(441 days)
20.1-inch (51cm) Color LCD Monitor CCL208 (CDL2013A) is intended 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.
CCL208 (CDL2013A) is a 20.1-inch (51 cm) Color LCD monitor whose display resolution is 1200 x 1600 (landscape), 1600 x 1200 (portrait) supporting DVI (digital visual interface).
This document is a 510(k) summary for the TOTOKU 20.1-inch (51 cm) Color LCD Monitor CCL208 (CDL2013A), a medical display device. The primary purpose of the submission is to demonstrate substantial equivalence to a predicate device.
The document does not describe any study that proves the device meets specific acceptance criteria in terms of performance for image interpretation or diagnostic accuracy. This is because the device is a monitor, and its "performance" is primarily related to display characteristics and technical specifications rather than diagnostic performance.
Therefore, many of the requested elements for a study proving device performance are not applicable to this submission. I will provide the information that is available in the document.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of diagnostic performance that would typically be described with metrics like sensitivity, specificity, accuracy, etc. Instead, the substantial equivalence argument relies on meeting technical specifications comparable to the predicate device.
The "performance" of this device is implicitly its ability to display medical images. The acceptance criteria would be that it functions as a display comparable to its predicate. The document states:
"CCL208 (CDL2013A) shares the same characteristics with our predicate devices, CCL202 (CDL2005A) (K063198) except for power supply, LCD panel, main board (driver board and sub board), tilt-stand, I/O position and inverter PWB for LCD backlight."
This implies that despite these component changes, the performance (i.e., its function as a display) is considered equivalent. The common elements like intended use for "displaying and viewing medical images for diagnosis" are the basis for equivalence.
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 is not a study assessing diagnostic performance on a dataset of medical images. The "test set" would refer to the monitor itself undergoing technical evaluation.
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, as this is not a diagnostic performance study where ground truth needs to be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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 monitor, not an AI or a diagnostic aid that would participate in an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (monitor), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The ground truth for a monitor would be its technical specifications meeting design requirements, not a diagnostic ground truth.
8. The sample size for the training set
Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
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TOTOKU
510(k) SUMMARY
NOV 1 9 2010
| 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: | Augsut 25, 2009 |
| Device Name: | 20.1-inch (51 cm) Color LCD Monitor CCL208 (CDL2013A) |
| Common Name: | CCL208 (CDL2013A) |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.1-inch 2-Megapixel Color LCD Display CCL202 (CDL2005A)(K021738) |
| Device Description: | CCL208 (CDL2013A) is a 20.1-inch (51 cm) Color LCD monitorwhose display resolution is 1200 x 1600 (landscape), 1600 x 1200(portrait) supporting DVI (digital visual interface). |
| Indended Use: | 20.1-inch (51 cm) Color LCD Monitor, CCL208 (CDL2013A) 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: | CCL208 (CDL2013A) shares the same characteristics with ourpredicate devices, CCL202 (CDL2005A) (K063198) except forpower supply, LCD panel, main board (driver board and subboard), tilt-stand, I/O position and inverter PWB for LCD backlight. |
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MDL2127A Premarket Notification
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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. 300 Oya, Ueda, Nagano 386-0192 JAPAN ·
NOV 1 9 2010
Re: K092728
Trade/Device Name: 20.1-inch (51 cm) Color LCD Monitor CC208 (CDL2013A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 4, 2010 Received: November 5, 2010
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
signature
David G. Brown. Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE
510(k) Number: K092728
NOV 1 9 2010
Device Name: 20.1-inch (51 cm) Color LCD Monitor CC208 (CDL2013A)
Indications for Use:
20.1-inch (51cm) Color LCD Monitor CCL208 (CDL2013A) is intended 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)
(Division Sign-Off)
Division of Radiological Devices
Division of Radiological De Office of In Vitro Diagnostic Device E
510K K092728
§ 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).