(80 days)
Not Found
No
The document describes a medical monitor for displaying images and mentions standard electrical safety, software validation, and display performance testing. There is no mention of AI, ML, or related concepts like training/test sets for algorithmic performance.
No
The device is a medical monitor used for displaying radiological images for diagnosis, not for providing therapy.
No
Explanation: The device is a medical monitor intended for displaying radiological images for review, analysis, and diagnosis by trained medical practitioners. It is not directly making a diagnosis itself, but rather facilitating the diagnostic process for human professionals.
No
The device is described as a "Medical Monitor" and the performance studies include electrical safety and electromagnetic compatibility testing (IEC 60601-1 and IEC 60601-1-2), which are standard tests for hardware medical devices. The description also mentions "high resolution color and grayscale medical imaging," implying a physical display component. While software validation is mentioned, the overall description and testing point to a hardware device with integrated software.
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. This involves interpreting images of the human body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description reinforces the use for displaying medical images from PACS and Radiology systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health status. This medical monitor's function is to display images generated by other diagnostic modalities (like X-ray, CT, MRI), which are then interpreted by a medical professional.
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
Radiological images
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/AMD2:2020
- Electromagnetic Compatibility Testing in accordance with EN 60601-1-2:2015(IEC 60601-1-2:2014)/ EN 60601-1-2:2015/A1:2021 (IEC 60601-1-2:2014/AMD1:2020)
- 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+A2:2020
- Software Validation
The software was designed and developed according to IEC 62304 software development process and was verified and validated. According to the guidance, we evaluated the level of Basic level documentation by identifying safety-related characteristics for device documentation level.
- The software information is provided in accordance with FDA guidance: Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff', issued on JUNE 2023.
- Guidance
- Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff, issued on SEPT 2022.
Measurements performed:
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) - Equivalent
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 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. - Equivalent
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. 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
g. 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
Key Result: According to the above test results, there are no significant performance differences between 24HR513C and the predicate devices that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate devices.
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). 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. % JongHyun Kim Chief Consultant GMS Consulting #B-612, 66 Chengcho-ro Gyeonggi-do, Goyang-si 10543 Korea, South
Re: K232985
December 11, 2023
Trade/Device Name: 24hr513c Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: November 22, 2023 Received: November 22, 2023
Dear JongHyun Kim:
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 OS 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 (OS) 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 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, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological 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) K232985
Device Name 24HR513C
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)
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3
K232985 510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
SEPT 22, 2023
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Sponsor: ● LG Electronics Inc.
- 222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek si, -Address:
- 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: 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, -39368, Republic of Korea
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: 24HR513C
- 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 |
4
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow;
Primary Predicate Device
| 510(k) Number:
| • | K223789 |
|---|---|
| Applicant: | |
| • | LG Electronics |
| Classification Name: | |
| • | Medical image management and processing system |
| Trade Name: | |
| • | 21HQ513D |
| Secondary Predicate Device |
| • 510(k) Number: | K221136 |
|---|---|
| • Applicant: | EIZO Corporation |
| • Classification Name: | Medical image management and processing system |
| • Trade Name: | RadiForce MX243W |
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.
5
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (24HR513C) and the legally marketed predicate devices (K223789 and K221136):
| Proposed Device | Primary Predicate Device | ||
|---|---|---|---|
| K Number | K232985 | K223789 | |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | |
| Model Name | 24HR513C | 21HQ513D | |
| 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 | ||
| indicated for use in displaying | |||
| radiological images for review, | |||
| analysis, and diagnosis by | |||
| trained medical practitioners. | |||
| The display is not intended for | |||
| mammography. | |||
| Power Consumption | MAX. 65W | ||
| Sleep Mode (Standby Mode): | |||
| ≤ 0.5W | |||
| Off Mode ≤ 0.3W | MAX. 120W | ||
| Off Mode ≤ 0.3W | |||
| LCD Screen | TFT LCD | TFT LCD | |
| Pixel Pitch | 0.27 x 0.27 mm | 0.2115 x 0.2115 mm | |
| Resolution | Max | ||
| Resolution/ | |||
| Recommended | |||
| Resolution | 1920 x 1200 | ||
| @ 60Hz | |||
| ([Screen | |||
| Rotation]: | |||
| [Landscape]) | |||
| 1200 x 1920 | |||
| @ 60Hz | |||
| ([Screen | |||
| Rotation]: | |||
| [Portrait - | |||
| 90°], | |||
| [Portrait +90 | |||
| °]) | 1,536 x 2,048 pixels | ||
| Horizontal Frequency | 30 kHz to 83kHz | ||
| ([Screen Rotation]: | |||
| [Landscape]) | |||
| 30 kHz to 120kHz ([Screen | |||
| Rotation]: [Portrait -90°], | |||
| [Portrait +90 °]) | 30 Hz to 130 Hz | ||
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | |
| Input video signals | DVI IN x 1 | DisplayPort x 2 |
6
| | DP IN x 1
HDMI x 1 | DVI-IN x 1 | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Calibration tools | Calibration software:
LG Calibration Studio Medical | Calibration software:
PerfectLum / LG Calibration
Studio Medical | |
| | Proposed Device | Secondary Predicate Device | |
| K Number | K232985 | K221136 | |
| Manufacturer | LG Electronics Inc. | EIZO Corporation | |
| Model Name | 24HR513C | RadiForce MX243W | |
| 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 Product is indicated for
use in displaying radiological
images for review, analysis,
and diagnosis by trained
medical practitioners. The
display is not intended for
mammography. | |
| Power Consumption | MAX. 65W
Sleep Mode (Standby Mode): ≤
0.5W
Off Mode ≤ 0.3W | MAX. 56W
Off Mode: 0.6W or less | |
| LCD Screen | TFT LCD | TFT LCD | |
| Pixel Pitch | 0.27 x 0.27 mm | 0.27 x 0.27 mm | |
| Resolution | Max
Resolution/
Recommended
Resolution | 1920 x 1200
@ 60Hz
([Screen
Rotation]:
[Landscape])
1200 x 1920
@ 60Hz
([Screen
Rotation]:
[Portrait -
90o],
[Portrait +90
o]) | 1920 x 1200 |
| Horizontal Frequency | 30 kHz to 83kHz
([Screen Rotation]:
[Landscape])
30 kHz to 120kHz ([Screen
Rotation]: [Portrait -90o],
[Portrait +90 o]) | 31 - 76 kHz | |
| Vertical Frequency | 56 Hz to 61 Hz | 59 - 61 Hz | |
| Input video signals | DVI IN x 1
DP IN x 1
HDMI x 1 | DVD-D x 1
DisplayPort x 1 | |
| Output video signals | DP Out x 1 | DisplayPort x 1 | |
| Calibration tools | Calibration software: | Calibration software: RadiCS | |
The comparison table shows that the subject device (24HR513C) has the similar indications for use the primary predicate device. Although the devices have some different technological characteristics (Power Consumption, Pixel Pitch, Resolution, horizontal/vertical frequency and input/output 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. 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
|--|
8
| LG Calibration Studio Medical | |
|---|---|
| The comparison table shows that the subject device (24HR513C) has the similar indications for use | |
| the Secondary predicate device. Although the devices have some different technological | |
| characteristics (Power Consumption, Pixel Pitch, Resolution, horizontal/vertical frequency and |
input/output 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. 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.
9
8. Non-Clinical Test summary
1) 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/AMD2:2020
- -Electromagnetic Compatibility Testing in accordance with EN 60601-1-2:2015(IEC 60601-1-2:2014)/ EN 60601-1-2:2015/A1:2021 (IEC 60601-1-2:2014/AMD1:2020)
- -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+A2:2020
2) Software Validation
The software was designed and developed according to IEC 62304 software development process and was verified and validated. According to the guidance, we evaluated the level of Basic level documentation by identifying safety-related characteristics for device documentation level.
- -The software information is provided in accordance with FDA guidance: Content of Premarket Submissions for Device Software Functions: Guidance for Industry and Food and Drug Administration Staff', issued on JUNE 2023.
3) Guidance
- Display Devices for Diagnostic Radiology Guidance for Industry and Food and Drug Administration Staff, issued on SEPT 2022.
| 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) | Equivalent | |
| 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 | Same |
According to the quidance, we test following performance items:
10
| Measurements | Description | SE Note |
|---|---|---|
| displaying a fixed test pattern for a period of time. | ||
| (Using 5x5 mosaic pattern, 64Gray / 127 Gray judgment) | ||
| 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 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. | Equivalent |
| 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. 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 |
| g. 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 |
According to the above test results, there are no significant performance differences between 24HR513C and the predicate devices that would adversely affect the use of the product. It has substantially equivalent performance compared to the predicate devices.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
11
9. 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 24HR513C is substantially equivalent in safety and effectiveness to the predicate devices as described herein.