(30 days)
32HL512D: 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.
31HN713D, 32HQ713D: 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.
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.
The provided text describes a medical monitor device (32HL512D, 31HN713D, 32HQ713D) and its associated software, "LG Calibration Studio Medical," which is used for calibration. The acceptance criteria and the study performed relate to the performance of the medical monitor and the calibration software, not an AI algorithm for image analysis. Therefore, there is no information about AI-specific aspects such as training sets, ground truth establishment for AI, or comparative effectiveness studies with human readers assisted by AI.
Here's the information derived from the text regarding the device and its software:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the medical monitors are derived from the FDA guidance "Display Devices for Diagnostic Radiology." The reported performance for all three models (32HL512D, 31HN713D, 32HQ713D) is that they "Pass" all tested measurements.
| Measurements | Acceptance Criteria | Reported Device Performance (32HL512D, 31HN713D, 32HQ713D) |
|---|---|---|
| a. Conformance to a grayscale-to-luminance function | Conformance to a grayscale-to-luminance function (implied by FDA guidance requirements) | Pass |
| b. Luminance uniformity or Mura test | Luminance uniformity or Mura test (implied by FDA guidance requirements) | Pass |
| c. Stability of luminance and chromaticity response with temperature and time of operation (on-time) | Stability of luminance and chromaticity response with temperature and time of operation (on-time) (implied by FDA guidance requirements) | Pass |
| d. Spatial noise | Spatial noise (implied by FDA guidance requirements) | Pass |
| e. Veiling glare or small-spot contrast | Veiling glare or small-spot contrast (implied by FDA guidance requirements) | Pass |
Note: The document states, "All display characteristics of the 32HL512D, 31HN713D and 32HQ713D have met the predefined criteria. Therefore, the performance of 32HL512D, 31HN713D and 32HQ713D were verified through the performance test." The FDA guidance "Display Devices for Diagnostic Radiology" serves as the basis for these predefined criteria.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated as the testing is on the physical device's characteristics rather than a dataset of medical images. The tests were performed on one or more units of each model (32HL512D, 31HN713D, 32HQ713D).
- Data Provenance: Not applicable in the context of device performance testing. The "data" here refers to measurements taken directly from the physical monitors during bench testing. The tests adhere to international standards (e.g., IEC standards) and FDA guidance for medical display devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. The ground truth for the performance of the medical monitors is established by objective physical measurements against established technical standards and FDA guidance, not by expert interpretation of images.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in image interpretation. This study involves objective technical measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. There is no mention of an MRMC study. The devices are medical monitors for displaying images, not AI algorithms.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
A standalone performance test was done for the device, focusing on its technical display characteristics. The "LG Calibration Studio Medical" software (a moderate level of concern software) was also verified and validated, but this is a calibration tool, not an image analysis algorithm. Therefore, "standalone (i.e. algorithm only without human-in-the-loop performance)" is applicable to the technical performance of the monitor as a device, and to the verification and validation of the calibration software, but not in the context of AI for medical image interpretation.
7. The Type of Ground Truth Used
The ground truth used for the device's performance testing is based on objective physical measurements and technical specifications set forth by international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304) and the FDA guidance "Display Devices for Diagnostic Radiology."
8. The Sample Size for the Training Set
Not applicable, as this is not an AI algorithm for image analysis. The "LG Calibration Studio Medical" is software, validated according to IEC 62304, but the text does not describe a "training set" in the machine learning sense for this calibration software.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set for an AI algorithm mentioned in relation to the devices or their calibration software.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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. % Daseul An RA Specialist LG Electronics 222, LG-ro, Jinwi-myeon Pyeongtaek-si, Gyeonggi-do 17709 KOREA
April 27, 2023
Re: K230845
Trade/Device Name: 32HL512D, 31HN713D, 32HO713D Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: March 24, 2023 Received: March 28, 2023
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801 and Part 809); 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-reporting-
combination-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.
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
Enclosure
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Indications for Use
510(k) Number (if known) K230845
Device Name 32HL512D, 31HN713D, 32HQ713D
Indications for Use (Describe) 32HL512D
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.
31HN713D, 32HQ713D
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.
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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Image /page/3/Picture/0 description: The image shows the text "K230845" at the top. Below the text is 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.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
March 24, 2023
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, 39368Republic of Korea |
| ● | Contact Name: | Daseul An / Regulatory Affairs Specialist |
| - | 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: 32HL512D, 31HN713D, 32HQ713D ●
- 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 smaller than the circle logo.
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 for 32HL512D
| • | 510(k) Number: | K192925 |
|---|---|---|
| • | Applicant: | LG Electronics |
| • | Classification Name: | Medical image management and processing system |
| • | Trade Name: | 32HL512D |
Predicate Device for 31HN713D
| • 510(k) Number: | K201777 |
|---|---|
| • Applicant: | LG Electronics |
| • Classification Name: | Medical image management and processing system |
| • Trade Name: | 31HN713D |
Predicate Device for 32HQ713D
| 510(k) Number: | K223423 |
|---|---|
| Applicant: | LG Electronics |
| Classification Name: | Medical image management and processing system |
| Trade Name: | 32H0713D |
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)]
- 32HL512D
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.
- 31HN713D, 32HQ713D
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.
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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 "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 devices and the primary predicate devices that would adversely affect the use of the product. The main change is the addition of the available calibration tool which is validated according to IEC 62304.
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K192925 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 32HL512D | 32HL512D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | Same |
| PowerConsumption | MAX. 65WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | MAX. 65WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | Same |
| Screen size | 718.2 x 414.3 mm | 718.2 x 414.3 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.18159 x 0.18159 mm | Same |
| Resolution | 3,840 x 2,160 pixels | 3,840 x 2,160 pixels | Same |
| HorizontalFrequency | 30 kHz to 135 kHz | 30 kHz to 135 kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2HDMI x 1 | DisplayPort x 2HDMI x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical | PerfectLum | Modified |
Table 1. Comparison of Proposed Device to Primary Predicate Device (32HL512D)
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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 white "L" and "." 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.
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K201777 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 31HN713D | 31HN713D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | Same |
| PowerConsumption | MAX. 150WSleep Mode ≤ 0.5WOff Mode ≤ 0.3W | MAX. 150WSleep Mode ≤ 0.5WOff 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 | 0.1554 x 0.1554 mm | 0.1554 x 0.1554 mm | Same |
| Resolution | 4,200 x 2,800 pixels | 4,200 x 2,800 pixels | Same |
| HorizontalFrequency | 30 kHz to 175 kHz | 30 kHz to 175 kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DisplayPort x 2HDMI x 1 | DisplayPort x 2HDMI x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical | PerfectLum | Modified |
Table 2. Comparison of Proposed Device to Primary Predicate Device (31HN713D)
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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 a stylized white "L" and "." 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.
| Proposed Device | Predicate Device | Equivalence | |
|---|---|---|---|
| K Number | TBD | K223423 | - |
| Manufacturer | LG Electronics Inc. | LG Electronics Inc. | - |
| Model Name | 32HQ713D | 32HQ713D | - |
| ClassificationName | Medical image management andprocessing system | Medical image management andprocessing system | Same |
| ClassificationNumber | 21 CFR 892.2050 | 21 CFR 892.2050 | Same |
| Indications for Use | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | This Medical Monitor is indicatedfor use in displaying radiologicalimages for review, analysis, anddiagnosis by trained medicalpractitioners. The display is notintended for mammography. | Same |
| PowerConsumption | MAX. 120WOff Mode ≤ 0.3W | MAX. 120WOff Mode ≤ 0.3W | Same |
| Screen size | 730.7 x 425.2 mm | 730.7 x 425.2 mm | Same |
| LCD Screen | TFT LCD | TFT LCD | Same |
| Pixel Pitch | 0.18159 x 0.18159 mm | 0.18159 x 0.18159 mm | Same |
| Resolution | 3,840 x 2,160 pixels | 3,840 x 2,160 pixels | Same |
| HorizontalFrequency | 30 kHz to 135kHz | 30 kHz to 135kHz | Same |
| Vertical Frequency | 56 Hz to 61 Hz | 56 Hz to 61 Hz | Same |
| Input video signals | DVI IN x 1,DP IN x 1DP OUT x 1 | DVI IN x 1,DP IN x 1DP OUT x 1 | Same |
| Calibration Tool | PerfectLum / LG Calibration StudioMedical | PerfectLum | Modified |
Table 2. Comparison of Proposed Device to Primary Predicate Device (32HQ713D)
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Image /page/8/Picture/0 description: The image shows the LG Electronics logo. The logo consists of a red circle with a stylized white face inside, next to the text "LG Electronics" in gray. The text is in a sans-serif font and is aligned horizontally with the circle.
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 32HL512D, 31HN713D and 32HQ713D contain a 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 since FDA 510(K) clearance.
The LG Calibration Studio Medical and PerfectLum are moderate level of concern software programs. The software programs were 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 Radiology" were tested on the 32HL512D, 31HN713D and 32HQ713D using PerfectLum and LG Calibration Studio Medical.
- -32HL512D
| Measurements | Test Result |
|---|---|
| a. Conformance to a grayscale-to-luminance function | Pass |
| Measurements | Test Result |
| a. Conformance to a grayscale-to-luminance function | Pass |
| b. Luminance uniformity or Mura test | Pass |
| c. Stability of luminance and chromaticity response withtemperature and time of operation (on-time) | Pass |
| d. Spatial noise | Pass |
| e. Veiling glare or small-spot contrast | Pass |
- 31HN713D
32HQ713D
| Measurements | Test Result | |
|---|---|---|
| a. | Conformance to a grayscale-to-luminance function | Pass |
| b. | Luminance uniformity or Mura test | Pass |
| c. | Stability of luminance and chromaticity response withtemperature and time of operation (on-time) | Pass |
| d. | Spatial noise | Pass |
| e. | Veiling glare or small-spot contrast | Pass |
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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 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.
All display characteristics of the 32HL512D, 31HN713D and 32HQ713D have met the predefined criteria. Therefore, the performance of 32HL512D, 31HN713D and 32HQ713D were verified through the performance test.
Display Devices for Diagnostic Radiology – Guidance for Industry and Food and Drug Administration Staff, issued on September 28, 2022
Clinical Test Summary:
No clinical studies were considered necessary and performed.
9. Conclusion [21 CFR 807.92(b)(3)]
The Medical Monitor 32HL512D, 31HN713D and 32HQ713D are found to be substantially equivalent in safety and effectiveness to the predicate devices based on the information provided in this premarket notification.
§ 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).