(13 days)
The MD242C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD242C2 cannot be used for a life-support system. This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Medical Display, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text describes a 510(k) premarket notification for a medical display monitor (MD242C2 24.1" Diagnostic Imaging LCD monitor). This document focuses on demonstrating substantial equivalence to a predicate device L217TG TFT Color LCD Monitor rather than conducting a clinical study to prove performance against specific acceptance criteria for a new medical algorithm or diagnostic tool.
Therefore, many of the requested sections about clinical study design, sample sizes, expert involvement, and ground truth establishment are not applicable. The device in question is a display monitor, not an AI-powered diagnostic device or an algorithm that interprets medical images.
Here's an attempt to answer the questions based only on the provided text, highlighting where information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical study assessing diagnostic performance. Instead, it compares the technical specifications and intended use of the new device (MD242C2) to a legally marketed predicate device (L217TG) to demonstrate substantial equivalence.
The "performance" is reported as its technical specifications, which are implicitly accepted if they are substantially equivalent to the predicate device.
| Items | Predicate Device (L217TG) Performance | Applicant Device (MD242C2) Performance | Implicit Acceptance Criteria (Substantial Equivalence) |
|---|---|---|---|
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 24.1" TFT Color LCD Monitor | Comparable size and type for diagnostic imaging. New device is larger, but still within acceptable medical monitor range. |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm | Identical |
| Display Color | 16,777,216 | 1,073,741,824 | Improved (more colors), therefore acceptable |
| Viewing Angles (°) (H,V) | H:176, V:176 | H:178, V:178 | Improved, therefore acceptable |
| Scanning Freq. (H,V) | 31.5-91.1kHz, 50-85 Hz | 31.5-93.8, 118.4kHz, 50-85 Hz | Comparable/Improved |
| Native Resolutions | 1600X1200 | 1920X1200 | Improved (higher resolution), therefore acceptable |
| Brightness | 400 cd/m² calibrated, 850 cd/m² Max. | 180 cd/m² calibrated, 350 cd/m² Max. | Calibrated brightness is lower, but still within specifications for diagnostic monitors (DICOM conformance is mentioned). Max brightness is lower. This is deemed acceptable as the device still conforms to relevant standards (e.g., DICOM part 14, DIN V 6868-57). |
| Contrast Ratio | 1050 : 1 (typical) | 1000 : 1 (typical) | Comparable |
| DOT Clock | 162 MHz | 202.5 MHz (Max) (Analog), 162 MHz (Max) (Digital) | Comparable/Improved |
| Input Signals/Terminals | D-sub analog VGA, DVI-I (x2) | DVI port, Display port, HDMI port | Different, but modern and functionally equivalent/improved for connecting to display controllers. |
| Active Display Size (H x V) | Landscape: 432mmX324mm, Portrait: 324X432mm | Landscape: 518.4mmX324mm, Portrait: 324X518.4mm | Increased, consistent with larger panel size, therefore acceptable. |
| Viewable Image Size (diagonal) | 540 mm | 540 mm | Identical |
| Luminance Calibration | Software | Software | Identical |
| Default Gamma | DICOM part 14 + off, etc. | DICOM part 14 | Simplified to primarily DICOM part 14, but still meeting the critical standard. |
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz | Identical |
| Power Consumption | 100W (Max) | 38.4W (Max) | Improved (lower consumption), therefore acceptable |
| Power Save Mode | <2W | <2W | Identical |
| Dimensions (W x H x D) | (Various, see table) | (Various, see table) | Different due to larger panel, but within reasonable limits for a medical display. |
| NET Weight | 10.7 kg | 10.2 kg | Comparable |
| Intended Use | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support / digital mammography. Interconnect with IEC60601-1. | Displaying and viewing of digital images for diagnosis by trained physicians. Not for life support / digital mammography. Interconnect with IEC60601-1-1. | Identical. Note updated IEC standard. |
| Certifications & Standards | CE ITE/Medical Device, UL/cUL (UL60601-1, CSA C22.2 No.601-1), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | CE ITE/Medical Device, UL/cUL (ANSI/AAMI ES 60601-1:2005), FCC Class B, EN60601-1-2, DIN V 6868-57, DICOM | Updated standard for UL/cUL (ANSI/AAMI ES 60601-1:2005), functionally equivalent and up-to-date. Otherwise identical. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a technical comparison for substantial equivalence of a display monitor, not a clinical study involving a test set of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth for patient images is not relevant for this device submission as it is not a diagnostic algorithm. The "truth" for the device is its adherence to technical specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set of patient cases requiring adjudication.
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. This is a display monitor, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device is primarily its adherence to relevant technical standards and regulations (e.g., DICOM part 14, IEC60601-1-1, EN60601-1-2, DIN V 6868-57), and the established performance of the predicate device. The comparison table directly serves as the evidence that the new device meets or exceeds these "ground truths" in most aspects or remains substantially equivalent in critical ones.
8. The sample size for the training set
Not applicable. This is a display monitor, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
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K132587
Page 1 of 4
510(K) Summary of Safety and Effectiveness
As required by 807.92
DEVICE ESTABLISHMENT AND CONTACT PERSON l.
Mr. Satoru Kotani Manager NEC Display Solutions Ltd. 4-28, Mita 1-chome, Minato-ku, Tokyo, Japan Ph: +81-465-85-2384 Fax: +81-465-85-2393
2. COMPANY REISTRATION NUMBER 3003623028
DATE SUMMARY PREPARED 3.
12 October 2012
4. DEVICE NAME
·
| Trade Name: | MD242C2 24.1" Diagnostic Imaging LCD monitor |
|---|---|
| Model Name: | MD242C2 |
| Common Name: | Color LCD Monitor, Color Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CF892.2050) |
4. PREDICATE DEVICE
L217TG TFT Color LCD Monitor by NEC Display Solutions Ltd. (K083907)
DEVICE DESCRIPTION 5.
Medical Display, MD242C2 is a 24.1" Color LCD monitor that displays image for medical use, It provides 2.3 mega pixel (1920*1200) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
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DEVICE OF INTENDED USE 6.
The MD242C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers.
MD242C2 cannot be used for a life-support system.
This device must not be used in digital mammography.
This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
7. SE Comparison Table:
| Items | L217TG | MD242C2 |
|---|---|---|
| 510(k) Number | K083907 | |
| Panel Size and Type | 21.3" TFT Color LCD Monitor | 24.1" TFT Color LCD Monitor |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270mm |
| Display Color | 16,777,216 | 1,073,741,824 |
| Viewing Angles (°) | H:176, V:176 | H:178, V:178 |
| Scanning Frequency (H, V) | 31.5-91.1kHz, 50-85 Hz | 31.5-93.8, 118.4kHz, 50-85 Hz |
| Native Resolutions | 1600X1200 | 1920X1200 |
| Brightness | 400 cd/m² calibrated,850 cd/m² Max. | 180 cd/m² calibrated,350 cd/m² Max. |
| Contrast Ratio | 1050 : 1 (typical) | 1000 : 1 (typical) |
| DOT Clock | 162 MHz | 202.5 MHz (Max) (Analog)162 MHz (Max) (Digital) |
| Input Signals | Three connectors: one D-subanalog VGA: and two DVI-I(VGA analog or digital) | Three connectors: one DVI port,one Display port, one HDMIport |
| Input Terminals | DVI-D, D-sub | DVI-D, Display port, HDMI |
| port | ||
| USB (option) / Standard | No | No |
| Active Display Size (H x | Landscape: 432mmX324mm | Landscape: 518.4mmX324mm |
| V) | Portrait: 324X432mm | Portrait: 324X518.4mm |
| Viewable Image Size | 540 mm (diagonal) | 540 mm (diagonal) |
| Luminance Calibration | Software | Software |
| Default Gamma | DICOM part 14 + off, 1.8,2.0,2.21.8.2.0,2.2 | DICOM part 14 |
| user | ||
| Power | AC100-240V, 50/60Hz | AC100-240V, 50/60Hz |
| Power Consumption | 100W (Max) | 38.4W (Max) |
| Power Save Mode | <2W | <2W |
| Dimensions | W: | W: |
| (W x H x D) | Landscape: 467.8mm | Landscape: 556.8mm |
| Portrait:361.6 mm | Portrait: 362.4 mm | |
| H: | H: | |
| Landscape: 434.3-584.3mm | Landscape: 378 - 528mm | |
| Portrait: 487.4-637.4mm | Portrait: 572.4-625.2mm | |
| D: 306 mm | D: 227.6 mm | |
| NET Weight | 10.7 kg | 10.2 kg |
| Intended of use | Displaying and viewing of digital | Displaying and viewing of |
| images for diagnosis by trained | digital images for diagnosis by | |
| physicians | trained physicians | |
| This device can not use for a life | This device can not use for a life | |
| support system. | support system. | |
| This device must not be use in | This device must not be use in | |
| digital mammography. | digital mammography. | |
| This device is designed for | This device is designed for | |
| exclusive interconnection with | exclusive interconnection with | |
| IEC60601-1 certified equipment | IEC60601-1-1 certified | |
| equipment | ||
| Certifications & | CE ITE/Medical Device Directive, | CE ITE/Medical Device |
| Standards | UL/cUL (UL60601-1, CSA C22.2 | Directive, UL/cUL |
| No.601-1), FCC Class B, | (ANSI/AAMI ES | |
| EN60601-1-2, DIN V 6868-57, | 60601-1:2005), FCC Class B, | |
| DICOM | EN60601-1-2, DIN V 6868-57, | |
| DICOM |
Comparison tables between MD242C2 & L217TG
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K132587
Page 4 of 4
CONCLUSION
These two devices have the same target population of trained practitioner in hospital; it shares the same design, same performance and is the same in radiation safety (EN60601-1-2), mechanical safety, electrical safety (AAMI/ES 60601-1) human factors and DICOM conformance. It use similar material, and have same compatibility with environment and other device. Comparison table of the principal characteristics of two devices is shown in the Section 3, table 3.3. These two devices also have the same intended use; Therefore we concluded that it is substantially equivalent to L217TG by NEC Display Solutions Ltd. (K083907)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 29, 2013
NEC Display Solutions Ltd. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Service LLC. 1394 25th Street NW BUFFALO MN 55313
Re: K132587
Trade/Device Name: MD242C2 24" Diagnostic Imaging LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 15, 2013 Received: August 16, 2013
Dear Mr. Job:
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). and Costinent for (100) that to nevice, subject to the general controls provisions of the Act. The r ou may, mereleve, manns of the Act include requirements for annual registration, listing of general volurols pro Prefering practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 or any I with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quand provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2-Mr. Job
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K132587
MD242C2 24" Diagnostice Imaging LCD Monitor Device Name:
Indications for Use:
The MD242C2 color display is intended to be used for displaying and viewing of digital images for diagnosis by trained physicians. To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display controllers. MD242C2 cannot be used for a life-support system.
This device must not be used in digital mammography. This device is designed for exclusive interconnection with IEC60601-1-1 certified equipment.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF .NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k)
Page 1 of 1
§ 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).