(15 days)
ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.
ME511L (MDL2105A) is a 21.3-inch 5 megapixcel monochrome LCD display whose display resolution is 2560x2048 (QSXGA), supporting DVI (ditital visual interface).
The provided text is a 510(k) summary for the TOTOKU ELECTRIC CO., LTD. 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies against specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria and a detailed study proving the device meets them is not explicitly present in the provided document.
However, based on the context of a 510(k) for a medical display, we can infer some aspects and highlight where the information is missing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or a dedicated performance study against such criteria. The substantial equivalence argument implies that the device's performance is at least equivalent to the predicate.
| Acceptance Criteria (Inferred from equivalence to predicate) | Reported Device Performance (From 510(k) summary) |
|---|---|
| Maximum Resolution: Must be equivalent to predicate (Barco MGD 521M) for digital mammography. | Maximum Resolution: 2560x2048 (QSXGA) - "maximum resolution... are the same" as predicate. |
| Luminance: Must be equivalent to predicate (Barco MGD 521M) for digital mammography. | Luminance: "luminance are the same" as predicate. |
| Intended Use: Compatible with PACS for medical imaging applications, including digital mammography. | Intended Use: "intended for used with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography." |
| Display Technology: Suitable for professional medical display. | Display Technology: 21.3-inch 5 megapixcel monochrome LCD display. |
| Interface: Compatible with medical imaging systems. | Interface: Supports DVI (digital visual interface). |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the 510(k) summary. For a display device, a "test set" in the context of diagnostic accuracy studies (like those for AI algorithms) is not directly applicable. Performance testing for a display would typically involve objective measurements of display characteristics (resolution, luminance, contrast, uniformity, viewing angle, etc.) using calibration equipment and potentially visual assessments by trained personnel, rather than a "test set" of medical images with ground truth. The document only mentions that the device "employs a different display system" but that resolution and luminance are the same as the predicate.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided and is generally not relevant for the regulatory submission of a medical display like this. Ground truth establishment with experts is crucial for evaluating AI algorithms that interpret medical images, but not for a hardware display device whose primary function is to render images accurately.
4. Adjudication Method
This information is not provided and is not relevant for this type of device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or reported in this 510(k) summary. MRMC studies are typically done for AI-powered diagnostic tools to assess how their use impacts human reader performance (e.g., diagnostic accuracy, reading time). This submission is for a display monitor.
6. Standalone Performance Study
A standalone performance study focused on diagnostic accuracy was not performed or reported in this 510(k) summary. The "performance" for a display is typically evaluated through technical specifications and adherence to standards (e.g., DICOM Part 14 for grayscale display function), not diagnostic accuracy in a clinical context. The claim of "substantial equivalence" is the primary "performance" argument in this document.
7. Type of Ground Truth Used
This information is not provided and is not relevant for this type of device. (See points 3 & 4).
8. Sample Size for the Training Set
This information is not provided. As this is a display monitor and not an AI algorithm, there would be no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not relevant for this type of device. (See point 8).
Summary of Device Approval Context:
The 510(k) process for this device relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (Barco MGD 521M Digital Mammography Display - K0338559). The core argument is that even though it uses a different display system, its key performance characteristics relevant to its intended use (maximum resolution and luminance) are the same as the predicate. The FDA's approval indicates that they found this argument of substantial equivalence sufficient, meaning the new device is as safe and effective as the predicate without requiring a new, extensive clinical performance study.
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JUL 1 3 2004
510(k) SUMMARY K041737
- TOTOKU ELECTRIC CO., LTD. Submitter Information: 300 Oya, Ueda Naqano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp Tel: +81.268.34.5469 Fax: +81.268.34.5548
Date Prepared: June 22, 2004
- 5M Monochrome Digital Mammography LCD Monitor ME511L Device Name: (MDL2105A)
- Common Name: ME511L, MDL2105A
Classification Name: Class II (Part 892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
- Barco MGD 521M Digital Mammography Display (K033859) Predicate Device:
- ME511L (MDL2105A) is a 21.3-inch 5 megapixcel monochrome Device Description: LCD display whose display resolution is 2560x2048 (QSXGA), supporting DVI (ditital visual interface).
- Indended Use: ME511L (MDL2105A) is intended for used with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including digital mammography.
- Substantial Equivalence: ME511L employs a different display system from Barco's MGD521M (K033859), but maximum resolution and luminance are the same.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 3 2004
Mr. Mikio Hasegawa General Manager Totoku Electric Co., Ltd. MM Company, Design Group 300 Oya, Ueda, Nagano, 386-0192 JAPAN
Re: K041737
Trade/Device Name: 5M Monochrome Digital Mammography LCD Monitor ME511L (MD2105A) Regulation Number: 21 CFR 892.2050 -Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: June 23, 2004 Received: June 28, 2004
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 The The The The The The The The The The The The The The The The The The 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.
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 (OS) 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 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
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:
Device Name: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) Indications for Use:
ME511L (MDL2105A) is intended for use with the Picture Archiving Communication Systems (PACS) for medical imaging applications by physicians, including 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 Reproductive, Abdominal,
and Radiological Devices
510(k) Number K041737
§ 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).