(21 days)
Not Found
No
The summary describes a medical monitor for displaying images and mentions image processing, but there is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML algorithms. The performance study focuses on display characteristics, not algorithmic performance.
No.
The device is a medical monitor used for displaying radiological images for diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" states that the device is indicated for use in "displaying radiological images for review, analysis, and diagnosis." This explicitly includes diagnosis as an intended use.
No
The device is described as a "Medical Monitor" and the performance studies refer to testing on a specific model number ("21HQ513D"), indicating it is a hardware device with integrated software for displaying images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "displaying radiological images for review, analysis, and diagnosis". 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".
- Input Imaging Modality: The input is "radiological images", which are generated through imaging techniques like X-ray, CT, MRI, etc., not from biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a medical imaging display device, not an IVD.
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 (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
Not Found
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 IEC 60601-1:2005/AMD2:2020 and IEC 60601-1-2:2014.
- Software Validation: The 21HQ513D contains MODERATE level of concern software. The software was designed, developed, verified, and validated according to a software development process. Firmware updates have been made. The newly added calibration tool is also a moderate level of concern software, verified and validated according to IEC 62304.
- Bench Test – Performance Test Report: Performance items suggested in the FDA guidance "Display Devices for Diagnostic Radiology" were tested. All display characteristics of the 21HQ513D met the pre-defined criteria. The performance tests included:Spatial resolution (Pass), Pixel defects (Pass), Artifacts (Pass), Temporal response (Pass), Luminance (Pass), Conformance to a grayscale-to-luminance function (Pass), Color tracking (Pass), Gray tracking (Pass). Items N/A included: 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.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA) along with the Department of Health & Human Services. The FDA logo features a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" in blue, and "ADMINISTRATION" in a smaller font size below. To the left of the FDA logo is the symbol of the Department of Health & Human Services, which consists of a stylized human figure.
LG Electronics Inc. % Daseul An RA Associate LG Electronics 222, LG-ro, Jinwi-myeon PYEONGTAEK-SI, GYEONGGI-DO 17709 KOREA, SOUTH
Re: K223789
January 9, 2023
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: December 16, 2022 Received: December 19, 2022
Dear Daseul An:
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
1
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 Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number K223789 PGY
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)
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Image /page/3/Picture/1 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized "L" inside, next to the text "LG Electronics" in gray. The "L" in the circle is designed to resemble a winking face.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
December 16, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
| • Name of Sponsor: | LG Electronics Inc. |
|---|---|
| - Address: | 222, LG-ro, Jinwi-myeon, Pyeongtaek-si, |
| Gyeonggi-do, 17709, Republic of Korea | |
| • Name of Manufacturer: | LG Electronics Inc. |
| - Address: | 168, Suchul-daero, Gumi-si, Gyeongsangbuk-do, 39368 |
| Republic of Korea | |
| • Contact Name: | Daseul An / Regulatory Affairs Associate |
| - Telephone No.: | +82-10-8914-0116 |
| - Email Address: | daseul.an@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 |
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Image /page/4/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 slightly larger than the logo itself.
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: | K212295 |
|---|---|
| • Applicant: | LG Electronics |
| • Classification Name: | Medical image management and processing system |
| • Trade Name: | 21HQ513D |
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.
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Image /page/5/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 words "LG Electronics" in gray. The logo is simple and modern, and it is easily recognizable.
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
The comparison table shows the technical characteristics of the subject device are substantially equivalent to the predicate device. There are no significant differences between the subject device and the primary predicate device (K212295) that would adversely affect the use of the product. The change is to addition of the available calibration tool which is validated according to IEC 62304.
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | Not known | K212295 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 21HQ513D | 21HQ513D | - |
| 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 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. | Same | ||
| Power | |||
| Consumption | MAX. 120W | ||
| Off Mode ≤ 0.3W | MAX. 120W | ||
| Off Mode ≤ 0.3W | Same | ||
| Screen size | 676.9 x 459.7 mm | 676.9 x 459.7 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.2115 x 0.2115 mm | 0.2115 x 0.2115 mm | Same |
| Resolution | 1,536 x 2,048 pixels | 1,536 x 2,048 pixels | Same |
| Horizontal | |||
| Frequency | 30 kHz to 130 kHz | 30 kHz to 130 kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2 | ||
| DVI-IN x 1 | DisplayPort x 2 | ||
| DVI-IN x 1 | Same | ||
| Calibration Tool | PerfectLum 4.0 / LG Calibration | ||
| Studio Medical | PerfectLum 4.0 | Modified |
Table 1. Comparison of Proposed Device to Primary Predicate Device K212295
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Image /page/6/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 words "LG Electronics" in gray. The "L" and "G" are designed to resemble a winking face, with the "L" forming the nose and the "G" forming the face.
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
-
IEC 60601-1:2005/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance-Collateral Standard: Electromaqnetic disturbances -Requirements and tests
-
- Software Validation
The 21HQ513D contain MODERATE level of concern software, The software was designed and developed according to a software development process and was verified and validated. There have been firmware updates.
The newly added calibration tool is a moderate level of concern software. The software was verified and validated according to IEC 62304.
- The software information is provided in accordance with FDA quidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005.
3) Bench Test – Performance Test Report
The performance items suggested in the FDA quidance "Display Devices for Diagnostic Radioloqy" were tested on the 21HQ513D.
- -Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on September 28, 2022
| Measurements | Test Result | |
|---|---|---|
| a. | Spatial resolution | Pass |
| b. | Pixel defects | Pass |
| c. | Artifacts | Pass |
| d. | Temporal response | Pass |
| e. | Luminance | Pass |
| f. | Conformance to a grayscale-to-luminance function | Pass |
| g. | Luminance at 30° and 45° in diagonal, horizontal, and | |
| vertical directions at center and four corners | N/A | |
| h. | Luminance uniformity or Mura test | N/A |
| i. | Stability of luminance and chromaticity response with | |
| temperature and time of operation (on-time) | N/A | |
| j. | Spatial noise | N/A |
| k. | Reflection coefficient | N/A |
| l. | Veiling glare or small-spot contrast | N/A |
| m. | Color tracking | Pass |
| n. | Gray tracking | Pass |
All display characteristics of the 21HQ513D have met the pre-defined criteria. Therefore, the performance of 21HQ513D was verified through the performance test.
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Image /page/7/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.
Clinical Test Summary:
No clinical studies were considered necessary and performed.
9. Conclusion [21 CFR 807.92(b)(3)]
The Medical Monitor 21HQ513D is found to be substantially equivalent in safety and effectiveness to the predicate devices based on the information provided in this premarket notification.