(53 days)
Not Found
No
The document 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. The performance studies focus on display characteristics and software validation, not AI/ML model performance.
No.
The device is a medical monitor used for displaying radiological images for review and diagnosis, not for providing therapy.
Yes
This device is specifically indicated for "review, and diagnosis by trained medical practitioners" of radiological images, including mammography and tomosynthesis, which are used for diagnostic purposes. The device's function is to display these images for the purpose of making a diagnosis.
No
The device is described as a "Medical Monitor" and the performance studies include measurements related to hardware characteristics like spatial resolution, luminance, and pixel defects, indicating it is a physical display device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The described device is a medical monitor used for displaying radiological images. Its function is to present visual information to a trained medical practitioner for review and diagnosis. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "displaying radiological images... for review, and diagnosis." This is a display function, not an in vitro diagnostic test.
- Device Description: The description reinforces that it's a "Medical monitor is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system."
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, performing chemical reactions, or using reagents, which are typical characteristics of IVD devices.
Therefore, this device falls under the category of a medical imaging display device, not an in vitro diagnostic device.
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, and diagnosis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
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 (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 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 21HQ613D contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.
- Guidance: Performance items were tested according to "Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017". These items include Spatial resolution, Pixel defects, Artifacts, Temporal response, Luminance, Conformance to a grayscale-to-luminance fuction, 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: According to the test results, there are no significant performance differences between 21HQ613D 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): 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
LG Electronics Inc. % Jonghyun Kim Chief Consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 KOREA
Re: K221061
June 3, 2022
Trade/Device Name: 21HO613D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: April 7, 2022 Received: April 11, 2022
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 (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
1
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 (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 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,
For
Michael D. O'Hara, Ph.D. Deputy Director DHT 8C: Division of Radiological Imaging and Radiation Therapy Devices OHT 8: Office of 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) K221061
Device Name 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, 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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3
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
April 07, 2022
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: | 21HQ613D |
|---|---|
| ------------- | ---------- |
- Common Name: ●
Medical Monitor
Republic of Korea
- 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;
RX560
EIZO Corporation
Medical image management and processing system.
Primary Predicate Device
| 510(k) Number: | |
|---|---|
| -- | ---------------- |
- Applicant:
- Classification Name: ●
- Trade Name: ●
Predicate Device
●
●
●
- K201777 510(k) Number: Applicant: LG Electronics Classification Name: Medical image management and processing system. Trade Name: 31HN713D
- ●
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 mammoqraphy and digital breast tomosynthesis) for review, analysis, and diagnosis by trained medical practitioners.
5
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The table below presents comparisons between the subject device (21HQ613D) and the legally marketed predicate devices (K172738 and K201777):
| Proposed Device | Primary Predicate Device | |
|---|---|---|
| K Number | Not known | K172738 |
| Manufacturer | LG Electronics Inc. | EIZO Corporation |
| Model Name | 21HQ613D | RX560 |
| 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 | ||
| (including full-field digital mammography | ||
| and digital breast tomosynthesis) for | ||
| review, analysis, and diagnosis by trained | ||
| medical practitioners. | This product is intended to be used in | |
| displaying and viewing digital images, | ||
| including standard and multiframe digital | ||
| mammography, for review, analysis and | ||
| diagnosis by trained medical | ||
| practitioners. It is specially designed for | ||
| breast tomosynthesis applications. | ||
| Display Technology | The 21HQ613D has a TM213XDGP31 | |
| module for displaying. The | ||
| TM213XDGP31 is a " TFT Liquid Crystal | ||
| Display module with LED Backlight unit | ||
| and one 30pin eDP port and 4ch-LVDS | ||
| interface. This module supports | ||
| 2048x2560 5M Pixel mode and can | ||
| display color driven by 10bit drivers. The | ||
| LCD module includes built-in converter | ||
| for Backlight | This is a color LCD monitor for viewing | |
| digital images, including standard and | ||
| multiframe digital mammography, for | ||
| review, analysis and diagnosis. The color | ||
| panel employs in-plane switching (IPS) | ||
| technology allowing wide viewing angles | ||
| and the matrix size (or resolution) is | ||
| 2048x2560 pixels. | ||
| Power Consumption | MAX. 120W | |
| Off Mode ≤ 0.3W | 87 W / Less than 1 W | |
| Screen size | 473.4 x 364.5 mm | 337.9 mm x 422.4 mm |
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm |
| Resolution | 2,048 x 2,560 pixels | 2,048 x 2,560 |
| Horizontal Frequency | 30 kHz to 135kHz | 31 kHz to 135 kHz |
| Vertical Frequency | 24 Hz to 61 Hz | 59 Hz to 61 Hz |
| Input video signals | DVI IN x 1, | |
| DP IN x 2 | ||
| DP OUT x 1 | DVI x 1 | |
| DP IN x 1 | ||
| DP OUT x 1 |
[Table 1. Comparison of Proposed Device to Primary Predicate Device]
The comparison table shows that the subject device (21HQ613D) has the similar indications for use the primary predicate device. Although the devices have some different technological characteristics (screen size, pixel pitch, Resolution, horizontal/vertical frequency and 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. 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.
6
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known | K201777 |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. |
| Model Name | 21HQ613D | 31HN713D |
| 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 (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. |
| Display Technology | The 21HQ613D has a TM213XDGP31 module for displaying. The TM213XDGP31 is a " TFT Liquid Crystal Display module with LED Backlight unit and one 30pin eDP port and 4ch-LVDS interface. This module supports 2048x2560 5M Pixel mode and can display color driven by 10bit drivers. The LCD module includes built-in converter for Backlight | 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. |
| Power Consumption | MAX. 120W | |
| Off Mode ≤ 0.3W | MAX. 150W | |
| Sleep Mode ≤ 0.5W | ||
| Off Mode ≤ 0.3W | ||
| Screen size | 473.4 x 364.5 mm | 676.9 x 459.7 mm |
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.165 x 0.165 mm | 0.1554 x 0.1554 mm |
| Resolution | 2,048 x 2,560 pixels | 4,200 x 2,800 pixels |
| Horizontal Frequency | 30 kHz to 135kHz | 30 kHz to 135kHz |
| Vertical Frequency | 24 Hz to 61 Hz | 56 Hz to 61 Hz |
| Input video signals | DVI IN x 1, | |
| DP IN x 2 | ||
| DP OUT x 1 | DisplayPort x 2 | |
| HDMI x 1 |
| [Table 2. Comparison of Proposed Device to Predicate Device] | ||||
|---|---|---|---|---|
| -------------------------------------------------------------- | -- | -- | -- | -- |
The comparison table shows that the subject device (21HQ613D) has the similar indications for use the predicate device. Although the devices have some different technological characteristics (screen size, pixel pitch, Resolution, horizontal/vertical frequency and 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. 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. Non-Clinical Test summary
-
- Electrical Safety and Electromagnetic Compatibility
The test results demonstrated that the proposed device complies with the following standards:
- Electrical Safety and Electromagnetic Compatibility
-
· 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 21HQ613D 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 guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
-
- 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) | 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 | Equivalent | ||
| 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. | 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. | 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. | Equivalent | ||
| h. | Luminance uniformity or | ||
| Mura test | Measurements of the uniformity of the | ||
| luminance across the display screen. | Equivalent | ||
| i. | 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. | Same | ||
| j. | 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 | |||
| are presented to the viewer and can | |||
| alter features that are relevant to the | |||
| interpretation process of the physician | |||
| or radiologist. | Equivalent | ||
| k. | 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. | Same | ||
| l. | Veiling glare or small-spot | ||
| contrast | Measurements of the contrast obtained | ||
| for small targets. | Equivalent | ||
| m. | 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 | ||
| n. | Gray tracking | Chromaticity at different luminance | |
| levels of gray shades, including the | |||
| white point, as indicated by the color | |||
| coordinates in an appropriate units | |||
| system | Equivalent |
According to the guidance, we test following performance items:
8
9
According to the above test results, there are no significant performance differences between 21HQ613D 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.
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 21HQ613D is substantially equivalent in safety and effectiveness to the predicate devices as described herein.