(39 days)
JUSHA-C33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
JUSHA-C33C LCD Monitor is the display system with the high resolution (2048*1536), high luminance (600 cd/m²), and10 bit display colors expanded to 12 bit color expansion technology, 8 DICOM look up table and 3 GAMMA look up table inside. In particular, JUSHA-C33C LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. JUSHA-C33C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. The product is consisted of the following components: - 21.3" Color TFT LCD Panel - JUSHA-C33/45T motherboard/FR-4/REV:0.9 - JUSHA-C33C LCD Monitor software - Power Adapter - Data Cable. The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards: IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 1988+A1 : 1991 + A2:1995 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.
This section describes the acceptance criteria and the study conducted to demonstrate that the JUSHA-C33C LCD Monitor meets these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary for the JUSHA-C33C LCD Monitor primarily focuses on demonstrating substantial equivalence to a predicate device (EIZO RX340) through non-clinical performance characteristics and compliance with recognized standards. Therefore, the "acceptance criteria" are implicitly defined by the predicate device's specifications and the safety and electrical standards. The study presented a direct comparison of key technical specifications.
| Attribute | Predicate Device (EIZO RX340 - K113562) Acceptance Criteria | Proposed Device (JUSHA-C33C LCD Monitor) Performance | Differences/Compliance |
|---|---|---|---|
| General | |||
| Product | EIZO RX340 | JUSHA-C33C LCD Monitor | N/A (Product Name) |
| 510(k) Number | K113562 | K141684 | N/A (Approval Number) |
| Display Characteristics | |||
| Screen Technology | 21.2" Color TFT LCD Panel | 21.3" Color TFT LCD Panel | Minor size difference |
| Viewing Angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 176°, Vertical 176° | Proposed device is better |
| Resolution | 2048 x 1536 / 1536 x 2048 | 2048 x 1536 / 1536 x 2048 | Identical |
| Display Area | 323.7 (H) x 431.6 (V) mm | 324.864 (H) x 433.152 (V) mm | Very similar |
| Contrast Ratio | 1400:1 | 1400:1 | Identical |
| Scanning Freq. (H; V) | 31 | 96.7kHz; 60Hz | Within typical ranges, presumed compatible |
| Recommended Luminance | 400cd/m² | 400cd/m² | Identical |
| Pixel Pitch | 0.21075 x 0.21075 mm | 0.2115 x 0.2115 mm | Very similar |
| Backlight | LED | LED | Identical |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit, 68.7 billion colors | Proposed device is better |
| Luminance Calibration | Built-in calibration sensor provided | Built-in calibration sensor provided | Identical |
| Connectivity & Power | |||
| Input Signals | DVI standard 1.0, DisplayPort 1.1a | DVI standard 1.0, DisplayPort 1.1a | Identical |
| Input Termination | DVI-D (dual link) x 1, DisplayPort x 1 | DVI-D (dual link) x 1, DisplayPort x 1 | Identical |
| Display Controller | Off the shelf | Off the shelf | Identical |
| Power Requirement | AC 100 | AC 100 | Identical |
| Power Consumption/Save Mode | 56W / less than 3W | 65W / less than 3W | Higher consumption (65W vs 56W) but same save mode. Acceptable. |
| Power Management | DVI DMPM, DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a | Identical |
| USB Ports/Standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | 1 upstream (endpoint), 2 downstream / Rev. 2.0 | Identical |
| Physical | |||
| Dimensions w/o stand (W x H x D) | Without stand: 376mm x 505mm x 98 mm | Without stand: 382mm x 490mm x 75mm | Minor differences |
| Standards Compliance | |||
| Applicable Standards | IEC 60601-1 (2005+CORR.1+CORR.2), IEC 60601-1-2 (Ed. 3:2007) | IEC 60601-1 (2005+CORR.1+CORR.2), IEC 60601-1-2 (Ed. 3:2007) | Identical |
2. Sample Size Used for the Test Set and Data Provenance
The submission refers to non-clinical tests and a comparison of technical specifications to a predicate device. There is no mention of a "test set" in the context of image data or patient studies. The performance is assessed by comparing the technical specifications of the proposed device against those of the predicate device. Therefore, no "sample size" in the conventional sense (e.g., number of images or patients) is applicable here.
The "data provenance" refers to the technical specifications of the JUSHA-C33C LCD Monitor and the EIZO RX340. This data would originate from the manufacturers' product specifications and potentially independent testing for compliance with standards. The nature of this comparative study means it is retrospective in the sense that the predicate device's specifications are already established.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
No explicit ground truth established by experts is mentioned as this is a comparison of technical specifications for a display monitor, not a diagnostic algorithm. The "ground truth" for this type of submission is the documented performance characteristics of the predicate device and the new device as per engineering specifications and standard testing.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring expert adjudication for a diagnostic task.
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 submission is for an LCD display monitor, not an AI diagnostic algorithm. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an AI algorithm but a hardware medical device (display monitor).
7. The Type of Ground Truth Used
The ground truth used for this submission is the technical specifications and performance characteristics of the predicate device (EIZO RX340) and the proposed device (JUSHA-C33C LCD Monitor), along with compliance with international safety and electrical standards (IEC 60601-1 and IEC 60601-1-2). This is based on objective, quantifiable engineering data and regulatory standards, rather than clinical outcomes or expert consensus on image interpretation.
8. The Sample Size for the Training Set
Not applicable. This is not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 1. 2014
Nanjing Jusha Display Technology Co., Ltd. % Ms. Li Le Certification Manager 8A. Block 1. Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street, Nanjing 210036 CHINA
Re: K141684
Trade/Device Name: Jusha-C33C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: June 24, 2014 Received: June 30, 2014
Dear Ms. Le:
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 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.
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 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/Resourcesfor You/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 yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K141684
Device Name
JUSHA-C33C LCD Monitor
Indications for Use (Describe)
JUSHA-C33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FDA
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 6, 2014 | ||
|---|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd | ||
| Add: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China | |||
| Contact Person: | Li le | ||
| Certification Manager | |||
| Nanjing Jusha Display Technology Co., Ltd | |||
| Tel: +86-25- 83305050 | |||
| Fax: +86-25- 58783271 | |||
| Device Trade Name: | JUSHA-C33C LCD Monitor | ||
| Common/Usual Name: | 3MP Color LCD Monitor | ||
| Classification Name: ProductCode: | Display, Diagnostic Radiology 21CFR 892.2050PGY | ||
| Predicate Device(s): | EIZO RX340;K113562 | ||
| Device Description: | JUSHA-C33C LCD Monitor is the display system with the highresolution (2048*1536), high luminance (600 cd/m²), and10 bitdisplay colors expanded to 12 bit color expansion technology, 8DICOM look up table and 3 GAMMA look up table inside. Inparticular, JUSHA-C33C LCD Monitor contains CGA function, it isspecially made by JUSHA, it can automatic identify gray and colorsignals, then gray area calls DICOM LUT and color area callsGAMMA2.2 LUT. JUSHA-C33C has ambient brightness adaptingand presence induction system, with these this display can automaticadjustment according to different requirements in order to achieve thebest results. | ||
| The product is consisted of the following components: | |||
| - 21.3" Color TFT LCD Panel | |||
| - JUSHA-C33/45T motherboard/FR-4/REV:0.9 | |||
| - JUSHA-C33C LCD Monitor software | |||
| - Power Adapter | |||
| - Data Cable. | |||
| The LCD Monitor is designed, tested, and will be manufactured inaccordance with both mandatory and voluntary standards: | |||
| IEC 60601-1Medical equipment medical electrical1.equipment - Part 1: General requirements for basic safetyand essential performance 1988+A1 : 1991 + A2:1995 | |||
| IEC 60601-1-2 Edition 3:2007, Medical electrical2.equipment - Part 1-2: General requirements for basic |
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| safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests. | |
|---|---|
| Intended Use: | JUSHA-C33C LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis. |
| Technology: | JUSHA-C33C LCD Monitor is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (600 cd/m²) and10 bit display colors expanded to 12 bit color expansion technology, 8 DICOM look up table and 3 GAMMA look up table inside. In particular, JUSHA-C33C LCD Monitor contains CGA function, it is specially made by JUSHA, it can automatic identify gray and color signals, then gray area calls DICOM LUT and color area calls GAMMA2.2 LUT. JUSHA-C33C has ambient brightness adapting and presence induction system, with these this display can automatic adjustment according to different requirements in order to achieve the best results. |
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:1 IEC 60601-1Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance 2005+CORR.1(2006)+CORR.2(2007)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.JUSHA-C33C is substantially equivalent to EIZO RX340. JUSHA-C33C employs the maximum resolution values same as that of EIZO RX340. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.The following quality assurance measures were applied to the development of the system:Risk AnalysisRequirements ReviewsDesign ReviewsRaw materials verificationTesting on unit level (Module verification)Integration testing (System verification)Final acceptance testing (Validation)Performance testing (Verification)Safety testing (Verification) |
| Summary of Clinical Tests:The subject of this premarket submission, LCD Monitor, did notrequire clinical studies to support substantial equivalence. | |
| The proposed device is Substantially Equivalent (SE) to the predicatedevice which is US legally market device. Therefore, the subjectdevice is determined as safe and effectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA-C33C LCD Monitor to be as safe, as effective, and performance issubstantially equivalent to the predicate device(s). |
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510(k) Premarket Notification Submission
Attachment 1:
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | EIZO RX340 | JUSHA-C33C LCD Monitor |
| 510(k) Number | K113562 | K141684 |
| Screen technology | 21.2" Color TFT LCD Panel | 21.3" Color TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 170°, Vertical 170° | Horizontal 176°, Vertical 176° |
| Resolution | 2048 x 1536/1536x 2048 | 2048 x1536/1536x 2048 |
| Display area | 323.7 (H) x431.6 (V) mm | 324.864 (H) x 433.152 (V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31 | 96.7kHz;60Hz |
| Recommended Luminance | 400cd/m² | 400cd/m² |
| Pixel Pitch | 0.21075 x 0.21075 mm | 0.2115x0.2115 mm |
| Backlight | LED | LED |
| Display Colors | 10-bit, 1.07 billion colors | 12-bit, 68.7billion colors |
| Luminance calibration | Built in calibration sensorprovided | Built in calibration sensorprovided |
| Input signals | DVI standard 1.0,DisplayPort 1.1a | DVI standard 1.0,DisplayPort 1.1a |
| Input terminational | DVI-D (dual link) x 1,DisplayPort x 1 | DVI-D (dual link) x 1,DisplayPort x 1 |
| Display controller | Off the shelf | Off the shelf |
| Power Requirement | AC 100 | AC 100 |
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| Power Consumption/SaveMode | 56W/less than 3W | 65W/less than 3W |
|---|---|---|
| Power Management | DVI DMPMDisplayPort 1.1a | DVI DMPMDisplayPort 1.1a |
| USB Ports/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 |
| Dimensions w/o stand(W x H x D) | Without stand:376mmx505mmx98 mmWith stand: | Without stand:382mm x490mm x75mm Withstand:382mm x533mm x238mm |
| Applicable standard | 1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility- Requirements and tests | 1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility -Requirements and tests |
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).