(41 days)
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
21.3-inch Monochrome LCD monitor that supports DVI video signal and provides QXGA (1536 X 2048) resolution for both landscape and portrait display.
The provided text is a 510(k) summary for a medical display monitor (TOTOKU 21.3-inch Monochrome LCD Monitor MDL2115A). This type of device is a display for medical images, not an AI/ML algorithm or diagnostic software that performs analysis or makes decisions.
Therefore, the information requested in your prompt (acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) does not apply to this specific device.
The 510(k) summary for a display monitor focuses on demonstrating substantial equivalence to a predicate device, primarily through comparing technical specifications (e.g., resolution, display technology, intended use) and conformity to relevant standards (e.g., DICOM Part 14 for grayscale display function, IEC standards for safety). There's no clinical performance study involving diagnostic accuracy, sensitivity, or specificity as there would be for an AI-powered diagnostic tool.
The summary states:
- Intended Use: "21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography."
- Substantial Equivalence: "MDL2115A (ME353i) (DV3MM-HB) (ME353iM) has almost the same characteristics as TOTOKU's predicate device MDL2110A (K050485) except for a LCD panel, an inverter and chassis."
The "acceptance criteria" for such a device would typically relate to its technical performance matching or exceeding the predicate device and meeting relevant industry standards for medical displays. This would involve measurements of luminance, contrast, resolution, noise, and compliance with the DICOM Part 14 standard for grayscale display function, but not clinical performance metrics tied to patient outcomes or expert diagnoses.
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SEP 2 2 2005 KD52199
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: +81.268.34.5565
Date Prepared: August 11, 2005
- 21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) Device Name: (ME353iM)
- Common Name: MDL2115A, ME353i, DV3MM-HB, ME353iM, 3M Monitor/Display
Classification Name: Class II (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: MDL2110A (K050485)
- MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is a 21.3-inch Monochrome Device Description: LCD monitor that supports DVI video signal and provides QXGA (1536 X 2048) resolution for both landscape and portrait display.
- Intended Use: 21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication system (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
- MDL2115A (ME353i) (DV3MM-HB) (ME353iM) has almost the same Substantial Equivalence: characteristics as TOTOKU's predicate device MDL2110A (K050485) except for a LCD panel, an inverter and chassis.
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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 circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Public Health Service
SEP 2 2 2005
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano, 386-0192 JAPAN
Re: K052199
Trade/Device Name: 21.3-inch (54cm) Monochrome L( Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: LLZ Dated: August 11, 2005 Received: August 12, 2005
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.
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.
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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 I b(R) 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.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" (21 CFR 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 the monther (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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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TOTOKU
INDICATIONS FOR USE
510(k) Number: Not Known
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) Device Name: (DV3MM-HB) (ME353iM).
Indications for use:
21.3-inch (54cm) Monochrome LCD Monitor MDL2115A (ME353i) (DV3MM-HB) (ME353iM) is to be used in conjunction with the picture archiving communication systems (PACS) for medical imaging applications. It is not meant to be used for digital mammography.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C brradon
Abdominal, diological Devices
:
§ 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).