(29 days)
21.3-inch (54cm) Monochrome LCD Monitor MDL2122A 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.
MDL2122A is a 21.3-inch Monochrome LCD Monitor that supports both digital & analog video signals, and provides UXGA (1600 x 1200) resolution for both landscape and portrait display.
Here's an analysis of the provided 510(k) summary regarding the TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A:
This 510(k) pertains to a medical display monitor, not an AI or diagnostic algorithm device. Therefore, many of the requested criteria such as sample size, expert ground truth, adjudication methods, multi-reader multi-case studies, and training set details are not applicable to this type of medical device submission. The substantial equivalence here is based on technical specifications and intended use compared to a predicate monitor.
1. Table of Acceptance Criteria and Reported Device Performance
For medical display monitors, acceptance criteria typically revolve around display characteristics meeting established standards for medical image viewing. The 510(k) summary implicitly relies on these standards being met to demonstrate substantial equivalence to the predicate device.
| Acceptance Criteria (Implied for medical displays) | Reported Device Performance (from 510(k) summary) |
|---|---|
| Display Type: Monochrome LCD | 21.3-inch Monochrome LCD Monitor |
| Resolution: UXGA (1600 x 1200) | Supports UXGA (1600 x 1200) resolution |
| Supported Video Signals: Digital & Analog | Supports both digital & analog video signals |
| Display Orientation: Landscape and/or Portrait | Supports both landscape and portrait display |
| Intended Use for medical image display (excluding mammography) | "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." |
| Substantial Equivalence to predicate device | "shares the same characteristics with our predicate device MDL2121A (K063198) except for the analog video signal." |
Note: The 510(k) summary does not provide specific performance metrics like luminance, contrast ratio, uniformity, or grayscale accuracy. Instead, it attests to the device's technical specifications matching those required for general medical image display and its substantial equivalence to a previously cleared device (MDL2121A, K063198).
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A). This 510(k) is for a medical display monitor. It does not involve a 'test set' of medical images or patient data in the way an AI diagnostic device would. Substantial equivalence is determined by comparing the technical specifications and intended use of the new device against a legally marketed predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable (N/A). As above, there is no 'test set' requiring expert ground truth for a medical display monitor.
4. Adjudication method for the test set
- Not Applicable (N/A). No test set involved.
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 (N/A). This is a hardware display monitor, not an AI or diagnostic algorithm. MRMC studies are not relevant for this device type.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A). This is a display monitor. It does not have a standalone algorithm performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable (N/A). Ground truth is not a concept applied to the evaluation of a medical display monitor in this context. The "truth" for such a device is whether its technical specifications (resolution, luminance, uniformity, etc.) meet the necessary standards for displaying medical images for diagnosis.
8. The sample size for the training set
- Not Applicable (N/A). There is no training set for a medical display monitor.
9. How the ground truth for the training set was established
- Not Applicable (N/A). No training set involved.
Summary of Device and Approval:
The TOTOKU 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A received 510(k) clearance based on its substantial equivalence to a predicate device (MDL2121A, K063198). The key characteristics for this determination were:
- Device Type: 21.3-inch Monochrome LCD Monitor
- Resolution: UXGA (1600 x 1200)
- Signal Support: Digital & Analog video signals
- Display Orientation: Landscape and Portrait
- Intended Use: Displaying and viewing medical images for diagnosis by trained medical practitioners, excluding digital mammography.
The basis for proving it meets acceptance criteria is primarily through demonstrating that its technical specifications and intended use are consistent with a previously cleared device of the same type, and presumably, adheres to relevant industry standards for medical displays (though these standards are not explicitly detailed in the summary). The only difference mentioned from the predicate is the analog video signal.
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TOTOKU
:
KOP370
510(k) SUMMARY
| Submitter Information: | TOTOKU ELECTRIC CO., LTD.300 Oya, UedaNagano 386-0192 Japan | MAR 09 2007 |
|---|---|---|
| Contact Person: | Mikio Hasegawa, General ManagerEmail: hasegawam@totoku.co.jpTel:+81.268.34.5469Fax:+81.268.34.5548 | |
| Date Prepared: | February 6, 2007 | |
| Device Name: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A | |
| Common Name: | MDL2122A, 2M Monitor/Display | |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) | |
| Predicate Device: | MDL2121A (K063198) | |
| Device Description: | MDL2122A is a 21.3-inch Monochrome LCD Monitor that supportsboth digital & analog video signals, and provides UXGA (1600 x1200) resolution for both landscape and portrait display. | |
| Intended Use: | 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A 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: | MDL2122A shares the same characteristics with our predicatedevice MDL2121A (K063198) except for the analog video signal. |
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Image /page/1/Picture/1 description: The image is a black and white circular logo. The logo contains the symbol of the Department of Health and Human Services (HHS), which is a stylized human figure embracing a sphere. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle. The logo is simple and recognizable, representing the HHS and its mission.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. Mikio Hasegawa General Manager TOTOKU Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano 386-0192 JAPAN
MAR 0 9 2007
Re: K070370
Trade/Device Name: 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 6, 2007 Received: February 8, 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 is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The seal has a dotted border.
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 Cbrogdon
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: 21.3-inch (54cm) Monochrome LCD Monitor MDL2122A Indications for Use:
21.3-inch (54cm) Monochrome LCD Monitor MDL2122A 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. Brogdon
(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).