(64 days)
Not Found
No
The summary describes a medical monitor for displaying images and video, with no mention of AI/ML capabilities, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is a medical monitor intended for displaying images from medical equipment; it does not directly treat or prevent any disease or condition.
No.
The device is a color video monitor that displays images from medical equipment for visualization, not for interpreting medical images or making diagnoses.
No
The device is described as a "color video monitor" and a "hardware component" intended to display images. The performance studies focus on hardware safety and EMC standards, not software validation.
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 for displaying color video displays and images from medical equipment like laparoscopy, endoscopy, and various medical imaging systems. This is a display function, not a diagnostic test performed on biological samples.
- Device Description: The description reinforces that it's a color video monitor intended to display viewable medical images.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to visually present information generated by other medical equipment.
N/A
Intended Use / Indications for Use
This 27HJ713S 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. This product does not support 3D.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The 27HJ713S is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery.
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
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)
Non-Clinical Test Summary
-
- 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: Testing to confirm compliance with the safety requirements of standard AAMI ES60601-1 Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2
- Electrical Safety and Electromagnetic Compatibility
-
- Software Validation
The 27HJ713S contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. 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.
- Software Validation
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
§ 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.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
DEPARTMENT OF HEALTH & HUMAN SERVICES · USA
May 30, 2017
LG Electronics Jinhwan Jun Chief Research Engineer 222, LG-ro, Cheongho-ri, Jinwi-mveon Pyeongtaek-si, Gyeonggi-do, 17709 Republic of Korea
Re: K170899
Trade/Device Name: 27HJ713S Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: March 17, 2017 Received: March 27, 2017
Dear Jinhwan Jun:
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. The general controls provisions of the Actinclude 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S" in a large, sans-serif font. The text is dark, and the background is a light gradient. The letters "FDA" are faintly visible in the background, suggesting a watermark or logo.
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face inside a circle and the letters "LG" next to it. Below the letters "LG" is the slogan "Life's Good".
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| See PRA Statement below. |
Indications for Use
| 510(k) Number (if known) | K170899 |
|---|---|
| Device Name | 27HI713S |
| Indications for Use (Describe) | This 27HJ713S 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. This product does not support 3D. |
| 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."
3
Image /page/3/Picture/2 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face inside a circle and the letters "LG" next to it. The face is red, and the letters are gray. Below the letters, the slogan "Life's Good" is written in a smaller font.
510(k) Summary
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
510(k) Number: K170899
March 17, 2017
2. Submitter's Information [21 CFR 807.92(a)(1)]
| Name of Sponsor: | LG Electronics |
|---|---|
| Address: | 222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si, |
| Gyeonggi-do, Republic of Korea |
- Contact Name: Jinhwan Jun / Chief Research Engineer ●
- Telephone No.: +82-31-8066-5641 -
- Email Address: jinhwan.jun@lge.com -
- Name of Manufacturer: Same as sponsor -Address: Same as sponsor
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
- Trade Name: 27HJ713S
- Common Name: Monitor ●
- Classification:
| Classification Name | Endoscope and Accessories |
|---|---|
| Classification Number | 21 CFR 876.1500 |
| Product Code | GCJ |
| Device Class | II |
| Review Panel | General & Plastic Surgery |
4
Image /page/4/Picture/2 description: The image shows the logo for LG, a South Korean multinational electronics company. The logo consists of two parts: a stylized image of a face within a circle and the letters "LG" in a bold, sans-serif font. Below the letters "LG" is the slogan "Life's Good" in a smaller, italicized font. The face and circle are in a shade of red, while the letters and slogan are in a shade of gray.
510(k) Number: K170899
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: K113203
- Applicant: SONY ELECTRONICS, INC.
- Classification Name: Endoscope and Accessories ●
- Trade Name: SONY LMD-2451MT LCD MONITOR
5. Description of the Device [21 CFR 807.92(a)(4)]
The 27HJ713S is a color video monitor intended to display viewable medical images transmitted by standard video signals. In particular, the device is intended for use as part of a visualisation system in endoscopic surgery.
6. Indications for Use [21 CFR 807.92(a)(5)]
This 27HJ713S 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. This product does not support 3D.
7. Technological Characteristics [21 CFR 807.92(a)(6)]
There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the 27HJ713S and the predicate device:
5
Image /page/5/Picture/2 description: The image shows the LG logo. The logo consists of a red circle with a stylized white "L" inside, and a white dot above the "L". To the right of the circle are the letters "LG" in gray, with the words "Life's Good" in a smaller font below the letters.
222, LG-ro, Cheongho-ri, Jinwi-myeon, Pyeongtaek-si,
510(k) Number: K170899
Gyeonggi-do, Republic of Korea Tel: +82-31-8066-5641
| Proposed Device | Predicate Device | |
|---|---|---|
| K Number | Not known K170899 | K113203 |
| Manufacturer | LG Electronics | SONY ELECTRONICS, INC. |
| Model Name | 27HJ713S | SONY LMD-2451MT LCD |
| MONITOR | ||
| Classification Name | Endoscope and Accessories | Endoscope and Accessories |
| Classification Number | 21 CFR 876.1500 | 21 CFR 876.1500 |
| Indications for Use | This 27HJ713S 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. This product does not | ||
| support 3D. | The Sony LMD-2451MT LCD | |
| Monitor is intended to provide | ||
| 3D and 2D) color video displays | ||
| of images from surgical | ||
| endoscopic/laparoscopic camera | ||
| systems and other compatible | ||
| medical imaging systems. The | ||
| LMD-2451IMT is a widescreen, | ||
| highdefinition, medical grade | ||
| monitor for real-time use during | ||
| minimally invasive surgical | ||
| procedures and is suitable for | ||
| use in hospital operating rooms, | ||
| surgical centers, clinics, doctors' | ||
| offices and similar medical | ||
| environments. | ||
| LCD Screen | TFT LCD | TFT LCD |
| Pixel Pitch | 0.1554 x 0.1554 mm | 0.3114 x 0.3114 mm |
| Resolution | 3,840 x 2,160 pixels | 1920 x 1080 pixels |
| Monitor Size (W x H x D) | 654.4 x 410.9 x 58.0 mm | 650.0 x 419.0 x 58.0 mm |
| Weight | 7.7 kg | 8.5 kg |
6
Image /page/6/Picture/2 description: The image shows the LG logo. The logo consists of a stylized face inside a circle on the left and the text "LG Life's Good" on the right. The face and circle are in a shade of red, while the "LG" text is in gray, and "Life's Good" is in black.
510(k) Number: K170899
Non-Clinical Test Summary
-
- 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: Testing to confirm compliance with the safety requirements of standard AAMI ES60601-1 Testing to confirm compliance with EMC requirements of standard IEC 60601-1-2
- Electrical Safety and Electromagnetic Compatibility
-
- Software Validation
The 27HJ713S contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. 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.
- Software Validation
Clinical Test Summary:
No clinical studies were considered necessary and performed.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]
There are no significant differences between 27HJ713S and the predicate device, K113203 that would adversely affect the use of the product. It is substantially equivalent to these devices in indications for use and technology characteristics.
9. Conclusion [21 CFR 807.92(b)(3)]
In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification LG Electronics, concludes that the 27HJ713S is substantially equivalent in safety and effectiveness to the predicate devices as described herein.