(21 days)
Not Found
No
The document describes a medical monitor for displaying images and mentions a "high performance image processing controller," but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The focus is on the display technology and image processing for rendering, not analysis or interpretation using AI/ML.
No
The device is a medical monitor designed for displaying medical images, not for directly treating or diagnosing medical conditions. It functions as a display tool for practitioners rather than a therapeutic intervention.
No
The device is a monitor used for displaying medical images; it does not perform any diagnostic functions itself. Its primary purpose is to present images for review and analysis by trained practitioners.
No
The device description explicitly states it is a "Medical LCD Monitor" and describes hardware components like an "LCD panel" and an "image processing controller." It also mentions testing for hardware characteristics like "Luminance Response," "Uniformity," and "Display Reflection."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The Medical LCD Monitor's intended use and description clearly state its purpose is to display and view medical digital images for review and analysis. It does not perform any tests on biological samples.
- Input: The input is medical imaging data (X-ray, radiology, MRI, endoscopy, mammography), not biological samples.
The device is a medical image display device, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
The Medical LCD Monitor 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 (comma separated list FDA assigned to the subject device)
PGY
Device Description
The Medical LCD Monitor (Model: KT-D213V5E) is designed for the purpose of medical applications such as X-ray, radiology, MRI, endoscopy or mammography imaging display. The high-resolution LCD panel with a resolution of 2560 x 2048, combined with a high performance image processing controller, provides the users high-definition and high-quality medical image displays. The medical monitor complies with international EMC/ safety standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, radiology, MRI, endoscopy or mammography
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests have been performed on the subject device and passed the pre-set criteria.
- Luminance Response
- Uniformity
- Miscellaneous Test
- Display Reflection
- Angular dependencies
- Clinical Reference Image
- Geometric Distortion
- Display Noise
- Display Veiling Glare
- Scheduler Table
- EMC and Electrical Safety Tests
- Software Verification and Validation
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/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 graphic of three human profiles facing to the right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2014
Kostec Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Avenue, Suite 110 FULLERTON CA 92831
Re: K141891
Trade/Device Name: Medical LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 7, 2014 Received: July 14, 2014
Dear Ms. Chung:
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. 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 comply 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 product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education 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.
FDA
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Medical LCD Monitor
Indications for Use (Describe)
The Medical LCD Monitor 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.
Type of Use (Select one or both, as applicable)
|× Prescription Use (Part 21 CFR 801 Subpart D)
■ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Image /page/2/Figure/14 description: The image shows a signature in black ink over a light gray FDA logo. The signature is illegible, but appears to be cursive. The FDA logo is a triangle with the letters "FDA" inside.
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510(k) Summary
This summary of 510(K) - safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 08/01/2014
1. Applicant / Submitter
KOSTEC Co., Ltd. #2-101, Medical Industry Technocenter, 1720-26 Taejang-dong, Wonju-si, Kangwon-do, 220-120, Republic of Korea Phone: +82-33-747-9672 Fax: +82-33-747-9673
2. Submission Correspondent
LK Consulting Group USA, Inc. 2651 E Chapman Ave. Ste 110, Fullerton, CA 92831 Priscilla Chung Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- Trade Name: Medical LCD Monitor (Model: KT-D213V5E)
- · Classification Name: Picture archiving and communications system
- · Classification regulation: 21 CFR 892.2050
- Product Code: PGY
4. Predicate Device:
Wide 5MP (Mammo) LCD Monitor System (K052312) by WIDE Corporation
5. Description:
The Medical LCD Monitor (Model: KT-D213V5E) is designed for the purpose of medical applications such as X-ray, radiology, MRI, endoscopy or mammography imaging display. The high-resolution LCD panel with a resolution of 2560 x 2048, combined with a high performance image processing controller, provides the users high-definition and high-quality medical image displays. The medical monitor complies with international EMC/ safety standards.
6. Indications for use:
The Medical LCD Monitor is intended to be used in displaying and viewing medical digital images
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for review and analysis by trained medical practitioners. It is specifically designed for digital mammography applications.
7. Comparison to the Cleared Device
The Medical LCD Monitor (KT-D213V5E) is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the subject device are the same as those of the predicate device and other differences have been independently validated. Any differences such as clock speed between the devices do not affect safety or effectiveness.
| Predicate Device | Subject Device | |
|---|---|---|
| Device Name | 5MP (Mammo) LCD Monitor | |
| System | Medical LCD Monitor | |
| 510K Number | K052312 | - |
| Manufacturer | WIDE Corporation | Kostec Co., Ltd. |
| Indications for Use | The 5MP (Mammo) 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. | The Medical LCD Monitor 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. | ||
| Panel | TFT AMLCD IPS | TFT AMLCD IPS |
| Screen size | 21.3" | |
| (422.4(H) x 337.92(V) | ||
| [mm]) | 21.3" | |
| (422.4(H) x 337.92(V) | ||
| [mm]) | ||
| Pixel pitch | 0.165(H) x 0.165(V) [mm] | 0.165(H) x 0.165(V) [mm] |
| Contrast ratio | 850:1 | 850:1 |
| Declared and actual array size | 422.4(H)x337.92(v)mm | 422.4(H)x337.92(v)mm |
| Max and min achievable | ||
| luminance | Typ: 1,100 cd/m2 | Typ: 1,100 cd/m2 |
| Luminance Calibration | Software(Optional) | |
| Sensor (optional) | Software(Optional) | |
| Sensor (optional) | ||
| Intrinsic bit-depth of the panel | 8bit | 8bit |
| True output bit-depth by | ||
| performing visual test | 14bit | 14bit |
| Luminance Uniformity | min : 70 | |
| L.U =(Min.lum | ||
| /Max.lum.)*100 | min : 70 | |
| L.U =(Min.lum /Max.lum.)*100 | ||
| Chromaticity measured at 5, 50 | ||
| and 95% (fefxox ISO13406-2) | x:0.294, y:0.309 | x:0.294, y:0.309 |
| Clock speed | 64.5MHz | 74 MHz |
| Spatial resolution, spatial MTF | 2,560(H)x2,048(V) | 2,560(H)x2,048(V) |
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8. Performance Data
The following tests have been performed on the subject device and passed the pre-set criteria.
- Luminance Response
- Uniformity
- Miscellaneous Test
- Display Reflection
- Angular dependencies
- Clinical Reference Image
- Geometric Distortion
- Display Noise
- Display Veiling Glare
- Scheduler Table
- EMC and Electrical Safety Tests
- Software Verification and Validation
9. Conclusion
We have concluded that our devices are substantially equivalent to the predicate device in safety and effectiveness. No new questions of safety and effectiveness have been raised.