(32 days)
JUSHA-M23C LCD Monitor is intended to be used in displaying digital images by trained medical practitioners. JUSHA-M23C LCD Monitor does not support the display of mammography images for diagnosis.
JUSHA-M23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance (1000cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M23C 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:
- 21.3inches, Mono-TFT LCD Panel
- JUSHA- SMS_19inch motherboard/FR-4/REV:0.1
- JUSHA-M23C LCD Monitor software
- Power Adapter
- Data Cable.
The provided document describes the JUSHA-M23C LCD Monitor, which is a medical display device, and its substantial equivalence to a predicate device.
Here's the information requested based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the JUSHA-M23C LCD Monitor are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (RADIFORCE GX240; K120407) and compliance with relevant medical device standards. The "performance" in this context refers to the technical specifications of the device itself and its adherence to these standards.
| Acceptance Criteria / Standard | Proposed Device (JUSHA-M23C) Performance/Compliance |
|---|---|
| Technical Specifications (Comparison to Predicate) | |
| Screen technology | 21.3" Monochrome TFT LCD Panel |
| Viewing angle (H, V) | Horizontal 176°, Vertical 176° |
| Resolution | 1600 x 1200 / 1200 x 1600 |
| Display area | 432.0 (H) x 324.0 (V) mm |
| Contrast Ratio | 1400:1 |
| Scanning frequency (H; V) | 52 |
| Recommended Luminance | 500cd/m² |
| Pixel Pitch | 0.27x0.27 mm |
| Backlight | LED |
| DICOM LUT | 12-bit: 4096 |
| Luminance calibration | Built-in calibration sensor provided |
| Input signals | DVI standard 1.0, DisplayPort 1.1a |
| Input terminational | DVI-D (dual link) x 1, DisplayPort x 1 |
| Display controller | Off the shelf |
| Power Requirement | AC 100 |
| Power Consumption/Save Mode | 45W / less than 3W |
| Power Management | DVI DMPM, DisplayPort 1.1a |
| USB Ports/standard | 1 upstream (endpoint), 2 downstream / Rev. 2.0 |
| Dimensions w/o stand (W x H x D) | Without stand: 382mm x490mm x75mm; With stand: 382mm x533mm x238mm |
| Bench Testing (Functional Performance) | |
| Angular dependency of luminance response | Meets performance standards (specific results not detailed) |
| Luminance non-uniformity characteristics | Meets TG18 guideline |
| Chromaticity non-uniformity characteristics | Meets TG18 guideline |
| Small-spot contrast ratio | Meets performance standards (specific results not detailed) |
| Temporal response | Meets performance standards (specific results not detailed) |
| Luminance stability | Meets performance standards (specific results not detailed) |
| Safety and EMC Standards | |
| Electrical safety | Complies with IEC 60601-1 |
| Electromagnetic compatibility (EMC) | Complies with IEC 60601-1-2 |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset used for evaluating an AI algorithm. This device is a medical monitor, and its evaluation involved bench testing of the physical device, not an analysis of a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The product is a display monitor, not an AI algorithm that requires expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set requiring adjudication is described.
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 device is a display monitor, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical display monitor, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not describe a ground truth in the context of medical efficacy or diagnostic performance. For the technical performance of the monitor, the "ground truth" or reference points are the specifications of the predicate device and the requirements of the international standards (IEC 60601-1, IEC 60601-1-2, and TGI18 guideline).
8. The sample size for the training set
Not applicable. The product is a hardware device (LCD monitor), not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for it.
Summary of the Study Proving Acceptance Criteria:
The study proving the JUSHA-M23C LCD Monitor meets its acceptance criteria is primarily an evaluation for substantial equivalence to a predicate device (RADIFORCE GX240) and compliance with established international standards for medical electrical equipment.
- Bench Testing: Various physical and performance characteristics of the monitor were measured, including angular dependency of luminance, luminance and chromaticity non-uniformity (against TG18 guideline), small-spot contrast ratio, temporal response, and luminance stability. The document states that the device "meets all performance standards" and complies with the TG18 guideline.
- Electrical Safety and EMC Testing: The device was tested for electrical safety against IEC 60601-1 and for electromagnetic compatibility against IEC 60601-1-2. The results indicate compliance with these standards.
- Comparison to Predicate: A direct comparison of technical specifications between the JUSHA-M23C and the predicate device (RADIFORCE GX240) was performed (as shown in the table in the 510(k) summary and Attachment 1). The conclusion is that the JUSHA-M23C employs maximum resolution values same as the predicate and is "substantially equivalent."
- Clinical Studies: The document explicitly states that the device "did not require clinical studies to support substantial equivalence." This is common for devices that are deemed to have similar technological characteristics and intended use as an already approved predicate.
In essence, the "study" for this device involved a thorough technical comparison, functional bench testing, and adherence to established safety and performance standards to demonstrate that it operates safely and effectively as a medical display monitor, similar to the predicate device.
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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a stylized caduceus symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The caduceus is depicted with a modern, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 12, 2015
Nanjing Jusha Display Technology Co., Ltd. % Mr. Ma Jing Certifical Engineer 301 Hanzhongmen Street, 8F Block A, No. 1 Nanjing International Service Outsourcing Mansion, Nanjing, 210036 CHINA
Re: K151238
Trade/Device Name: JUSHA-M23C LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: March 16, 2015 Received: May 11, 2015
Dear Ma Jing:
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 (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.
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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,
Robert A Ochs
Robert Ochs. Ph.D. Acting 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) K151238
Device Name JUSHA-M23C LCD monitor
Indications for Use (Describe)
JUSHA-M23C LCD Monitor is intended to be used in displaying digital images by trained medical practitioners. JUSHA-M23C LCD Monitor 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
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | May 6, 2015 | |
|---|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., LtdAdd: 8A, Block 1. Nanjing International Service Outsourcing Mansion, No. 301, Hanzhongmen street, Nanjing, China. | |
| Contact Person: | Ma JingCertification EngineerNanjing Jusha Display Technology Co., LtdTel: +86-25- 83305050Fax: +86-25- 58783271 | |
| Device Trade Name: | JUSHA-M23C LCD Monitor | |
| Common/Usual Name: | 2MP Monochrome LCD Monitor | |
| Classification Name: Product Code: | System, image processing 21CFR 892.2050PGY | |
| Predicate Device(s): | RADIFORCE GX240; K120407 | |
| Device Description: | JUSHA-M23C LCD Monitor is the display system with the high resolution (1600*1200), high luminance (1000cd/m²), and 1024 simultaneous shades of gray out of a palette of 4096, 10 DICOM look up table and 3 GAMMA look up table inside. JUSHA-M23C 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:- 21.3inches, Mono-TFT LCD Panel- JUSHA- SMS_19inch motherboard/FR-4/REV:0.1- JUSHA-M23C LCD Monitor software- Power Adapter- Data Cable. | |
| The LCD Monitor is designed, tested, and will be manufactured inaccordance with both mandatory and voluntary standards:1. IEC 60601-1Medical equipment medical electricalequipment - Part 1: General requirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007)2. IEC 60601-1-2 Edition 3:2007, Medical electricalequipment - Part 1-2: General requirements for basicsafety and essential performance - Collateral standard:Electromagnetic compatibility - Requirements and tests. | ||
| Intended Use: | JUSHA-M23C LCD Monitor is intended to be used in displaying andviewing digital images by trained medical practitioners.JUSHA-M23C LCD Monitor does not support the display ofmammography images for diagnosis. | |
| Technology: | JUSHA-M23C LCD Monitor is the display system with the highresolution monitor (2 megapixels) with electronic capabilities forevaluation of high resolution medical images, high luminance (1000cd/m²) and 1024 simultaneous shades of gray out of a palette of 4096,10 DICOM look up table and 3 GAMMA look up table inside.JUSHA-M23C has ambient brightness adapting and presenceinduction system, with these this display can automatic adjustmentaccording to different requirements in order to achieve the bestresults. | |
| Determination of SubstantialEquivalence: | 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 essentialperformance 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 essentialperformance - Collateral standard: Electromagnetic compatibility- Requirements and tests.JUSHA-M23C is substantially equivalent to RADIFORCE GX240.JUSHA-M23C employs the maximum resolution values same as thatof RADIFORCE GX240. Comparison table of the principalcharacteristics of 2 devices is shown in the Attachment 1.Attachment 1 | |
| 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-M23C LCD Monitor to be as safe, as effective, and | ||
| performance is substantially equivalent to the predicate device(s). |
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This comparison identifies the similarities and differences of the proposed JUSHA-M23C LCD Monitor device to the legally marketed predicate EIZO RADIFORCE GX240 LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device |
|---|---|---|
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| Display Performance/Specifications | ||
| Screen technology | 21.3" Monochrome TFTLCD Panel | 21.3" Monochrome TFTLCD Panel |
| Viewing angle (H, V) | Horizontal 176 °,Vertical176 ° | Horizontal 176 °,Vertical176 ° |
| Resolution | 1600 x 1200/1200 x 1600 | 1600 x 1200/1200 x 1600 |
| Display area | 432.0 (H) x 324.0(V) mm | 432.0 (H) x 324.0(V) mm |
| Contrast Ratio | 1400:1 | 1400:1 |
| Scanning frequency (H; V) | 31 | 52 |
| Recommended Luminance | 500cd/m² | 500cd/m² |
| Pixel Pitch | 0.27x0.27 mm | 0.27x0.27 mm |
| Backlight | LED | LED |
| DICOM LUT | 10-bit (Display Port) : 10248-bit: 256 | 12-bit:4096 |
| Luminance calibration | Built in calibration sensor provided | Built in calibration sensor provided |
| 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 |
| Attributes | Predicate Device | Proposed Device |
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| PowerConsumption/Save Mode | 36W/less than1.6W | 45W/less than 3W |
| PowerManagement | DVI DMPMDisplayPort 1.1a | DVI DMPMDisplayPort 1.1a |
| USBPorts/standard | 1 upstream (endpoint),2 downstream/ Rev. 2.0 | 1 upstream (endpoint),2 downstream/ Rev. 2.0 |
| Dimensions w/ostand(W x H x D) | Without stand:376mmx505mmx98mmWith stand:376mmx599mmx245.5 mm | Without stand:382mm x490mm x75mmWith stand:382mm x533mm x238mm |
| Indication foruse | RADIFORCE GX240 isintended to be used indisplaying and viewingdigital images by trainedmedical practitioners.RADIFORCE GX240Monitor does not support thedisplay of mammographyimages for diagnosis. | JUSHA-M23C LCD Monitoris intended to be used indisplaying and viewingdigital images by trainedmedical practitioners.JUSHA-M23C LCD Monitordoes not support the displayof mammography images fordiagnosis. |
| Attributes | Predicate Device | Proposed Device |
| Product | RADIFORCE GX240 | JUSHA-M23C LCD Monitor |
| 510(k) Number | K120407 | / |
| Applicablestandard | 1 IEC 60601-1Medicalequipment medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance2005+CORR.1(2006)+CORR.2(2007) | 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. | 2 IEC 60601-1-2 Edition3:2007, Medical electricalequipment - Part 1-2:General requirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - 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-M23C 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-M23C. 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-M23C, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
JUSHA-M23C 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 should perform as intended in the specified use conditions. Nanjing Jusha Display Technology Co., Ltd considers the JUSHA-M23C 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).