(60 days)
K 113203
Not Found
No
The document describes a medical-grade LCD monitor for displaying images. There is no mention of AI, ML, or any image processing capabilities beyond basic signal conversion and display. The performance studies focus on display characteristics and electrical safety, not algorithmic performance.
No
A therapeutic device is one that treats a disease or condition. This device is a monitor intended for displaying images during surgical procedures, which is a diagnostic or imaging function, not a therapeutic one.
No
The device is an LCD monitor intended to display images from surgical endoscopic/laparoscopic camera systems and other medical imaging systems. It does not perform any analysis or interpretation of these images to provide a diagnosis.
No
The device description clearly states it is an "LCD Monitor" and describes physical components like a "23.8-inch widescreen LCD display panel" and "two built-in option slots," indicating it is a hardware device.
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 providing 2D color video displays of images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems. This is a display function for images generated in vivo (within the body) or from other medical imaging modalities, not for examining specimens in vitro (outside the body).
- Device Description: The description reinforces its function as a monitor for displaying images from surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, calibrators, controls, or any other components typically associated with IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This monitor's function is to display images from medical procedures, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, 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.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor is intended primarily for use in a medical environment for displaying images captured during minimally invasive surgical procedures. The monitor features a 23.8-inch widescreen LCD display panel and employs full WUXGA high-definition (HID) performance. In addition to digital signals, the E240AG accepts analog signals and converts them to digital signals. The E240AG LCD Monitor is designed with the flexibility to support a variety of formats with two built-in option slots to select, expand, and change input/output signals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
images from surgical endoscopic/laparoscopic camera systems and other compatible medical imaging systems.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
hospital operating rooms, surgical centers, clinics, doctors' offices and similar medical environments.
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 testing was conducted to demonstrate the E240AG meets all performance standards as follows: Measurement of the luminance non-uniformity characteristics of the display screen, Measurement of the chromaticity non-uniformity characteristics of the display screen, Measurement of contrast ratio, Performance data on luminance stability.
Electrical safety and electromagnetic compatibility (EMC) testing were conducted on the E240AG. The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
The subject of this premarket submission, E240AG, does not require animal or clinical studies to support substantial equivalence.
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.
Sony LMD-2451MT LCD Monitor, K 113203
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.
May 31, 2019
Nanjing Jusha Display Technology Co., Ltd Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing International Service Outsourcing Mansion Nanjing, China 210036
Re: K190831
Trade/Device Name: E240AG LCD Monitor, E240A LCD Monitor, JUSHA-E240AG LCD Monitor, JUJSHA-E240A LCD Monitor, C230A LCD Monitor, JUSHA-C230A LCD Monitor, C230M LCD Monitor, JUSHA-C230M LCD Monitor Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: GCJ Dated: April 1, 2019 Received: April 1, 2019
Dear Zilong Liang:
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
1
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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Jennifer R. Stevenson Acting Division 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
2
Indications for Use
510(k) Number (if known) K190831
Device Name
E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230M, JUJSHA-E240A LCD Monitor
Indications for Use (Describe)
The E240AG LCD Monitor is intended to provide 2D color video displays of images from surgical endoscopic/ laparoscopic camera systems and other compatible medical imaging systems. The E240AG is a widescreen, high definition, 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.
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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1
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
F
| Date: | December 2,2018 | ||
|---|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd | ||
| Add: 301, Hanzhongmen Street, 8F Block A, No.1, | |||
| Nanjing International Service Outsourcing Mansion, | |||
| Nanjing, 210036 China | |||
| Primary Contact Person: | Zilong Liang | ||
| Certification Manager | |||
| Nanjing Jusha Display Technology Co., Ltd | |||
| Tel: +86-25- 83305050 | |||
| Fax: +86-25- 58783271 | |||
| Secondary Contact Person: | Dongdong Li | ||
| Quality Manager | |||
| Nanjing Jusha Display Technology Co., Ltd | |||
| Tel: +86-25- 83305050 | |||
| Fax: +86-25- 58783271 | |||
| Device Trade Name: | E240AG, C230A, C230M, E240A, JUSHA-E240AG, | ||
| JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor | |||
| Common/Usual Name: | LCD Monitor | ||
| Classification Name: | Endoscope and Accessories | ||
| Product Code: | GCJ | ||
| Predicate Device(s): | Sony LMD-2451MT LCD Monitor, K 113203 | ||
| Device Description: | The E240AG, C230A, C230M, E240A, JUSHA-E240AG, | ||
| JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD | |||
| Monitor is intended primarily for use in a medical |
4
| environment for displaying images captured during
minimally invasive surgical procedures. The monitor features
a 23.8-inch widescreen LCD display panel and employs full
WUXGA high-definition (HID) performance. In addition
to digital signals, the E240AG accepts analog signals and
converts them to digital signals.
The E240AG LCD Monitor is designed with the flexibility to
support a variety of formats with two built-in option slots to
| select, expand, and change input/output signals. | |
|---|---|
| Intended Use: | The E240AG, C230A, C230M, E240A, JUSHA-E240AG, |
| JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor | |
| is intended to provide 2D color video displays of images from | |
| surgical endoscopic/laparoscopic camera systems and other | |
| compatible medical imaging systems. The E240AG is a | |
| widescreen, high-definition, 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. | |
| Technological | |
| characteristic | |
| and Substantial | |
| equivalence: | The E240AG, C230A, C230M, E240A, JUSHA-E240AG, |
| JUSHA-C230A, JUSHA-C230M, JUJSHA-E240A LCD Monitor | |
| has the same overall purpose and function as the predicate device | |
| cited above. Both of the devices are intended to provide color | |
| video displays of images from surgical camera systems, primarily | |
| in endoscopic/laparoscopic applications. | |
| Performance | |
| Testing: | Testing of the E240AG, C230A, C230M, E240A, |
| JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M, | |
| JUJSHA-E240A LCD Monitor demonstrated that the device | |
| is in compliance with applicable requirements of recognized | |
| standards for electromagnetic compatibility and electrical | |
| safety. | |
| Conclusion: | Based on the similarities in overall purpose and function, the |
| E240AG LCD Monitor has demonstrated substantial equivalence | |
| to the cited predicate device and any differences do not affect the | |
| safety or effectiveness of the device. |
5
12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed E240AG LCD Monitor device to the legally marketed predicate Sony LMD-2451MT LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product | Sony LMD-2451MT | E240AG, C230A, C230M,
E240A, JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor | |
| 510(k) Number | K113203 | / | |
| Display Performance/Specifications | | | |
| Screen technology | 24" TFT LCD Panel | 23.8" TFT LCD Panel | Same |
| Viewing angle
(H,V) | Horizontal
178°, Vertical 178° (the
contrast ratio ≥ 10 : 1 ) | Horizontal 178°, Vertical
178° (the contrast ratio ≥ 10 :1) | Same |
| Resolution | $1920 \times 1200$ | $1920 \times 1080$ | Different Resolution
design due to the
different panel size. |
| Display area | $518.4 \times 324.0$ mm | $527.04 \times 296.46$ mm | Different Display
area design due to the
different panel size. |
| Contrast
Ratio(typ) | 1000:1 | 1000:1 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | Sony LMD-2451MT | E240AG, C230A, C230M,
E240A, JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor | |
| 510(k) Number | K113203 | / | |
| Recommended
brightness | 300cd/m² | 300cd/m² | Same |
| Pixel Pitch | 0.27×0.27 mm | 0.27×0.27 mm | Same |
| Backlighting | LED backlight | LED backlight | Same |
| grayscale | 1024 | 1024 | Same |
| Response time | 14ms | 14ms | Same |
| Sensor | Backlight sensor | Backlight sensor | Same |
| Input signals | BNC、DVI、SDI、
Y/C(S-Video)、YPbPr、
RGBS、HD15 | VGA、DVI-A/D、SDI、
Y/C(S-Video)、YPbPr、RGBS、
CVBS | The differences
caused by different
signals interface type
used in the medical
display, the E240AG
has
VGA&CVBS ,This
only shows the
signals interface type
is
different, nothing
to do with the display
function |
| Input
terminational | 1 DVI-D Dual Link
1 HDMI Port | 1 DVI-D Dual Link
1 HDMI Port | Same |
| Display controller | Off the shelf | Off the shelf | Same |
| Video Signal Output | | | |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | Sony LMD-2451MT | E240AG, C230A, C230M,
E240A, JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor | |
| 510(k) Number | K113203 | / | |
| Output signals | BNC\u3001DVI\u3001SDI\u3001
Y/C(S-Video)\u3001YPbPr\u3001
RGBS\u3001HD15 | DVI-D\u3001SDI\u3001Y/C
(S-Video)\u3001YPbPr\u3001RGBS\u3001
CVBS | The differences
caused by different
signals interface type
used in the medical
display, the E240AG
has
VGA&CVBS ,This
only shows the
signals interface type
is different, nothing
to do with the display
function |
| Power
Requirement | 100 V - 240 Vac \u00b110%,
50/60 Hz 1.53 A - 0.58 A | 100 - 240 Vac \u00b110%, 47-63
Hz 1.4 - 0.6A | Same |
| Power
Consumptions/Sav
e Mode | 125W/less than 0.7W | 35W/less than 0.5W | The differences
caused by different
adapter and
components used in
the medical
display,the E240AG
has lower power
consumptions,This
only shows the power
consumption is
different, nothing to
do with the display
function |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | Sony LMD-2451MT | E240AG, C230A, C230M,
E240A, JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor | |
| 510(k) Number | K113203 | / | |
| Dimensions w/o
stand
(W x H x D) | With stand:
$602.4\u00d7454\u00d7302$ mm
Without stand:
$602.4\u00d7386.2\u00d7110$ mm | With stand:
565.3x238x460.3mm
Without stand:
565.3x65x375.3mm | Different housing
design due to the
different panel size. |
| Indication for use | The Sony LMD-2451MT
LCD Monitor is intended
to provide 3D and 2Dcolor
video
displays of images from
surgical
endoscopic/laparoscopic
camera systems and other
compatible medical
imaging systems. The
LMD-2451MT is a
widescreen,
high-definition, 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. | The E240AG, C230A,
C230M, E240A,
JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor is intended to
provide 2D color video
displays of images from
surgical
endoscopic/laparoscopic
camera systems and other
compatible medical
imaging systems. The
E240AG is a widescreen,
high-definition, 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. | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of
Differences |
| Product | Sony LMD-2451MT | E240AG, C230A, C230M,
E240A, JUSHA-E240AG,
JUSHA-C230A,
JUSHA-C230M,
JUJSHA-E240A LCD
Monitor | |
| 510(k) Number | K113203 | / | |
| Applicable
standard | 1 IEC 60601-1Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance
1988+A1 : 1991 + A2:1995
2 IEC 60601-1-2 Edition
3:2007, Medical electrical
equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic compatibility
Requirements and tests | 1 IEC 60601-1:2012 Medical
equipment medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance.
2 IEC 60601-1-2:2014,
Medical electrical
equipment-Part 1-2:General
requirements for basic safety
and essential
performance-Collateral
Standard:Electromagnetic
disturbances-Requirements and
tests | Same |
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PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the E240AG meets all performance standards as follows:
Measurement of the luminance non-uniformity characteristics of the display screen
Measurement of the chromaticity non-uniformity characteristics of the display screen
Measurement of contrast ratio.
Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the E240AG The device complies with the IEC 60601-1 standard for safety and the IEC 60601-1-2 standard for EMC.
Animal and clinical study
The subject of this premarket submission, E240AG, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
E240AG, C230A, C230M, E240A, JUSHA-E240AG, JUSHA-C230A, JUSHA-C230M,
JUJSHA-E240A LCD Monitor is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The non-clinical data support the safety of the device. The device should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the E240AG Medical Display does not raise any new issues of safety or effectiveness.