(55 days)
Not Found
No
The device description clearly states it is an LCD monitor that displays images from medical equipment. There is no mention of AI, machine learning, or deep learning in the document. The software validation section indicates the presence of software but does not imply AI functionality.
No
The device is a medical monitor intended to display images from medical equipment and imaging systems, not to provide therapy.
No
Explanation: This device is a monitor intended for displaying images from medical equipment, not for interpreting or analyzing those images to make a diagnosis. Its function is display, not diagnostic.
No
The device is a hardware medical device (an LCD monitor) designed to display video and images from medical equipment. While it contains software, the software's purpose is to operate the hardware, not to independently perform a medical function as a standalone software product. The testing includes electrical safety and electromagnetic compatibility which are specific to hardware devices.
No.
The device is a medical monitor that displays images from various medical equipment, such as laparoscopic and endoscopic systems. It does not perform in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
32HS710S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDMI, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
laparoscopy and endoscopy systems for surgery and various medical imaging systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- IEC60601-1 Edition 3.2 2020-08 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC TR 60601-4-2 Edition 1.0 2016-05 Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
The software was designed and developed according to a software development process and was verified and validated according to IEC 62304.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
FDA 510(k) Clearance Letter - Medical Monitor (32HS710S)
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
June 12, 2025
LG Electronics Inc.
Daseul An
RA Specialist
168, Suchul-daero
Gumi-si, Gyeongsangbuk-do 39368
Korea, South
Re: K251209
Trade/Device Name: Medical Monitor (32HS710S)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: GCJ
Dated: April 15, 2025
Received: April 18, 2025
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 (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"
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K251209 - Daseul An Page 2
(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).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-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 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.
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K251209 - Daseul An Page 3
See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.06.12 12:30:14 -04'00'
Tanisha Hithe
Assistant Director
DHT4A: Division of General Surgery Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.
510(k) Number (if known)
K251209
Device Name
Medical Monitor (32HS710S)
Indications for Use (Describe)
This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
510(k) #: K251209 Prepared on: 2025-06-09
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | LG Electronics Inc. |
| Applicant Address | 168, Suchul-daero Gumi-si Gyeongsangbuk-do 39368 Korea, South |
| Applicant Contact Telephone | +82-1089140116 |
| Applicant Contact | Mrs. Daseul An |
| Applicant Contact Email | DL-FDA@lge.com |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | Medical Monitor (32HS710S) |
| Common Name | Endoscope and accessories |
| Classification Name | Laparoscope, General & Plastic Surgery |
| Regulation Number | 876.1500 |
| Product Code(s) | GCJ |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K241402 | 32HR734S | GCJ |
Device Description Summary
21 CFR 807.92(a)(4)
32HS710S LCD monitor is intended to provide color video displays of images from surgical endoscope, laparoscopic camera system and other compatible medical imaging systems. This Medical Monitor has multiple video interface ports such as Display port, HDMI, DVI and SDI. This monitor displays color video and images from medical equipment which include various medical imaging systems. This monitor can be covered over 100% of the sRGB spectrum.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
This medical monitor is intended to provide color video displays and images from medical equipment which include laparoscopy and endoscopy systems for surgery and various medical imaging systems.
Indications for Use Comparison
21 CFR 807.92(a)(5)
When comparing the indications for use statements, the terminology demonstrates that the proposed device shares the same indications for use as the predicate device. Therefore, it supports the determination of substantial equivalence between the proposed device and predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The comparison tables show some differences in specifications such as resolution, connectors, maximum power consumption and physical specifications (weight). However, these differences do not affect the safe and effective use of the device. The performance of 32HS710S has been validated in the software validation report. In addition, the safety of 32HS710S has been confirmed through the test according to IEC 60601-1 and 60601-1-2.
Page 6
Those reports confirm that all the differences between the proposed and predicate devices do not affect safety and effectiveness of the device.
Therefore, the proposed device is substantially equivalent to the predicate device in terms of technological characteristics.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
The following data were provided in support of the substantial equivalence determination:
1) Electrical Safety and Electromagnetic Compatibility
Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
-
IEC60601-1 Edition 3.2 2020-08
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance -
IEC60601-1-2 Edition 4.1 2020-09
Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests -
IEC TR 60601-4-2 Edition 1.0 2016-05
Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
2) Software Validation
32HS710S contain software that belongs to Basic Documentation Level. The software was designed and developed according to a software development process and was verified and validated according to IEC 62304. Software information is provided in accordance with FDA guidance:
- The content of premarket submissions for Device Software Functions (June 14, 2023)
No clinical studies were considered necessary, and therefore, none were conducted.
Based on the information provided in this premarket notification and in accordance with the Federal Food, Drug, and Cosmetic Act, 21 CFR Part 807, LG Electronics Inc. has determined that there are no significant differences between the proposed device and the predicate device that would adversely affect its effectiveness and safety. The proposed device has been proved to be as safe and effective as the predicate devices, which was previously cleared in K241402. They shares the same indications for use and similar technological characteristics, with any differences supported by software validation reports that demonstrate the proposed device's safety and effectiveness. Therefore, the technological differences between the proposed device and its predicate device do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate devices.