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.

Device Description

27HS714S 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, HDM, 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 99% of the sRGB spectrum.

AI/ML Overview

This document, K243439, is a 510(k) premarket notification for a medical monitor (27HS714S). The information provided focuses on demonstrating substantial equivalence to a predicate device (K241402) rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested elements regarding acceptance criteria for AI/ML performance, ground truth establishment, expert adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as the device is a monitor, not an AI/ML-driven diagnostic tool.

However, I can extract information related to the device's functional performance and safety validations:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for performance in the sense of diagnostic accuracy or output quality against a ground truth, as it is a display monitor. Instead, the acceptance criteria are implied by compliance with established medical device standards for electrical safety, electromagnetic compatibility, and software validation. The "reported device performance" is essentially that it met these standard requirements.

Acceptance Criteria Category	Specific Standard/Requirement Met	Reported Device Performance Summary
Electrical Safety	IEC60601-1 Edition 3.2 2020-08	Verified by bench tests; complies with standard.
Electromagnetic Compatibility (EMC)	IEC60601-1-2 Edition 4.1 2020-09	Verified by bench tests; complies with standard.
	IEC TR 60601-4-2 Edition 1.0 2016-05	Verified by bench tests; complies with standard.
Software Validation	IEC 62304	Software designed, developed, verified, and validated according to standard.
	FDA Guidance: "The content of premarket submissions for Device Software Functions (June 14, 2023)"	Software information provided in accordance with FDA guidance.
Image Display (Color Spectrum)	Not a formal "acceptance criteria" but a performance characteristic mentioned.	Can be covered over 99% of the sRGB spectrum.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. The document describes bench tests for electrical safety, EMC, and software validation, not a test set of clinical cases or data for AI/ML performance.
Data Provenance: Not applicable for AI/ML data. The tests are laboratory/bench-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/ML (e.g., disease presence/absence determined by experts) is not relevant for this device's validation. Validation was against technical standards.

4. Adjudication method for the test set

Not applicable. There was no expert adjudication of clinical cases.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a medical monitor, not an AI-assisted diagnostic tool. No MRMC study was conducted or is relevant for its performance validation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device. Its "performance" relates to its ability to display images accurately and safely, not to independently analyze data.

7. The type of ground truth used

The "ground truth" for this device's validation were the requirements of the specified international standards (IEC 60601-1, IEC 60601-1-2, IEC TR 60601-4-2, IEC 62304) and FDA guidance documents. Compliance with these standards served as the benchmark for acceptance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Device's Validation Study (as described in the document):

The study to prove the device (Medical Monitor 27HS714S) meets acceptance criteria primarily consists of bench tests and software validation.

Purpose: To demonstrate the device's compliance with electrical safety, electromagnetic compatibility, and software development standards, and thus its substantial equivalence to the predicate device.
Methodology:
- Electrical Safety & EMC: Bench tests were conducted against harmonized standards: IEC60601-1 Edition 3.2 2020-08, IEC60601-1-2 Edition 4.1 2020-09, and IEC TR 60601-4-2 Edition 1.0 2016-05. These tests verify the device's safe operation and its ability to function correctly in its electromagnetic environment.
- Software Validation: The software was designed, developed, verified, and validated according to IEC 62304, a standard for medical device software life cycle processes. Information was provided in accordance with FDA guidance "The content of premarket submissions for Device Software Functions (June 14, 2023)."
Results: The tests demonstrated that the proposed device complies with all specified standards.
Clinical Studies: None were considered necessary or conducted, as the device's function as a display monitor does not typically require clinical performance studies for safety and effectiveness demonstration in a 510(k) context, especially when demonstrating substantial equivalence. The document explicitly states: "No clinical studies were considered necessary, and therefore, none were conducted."

Summary

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January 28, 2025

Image /page/0/Picture/1 description: The image shows 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" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

LG Electronics Inc. Hanseul Park RA Specialist 168, Suchul-daero Gumi-si, Gyeongsangbuk-do 39368 Korea. South

Re: K243439

Trade/Device Name: Medical Monitor (27HS714S) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: GCJ Dated: October 31, 2024 Received: November 6, 2024

Dear Hanseul Park:

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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(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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 Rue"). 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-advicecomprehensive-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-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).

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Sincerely,

Digitally signed by YAN FU -YAN FU -C -S Digitally signed by ANTE
S Date: 2025.01.28 18:37:10 -05'00'

for 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

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Indications for Use

510(k) Number (if known) K243439

Device Name Medical Monitor (27HS714S)

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)

|--|--|

|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K243439

510(k) Summary

Prepared on: 2025-01-22

Contact Details		21 CFR 807.92(a)(1)
Applicant Name	LG Electronics Inc.
Applicant Address	168, Suchul-daero Gumi-si Gyeongsangbuk-do 39368 Korea, South
Applicant Contact Telephone	+82-1094902109
Applicant Contact	Mrs. Hanseul Park
Applicant Contact Email	hs.park@lge.com
Correspondent Name	LG Electronics Inc.
Correspondent Address	168, Suchul-daero Gumi-si Gyeongsangbuk-do 39368 Korea, South
Correspondent Contact Telephone	+82-1094902109
Correspondent Contact	Mrs. Hanseul Park
Correspondent Contact Email	hs.park@lge.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Medical Monitor (27HS714S)
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 #	K241402
Predicate Trade Name (Primary Predicate is listed first)	32HR734S
Product Code	GCJ
Device Description Summary		21 CFR 807.92(a)(4)

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.

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Indications for Use Comparison

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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

The indications for use, display technology, power, video signals are identical to the predicate device. The differences in specifications include:

Pixel pitch: 0.1554 mm x 0.1554 mm (Predicate: 0.18159 mm x 0.18159 mm)
Resolution: SDI (Display Port) 3840 x 2160 mm @ 60 Hz (Predicate: No recommended resolution for SDI)
Maximum power consumption: 120 W (Predicate: 130 W)
Output video signals: SDI OUT x 4, DVI-D OUT x 1, DP OUT x 1 (Predicate: SDI OUT x 4, HDMI OUT x 1)

These differences do not affective use of the device. The performance of 27HS714S has been validated in the software validation report. In addition, the safety of 27H5714S has been confirmed through the test according to IEC 60601-1-2. Those reports confirm that all the differences between the proposed and predicate devices do not affectiveness 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:

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

Software Validation

27H5714S 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 quidance:

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 neqatively impact its effectiveness and safety. The proposed device has been proved to be as safe and effective as the predicate device, 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 o the predicate device.

Regulation Number and Section

§ 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.