(55 days)
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
The provided text is a 510(k) summary for a medical display device, the NEC Medical Display, MD205MG-1. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way a clinical trial or AI algorithm validation study would.
Therefore, much of the requested information (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details) is not applicable or not present in this type of regulatory submission.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
This document describes a device (a medical display monitor) and its intended use, rather than a diagnostic algorithm or a device with specific performance metrics like sensitivity or specificity. The "acceptance criteria" here refer to conformity with established standards for medical devices and displays, and "device performance" refers to its technical specifications matching the predicate device or meeting those standards.
| Acceptance Criteria / Standard | Reported Device Conformance / Specification |
|---|---|
| Intended Use | "displaying and viewing of digital image diagnosis including digital mammography system by trained physicians." |
| Resolution | 5 mega pixel (2560*2048) |
| Gamma grayscale | Adjustable |
| Standards Compliance | UL60601-1, EN60601-1-2, PAS-1054, DDN6868-57, ISO13406-2 |
| Compatibility | Must be used with NEC approved display cards |
| Safety | Does not contact with the patient, does not control any life-sustaining device |
| Interconnection | Designed for exclusive interconnection with IEC60601-1 certified equipment |
| Equivalence to Predicate | Substantially equivalent to MDM2010-5NC (K063269) for intended use, despite differences in panel, luminance, and scanning frequency. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a hardware conformity assessment, not an algorithmic performance study on a test dataset of images/patients.
- Data Provenance: Not applicable for an "algorithm test set." The device itself (the monitor) underwent testing against compliance standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" for a test set of medical cases/images in this context, as it's a display monitor. The compliance standards themselves form the basis of evaluation.
4. Adjudication method for the test set
- Not applicable. No adjudication method for medical cases is described.
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 hardware device (a display monitor), not an AI algorithm. Therefore, no MRMC study, AI assistance, or effect size is relevant or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware device.
7. The type of ground truth used
- Not applicable in the context of clinical "ground truth" from pathology, expert consensus, or outcomes data. The "ground truth" for this device's evaluation is its adherence to technical specifications, safety standards (UL60601-1, EN60601-1-2, etc.), and functional equivalence to the predicate device.
8. The sample size for the training set
- Not applicable. This is a hardware display device, not an AI algorithm.
9. How the ground truth for the training set was established
- Not applicable. This is a hardware display device, not an AI algorithm.
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ਕਿ 2001 (Video
510(K) Summary of Safety and Effectiveness
As required by 807.92
| 1. | DEVICE ESTABLISHMENT AND CONTACT PERSON |
|---|---|
| Mr. Shuichi Kino | |
| General Manager | |
| NEC Display Solutions Ltd. | |
| 686-1 Nishioi, Oi-Machi | |
| Ashigarakami-Gun, Kanagawa | |
| Japan 258-8533 | |
| Ph: +81-465-85-2376 |
OCT 23 2008
| 2. | COMPANY REISTRATION NUMBER |
|---|---|
| ---- | ---------------------------- |
AUG 29 20083003623028
DATE SUMMARY PREPARED 3.
01 July 2008
DEVICE NAME 4.
| Trade Name: | Medical Display, MD205MG-1 |
|---|---|
| Common Name: | Monochrome LCD Monitor, Monochrome Diagnostic Display, etc. |
| Classification Name: | System, Image Processing, Radiological (CLASS II CFR 892.2050) |
PREDICATE DEVICE 4.
MDM2010-5NC 20.1" 5MP Monochrome LCD Monitor by CHILIN Technology Co., Ltd. (K063269).
5. DEVICE DESCRIPTION
Medical Display, MD205MG-1 is a 20.1" monochrome LCD monitor that displays image for medical use. It provides 5 mega pixel (2560*2048) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS, and PACS.
K17
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6. DEVICE OF INTEND USE
The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography system by trained physicians.
To guarantee the display performance as specified, it must only be used for in conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 certified equipment.
7. CONCLUSION
Medical Display, MD205MG-1 has the same intended use as the predicate device MDM2010-5NC. Though the brand name and model name are different, MD205MG-1 is a modified device from MDM2010-5NC. The only differences are panel, luminance and scanning frequency. The modified device is sent to test against standards: UL60601-1, EN60601-1-2, PAS-1054, DDN6868-57 and ISO13406-2 and based on the Risk Analysis we know that they do not effect the device efficiency nor raise any safety issue. The device does not contact with the patient nor does it control any life-sustaining device. Therefore we concluded that it is substantially equivalent to MDM2010-5NC by CHILIN Technology Co., Ltd. (K063269).
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its wings or feathers. The symbol is black, and the text is also likely black or a dark color.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 3 2008
NEC Display Solutions Ltd. % Mr. Morten Simon Christensen Staff Engineer & FDA Accredited Person Program Coordinator, Program Reviewer Underwriters Laboratories, Inc. 455 E. Trimble Road SAN JOSE CA 95131-1230
Re: K082493
Trade/Device Name: Medical Display, MD205MG-1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 8, 2008 Received: October 14, 2008
Dear Mr. Christensen:
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 (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.
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Page 2
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.
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 this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
hoque An Whang
Joyce M. Whang, Ph.D. Acting 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 (if known): K082493
Device Name: Medical Display, MD205MG-1
Indications for use: The MD205MG-1 grayscale display is intended to be used for displaying and viewing of digital image diagnosis including digital mammography by trained physicians.
To guarantee the display performance as specified, it must only be used for in Conjunction with NEC approved display cards.
The MD205MG-1 cannot be used for a life-support system.
This unit is designed for exclusive interconnection with IEC60601-1 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 Device Evaluation (ODE)
Helen Rumer
(Division Sign-Off) Division of Reproductive, Abdominal a 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).