(51 days)
21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) 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.
CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel Color LCD monitor that supports DVI video signal and provides UXGA (1200 x 1600) resolution for both landscape and portrait display.
This document describes the 510(k) summary for a medical display device, the 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A). The information provided is primarily focused on the device's technical specifications and its substantial equivalence to a predicate device, rather than a detailed clinical study demonstrating its performance in a diagnostic context.
Therefore, much of the requested information regarding clinical study methodology (sample size, expert qualifications, adjudication, MRMC studies, training set details) is not available in the provided text, as it doesn't describe such a study for this display monitor. The acceptance criteria and "reported device performance" are more about the display's technical capabilities validating its suitability for medical imaging rather than a direct measure of diagnostic accuracy.
Here's the information that can be extracted or reasonably inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance (From 510(k) Summary) |
|---|---|
| Display medical images for diagnosis by trained medical practitioners. | Intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. (Implied that the technical specifications support this) |
| Not to be used for digital mammography. | It is not meant to be used for digital mammography. (Explicit statement) |
| Technical specifications suitable for medical image display (e.g., resolution, color). | 2M Color LCD monitor that supports DVI video signal. Provides UXGA (1200 x 1600) resolution for both landscape and portrait display. |
| Substantial equivalence to a legally marketed predicate device. | Shares the same characteristics with predicate device CCL252i2 (CDL2120A) (K063199) except for power supply, front bezel, frame, fan, PCB and LCD screen. |
| Meets Class II regulatory requirements for Picture Archiving and Communication Systems (PACS) monitors. | Classified as Class II (Part 892 Radiology Devices, Sec. 892.2050 Picture Archiving and Communication System). |
2. Sample size used for the test set and the data provenance
- Not Applicable. This document does not describe a clinical test set or diagnostic study involving a sample of patient data. The "study" here refers to the technical validation of the display monitor itself against predetermined specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. There is no mention of experts establishing ground truth for a test set in the context of a diagnostic study for this device. The assessment revolves around the monitor's technical compliance and substantial equivalence to a predicate.
4. Adjudication method for the test set
- Not Applicable. No test set or adjudication method for diagnostic performance is described.
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. This is a passive display monitor, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is a display monitor, not an algorithm. Its performance is evaluated based on its display characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense of a diagnostic study. For this device, the "ground truth" would be the required technical specifications for medical display monitors and the performance characteristics of the predicate device (K063199). The device's performance is measured against these technical standards.
8. The sample size for the training set
- Not Applicable. As a display monitor, there is no AI algorithm being trained, and thus no training set.
9. How the ground truth for the training set was established
- Not Applicable. Refer to point 8.
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08/055
JUN - 4 2008
: : :
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: | March 17, 2008 | |
| Device Name: | 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) | |
| Common Name: | CCL254i2, CDL2125A | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 2M Color LCD Monitor CDL2120A (CCL252i2) (K063199) | |
| Device Description: | CCL254i2 (CDL2125A) is a 21.3-inch (54cm) 2 megapixel ColorLCD monitor that supports DVI video signal and provides UXGA(1200 x 1600) resolution for both landscape and portrait display. | |
| Intended Use: | 21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) isintended to be used in displaying and viewing medical images fordiagnosis by trained medical practitioners. It is not meant to beused for digital mammography. | |
| Substantial Equivalence: | CCL254i2 (CDL2125A) shares the same characteristics with our |
predicate device CCL252i2 (CDL2120A) (K063199) 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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
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: K081055
Trade/Device Name: 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) 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 Bragdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 21.3-inch (54 cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) Indications for Use:
21.3-inch (54cm) 2M Color LCD Monitor CCL254i2 (CDL2125A) 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)
Vorzu Th Whay
(Division S 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).