(101 days)
Not Found
No
The summary describes a medical monitor for displaying images and mentions standard performance testing for displays, not AI/ML algorithms.
No
The device is a medical monitor used for displaying radiological images for review, analysis, and diagnosis; it does not directly treat or alleviate a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in displaying radiological images... for review, analysis, and diagnosis." The use of "diagnosis" indicates its role in a diagnostic context.
No
The device description explicitly states it is a "Medical monitor," which is a hardware component used for displaying images. The performance studies also mention electrical safety and electromagnetic compatibility testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to display radiological images for review, analysis, and diagnosis by trained medical practitioners. This involves interpreting images generated from within the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a medical monitor for displaying medical images. This is a display device, not a device that performs tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information about a patient's health status based on analysis of biological samples.
IVDs are devices used to perform tests on samples taken from the human body to provide information about a person's health. This medical monitor's function is to display images generated by other medical devices (like mammography machines) for visual interpretation by a medical professional.
N/A
Intended Use / Indications for Use
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
Product codes
PGY
Device Description
The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiological images (including full-field digital mammography and digital breast tomosynthesis)
Anatomical Site
Breast (implied by mammography and tomosynthesis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained medical practitioners / Not Found
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
Non-Clinical Test summary:
- Electrical Safety and Electromagnetic Compatibility: The test results demonstrated that the proposed device complies with IEC 60601-1:2005/AMD1:2012, IEC 60601-1-2 Edition 4.0:2014, and IEC 60601-1-6:2010/A1:2013.
- Software Validation: The 31HN713D contains MODERATE level of concern software. The software was designed, developed, verified, and validated according to a software development process and FDA guidance.
- Guidance: The device was tested according to "Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017" for spatial resolution, pixel defects, artifacts, temporal response, luminance, conformance to a grayscale-to-luminance function, luminance at 30° and 45° in diagonal, horizontal, and vertical directions at center and four corners, luminance uniformity or Mura test, stability of luminance and chromaticity response with temperature and time of operation (on-time), spatial noise, reflection coefficient, veiling glare or small-spot contrast, color tracking, and gray tracking.
Key results: None of the tests showed significant performance differences that would adversely affect the use of the product, indicating substantially equivalent performance to the predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
Key Metrics
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).
0
October 8, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is a blue square with the letters FDA in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
LG Electronics, Inc. % Jinhwan Jun Chief Research Engineer 222, LG-ro, Cheongho-ri, Jinwi-myeon Pyeongtaek-Si. Gyeonggi-do 17709 REPUBLIC OF KOREA
Re: K201777
Trade/Device Name: 31HN713D Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: September 7, 2020 Received: September 10, 2020
Dear Jinhwan Jun:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201777
Device Name 31HN713D
Indications for Use (Describe)
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
| 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) |
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510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
June 25, 2020
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Name of Sponsor: | LG Electronics Inc. |
|---|---|
| Address: | 222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, |
| Gyeonggi-do, 17709, Republic of Korea | |
| Contact Name: | Jinhwan Jun / Chief Research Engineer |
| Telephone No.: | +82-31-8066-5641 |
| Email Address: | jinhwan.jun@lge.com |
| Name of Manufacturer: | LG Electronics Inc. |
| Address: | 77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381, |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| • Trade Name: | 31HN713D |
|---|---|
| • Company Name: | Medical Monitor |
- . Common Name:
| Medical Monitor | |
|---|---|
Republic of Korea
- Classification: ●
| Classification Name | Picture archiving and communications system |
|---|---|
| Classification Number | 21 CFR 892.2050 |
| Product Code | PGY |
| Device Class | II |
| Review Panel | Radiology |
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4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate devices within this submission are shown as follow;
Predicate Device
| • 510(k) Number: | K141428 |
|---|---|
| • Applicant: | BARCO N.V. |
| • Classification Name: | Picture archiving and communications system |
| • Trade Name: | MDMC-12133 |
5. Description of the Device [21 CFR 807.92(a)(4)]
The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images
6. Indications for use [21 CFR 807.92(a)(5)]
This Medical Monitor is indicated for use in displaying radiological images (including full-field digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
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7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (31HN713D) and the legally marketed predicate device (K141428):
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K141428 |
| Manufacturer | LG Electronics Inc. | BARCO N.V. |
| Model Name | 31HN713D | MDMC-12133 |
| Classification Name | Picture archiving and communications system | Picture archiving and communications system |
| Classification Number | 21 CFR 892.2050 | 21 CFR 892.2050 |
| Indications for Use | This Medical Monitor is indicated for use | |
| in displaying radiological images | ||
| (including full-field digital mammography | ||
| and digital breast tomosynthesis) for | ||
| review, analysis, and diagnosis by trained | ||
| medical practitioners. | The MDMC- 12133 is intended to be used | |
| in displaying arid viewing digital images, | ||
| including standard and multi-frame | ||
| digital mammography. for review, | ||
| analysis and diagnosis by trained medical | ||
| practitioners. It is especially designed for | ||
| breast tomosynthesis applications. | ||
| Display Technology | The 31HN713D has a LB310FTM | |
| module for displaying. The LB310FTM is | ||
| a 31" TFT Liquid Crystal Display module | ||
| with LED Backlight unit. This module | ||
| supports 4,200 x 2,800 pixels and can | ||
| display color driven by 10bit drivers. | Coronis Uniti Barco is a color LCD | |
| monitor for viewing radiology, | ||
| mammography, and breast | ||
| tomosynthesis images. The color panel | ||
| employs in-plane switching (IPS) | ||
| technology allowing wide viewing angles | ||
| and the matrix size (or resolution) is | ||
| 4,200 x 2,800 pixels. | ||
| Power Consumption | MAX. 150W | |
| Sleep Mode ≤ 0.5W | ||
| Off Mode ≤ 0.3W | 190W (nominal) |