(134 days)
No
The summary describes a medical monitor for displaying images and mentions standard performance testing for display devices. There is no mention of AI, ML, or any features that would suggest the device processes images using such technologies for analysis or diagnosis beyond simple display.
No.
The device is a medical monitor used for displaying radiological images for review, analysis, and diagnosis, not for treating or preventing a disease or condition.
No
The device is a medical monitor intended for displaying radiological images for review, analysis, and diagnosis. While it supports diagnosis, the device itself performs no diagnostic function; it merely displays the images. The diagnostic function is performed by a trained medical practitioner.
No
The device description explicitly states "The Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system." and the performance studies include testing for hardware characteristics like Spatial resolution, Pixel defects, Artifacts, Temporal response, Luminance, and Color tracking, which are associated with display hardware, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "displaying radiological images for review, analysis, and diagnosis". This involves displaying images generated from within the body (in vivo), not analyzing samples taken from the body (in vitro).
- Device Description: The description reinforces the use for "displaying, reviewing, and analysis of medical images" from PACS and Radiology systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are used to examine specimens, such as blood, urine, or tissue, to provide information about a person's health. This medical monitor's function is to display images generated by other medical devices (like X-ray machines, CT scanners, etc.) that capture images of the inside of the body.
N/A
Intended Use / Indications for Use
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
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
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test summary:
- Electrical Safety and Electromagnetic Compatibility
The test results demonstrated that the proposed device complies with the following standards:
• Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601- 1:2005/AMD1:2012
• Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 Edition 4.0:2014
• Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability in accordance with IEC 60601-1-6:2010/A1:2013 - Software Validation
The 21HQ513D contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. - Guidance
Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017
Performance items tested: Spatial resolution, Pixel defects, Artifacts, Temporal response, Luminance, Color tracking, Conformance to a grayscale-to-luminance function.
Key results: According to the above test results, there are no significant performance differences between 21HQ513D and the predicate device that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate device.
Clinical Test Summary: No clinical studies were considered necessary and performed.
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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym with the full name of the agency on the right. The FDA acronym is in a blue square, and the full name of the agency is in blue text.
LG Electronics Inc. % DoGyun Im Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 Korea, South
December 7, 2021
Re: K212295
Trade/Device Name: 21HO513D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: November 3, 2021 Received: November 4, 2021
Dear DoGyun Im:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated December 3, 2021. Specifically, FDA is updating this SE Letter as an administrative correction. The missing information for the "Dated" field in the original letter should have been November 3, 2021. Additionally, the trade name should have been listed as 21HQ513D.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Dr. Jessica Lamb, Assistant Director, Office of in vitro Diagnostics and Radiological Health at 301-796-6167 or Jessica.Lamb@fda.hhs.gov.
Sincerely
Jessica Lamb
Jessica Lamb, Ph.D. Assistant Director Mammography Ultrasound and Imaging Software Branch 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. % Dogyun Im Senior Researcher GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 Korea, South
Re: K212295
Trade/Device Name: 21hq513d Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: [NOTE: Use date of most recent supplement] Received: November 4, 2021
Dear Dogyun Im:
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 mav, 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
December 3, 2021
2
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 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 (OS) 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,
Jessica Lamb
Jessica Lamb Assistant Director, Mammography Ultrasound and Imaging Software Branch 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
3
Indications for Use
510(k) Number (if known) K212295
Device Name 21HQ513D
Indications for Use (Describe)
This Medical Monitor is indicated for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
July 20, 2021
.
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Name of Sponsor: | LG Electronics Inc.
77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,
Republic of Korea |
|-----------------------|------------------------------------------------------------------------------------------------|
| Name of Manufacturer: | LG Electronics Inc.
77, Sanho-daero, Gumi-si, Gyeongsangbuk-do, 39381,
Republic of Korea |
- Contact Name: Jinhwan Jun / Chief Research Engineer Telephone No.: +82-31-8066-5641 -
- Email Address: jinhwan.jun@lge.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
-
Trade Name: ●
21HQ513D -
Common Name: ●
Medical Monitor -
Classification: ●
| Classification Name | Medical image management and processing system |
|---|---|
| Classification Number | 21 CFR 892.2050 |
| Product Code | PGY |
| Device Class | II |
| Review Panel | Radiology |
5
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:
- Applicant:
- Classification Name:
- Trade Name:
LG Electronics Inc. Medical image management and processing system 21HK512D
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 for review, analysis, and diagnosis by trained medical practitioners. The display is not intended for mammography.
7. Intended Use [21 CFR 807.92(a)(5)]
The 21HQ513D is a prescription device, and the display is not intended for mammography.
- -The display is indicated for use to display radiological images for review, analysis, and diagnosis.
- -The display is indicated for use by trained medical practitioners.
- -The display is indicated to provide high-resolution color and grayscale medical imaging for PACS and Radiology systems.
6
8. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (21HQ513D) and the legally marketed predicate device (K191864):
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K191864 |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. |
| Model Name | 21HQ513D | 21HK512D |
| Classification Name | Medical image management and | |
| processing system | Medical image management and | |
| processing 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 for review, analysis, and | ||
| diagnosis by trained medical | ||
| practitioners. The display is not | ||
| intended for mammography. | This Medical Monitor is intended | |
| to be used by trained medical | ||
| practitioners for displaying, | ||
| reviewing, and analysis of | ||
| medical images. The display is | ||
| not intended for mammography. | ||
| Power Consumption | MAX. 120W | |
| Off Mode ≤ 0.3W | MAX. 85W | |
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm |
| Resolution | 1,536 x 2,048 pixels | 1,536 x 2,048 pixels |
| Horizontal Frequency | 30 kHz to 130 kHz | 63 kHz to 96 kHz |
| Vertical Frequency | 56 Hz to 61 Hz | 50 Hz to 75 Hz |
| Input video signals | DisplayPort x 2 | |
| DVI-IN x 1 | DisplayPort x 1 | |
| DVI-IN x 1 | ||
| Calibration Tool | PerfectLum 4.0 | PerfectLum 3.9 |
The comparison table shows that the subject device (21HQ513D) has the same indications for use the predicate one. Although the devices have some different technological characteristics (power consumption, horizontal & vertical frequency, input video signals), these differences do not make the subject device less safe and reliable, so the subject device fits for diagnostic use as the predicate device does. And there is a difference in the calibration tool. 21HQ513D uses the updated version of the PerfectLum. PerfectLum 4.0 only have differences in UI/UX improvements, supported OS extensions, functional improvements for remote control server. So it does not affect the calibration function of the PerfectLum. And PerfectLum 4.0 was also validated according to the ISO 62304. Therefore, there are no significant differences in the technological characteristics of the subject device. All the differences between the subject and predicate device do not raise different questions of safety and effectiveness. It is substantially equivalent to a predicate device in indications for use and technology characteristics.
7
9. Non-Clinical Test summary
-
- Electrical Safety and Electromagnetic Compatibility
- The test results demonstrated that the proposed device complies with the following standards: · Electrical Basic Safety and Essential Performance reguirements in accordance with IEC 60601-
- 1:2005/AMD1:2012 • Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2 Edition 4.0:2014
- · Medical Electrical Equipment Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability in accordance with IEC 60601-1-6:2010/A1:2013
-
- Software Validation
The 21HQ513D contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA quidance: The content of premarket
-
- Guidance
Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017
- Guidance
| Measurements | Description | SE Note | |
|---|---|---|---|
| a. | Spatial resolution | Measurements of the transfer of | |
| information from the image data to the | |||
| luminance fields at different spatial | |||
| frequencies of interest typically done by | |||
| reporting the modulation transfer | |||
| function. Non-isotropic resolution | |||
| properties should be characterized | |||
| properly by providing two-dimensional | |||
| measurements or measurements along | |||
| at least two representative axes. | |||
| (Using TG18 QC Test Pattern) | Same | ||
| b. | Pixel defects | Measurements (count, types (e.g., sub- | |
| pixel or entire pixel, always-on, always- | |||
| off), and locations (map) of pixel | |||
| defects. This is typically provided as a | |||
| tolerance limit. Pixel defects can | |||
| interfere with the visibility of small | |||
| details in medical images. | Equivalent | ||
| c. | Artifacts | Evaluate for image artifacts such as | |
| ghosting and/or image sticking from | |||
| displaying a fixed test pattern for a | |||
| period of time. | |||
| (Using 5x5 mosaic pattern, 64Gray / | |||
| 127 Gray judgment) | Same | ||
| d. | Temporal response | Measurements of the temporal behavior | |
| of the display in responding to changes | |||
| in image values from frame to frame. | |||
| Since these transitions are typically not | |||
| symmetric, rise and fall time constants | Equivalent |
According to the quidance, we test following performance items:
submissions for software contained in medical devices, on May 11, 2005.
8
| Measurements | Description | SE Note | |
|---|---|---|---|
| are needed to characterize the system. | |||
| Slow displays can alter details and | |||
| contrast of the image when large image | |||
| stacks are browsed or in video, | |||
| panning, and zooming modes. | |||
| e. | Luminance | Measurements of the maximum and | |
| minimum luminance that the device | |||
| outputs as used in the application under | |||
| recommended conditions and the | |||
| achievable values if the device is set to | |||
| expand the range to the limit. | Same | ||
| f. | Color tracking | Chromaticity at different luminance | |
| levels of primary colors as indicated by | |||
| the color coordinates in an appropriate | |||
| units system (e.g., CIE u'v') and the | |||
| color gamut enveloped by the primary | |||
| colors. | Equivalent | ||
| g. | Conformance to a | ||
| grayscale-to-luminance | |||
| function | Measurements of the mapping between | ||
| image values and the luminance output | |||
| following a target model response for | |||
| 256 or more levels. | Equivalent |
According to the above test results, there are no significant performance differences between 21HQ513D and the predicate device that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate device.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification LG Electronics, concludes that the 21HQ513D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.