(63 days)
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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
- DMX0704AR1/Main Board/REV: 1.2
- C510G LCD Monitor software
- Power Adapter
- Data Cable.
The provided text describes the regulatory clearance for the Nanjing Jusha Display Technology Co., Ltd's C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor. This device is a medical display intended for viewing and diagnosing digital images, including mammography and breast tomosynthesis applications.
Crucially, the document states: "The subject of this premarket submission, LCD Monitor, did not require clinical studies to support substantial equivalence." and "The subject of this premarket submission, C510G, does not require animal or clinical studies to support substantial equivalence."
Therefore, the following points regarding acceptance criteria and study proving performance are not applicable as they relate to clinical studies or studies using ground truth established by experts/pathology/outcomes data. The device's clearance was based on demonstrating substantial equivalence to a predicate device (JUSHA-M550G; K190848) through non-clinical bench testing and adherence to relevant standards.
Based on the provided document, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document describes performance measurements that were conducted as part of bench testing, but it does not specify explicit "acceptance criteria" values against which these measurements were compared. Instead, it states that the device "meets all performance standards" and "complies with" certain IEC standards. The comparison table shows the specifications of the proposed device against the predicate.
| Performance Measurement Conducted (Bench Testing) | Proposed Device (C510G) Performance (as reported) | Implicit Acceptance Criteria / Standard Met |
|---|---|---|
| Measurement of the angular dependency of luminance response in horizontal, vertical and diagonal directions | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of the luminance non-uniformity characteristics of the display screen | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of the chromaticity non-uniformity characteristics of the display screen | Data not explicitly detailed, assumed to meet standards | TGI18 guideline (implied, not explicitly stated as a pass/fail value) |
| Measurement of small-spot contrast ratio | Data not explicitly detailed, assumed to meet standards | Not specified |
| Measurement of temporal response | Data not explicitly detailed, assumed to meet standards | Not specified |
| Performance data on luminance stability | Data not explicitly detailed, assumed to meet standards | Not specified |
| Electrical safety and electromagnetic compatibility (EMC) | Complies with IEC 60601-1 and IEC 60601-1-2 | IEC 60601-1 and IEC 60601-1-2 standards |
| Key Display Specifications (from Product Comparison Table): | Proposed Device (C510G) Specification | Predicate Device (JUSHA-M550G) Specification (for comparison, not acceptance criteria) |
| Resolution | 2560 x 2048 / 2048 x 2560 | 2560 x 2048 / 2048 x 2560 (Same) |
| Contrast Ratio | 2000:1 | 1700:1 (Better) |
| DICOM calibrated luminance | 500 cd/m2 | 1000 cd/m2 (Different panels with different brightness, but same 5MP resolution for Mammo diagnosis) |
| Pixel Pitch | 0.165 x 0.165 mm | 0.165 x 0.165 mm (Same) |
| DICOM LUT | 16-bit: 65536 | 16-bit: 65536 (Same) |
The following information cannot be provided from the given document because the device did not require clinical studies for its substantial equivalence determination:
2. Sample size used for the test set and the data provenance: Not applicable (no clinical test set).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable (no clinical test set requiring ground truth).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable (no clinical test set requiring adjudication).
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 (no AI component, no MRMC study).
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable (this is a display monitor, not an algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable (no clinical study or ground truth required).
8. The sample size for the training set: Not applicable (no training set for a display monitor).
9. How the ground truth for the training set was established: Not applicable (no training set).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Nanjing Jusha Display Technology Co., Ltd Donny Lee Certification Engineer 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301 Hanzhongmen Street NANJING, JIANGSU 210036 CHINA
May 18, 2023
Re: K230723
Trade/Device Name: C510G/JUSHA-C510G/C510/JUSHA- C510 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: PGY Dated: March 16, 2023 Received: March 16, 2023
Dear Donny Lee:
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
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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/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 medical devices and radiation-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,
Jessica Lamb
Jessica Lamb. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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) K230723
Device Name C510G/JUSHA-C510G/C510/JUSHA-C510
Indications for Use (Describe)
C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for view, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
| 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
(K230723)
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | March 16, 2023 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 301, 8F Block A, No.1, Nanjing International ServiceOutsourcing Mansion, Hanzhongmen Street, Nanjing, 210036 China |
| Contact Person: | Donny LeeCertification ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783273lidongdong@jusha.com.cn |
| Device Trade Name: | C510G/JUSHA-C510G/C510/JUSHA-C510 LCD Monitor |
| Common/Usual Name: | 5MP Color LCD Monitor |
| Classification Name: | Medical image management and processing system 21CFR 892.2050 PGY |
| Product Code: | JUSHA-M550G; K190848 |
| Predicate Device(s): | JUSHA-M550G; K190848 |
| Device Description: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is the display system with the high resolution (2560*2048), high luminance (1150 cd/m2), and 16-bit (65536 level), built-in DICOM standard LUT. In particular, C510G has ambient brightness adapting, real-time DICOM automatic calibration, full-screen brightness equalization 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- DMX0704AR1/Main Board/REV: 1.2- C510G LCD Monitor software |
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| - Power Adapter | ||||
|---|---|---|---|---|
| - Data Cable. | ||||
| 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 equipmentmedical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance. | ||||
| 2. IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015,Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral standard: Electromagnetic disturbances -Requirements and tests. | ||||
| Intended Use: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is intendedto be used in displaying and viewing digital images, includingstandard and multi-frame digital mammography, for view, analysis,and diagnosis by trained medical practitioners. It is specially designedfor breast tomosynthesis applications. | |||
| Technology: | C510G/JUSHA-C510G/JUSHA-C510/C510 LCD Monitor is thedisplay system with the high resolution (2560*2048), high luminance(1150 cd/m2), and 16-bit grayscale (65536 level), built-in DICOMstandard LUT. In particular, C510G has ambient brightness adapting,real-time DICOM automatic calibration, full-screen brightnessequalization and presence induction system, with these this displaycan automatic adjustment according to different requirements in orderto achieve the best results. | |||
| Determination of SubstantialEquivalence: | 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 C22.2NO.60601-1:14, Medical equipment medical electrical equipment- Part 1: General requirements for basic safety and essentialperformance.2 IEC 60601-1-2 Edition 4:2014, EN 60601-1-2:2015, Medicalelectrical equipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard: | |||
| C510G is substantially equivalent to JUSHA-M550G. C510Gemploys the maximum resolution values same as that of JUSHA-M550G.The following quality assurance measures were applied to thedevelopment 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 C510GLCD Monitor to be as safe, as effective, and performance issubstantially equivalent to the predicate device JUSHA-M550G. |
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Product Comparison
This comparison identifies the similarities and differences of the proposed C510G LCD Monitor device to the legally marketed predicate JUSHA-M550G LCD Monitor device to which substantial equivalency is claimed.
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-M550G LCDMonitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Display Performance/Specifications | |||
| Screentechnology | 21.3inches, Mono-TFT LCDPanel | 21.3inches, Color-TFT LCDPanel | Same |
| Viewing angle(H, V) | Horizontal 178°,Vertical 178° | Horizontal 178°,Vertical 178° | Same |
| Resolution | 2560 x 2048/2048x 2560 | 2560 x2048/2048x 2560 | Same |
| Display area | 422.4(H) x 377.9 (V) mm | 422.4(H) x337.9 (V) mm | The twomonitors havedifferent frontframe style whilethe M550Gemploy a SlimBezel design sothat the displayarea is different. |
| Contrast Ratio | 1700:1 | 2000:1 | C510G hasbetter contrastratio for thepanel, while thedifference doesnot makedifference to thediagnosis. |
| DICOMcalibratedluminance | 1000cd/m2 | 500cd/m2 | The two modelshave differentpanels withdifferentbrightness butthey have thesame resolutionfor 5MP forMammo imagediagnosis. |
| Pixel Pitch | 0.165x0.165 mm | 0.165x0.165 mm | Same |
| Backlight | LED | LED | Same |
| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
| Product | JUSHA-M550G LCDMonitor | C510G LCD Monitor | Same |
| 510(k) Number | K190848 | K230723 | Same |
| DICOM LUT | 16-bit: 65536 | 16-bit: 65536 | Same |
| Luminancecalibration | Built in calibration sensorprovided | Built in calibration sensorprovided | Same |
| Video Signal Input | |||
| Input signals | DVI standard 1.0,DisplayPort 1.2a | DVI standard 1.0,DisplayPort 1.2a | Same |
| Inputterminational | DVI-D x 1,DisplayPort x 1 | DVI-D x 1,DisplayPort x 1 | Same |
| Output signals | DisplayPort 1.2a | DisplayPort 1.2a | Same |
| Output | DisplayPort x 1 | DisplayPort x 1 | Same |
| TerminationalDisplaycontroller | Off the shelf | Off the shelf | Same |
| Power Related Specification | |||
| PowerRequirement | DC 24V | DC 24V | Same |
| PowerConsumption/Save Mode | 55W/less than 0.5W | 55W/less than 0.5W | Same |
| PowerManagement | DVI DMPMDisplayPort 1.2a | DVI DMPMDisplayPort 1.2a | Same |
| Miscellaneous Features/Specifications | |||
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | Same |
| Attributes | Predicate Device | Proposed Device | Discussion of Differences |
| Product | JUSHA-M550G LCD Monitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Dimensions w/o stand(W x H x D) | Without stand:363mm x475mm x66mmWith stand:363mm x522mm x238mm | Without stand:399mm x491mm x74mmWith stand:399mm x530mm x238mm | Different Dimensions design due to the different structure size. |
| Indication for use | JUSHA-M550G/JUSHA-M550/M550G/M550 LCDMonitor is intended to beused in displaying andviewing digital images,including standard andmulti-frame digitalmammography, for view,analysis, and diagnosis bytrained medical practitioners.It is specially designed forbreast tomosynthesisapplications. | C510G/JUSHA-C510G/C510/JUSHA-C510LCD Monitor is intended tobe used in displaying andviewing digital images,including standard andmulti-frame digitalmammography, for view,analysis, and diagnosis bytrained medical practitioners.It is specially designed forbreast tomosynthesisapplications. | Same |
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| Attributes | Predicate Device | Proposed Device | Discussion ofDifferences |
|---|---|---|---|
| Product | JUSHA-M550G LCDMonitor | C510G LCD Monitor | |
| 510(k) Number | K190848 | K230723 | |
| Applicablestandard | 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 essentialperformance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and 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 essentialperformance.2 IEC 60601-1-2 Edition4:2014, EN 60601-1-2:2015,Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic disturbances- Requirements and tests | Same |
PERFORMANCE DATA:
The following performance data were provided in support of the substantial equivalence determination.
Bench testing:
Bench testing was conducted to demonstrate the C510G 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 ●
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- Performance data on luminance stability .
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the C510G 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, C510G, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
C510G 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 C510G 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).