(18 days)
20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) 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.
CDL2119A (CCL352i2) is a 20.8-inch (53cm) 3 megapixel color LCD monitor that supports DVI video signal and provides UXGA (1536 x 2048) resolution for both landscape and portrait display.
The provided text describes a 510(k) summary for a medical display monitor, not a device that uses AI or processes medical images for diagnostic purposes. Therefore, most of the requested information regarding acceptance criteria and study design (especially related to AI, ground truth, expert adjudication, and sample sizes for training/test sets) is not applicable to this submission.
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, which is typical for hardware components like monitors. The primary "performance" in this context relates to technical specifications ensuring suitable image display for medical diagnosis, rather than the accuracy of a diagnostic algorithm.
However, I can extract the relevant information that is available:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the format of a clinical trial or performance study for an AI-powered device. For a medical display monitor, "performance" is generally assessed against technical specifications to ensure it meets the requirements for displaying medical images.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary) |
|---|---|
| Image Display Resolution | UXGA (1536 x 2048) resolution for both landscape and portrait display |
| Screen Size | 20.8-inch (53cm) |
| Type | 3 megapixel color LCD monitor |
| Signal Support | Supports DVI video signal |
| Intended Use | Displaying and viewing medical images for diagnosis by trained medical practitioners (excluding digital mammography) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a medical monitor, not a device that processes or analyzes data. No "test set" of medical images was used in the context of an algorithm's performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method for the test set
- Not Applicable. See point 2.
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 display monitor, not an AI-assisted diagnostic tool.
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 an algorithm.
7. The type of ground truth used
- Not Applicable. See point 2.
8. The sample size for the training set
- Not Applicable. See point 2.
9. How the ground truth for the training set was established
- Not Applicable. See point 2.
Summary of Device and Evidence:
The submission K072065 is for a 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2). Its intended use is for "displaying and viewing medical images for diagnosis by trained medical practitioners," explicitly excluding digital mammography.
The "study" or evidence provided for this type of device is primarily a comparison to a predicate device to establish substantial equivalence. The predicate device is identified as the "3M Color LCD Monitor CCL350i (CDL2112A) (DV3MC-HB) (K050619)."
The basis for substantial equivalence is that the new device "shares the same characteristics with our predicate device CCL350i (CDL2112A) (DV3MC-HB) (K050619) except for a LCD panel, power supply and (additional) fan." This implies that the manufacturer would have provided technical specifications and potentially conducted engineering tests to demonstrate that these new components do not alter the fundamental safety and effectiveness of displaying medical images compared to the predicate. The resolution (UXGA 1536x2048) and other display characteristics are key "performance" metrics for such a device, ensuring it can adequately present diagnostic images. No clinical performance study with human readers or AI algorithms is mentioned or expected for a medical display monitor in this context.
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K072065
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan | AUG 14 2007 |
|---|---|---|
| Contact Person: | Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548 | |
| Date Prepared: | July 24, 2007 | |
| Device Name: | 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2) | |
| Common Name: | CDL2119A, CCL352i2 | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | 3M Color LCD Monitor CCL350i (CDL2112A) (DV3MC-HB)(K050619) | |
| Device Description: | CDL2119A (CCL352i2) is a 20.8-inch (53cm) 3 megapixel colorLCD monitor that supports DVI video signal and provides UXGA(1536 x 2048) resolution for both landscape and portrait display. | |
| Indended Use: | 20.8-inch (53cm) 3M Color LCD Monitor CDL2119A (CCL352i2) 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: | CDL2119A (CCL352i2) shares the same characteristics with ourpredicate device CCL350i (CDL2112A) (DV3MC-HB) (K050619)except for a LCD panel, power supply and (additional) fan. |
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Image /page/1/Picture/0 description: The image shows a circular seal with the words "U.S. Department of Health & Human Services" written around the edge. In the center of the seal is a stylized image of an eagle with three lines extending from its wing. The seal is black and white and appears to be a scan of a printed document.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. Intelligent Devices and Solutions Division 300 Oya, Ueda, Nagano 386-0192 JAPAN
Re: K072065
Trade/Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2007 Received: July 27, 2007
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 (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.
Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. Below this text is a large "FDA" abbreviation. The word "Centennial" is written below the abbreviation. There are three stars below the word "Centennial".
Protecting and Promoting Public Health
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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 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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy Chogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Healt
Enclosure
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K072065 INDICATIONS FOR USE
510(k) Number: Not Known
Device Name: 20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) Indications for Use:
20.8-inch (53cm) Color LCD Monitor CDL2119A (CCL352i2) 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)
Thhang
Division of Reproductive. Abdominal a 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).