(115 days)
JUSHA-C31 Medical Display 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 must not be used for digital mammography system.
JUSHA-C31 Medical Display is 53cm(20.8") color medical display with the high resolution(2048 x 1536), the product is consisted of the following components:
- 20.8 inch, Color Active Matrix TFT Liquid Crystal Display
- Motherboard HDVI-3M V1.0
- JUSHA-C31 Medical Display software
- Power Adapter
- Data Cable.
The Medical Display 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 submission describes a medical display device, not an AI or algorithm-driven device. Therefore, the information typically requested for AI-enabled devices (like acceptance criteria for algorithms, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance, etc.) is not applicable here.
This 510(k) summary focuses on the substantial equivalence of the JUSHA-C31 Medical Display to a predicate device (RADIFORCE R31; K052344) based on non-clinical performance and safety testing.
Here's the relevant information that can be extracted from the provided text for a medical display device:
1. Acceptance Criteria and Reported Device Performance (Non-Clinical)
The submission does not explicitly list quantitative acceptance criteria in a table format for performance metrics that would be typical for an AI device (e.g., sensitivity, specificity, AUC). Instead, it states compliance with recognized industry standards and performance attributes of the display itself.
However, based on the "Technology" and "Device Description" sections, we can infer some key performance characteristics:
| Acceptance Criteria (Inferred from Device Description/Technology) | Reported Device Performance (JUSHA-C31 Medical Display) |
|---|---|
| High resolution | 2048 x 1536 (3 megapixels) |
| High luminance | 450 cd/m² max |
| Display Color | 16.7M (8-bits data per R,G,B each) |
| DICOM compliance | 3 DICOM look up tables inside |
| Compliance with IEC 60601-1 (Medical equipment safety) | Complies with IEC 60601-1:1988+A1:1991+A2:1995 |
| Compliance with IEC 60601-1-2 (Electromagnetic compatibility) | Complies with IEC 60601-1-2 Edition 3:2007 |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a hardware display device, not an algorithm being tested on a data set. The testing performed was for product safety and performance against technical specifications, not clinical data sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of clinical data, is not relevant for this type of device submission. The "testing" involved verifying the display's technical specifications and compliance with standards.
4. Adjudication Method for the Test Set
Not applicable. There was no clinical test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This type of study is for evaluating human performance (with or without AI assistance) on clinical cases, which is not relevant for a display device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This submission is for a display device, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. For a display device, the "truth" is its adherence to technical specifications and safety standards.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device; there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of Determination of Substantial Equivalence (from the document):
The device manufacturer asserts that "JUSHA-C31 Medical Display is the display system with the high resolution monitor (3 megapixels) with electronic capabilities for evaluation of high resolution medical images, high luminance (450 cd/m² max) and 16.7M (8-bits data per R,G,B each)display color, 3 DICOM look up table inside."
The "Summary of Non-Clinical Tests" indicates that the display complies with voluntary standards (IEC 60601-1 and IEC 60601-1-2). Quality assurance measures included "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), [and] Safety testing (Verification)."
The submission explicitly states: "The subject of this premarket submission, Medical Display, did not require clinical studies to support substantial equivalence."
Conclusion: The manufacturer concludes that the JUSHA-C31 Medical Display is "as safe, as effective, and performance is substantially equivalent to the predicate device(s) [RADIFORCE R31; K052344]." The FDA's letter (K131389) confirms this determination of substantial equivalence.
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | April 21,2013 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 301, Hanzhongmen Street, 8F Block A, No.1, NanjingInternational Service Outsourcing Mansion, Nanjing, 210036China |
| Primary Contact Person: | Mike GuRegulatory ManagerGuangzhou Osmunda Medical Device Consulting Co., LtdTel: +86-20-62321333Fax: +86-20-86330253 |
| Secondary ContactPerson: | Zhu chengshunQuality ManagerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271 |
| Device Trade Name: | JUSHA-C31 Medical Display |
| Common/Usual Name: | Image display system, medical image workstation, imagemonitor/display, and others |
| Classification Name:Product Code: | System, image processing90LLZ |
| Predicate Device(s): | RADIFORCE R31;K052344 |
| Device Description: | JUSHA-C31 Medical Display is 53cm(20.8") color medicaldisplay with the high resolution(2048 x 1536), the product isconsisted of the following components:- 20.8 inch, Color Active Matrix TFT Liquid Crystal Display- Motherboard HDVI-3M V1.0- JUSHA-C31 Medical Display software- Power Adapter- Data Cable.The Medical Display is designed, tested, and will bemanufactured in accordance with both mandatory andvoluntary standards:1. IEC 60601-1Medical equipment medical electricalequipment - Part 1: General requirements for |
| basic safety and essential performance 1988+A1:1991 + A2:19952. IEC 60601-1-2 Edition 3:2007, Medical electricalequipment - Part 1-2: General requirements forbasic safety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements and tests. | |
| Intended Use: | JUSHA-C31 Medical Display is intended to be used indisplaying and viewing digital images for diagnosis of X-rayor MRI, etc. by trained medical practitioners. The device isnot specified for digital mammography system. |
| Technology: | JUSHA-C31 Medical Display is the display system with thehigh resolution monitor (3 megapixels) with electroniccapabilities for evaluation of high resolution medical images,high luminance (450 cd/m² max) and 16.7M(8-bits data perR,G,B each)display color, 3 DICOM look up table inside |
| Determination ofSubstantial Equivalence: | Summary of Non-Clinical Tests:The Medical Display complies with voluntary standards asdetailed in Section 9, 11 and 17 of this premarketsubmission. The following quality assurance measures wereapplied 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, Medical Display,did not require clinical studies to support substantialequivalence.The proposed device is Substantially Equivalent (SE) to thepredicate device which is US legally market device. |
| Therefore, the subject device is determined as safe andeffectiveness. | |
| Conclusion: | Nanjing Jusha Display Technology Co., Ltd Considers theJUSHA-C31 Medical Display to be as safe, as effective, andperformance is substantially equivalent to the predicatedevice(s). |
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K131389
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510(k) Premarket Notification Submission
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510(k) Premarket Notification Submission
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Harnoshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2013
Nanjing Jusha Display Technology Co., Ltd. % Mr. Mike Gu Regulatory Manager Guangzhou Osmunda Medical Device Consulting Co., Ltd. 710 Floor, 982 Congyun Road, Baiyun District Guangzhou, Guangdong 510420 CHINA
Re: K131389
Trade/Device Name: Jusha-C31 Medical Display Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2013 Received: August 27, 2013
Dear Mr. Gu:
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
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Page 2-Mr. Gu
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/dcfault.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 Small Manufacturers, International and Consumer Assistance 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,
Smh7)
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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Indications for Use
510(k) Number (if known): K 131389
Device Name: JUSHA-C31 Medical Display
Indications for Use:
JUSHA-C31 Medical Display 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 must not be used for digital mammography system.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Sm.h.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k) K131389
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§ 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).