(68 days)
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality. The monitor can be used in portrait or landscape version, simply by turning the panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. The image brightness can be adjusted by means of a control wheel on the monitor. The LCD panel adopts Super Advanced-Super Fine TFT(SA-SFT) for the MD21GS-3MP-CB, BB and MD211GS3P-CB, BB. Additionally, a low reflection overooat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass. This process also provides for a truer representation of black and a higher contrast ratio. The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel. The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle. In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
The provided text is a 510(k) Summary for a monochrome LCD monitor (NEC MD21GS-3MP-CB, NEC MD21GS-3MP-BB, MITSUBISHI MD211GS3P-CB, MITSUBISHI MD211GS3P-BB). This document aims to demonstrate "substantial equivalence" to a predicate device (Barco Coronis 3MP Medical Flat Panel Display System, K013922), not to conduct a study proving the device meets specific acceptance criteria in the context of a clinical performance study.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this regulatory document. The document focuses on comparing technical specifications and intended use of the new device against a predicate device to establish that it is "substantially equivalent" for market approval.
Here's a breakdown of what can and cannot be provided based on the input:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from predicate) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Displaying and viewing digital images for review by trained medical practitioners. | Displaying and viewing of digital images for diagnosis by trained physicians. (Exclusion: Not for primary diagnostic in mammography) |
| Resolution | Not explicitly stated for predicate, but new device aims for equivalence. | Can select 20481536 (landscape) or 15362048 (portrait modes). |
| Viewing Angle | 170° (Barco Coronis 3MP) | 176° (by adoption of SA-SFT panel) |
| Grayscale Reproduction | Not explicitly stated for predicate in number, but new device aims for equivalence. | Supports up to 1024 grayscales from a palette of 3061. 10-bit gamma correction. |
| Power Supply | Built-in circuit of power supply or AC adapter (described for predicate). | AC voltage converts to DC voltage within the device. |
| Safety Standard | UL60950 (Barco Coronis 3MP) | UL60601 (severer safety standard) |
| Panel Type | TFT liquid crystal display panel structure | Super Advanced-Super Fine TFT (SA-SFT) |
| Reflection | Not explicitly stated | Low reflection overcoat applied, low and uniform reflection. |
| Contrast Ratio | Not explicitly stated | Higher contrast ratio |
| Adjustability | Tilt and swivel foot | Tilt and swivel foot, plus height adjustment function. |
Missing Information/Not Applicable:
The document does not describe a clinical study with specific performance metrics like sensitivity, specificity, accuracy, or reader performance improvement. The "acceptance criteria" here are a comparison of technical specifications and intended use to an existing legally marketed device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a technical comparison for substantial equivalence for a medical display device, not a clinical study involving a test dataset of images or patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth as typically understood in clinical studies (e.g., confirmed diagnoses) is not relevant for this type of regulatory submission concerning a display monitor.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This document does not describe a clinical study comparing human reader performance with and without AI assistance. The device is a display monitor.
6. Standalone Performance Study
Not applicable. This document describes a display monitor, not an algorithm. Standalone performance (algorithm-only) would not be directly relevant for this device. The closest concept would be the technical performance of the monitor itself (resolution, brightness, grayscale), which is discussed via comparison to the predicate.
7. Type of Ground Truth Used
Not applicable in the clinical sense. For this device, "ground truth" would relate to measurable physical properties of the display (e.g., luminance, contrast, uniformity) and its adherence to relevant standards. The document implies these are met by virtue of design and comparison to the predicate, and by mentioning adherence to standards (e.g., 10-bit gamma correction).
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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DEC 2 7 2005
·Section E -
510(k) Summary
E-1. 510(k) Application Date July 28, 2005
E-2. Manufacturer
Submitter Name : NEC Display Solutions, Ltd.
Address : 4-13-23 Shibaura, Minato-ku, Tokyo, 108-0023 Japan
E-3. Contact Person
Name : Shuichi Kino (Mr.)
Manager
Engineering Administration Section, Planning and Administration Department R&D and Product Supply Division
Address : 686-1, Nishioi, Oi-machi, Ashigarakami-gun, Kanagawa, 258-8533 Japan Tel : +81-465-85-2376
Fax : +81-465-85-2378
E-4. Device
Device Name : 21.3inch Monochrome LCD Monitor Model : NEC MD21GS-3MP-CB NEC MD21GS-3MP-BB MITSUBISHI MD211GS3P-CB
MITSUBISHI MD211GS3P-BB
These are identical each other, except for model designation..
E-5. Common Name
Monochrome LCD Monitor
E-6. Registration Number
Manufacturer: NEC Display Solutions, Ltd. Registration Number: 3003623028 Factory: NPG DISPLAY (DONG GUAN) CO., LTD. Registration Number: 3002808782
E1
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E-7. Factory
Name : NPG DISPLAY (DONG GUAN) Co., LTD. Address : Jin Xing Industrial Zone, Qing Xi Zhen, Dong Guan, Guang Dong Sheng 511746, P.R. China
E-8. Classification
Device Class : Class II
Classification Name : System, image processing, Radiological Regulation Number : 21 CFR Part 892 Radiology Devices Subpart B Section 882,2050 Device Description : Picture Archiving and Communications System Product code : 90 LLZ
E-9. Reason for Submission
First time submission to market this LCD Monitor as Medical Device in the USA.
E-10. Description of Marketed Device
Device Name : Barco Coronis 3MP Medical Flat Panel Display System
510(k) number : K013922
Intended use :
The Barco Coronis 3MP Medical Flat Panel Display System is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
Device description :
The monitor combines a TFT(thin film transistor) liquid crystal display panel structure and a built-in backlight with inverter for a better picture quality.
The monitor can be used in portrait or landscape version, simply by turning the panel.
The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle.
The image brightness can be adjusted by means of a control wheel on the monitor.
The 21.3inch Monochrome LCD Monitor has the same intended use, technical characteristics and performance as the legally marketed device (K013922) and thus Substantial Equivalence is given.
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E-11. Substantial Equivalence Comparison
Device Description :
The LCD panel adopts Super Advanced-Super Fine TFT(SA-SFT) for the MD21GS-3MP-CB, BB and MD211GS3P-CB, BB.
Additionally, a low reflection overooat is applied on top of the bead layer, which yields a low, uniform reflection over the surface of the glass.
This process also provides for a truer representation of black and a higher contrast ratio.
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB can select the use of the landscape or the portrait only by rotating the LCD panel.
The tilt and swivel foot allows ideal positioning of the panel, in height and viewing angle.
In addition, because our device has the height adjustment function of the stand, a more ideal positioning can be offered.
Please refer to "Table E-11".
Intended Use :
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB are intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
These gray scale display must not be used for primary diagnostic in mammography.
Barco Coronis 3MP is intended to be used in displaying and viewing digital images for review by trained medical practitioners.
It is intended to be used to support the diagnosis to either device.
Technical Characteristics and performance :
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB can select the use of 20481536 of the landscape modes or the portrait modes of 15362048 only by rotating the panel equally to the legally marketed device.
Barco Coronis 3MP has the viewing angle of 170°,
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB greatly decreases the shift of the Gamma characteristic by the view corner by the wide viewing angle of 176° by the adoption of the latest SA-SFT panel.
The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB provides support for improved diagnostic accuracy with simultaneous reproduction of up to 1024 from a palette of 3061 possible grayscales.
The 10-bit gamma correction ensures precise and smooth grayscale tuning and better representation of just noticeable difference.
Up to 1024 grayscales can be depicted at the same time for film-less diagnosis.
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The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB are different in the following points compared with the legally marketed device.
Barco Coronis 3MP in difference of built-in circuit of power supply instead of AC adapter.
In Barco Coronis 3MP, the AC voltage converts into the DC voltage with the AC adaptor and is supplied to the device.
In The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB, the AC voltage converts into the DC voltage in the device.
Therefore, the monitor is operated by the dc voltage, and is substantial equivalent to the legally marketed device.
The Barco Coronis 3MP has the insulation structure which meets the standard of UL60950.
However, The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB has the insulation structure which meets the standard of UL60601.
The MD21GS-3MP-CB, BB and MD211GS3P-OB, BB are applied a severer safety standard compared with the legally marketed device.
Therefore, our monitor safety is more excellent than the legally marketed device.
Therefore, The MD21GS-3MP-CB, BB and MD211GS3P-CB, BB are device with higher safety compared with the legally marketed device.
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Image /page/4/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 7 2005
NEC-Mitsubishi Electric Visual Systems Corp. c/o Tamas Borsai TÜV Rheinland of North America 12 Commerce RD. NEWTON, CT 06470
Re: K052942 Trade/Device Name: 21.3inch Monochrome LCD Monitor (Models: NEC MD21GS-3MP-CB, NEC MD21GS-3MP-BB, MITSUBISHI MD211GS-3MP-CB, and MITSUBISHI MD211GS-3MP-BB) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 13, 2005 Received: December 15, 2005
Dear Mr. Borsai:
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 the cholosate) to regally mantowa of the Medical Device Amendments, or to devices that have been reay 20, 1770, the chavanentitit 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 do not require approval or a provisions of the Act. The general controls provisions of the Act devices to and got to 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 if your device is olasonia (500 such additional controls. Existing major regulations affecting your Apple rary, it ifaly economic 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 I Toase or advise 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 r oderal hatenents, 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 clectronic 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)
. I early This letter will allow you to ocgin manceme your and a couvalence of your device to a legally market notification. The PDA thing of sabstantial of 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), pleased If you desire specific advice for your device on our laboring 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 Also, please note the regulation entition on your responsibilities under the Act from the 807.97). You may obtain other general informational and Consumer Assistance at its toll-free number (800) DIVISIOn of City 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
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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-Section D - Indications for use
D-1. Indications for use
...
INDICATIONS FOR USE
510(K)Number : Not Known
Device Name : 21.3inch Monochrome LCD Monitor
Model : NEC MD21GS-3MP-CB
NEC MD21GS-3MP-BB
MITSUBISHI MD211GS3P-CB
MITSUBISHI MD211GS3P-BB
Indications for Use :
The 21.3inch Monochrome LCD Monitor is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
The 21.3inch Monochrome LCD Monitor must not be used for primary diagnostic in mammography.
Prescription Use ___ AND/OR
(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)
Concurrence of CDRH, Office of Device Evaluation(ODE)
David A. Lyon
(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).