(8 days)
The WIDE 3MP grayscale TFT LCD monitor IF2103A™is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
The WIDE 3MP grayscale TFT LCD monitor IF2103A™is a flat panel hiresolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
The provided document is a 510(k) summary for the WIDE 3MP grayscale TFT LCD monitor IF2103A™. This document focuses on demonstrating substantial equivalence to a predicate device for a display monitor, not an AI-powered diagnostic device or a system that performs analysis. Therefore, much of the requested information regarding acceptance criteria for device performance, study designs common for AI/diagnostic devices (e.g., sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance), is not applicable to this type of submission.
The "device performance" in this context refers to the technical specifications and safety standards of the monitor itself, ensuring it can display medical images adequately and safely. The acceptance criteria relate to these technical specifications and adherence to recognized standards.
Here's an attempt to answer the questions based on the available information, noting where specific questions are not relevant:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria and reported device performance in the format typically seen for algorithms or diagnostic tools. Instead, it refers to compliance with safety and voluntary standards. The "performance" of this device is its ability to display images, which is assumed to meet the requirements of medical image display through its technical specifications and compliance.
| Acceptance Criteria Category | Reported Device Performance (Implied by Compliance) |
|---|---|
| Display of Digital Medical Images | Intended for displaying and viewing digital medical images for review and analysis. |
| Safety Standards | UL2601-1/EN60601-1 / IEC601-1 (Electrical Safety) |
| EMC/EMI Compatibility | FCC Class B, CE, VCCI, MIC FCC Class B digital device (Electromagnetic Compatibility) |
| General Product Safety | UL 950, cUL2601-1 (General Product Safety) |
| Substantial Equivalence | Found substantially equivalent to CORNIS 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM (K013922) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. This device is a display monitor. There is no "test set" of medical images or patient data in the context of diagnostic performance evaluation mentioned in this document. The evaluation focuses on the monitor's technical specifications and compliance with standards.
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. As this is a display monitor, there is no "ground truth" establishment for diagnostic purposes mentioned in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set of medical images for diagnostic purposes is discussed.
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-assisted diagnostic tool.
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, and does not operate in a standalone diagnostic capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth for diagnostic accuracy is not relevant for a display monitor. The "ground truth" for the monitor's function is its technical specifications (e.g., resolution, luminance, uniformity) and adherence to industry standards, which are evaluated through engineering tests, not clinical "ground truth" based on patient data.
8. The sample size for the training set
Not applicable. This device is a display monitor, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI model, ground truth establishment is not relevant.
{0}------------------------------------------------
JUL 2 4 2003
032174
Image /page/0/Picture/2 description: The image shows the word "WIDE" in white letters on a black background. Below the word "WIDE" is some smaller text that is difficult to read. The text is also in white. The image is a logo or advertisement for something.
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: June 7, 2002
Submitter's Information: 21 CFR 807.92(a)(1) WIDE Corporation Mr. YS Lim, President & CEO 576-5 Miwon-Ri, Miwon-Myun, Cheongwon-Gun Chung, Korea 363-874
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) WIDE 3MP grayscale TFT LCD monitor IF2103A TM Trade Name: Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K013922 |
| Device Name | CORNIS 3MP MEDICAL FLAT PANEL DISPLAYSYSTEM |
| Applicant | BARCO NVP.O. BOX 12038LA JOLLA, CA 92039 2038 |
| Product Code | LLZ |
| Decision Date | 12/23/2002 |
Device Description: 21 CFR 807 92(a)(4)
The WIDE 3MP grayscale TFT LCD monitor IF2103A™is a flat panel hiresolution LCD monitor system for displaying digital medical images. The system consists of a state-of-the-art LCD monitor and a high-resolution graphic control board that connects to a PACS workstation for grayscale image display. The WIDE controller board is installed into the PACS workstation computer or other computer system used to display PACS medical images.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the word "WIDE" in large, bold, white letters against a black background. The word is centered and takes up most of the frame. Below the word "WIDE" is some smaller text that is difficult to read due to the image quality.
Indications for Use: 21 CFR 807 92(a)(5)
The WIDE 3MP grayscale TFT LCD monitor IF2103A ™ is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is an image display system consisting of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for the WIDE 3MP grayscale TFT LCD monitor IF2103A ™ contains adequate information and data to enable FDA -CDRH to determine substantial equivalence to the predicate device.
The WIDE 3MP grayscale TFT LCD monitor IF2103A ™ will be manufactured by WIDE Corporation in accordance with the voluntary and safety standards, i.e. Safety / Immunity UL2601-1/EN60601-1 / IEC601-1, FCC Class B, CE, VCC, UL 950, cUL2601-1, CE Mark EMC/IEC = VCCI, CE, MIC FCC Class B digital device, pursuant to Part 15.
The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 4 2003
WIDE Corporation % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K032174
Trade/Device Name: WIDE 3MP grayscale TFT LCD monitor IF2103A Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ
Dated: June 30, 2003 Received: July 16, 2003
Dear Mr. Devine:
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 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 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.
{3}------------------------------------------------
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.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
{4}------------------------------------------------
(Indications for Use Form)
510(k) Number: K632174
Device Name: WIDE 3MP grayscale TFT LCD monitor IF2103A ™
Indications for Use:
The WIDE 3MP grayscale TFT LCD monitor IF2103A™is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
OR
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
David R. Lyman
§ 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).