(261 days)
No
The description focuses on the monitor hardware and its intended use for displaying images, with no mention of AI or ML capabilities for image analysis or processing. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
This device is a monitor system used for displaying medical images, not for directly treating or diagnosing patients. Its function is to provide a visual interface for medical practitioners to review and analyze images, which is a supportive rather than a therapeutic role.
No
Explanation: The device is a monitor system for displaying medical images; it does not directly perform diagnostic functions itself but is used by medical practitioners for review and analysis which can lead to a diagnosis.
No
The device description explicitly states it is a "flat panel hi-resolution LCD monitor system" and lists hardware components like the LCD monitor itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to display and view medical digital images for review and analysis by trained medical practitioners. This is a function related to image display and interpretation, not the analysis of biological samples or specimens.
- Device Description: The device is a monitor system for displaying images. It does not involve the collection, preparation, or analysis of biological materials.
- Input: The input is digital mammography images, which are generated from a medical imaging procedure, not from a biological sample.
IVDs are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for diagnostic purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The MW100 (Mammography) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
Product codes
LLZ
Device Description
The MW100 (Mammography) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor that connects to a hi-resolution graphic control board (not supplied by WIDE Corporation), that is installed into a PACS workstation.
The MW100 (Mammography) LCD Monitor System consists LCD monitor. The computer, computer hardware, any workstation PACS software, monitor image calibration software (e.g. Lumical Software and graphic interface is supplied by the user and should be based upon WIDE Corporation recommendations as described in the MW-100 User Manual.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Validation Test Plan was designed to evaluate all inout functions, output functions, and that as required by the risk analysis, designated individuals performed all verification and validation activities on the WIDE MW-100 device. The results demonstrated that the predetermined acceptance criteria were met. The nonclinical testing results using WIDE test plance and the requirements for monitors as outlined in AMLCD AAPM TG 18 & Specifications are provided in the 510(k).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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510(k) Summary of Safety
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: February 4, 2011
Submitter's Information: 21 CFR 807.92(a)(1)
Mr. Wongkyum Kim / CEO
WIDE Corporation
Leaders Tower Building 7FL, 456, Gomae-dong, Giheung-gu
Yongin-si, Gyeonggi-do, Republic of Korea, 446-901
Fax: +82-31-274-7400 Email: ceo@widecorp.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Proprietary (Trade) Name: | MW100 (Mammography) LCD Monitor System™TM |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Classification Name: | System, Image Possessing |
| Device Classification: | 892.2050 |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K052312 |
| Device Name | WIDE 5MP (MAMMO) LCD MONITOR |
| SYSTEM | |
| Applicant | WIDE CORPORATION |
| Requlation Number | 892.2050 |
| Classification Product Code | LLZ |
| Decision Date | 10/07/2005 |
| Decision | substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
| Type | Traditional |
| Reviewed by Third Party | No |
Device Description: 21 CFR 807 92(a)(4)
The MW100 (Mammography) LCD Monitor System™ is a flat panel hi-resolution LCD monitor system for displaying medical images. The system consists of a state-of-the-art LCD monitor that connects to a hi-resolution graphic control board (not supplied by WIDE Corporation), that is installed into a PACS workstation.
The MW100 (Mammography) LCD Monitor System consists LCD monitor. The computer, computer hardware, any workstation PACS software, monitor image calibration software (e.g. Lumical Software and graphic interface is supplied by the user and should be based upon WIDE Corporation recommendations as described in the MW-100 User Manual.
Indications for Use: 21 CFR 807 92(a)(5)
The MW100 (Mammography) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
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Technological Characteristics: 21 CFR 807 92(a)(6)
The MW100 (Mammography) LCD Monitor System™ device is a medical image viewing system that does not contact the patient, nor does it control any life sustaining devices. Diagnosis is not performed by the monitor but by Radiologists, Clinicians and referring Physicians. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Note: The subiect device does not include any automated or semi-automated process for the detection of nodules or other shapes.
Nonclinical Testing:
The complete system configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Validation Test Plan was designed to evaluate all inout functions, output functions, and that as required by the risk analysis, designated individuals performed all verification and validation activities on the WIDE MW-100 device. The results demonstrated that the predetermined acceptance criteria were met. The nonclinical testing results using WIDE test plance and the requirements for monitors as outlined in AMLCD AAPM TG 18 & Specifications are provided in the 510(k).
If the device is installed by INFINITT Co., Ltd, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.
Conclusion: 21 CFR 807 92(b)(1)
The Pre-Market Notification for MW100 (Mammography) LCD Monitor System™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
The subject device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. Any differences between the predicate devices and the subject device are not significant since they do not raise any new or potential safety risks to the user or patient and is equivalent in performance to existing legally marketed devices.
Nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate devices. Therefore, MW100 (Mammography) LCD Monitor System™ is substantially equivalent to the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
NOV 1 8 2011 .
WIDE Corporation % Mr. Carl Alletto OTECH, Inc. 1600 Manchester Way CORINTH TX 76210
Re: K110596
Trade/Device Name: WIDE MW-100 Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 26, 2011 Received: September 29, 2011
Dear Mr. Alletto:
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K110596
Device Name: WIDE MW-100 Monitor
Indications for Use:
The MW100 (Mammography) LCD Monitor System™ is intended to be used in displaying and viewing medical digital images for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
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 OF NEEDED)
Concurrence of EDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off Office of In Vitro Diagnostic Device
510(k) K110596
Evaluation and Safety
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