Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a medical monitor for displaying images and mentions image processing, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on display characteristics, not algorithmic performance.

Therapeutic

No
The device is a medical monitor used for displaying and reviewing radiological images for diagnosis, not for treating or preventing a disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is for "review, analysis, and diagnosis by trained medical practitioners."

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Medical monitor," which is a hardware component used for displaying images. The performance studies also focus on testing the physical characteristics of the monitor.

IVD (In Vitro Diagnostic)

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 by trained medical practitioners." This involves interpreting images generated from within the body, not analyzing samples taken from the body (which is the core of IVD).
Device Description: The description reinforces this by stating it's for "displaying, reviewing, and analysis of medical images."
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.

In summary, this device is a medical monitor used for displaying and interpreting medical images, which falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

radiological images (including full-field digital mammography and digital breast tomosynthesis)

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

Bench Test Performance Test: Physical Laboratory Test items suggested in the FDA guidance "Display Devices for Diagnostic Radiology" were tested on 21HQ613D using LG Calibration Studio Medical and DBI Calibration Feedback System. Measurements including 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 (primary colors and color gamut), Gray tracking (gray shades and white point) all passed. All display characteristics of 21HQ613D have met the pre-determined criteria. Therefore, the performance of the proposed 21HQ613D has been verified through the physical laboratory test.

Key Metrics

Not Found

Predicate Device(s)

K221061

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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Image /page/0/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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

LG Electronics Inc. Hanseul Park RA Specialist 168, Suchul-Daero Gumi-Si, 39368 Korea. South

Re: K240130

February 15, 2024

Trade/Device Name: Medical Monitor (21HQ613D) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: January 5, 2024 Received: January 17, 2024

Dear Hanseul Park:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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 Imaging Software Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

2

Indications for Use

510(k) Number (if known) K240130

Device Name Medical Monitor (21HQ613D)

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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3

K240130

Image /page/3/Picture/1 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.

510(K) Summary

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Image /page/4/Picture/1 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "G" inside. To the right of the circle, the words "LG Electronics" are written in gray.

510(k) Summary

[As Required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

February 14, 2024

2. Submitter's Information [21 CFR 807.92(a)(1)]

Name of Applicant: LG Electronics Inc. .
- Address: 168, Suchul-Daero, Gumi-Si, KR 39368 -
- Contact Name: Hanseul Park / RA Specialist -
- Telephone No.: +82-10-9490-2109 -
- Email Address: hs.park@lge.com -

• Name of Manufacturer:	LG Electronics Inc.
- Address:	168, Suchul-Daero, Gumi-Si, KR 39368

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Common name	Medical Monitor
Trade Name	21HQ613D
Classification Name	Medical image management and
processing system
Classification Product Code	PGY
Regulation Number	21 CFR 892.2050
Device Class	II
510k Review Panel	Radiology

5

Image /page/5/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.

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: K221061 ●
Applicant: LG Electronics Inc. ●
Trade/Device Name: 21HQ613D ●
Classification Name: Medical image management and processing system
Regulation Number: 21 CFR 892.2050 ●
. Classification Product Code: PGY
Device Class: II ●
510(k) Review Panel: Radiology ●

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 fullfield digital mammography and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.

6

Image /page/6/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a stylized red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in a gray sans-serif font. The logo is simple and modern, and it is easily recognizable.

7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]

Compared with the predicate device, the technological characteristics of the proposed device are substantially equivalent to those of the predicate device. The proposed device is functionally similar to the predicate device. The table below presents comparisons for each device:

	Proposed Device	Predicate Device	SE Note
K Number	K240130	K221061	-
Manufacturer	LG Electronics Inc.	LG Electronics Inc.	-
Model Name	21HQ613D	21HQ613D	-
Classification
Name	Medical Image management and
processing system	Medical Image management and
processing system	Same
Classification
Number	21 CFR 892.2050	21 CFR 892.2050	Same
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.	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.	Same
Display
Technology	TFT (Thin Film Translator)
LCD (Liquid Crystal Display)
Screen	TFT (Thin Film Translator)
LCD (Liquid Crystal Display)
Screen	Same
Power
Consumption	MAX. 120W
Off Mode ≤ 0.3W	MAX. 120W
Off Mode ≤ 0.3W	Same
Screen size	473.4 x 364.5 mm	473.4 x 364.5 mm	Same
Pixel Pitch	0.165 x 0.165 mm	0.165 x 0.165 mm	Same
Resolution	Max.:
2,048 x 2,560 pixels @60Hz
(This is supported in DP IN 2 port
only)
Recommended:
2,048 x 2,560 pixels @48Hz
(This is supported in DP IN 1 port
only)
2,048 x 2,560 pixels @60Hz
(This is supported in DP IN 2 port
only)	Max.:
2,048 x 2,560 pixels @ 50Hz
(This is supported in both DP IN 1 and
DP IN 2 ports)
Recommended:
2,048 x 2,560 pixels @ 50Hz
(This is supported in both DP IN 1 and
DP IN 2 ports)	Different
Horizontal
Frequency	30 kHz to 135kHz	30 kHz to 135kHz	Same
Vertical
Frequency	24 Hz to 61 Hz	24 Hz to 61 Hz	Same
Input video
signals	DVI IN x 1,
DP IN x 2
DP OUT x 1	DVI IN x 1,
DP IN x 2
DP OUT x 1	Same
Calibration
Tool	LG Calibration Studio Medical /
DBI Calibration Feedback
System	PerfectLum	Different

[Table. Comparison of Proposed Device to Predicate Device]

7

Image /page/7/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a simple, sans-serif font and is positioned to the right of the circular logo.

The comparison table shows the proposed device (21HQ613D) has shares the same indications for use as the predicate device. Although there are some technological differences, they do not compromise the safety and performance of the proposed device. The major changes include: 1) calibration tools, which have been validated according to IEC 62304, and 2) its module, which also has been verified and validated through physical laboratory testing conducted according to the FDA Guidance. "Display Devices for Diagnostic Radiology".

Based on the physical laboratory test results and software validation reports, all the differences between the proposed and predicate device do not raise any concerns regarding safety and effectiveness of the device.

Therefore, the proposed device is substantially equivalent to the predicate device in terms of its indications for use and technological characteristics.

8. Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

The following data were provided in support of the substantial equivalence determination:

1. Electrical Safety and Electromagnetic Compatibility
  The test results demonstrated that the proposed device complies with the following standards:
IEC60601-1 Edition 3.2 2020-08 -
Medical electrical equipment - Part 1: General requirements for basic safety and essential
-IEC60601-1-2 Edition 4.1 2020-09
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

8

Image /page/8/Picture/0 description: The image shows the logo for LG Electronics. The logo consists of a stylized red circle with the letters "L" and "G" inside, followed by the words "LG Electronics" in gray. The text is written in a sans-serif font and is positioned to the right of the circular logo.

2) Software Validation

21HQ613D contain software that belongs to Basic Documentation Level. The software was designed and developed according to a software development process and was verified and validated.

Its calibration tools, LG Calibration Studio Medical and DBI Calibration Feedback System (CFS), belong to Basic Documentation Level. The software programs were verified and validated according to IEC 62304. Software information is provided in accordance with FDA guidance:

. The content of premarket submissions for Device Software Functions (June 14, 2023)
1. Cybersecurity

Cybersecurity documents are provided in accordance with the below FDA guidance:

· Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (September 27, 2023)
. Postmarket Management of Cybersecurity in Medical Devices (December 28, 2016)
1. Bench Test Performance Test
- · Physical Laboratory Test items suggested in the FDA guidance "Display Devices for Diagnostic Radiology" were tested on 21HQ613D using LG Calibration Studio Medical and DBI Calibration Feedback System.

Measurement	Description	Test result
1. 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.	PASS
2. 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	PASS
		with the visibility of small details in medical
images.
		Evaluate for image artifacts such as ghosting
and/or image sticking from displaying a fixed test
pattern for a period of time.
3.	Artifacts		PASS
		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 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.
For mammography displays, you should measure
the rise and fall time constants at several (e.g.,
every 15 levels) grayscale intervals between 0 and

| |
| 4. | Temporal response | | PASS |
| | | 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. | |
| 5. | Luminance | | PASS |
| 6. | 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. | PASS |
| 7. | Luminance at 30° and
45° in diagonal,
horizontal, and vertical
directions at center and
four corners | Measurements of the luminance response at off-
normal viewing related to the target model for the
luminance response. | PASS |
| 8. | Luminance uniformity
or Mura test | Measurements of the uniformity of the luminance
across the display screen. | PASS |
| 9. | Stability of luminance
and chromaticity
response with
temperature and time
of operation (on-time) | Measurements of the change in luminance and
chromaticity response with temperature and use
time. | PASS |
| 10. | Spatial noise | Measurements of the spatial noise level as
represented by the noise power spectrum using an
appropriate ratio of camera and display pixels.
Spatial noise and resolution affect the way images | PASS |
| | | | |
| | are presented to the viewer and can alter features
that are relevant to the interpretation process of the
physician or radiologist. | | |
| 11. Reflection coefficient | Measurements of the reflection coefficients of the
display device. Specular and diffuse reflection
coefficients can be used as surrogates for the full
bidirectional reflection distribution function. | PASS | |
| 12. Veiling glare or small-
spot contrast | Measurements of the contrast obtained for small
targets. | PASS | |
| 13. Color tracking
(primary colors and color
gamut) | 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. | PASS | |
| 14. Gray tracking (gray
shades and white point) | Chromaticity at different luminance levels of gray
shades, including the white point, as indicated by
the color coordinates in an appropriate units
system | PASS | |

Please refer to below table for the summary of its physical laboratory test results.

9

Image /page/9/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.

10

Image /page/10/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" and "G" inside, followed by the text "LG Electronics" in gray. The text is in a sans-serif font and is aligned to the right of the circular logo.

All display characteristics of 21HQ613D have met the pre-determined criteria. Therefore, the performance of the proposed 21HQ613D has been verified through the physical laboratory test.

9. Clinical Test Summary [21 CFR 807.92(b)(2)]

No clinical studies were considered necessary and performed.

10. Conclusion [21 CFR 807.92(b)(3)]

Based on the information provided in this premarket notification and in accordance with the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807, LG Electronics Inc. has determined that there are no significant differences between the proposed device and the predicate device that would negatively impact its use and safety. The proposed device has been proved to be as safe and effective as the predicate device, which was previously cleared in K221061. It shares the same indications for use and similar technological characteristics, with any differences supported by software validation reports and performance test results that demonstrate the proposed device's safety and effectiveness. Therefore, the technological differences between

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Image /page/11/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white "L" and "G" inside, followed by the text "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.

the proposed device and its predicate device do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate device.