(41 days)
20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) (DV3MM-HB) 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.
MDL2110A (ME351i) (DV3MM-HB) is a 20.8-inch Monochrome LCD monitor that supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
This 510(k) summary describes a monochrome LCD monitor, not an AI/ML device or a medical image analysis algorithm. Therefore, the detailed information requested regarding acceptance criteria, study design, ground truth, and human-in-the-loop performance is not applicable to this document.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (ME315L (K030274)) for regulatory clearance. The "device performance" in this context refers to the technical specifications of the monitor rather than diagnostic accuracy or effectiveness in analyzing medical images.
Here's an attempt to answer the relevant parts, noting the limitations:
1. Table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in the way one would for an AI/ML device's diagnostic performance (e.g., sensitivity, specificity thresholds). Instead, it implies acceptance based on similarity to the predicate device's technical specifications.
| Acceptance Criteria (Implied) | Reported Device Performance (MDL2110A) |
|---|---|
| Resolution | QXGA (2048 x 1536) |
| Display Type | Monochrome LCD |
| Screen Size | 20.8-inch (53cm) |
| Video Signal Support | DVI |
| Intended Use Consistency with Predicate | "used in conjunction with the picture archiving communication system (PACS) for medical imaging applications" (excluding digital mammography) |
| Characteristics "almost the same" as predicate (ME315L, K030274) | "almost the same characteristics as TOTOKU's predicate device ME315L (K030274) except for the molds, the AC adaptor, which has higher capacity and longer lifetime, and the front sensor, which has been newly placed." |
2. Sample size used for the test set and the data provenance:
Not applicable. This is a monitor, not a diagnostic algorithm evaluated on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.
7. The type of ground truth used:
Not applicable.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
Summary of the Study (Implied from the 510(k) Summary):
The "study" or justification for clearance for this device centers on demonstrating substantial equivalence to an already legally marketed predicate device (TOTOKU ME315L, K030274).
- Study Type: Substantial Equivalence Comparison.
- Methodology: The manufacturer compared the technical specifications and intended use of the MDL2110A monitor to the predicate device ME315L.
- Key Finding: The MDL2110A has "almost the same characteristics" as the predicate, with minor changes (molds, AC adaptor, front sensor) that are not presented as impacting the fundamental safety or effectiveness for its intended use in medical imaging applications (excluding digital mammography).
- Acceptance: The FDA's letter (K050485) confirms that, based on this comparison, the device is substantially equivalent for the stated indications for use.
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APR 7 2002
510(k) SUMMARY
Submitter Information: TOTOKU ELECTRIC CO., LTD. 300 Ova, Ueda Nagano 386-0192 Japan
Contact Person: Mikio Hasegawa, General Manager Email: hasegawam@totoku.co.jp +81.268.34.5484 Tel: +81.268.34.5565 Fax:
Date Prepared: February 21, 2005
20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (351i) (DV3MM-HB) Device Name:
MDL2110A, ME351i, DV3MM-HB, 3M Monitor/Display Common Name:
Class II Classification Name: (Part892 Radiology Devices Sec. 892.2050 Picture Archiving and Communication System)
Predicate Device: ME315L (K030274)
MDL2110A (ME351i) (DV3MM-HB) is a 20.8-inch Monochrome LCD monitor Device Description: that supports DVI video signal and provides QXGA (2048 x 1536) resolution for both landscape and portrait display.
- 20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) Intended Use: (DV3MM-HB) 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.
- MDL2110A (ME351i) (DV3MM-HB) has almost the same characteristics as Substantial Equivalence: TOTOKU's predicate device ME315L (K030274) except for the molds, the AC adaptor, which has higher capacity and longer lifetime, and the front sensor, which has been newly placed.
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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the top of the logo.
APR 7 2005 Food and Drug Administration 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: K050485 Trade/Device Name: 20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) (DV3MM-HB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 21, 2005 Received: February 25, 2005
Dear Mr. Hasegawa:
We have reviewed your Section 510(k) premarket notification of intent to market the device in We have reviewed your Section 510(R) premainting equivalent (for the indications for use stated in
above and have determined the device is substantially equivalence program p above and have determined the do rice is a claimes marketed in interstate commerce prior to the enclosure) to regally manelece predicato device Amendments, or to devices that have been May 28, 1978, the ellacinem use of the Federal Food, Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of the reson (PMA). You may, therefore, market the councisions of the councisions of the councisions of the consisions of the c do not require approval of a premiatics approval approval controls provisions of the Act. device, subject to the general controls provinsition 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 If your device is classified (see above) into entrols = Existing major regulations affecting your Approval), it may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 8 device can be found in the South of Concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA 's Issualled of a saccemination with other requirements of the Act of any FDA has made a delemination mar your do rise Federal agencies. You must comply with all the Federal statues and regulations administered of Cation of China (2) CFR Patt 807); labeling Act's requirements, including, but not minted to registerents as set forth in the quality systems (QS) (ZT CFR Part 801), good manufacturing practice 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)
10 a leadl This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales of your de premarket notification. The FDA miding of substantial equil 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
r problem in the fill of the fill and the counters, becad on the regulati If you desire specific advice for your device on our labeling regaration in a
contact the Office of Compliance at one of the following numbers, based on the regulation number 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 prematice notification" (21 CFR Also, please note the regulation entitical "finisorialian on your responsibilities under the Act from the 807.97). You may obtain other gelleral miormation on your respections and its toll-free number (800) Division of (301) 443-6597 or at its Internet address 056-2041 or (5.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 20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) Device Name: (DV3MM-HB). Indications for use:
20.8-inch (53cm) Monochrome LCD Monitor MDL2110A (ME351i) (DV3MM-HB) 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)
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. Broadon
(Division Sign-Off Division of Reproductive, 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).