(123 days)
JUSHA-CP610 LCD Monitor, CP610 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-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g weight make it is easy to carry. 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:
- 13.5" Color TFT LCD Panel
- DMS0600A board/4 layer/233*127mm/1.0mm/REV:1.1
- JUSHA-CP610 LCD Monitor software
- Power Adapter
- Data Cable.
The software that supports the functions of the CP610 is the same as the software used with the predicate JUSHA C61. The level of concern was determined to be Moderate for the JUSHA-CP610 LCD Monitor.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards:
- IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.
The provided document is a 510(k) summary for the JUSHA-CP610 LCD Monitor. It describes the device, its intended use, and a comparison to a predicate device (JUSHA-C61 LCD Monitor) to demonstrate substantial equivalence.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" in a clearly defined pass/fail format for clinical efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing technical specifications and adherence to relevant standards. The "performance" described is in terms of meeting these standards and having comparable or improved technical characteristics.
Here's an attempt to structure the information as requested, drawing from the "Product Comparison" table and "Performance Data" section. Note that "acceptance criteria" for a display device are often encapsulated by adherence to industry standards for medical displays.
| Acceptance Criteria (Implied by Standards & Predicate Comparison) | Reported Device Performance (JUSHA-CP610) |
|---|---|
| Adherence to IEC 60601-1 (Electrical Safety) | Complies with IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14 |
| Adherence to IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017 |
| Maximum Resolution (>= 6 megapixels of predicate) | 3000x2000 (stated as meeting 6megapixels requirement) |
| Screen Technology | Color TFT LCD Panel |
| Viewing Angle | Horizontal 170°, Vertical 170° |
| Backlight Type | LED |
| Intended Use | Displaying and viewing digital images for diagnosis of X-ray or MRI, etc. (does not support mammography) |
| Luminance Response Angular Dependency | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Luminance Non-uniformity (TG18 guideline) | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Chromaticity Non-uniformity (TG18 guideline) | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Small-spot Contrast Ratio | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Temporal Response | Measurement conducted. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Luminance Stability | Performance data compiled. (No specific value provided, but implies satisfactory performance to support substantial equivalence) |
| Power Consumption (for demonstration of difference) | 15W (Predicate: 100W) - This is a difference noted, not an "acceptance criterion" per se, but shows characterization. |
| Display Colors (for demonstrating improvement) | 14-bit, 4398 billion colors (Predicate: 12-bit, 68.7 billion colors) - This is an improvement, not an "acceptance criterion," but demonstrates a characteristic. |
| Pixel Pitch (for demonstrating improvement) | 0.0951x0.0951mm (Predicate: 0.197x0.197mm) - This is an improvement, not an "acceptance criterion," but demonstrates a characteristic which improves pixel density. |
Here's the additional information requested:
-
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of clinical data for software performance. The device is a display monitor, and its performance was evaluated through bench testing and adherence to international standards. There is no information about data provenance or sample size for a "test set" of medical images as it primarily relies on the physical and electrical characteristics of the display. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. The ground truth concept for clinical performance data is not relevant here as the device is a display monitor, not an AI algorithm performing diagnosis. The "truth" for this device lies in its ability to accurately and consistently display images according to technical specifications and standards (e.g., DICOM standard LUT). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as there is no "test set" or clinical adjudication process described for this display device. -
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
No. This is a display monitor, not an AI-powered diagnostic system. No MRMC study was conducted or is relevant for this type of device. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a display monitor, not a standalone algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For a display monitor, the "ground truth" used for evaluation is based on technical specifications, industry standards (e.g., DICOM, TG18), and physical measurements. The performance data section describes measurements against these standards (e.g., luminance, chromaticity, contrast ratio). -
The sample size for the training set
Not applicable. The device is a display monitor, not an AI algorithm that requires a training set. -
How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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July 24, 2020
Nanjing Jusha Display Technology Co., Ltd. % Mr. Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
Re: K200742
Trade/Device Name: JUSHA-CP610 LCD Monitor, CP610 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: July 1, 2020 Received: July 1, 2020
Dear Mr. 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 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
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devices or postmarketing safety reporting (21 CFR 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 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 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).
Sincerely.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K200742
Device Name JUSHA-CP610 LCD Monitor, CP610 LCD Monitor
Indications for Use (Describe)
JUSHA-CP610 LCD Monitor, CP610 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ---------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------- |
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510(k) Summary
K200742
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | September 23, 2019 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International Service OutsourcingMansion, Hanzhongmen Street, Nanjing, 210036 China |
| Contact Person: | Zilong LiangCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273 |
| Device Trade Name: | JUSHA-CP610 LCD Monitor, CP610 LCD Monitor |
| Common/Usual Name: | 6MP Color LCD Monitor |
| Classification Name: | Display, Diagnostic Radiology 21CFR 892.2050 |
| Product Code: | PGY |
| Regulatory name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II |
| Predicate Device(s): | JUSHA-C61; K141679Classification Name: Display, Diagnostic Radiology 21CFR 892.2050Product Code: PGYRegulatory name: Picture Archiving and Communications SystemRegulatory Class: Class II |
| Device Description: | JUSHA-CP610/CP610 LCD Monitor is the display system with the highresolution (30002000), high luminance (300 cd/m²), and 4398 billioncolors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCDMonitor is portable and light, the 850g weight make it is easy to carry. Withthese this display can automatic adjustment according to differentrequirements in order to achieve the best results.The product is consisted of the following components:- 13.5" Color TFT LCD Panel- DMS0600A board/4 layer/233127mm/1.0mm/REV:1.1- JUSHA-CP610 LCD Monitor software- Power Adapter- Data Cable.The software that supports the functions of the CP610 is the same as thesoftware used with the predicate JUSHA C61. The level of concern wasdetermined to be Moderate for the JUSHA-CP610 LCD Monitor.The LCD Monitor is designed, tested, and will be manufactured inaccordance with both mandatory and voluntary standards:1. IEC 60601-1:2012, EN 60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA |
| C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests. | |
| Intended Use: | JUSHA-CP610/CP610 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-CP610/CP610 LCD Monitor is the display system with the high resolution (3000*2000), high luminance (300 cd/m²), and 4398 billion colors, built-in DICOM standard LUT. In particular, JUSHA-CP610 LCD Monitor is portable and light, the 850g weight make it is easy to carry. 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 60601-1:2012, EN 60601-1:2013, ANSI/AAMI ES60601-1:2005+A1:2012+C1:2009+A2:2010, CAN/CSA C22.2 NO.60601-1:14, Medical equipment medical electrical equipment - Part 1: General requirements for basic safety and essential performance.2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, CFR 47 FCC Part15 subpart B: 2017, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests.JUSHA-CP610 /CP610 LCD Monitor is substantially equivalent to JUSHA-C61. JUSHA-CP610 LCD/CP610 LCD Monitor employs the maximum resolution values same as that of JUSHA-C61. At a high level, the subject and predicate devices are based on the following same technological elements:• Maximum resolution: 6megapixels• Screen technology: Color TFT LCD Panel• Viewing angle: Horizontal 170°,Vertical 170°• LED Backlight• Intended Use• Software function: DICOM calibration function and The host computer communication. |
| predicate devices: | |
| • | Screen Size: The subject device uses a smaller screen size to reduce weight and improve the portability. |
| • | Display Colors: The subject device uses a color bit expansion technology to improve image display quality, the image clarity is better than the image displayed on the predicate device. |
| • | Software function: The new functions Grayscale expansion and Signal scanning and switching module were used in the subject device. |
| The following quality assurance measures were applied to the development of the system: | |
| • | Risk Analysis |
| • | Requirements Reviews |
| • | Design Reviews |
| • | Raw materials verification |
| • | Testing 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 not require clinical studies to support substantial equivalence. | |
| The proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device. Therefore, the subject device is determined as safe and effectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers the JUSHA-CP610 LCD Monitor to be as safe, as effective, and performance is substantially equivalent to the predicate device(s). |
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12.1 Product Comparison
This comparison identifies the similarities and differences of the proposed JUSHA-CP610 LCD Monitor device to the legally marketed predicate JUSHA-C61 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Display Performance/Specifications | |||
| Screen technology | 30" Color TFT LCD Panel | 13.5" Color TFT LCD Panel | TheJUSHA-CP610LCD Monitoruses a smallerLCD Panel toreduce weightand improvethe portability ofthe device. |
| Viewing angle(H, V) | Horizontal 170°,Vertical170° | Horizontal 170°,Vertical170° | Same |
| Resolution | $3280×2048$ | $3000×2000$ | This differencebetween the twodevices is causedby the LCDPanel, and theJUSHA CP610LCD Monitorcould also meetthe requirementof 6megapixels. |
| Display area | 403.0(V) ×645.5(H) mm | 285.3(V)×190.2(H)mm | - |
| Contrast Ratio | 1000:1 | 1800:1 | - |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Scanningfrequency (H; V) | 52 | 94.94~123.84kHz; 60Hz | This differencebetween the twodevice is causedby the differentno display areadefined bydifferentmanufacturers,nothing to dowith the displayfunction |
| RecommendedLuminance | 400cd/m² | 300cd/m² | This differencebetween the twodevices is causedby factorysetting, nothingto do with thedisplay function |
| Pixel Pitch | 0.197×0.197 mm | 0.0951×0.0951mm | TheJUSHA-CP610LCD uses asmaller PixelPitch to improvethe pixel density. |
| Backlight | LED | LED | Same. |
| Display Colors | 12-bit , 68.7 billion colors | 14-bit, 4398 billion colors | TheJUSHA-CP610LCD Monitoruses a color bitexpansiontechnology toimprove imagedisplay quality,the image clarityis better than theimage displayedon the predicatedevice. |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| Luminancecalibration | Built in calibration sensorprovided | General calibration sensor | The JUSHACP610 LCDMonitor use thegeneral sensor toinstead thebuild-in sensorto reduce weightand improve theportability of thedevice |
| Video Signal Input | |||
| Input signals | DVI-D Dual Link x2Display Port x2 | Type-C×1,Mini DP×1 | - |
| Output signals | - | - | - |
| Displaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | AC 100 | AC 100 | Same |
| PowerConsumption/Save Mode | 100W/less than 1.5W | 15W / N/A | The differencescaused bycomponents usedin the LCDMonitor. Thisonly shows thepowerconsumption isdifferent,nothing to dowith the displayfunction |
| PowerManagement | DVI DMPMDisplayPort 1.1a | N/A | - |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-C61 | JUSHA-CP610 | |
| 510(k) Number | K141679 | / | |
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | upstream (endpoint)/Rev.3.1 | - |
| Dimensions (W x H x D) | Without stand:704mm x 478mm x 81mmWith stand:704mm x 611mm x292mm | 323mm×225×11.5mm | Differenthousing designdue to thedifferent panelsize. |
| Indication foruse | JUSHA-C61 LCD Monitoris intended to be used indisplaying and viewingdigital images for review andanalysis by trained medicalpractitioners. It does notsupport the display ofmammography images fordiagnosis. | JUSHA-CP610 LCDMonitor is intended to beused in displaying andviewing digital images fordiagnosis of X-ray or MRI,etc. by trained medicalpractitioners. The devicedoes not support the displayof mammography images fordiagnosis | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-C61 | JUSHA-CP610 | / |
| 510(k) Number | K141679 | / | |
| Applicablestandard | 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:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests. | 1 IEC 60601-1:2012, EN60601-1:2013, ANSI/AAMIES60601-1:2005+A1:2012+C1:2009+A2:2010,CAN/CSA C22.2NO.60601-1:14, Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,CFR 47 FCC Part15 subpartB: 2017, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticdisturbances - Requirementsand tests. | - |
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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 JUSHA-CP610 meets all performance standards as follows:
- Measurement of the angular dependency of luminance response in horizontal, ● vertical and diagonal directions
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in TGI18 guideline.
- Measurement of the chromaticity non-uniformity characteristics of the display ● screen as specified in TG18 guideline.
- Measurement of small-spot contrast ratio. ●
- Measurement of temporal response
- . Performance data on luminance stability
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the JUSHA-CP610 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, JUSHA-CP610, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-CP610 Medical Display 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 JUSHA-CP610 Medical Display does not raise any new issues of safety or effectiveness.
§ 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).