(15 days)
1.3MP Medical Monochrome Reference Display, MDM1900-1NG MDM1900-1NR is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
Medical Display, MDM1900-1NG is a 19" monochrome LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
The provided document describes a 510(k) submission for a medical display, the MDM1900-1NG (1NR), and primarily focuses on establishing substantial equivalence to a predicate device. It does not contain a study demonstrating device performance against specific acceptance criteria in the way one would for a diagnostic algorithm or a novel medical device with new features.
Instead, the submission for this medical display is based on establishing equivalence to an existing device (RadiForce G22 19.6" Class Monochrome LCD Monitor by EIZO NANAO CORPORATION, K041597) by showing similar characteristics and intended use, and no new questions of safety or effectiveness.
Therefore, many of the requested details about acceptance criteria and a study proving their fulfillment are not present in this type of 510(k) submission for a display monitor.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a display monitor establishing substantial equivalence, explicit "acceptance criteria" for a study demonstrating diagnostic performance are not provided. The criteria for equivalence are based on the device's technical specifications and intended use being similar to the predicate.
| Feature / Criterion | Acceptance Criteria (implied by predicate) | Reported Device Performance (MDM1900-1NG) |
|---|---|---|
| Intended Use | Displaying images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Not suitable for digital mammography. | Displaying images for review and analysis by trained medical practitioners for diagnosis in CT, MRI, HIS, and PACS. Not suitable for digital mammography. |
| Device Type | 19.6" Monochrome LCD Monitor | 19" monochrome LCD monitor |
| Resolution | (Predicate not explicitly stated, but assumed to be adequate for medical imaging) | 1.3 mega pixel (1280 x 1024 / 1024 x 1280) |
| Grayscale | Adjustable gamma grayscale for precise diagnosis | Adjustable gamma grayscale for more precise diagnosis |
| Interaction with Patient | No contact with patient | No contact with patient |
| Control of Life-Sustaining Device | Does not control life-sustaining device | Does not control life-sustaining device |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission does not involve a diagnostic performance study with a test set of images. It is a review of the device's technical specifications and intended use against a predicate device.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth establishment for a test set of images was performed or reported as part of this submission. The "ground truth" for the device's equivalence is based on regulatory review of technical specifications.
4. Adjudication method 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
- No MRMC study was conducted or reported. This device is a display monitor, not an AI or CAD system.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a display monitor, not an algorithm.
7. The type of ground truth used
- Not applicable in the context of diagnostic performance. The "ground truth" for this 510(k) application is the established regulatory framework for medical device equivalence, relying on comparison of technical specifications and intended use to a legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This device is a display monitor, not an AI system that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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510(K) Summary of Safety and Effectiveness
As required by 807.92
1. DEVICE ESTABLISHMENT AND CONTACT PERSON
Phil Chen CHILIN TECHNOLOGY CO. LTD No.71, Te Lun Road, Jen Te Hsian, Tainan County 717, Taiwan, R.O.C. Ph: +886-6-279 - 4113 ext. 533 Facsimile: +886-6-249 - 4751
2. DATE SUMMARY PREPARED
14 December 2005
3. DEVICE NAME
Trade Name: Medical Display, MDM1900-1NG (1NR) Common Name: Monochrome LCD Monitor, MonochromeDiagnostic Display, etc. Classification Name: System, Image Processing, Radiological (CLASS II CFR 892.2050)
4. PREDICATE DEVICE
RadiForce G22 19.6" Class Monochrome LCD Monitor by EIZO NANAO CORPORATION (K041597)
5. DEVICE DESCRIPTION
Medical Display, MDM1900-1NG is a 19" monochrome LCD monitor that displays image for medical use. It provides 1.3 mega pixel (1280 x 1024/1024 x 1280) resolution with adjustable gamma gray scale for more precise diagnose use in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
DEVICE OF INTEND USE 6.
Medical Display, MDM1900-1NG is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and PACS. This device is not suitable for a digital mammography system.
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7. CONCLUSION
Medical Display, MDM1900-1NG (1NR) has the same intended use as the predicate device G22, and they both share the similar characteristics except some minor differences which do not raise new questions of safety and effectiveness. The device does not contact with the patient nor does it control any life sustaining device. I Therefore we concluded that it is substantially equivalent to G22 by EIZO NANAO CORPORATION (K041597).
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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol.
MAY 2 5 2006
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Chilin Technology Co., LTD % Mr. Marc M. Mouser Senior Project Engineer, Program Reviewer Underwriters Laboratories, Inc. 2600 N.W Lake Road CAMAS WA 98607-8542
Re: K061303
Trade/Device Name: Medical Display, MDM1900-1NG (1NR) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 27, 2006 Received: May 10, 2006
Dear Mr. Mouser:
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Below the letters, the word "Centennial" is written in a stylized font. Three stars are arranged below the word "Centennial".
Protecting and Promoting Public Health
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that I lease of actives that I Driver that your device complies with other requirements of the Act or any I Dri has made a dicerministered 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) Fins lotter will and in your e FDA finding of substantial equivalence of your device to a legally premated predicated on 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 11 you a went office of Compliance at one of the following 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 807.97). 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) 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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Indications for Use
510(k) Number (if known):
Device Name: Medical Display, MDM1900-1NG (1NR)
Indications For Use: 1.3MP Medical Monochrome Reference Display, MDM1900-1NG MDM1900-1NR is intended to use in displaying images for review and analysis by trained medical practitioner for diagnose in CT, MRI, HIS and This device is not suitable for a digital mammography system. PACS.
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)
Nancy Chroston
(Division Sign-Off) (Division Sigar of Reproductive, Abdom 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).