(87 days)
Not Found
No
The 510(k) summary describes a medical monitor that displays images from other medical equipment. There is no mention of image processing, AI, DNN, or ML in the device description, intended use, or performance studies. The device appears to be a passive display unit.
No
This device is a medical monitor intended for displaying images, not for providing therapy.
No
The device is a medical monitor intended to display images from medical equipment. It does not perform any analysis or interpretation of medical data to diagnose a condition.
No
The device description explicitly states it is an "LCD monitor" and details its hardware components and interfaces (DP, HDMI, DVI, SDI input). 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:
- Intended Use: The intended use clearly states that the device is a medical monitor intended to display images from medical equipment like laparoscopy and endoscopy systems. This is for viewing images generated within the body or from other medical imaging modalities, not for examining specimens outside the body.
- Device Description: The description reinforces its function as a display for medical imaging systems.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, tissue, urine, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This monitor's function is solely to display images generated by other medical devices.
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
32HR734S 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 DP, HDMI, DVI, SDI input. 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, endoscopy systems, 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
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
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical studies were considered necessary, and therefore, none were conducted.
The major change is the addition of "CLONE SCREEN" available in HDM OUT, which also have been validation report. Based on the software validation report, all the differences between the proposed and predicate and effectiveness of the device.
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.
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August 12, 2024
LG Electronics Inc. Hanseul Park RA Specialist 168, Suchul-daero Gumi-si. Gyeongsangbuk-do 39368 Korea, South
Re: K241402
Trade/Device Name: Medical Monitor (32HR734S) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: May 17, 2024 Received: May 17, 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 820.70) 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.
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).
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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-devices/deviceadvice-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 00700 - 3 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 - 8 -
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) K241402
Device Name Medical Monitor (32HR734S)
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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| K241402 | Page 1 of 2 | ||||
|---|---|---|---|---|---|
| 510(k) Summary | Prepared on: 2024-08-08 |
| 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 | +821094902109 |
| 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 | +821094902109 |
| 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 (32HR734S) |
| 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 |
|---|---|---|
| K170899 | 27HJ713S | GCJ |
| K231066 | CuratOR EX3242-FD | GCJ |
| Device Description Summary | 21 CFR 807.92(a)(4) |
|---|---|
| ---------------------------- | --------------------- |
32HR734S 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 DP, HDMI, DVI, SDI input. 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
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endoscopy systems for surgery and various medical imaging systems.
Indications for Use Comparison
When comparing the indications for use statements, the terminology demonstrates that the proposed device shares the same indications for use as the primary predicate devices. Therefore, it supports the determination of substantial equivalence between the proposed device and predicate devices.
Technological Comparison
The comparison tables show some differences in specifications such as maximum resolution available at SDJ, connectors, and physical specifications. However, these differences do not affective use of the device. The performance of 32HR734S device has been validated as per the software validation, its safety has been confirmed through tests conducted in accordance with IEC 60601-1 and 60601-1-2 standards.
The major change is the addition of "CLONE SCREEN" available in HDM OUT, which also have been validation report. Based on the software validation report, all the differences between the proposed and predicate and effectiveness of the device.
Therefore, the proposed device is substantially equivalent to the predicate devices 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
32HR734S 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 devices that would negatively impact its effective use and safety. The proposed to be as safe and effective as the predicate devices, which were previously cleared in K170899 and K231066. 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 devices do not raise any new concerns regarding safety or effectiveness, and the proposed device can be considered substantially equivalent to the predicate devices.