of specific quantitative acceptance criteria (e.g., specific luminance levels, contrast ratios, or color accuracy metrics) or a study reporting the device's performance against such criteria. The submission primarily relies on demonstrating substantial equivalence to a predicate device.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study with a test set of data/images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This 510(k) summary for a medical monitor does not describe a clinical performance study requiring adjudication.
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 510(k) summary is for a medical display monitor, not an AI-powered diagnostic algorithm. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance was not conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a display monitor, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. This 510(k) submission for a display monitor does not involve a clinical study requiring ground truth for diagnostic accuracy.
8. The sample size for the training set
Not applicable. This device is a display monitor and does not involve machine learning or a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a display monitor and does not involve machine learning or a training set with ground truth.
Summary of Device and Evidence Presented in 510(k):
The 510(k) submission for the 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) establishes substantial equivalence to its predicate device, the 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065).
The basis for acceptance (regulatory clearance) is the demonstration of substantial equivalence. The argument for substantial equivalence is that the new device shares the "same characteristics" as the predicate device, with differences only in power supply, front bezel, frame, fan, PCB, and LCD screen. These differences are presumably not considered to affect the fundamental performance parameters relevant to its intended use for displaying and viewing medical images for diagnosis.
No specific quantitative acceptance criteria or detailed performance study results are provided in the excerpt. The regulatory submission relies on the established equivalence to a previously cleared device that meets the general controls and requirements for medical image display.
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K08/056
JUN - 4 2008
510(k) SUMMARY
- Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Oya, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548
Date Prepared: March 17, 2008
- Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A)
- Common Name: CCL354i2, CDL2126A
- Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Predicate Device: 3M Color LCD Monitor CDL2119A (CCL352i2) (K072065)
Device Description: CCL354i2 (CDL2126A) is a 21.3-inch (54cm) 3 meqapixcel Color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.
- Indended Use: 21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is intended 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.
- CCL354i2 (CDL2126A) shares the same characteristics with our Substantial Equivalence: predicate device CCL352i2 (CDL2119A) (K072065) except for power supply, front bezel, frame, fan, PCB and LCD screen.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 4 2008
Mr. Mikio Hasegawa General Manager TOTOKU ELECTRIC CO., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K081056
Trade/Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 2, 2008 Received: April 14, 2008
Dear Mr. Hasegawa:
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 (PMA), 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54 cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) Indications for Use:
21.3-inch (54cm) 3M Color LCD Monitor CCL354i2 (CDL2126A) is to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in 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)
Amst. M. Why
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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).