(109 days)
R190/R191 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.
R190/R191 LCD Monitor is the display system with the resolution (1280*1024), high luminance (800cd/m2), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time.
The product is consisted of the following components:
-19inches, Mono-TFT LCD Panel
- M150M/P38 motherboard/FR-4
- R190/R191 LCD Monitor software
- Power cable
- Data Cable.
The LCD Monitor is designed, tested, and will be manufactured in accordance with both mandatory and voluntary standards.
Here's a breakdown of the acceptance criteria and study information for the Nanjing Jusha Display Technology Co., Ltd. R190/R191 LCD Monitor:
1. Table of Acceptance Criteria and Reported Device Performance
The submission for the R190/R191 LCD Monitor primarily focuses on demonstrating substantial equivalence to a predicate device (CHILIN MDM 1900-1NR LCD Monitor) through technical specifications and adherence to safety and EMC standards. As such, the "acceptance criteria" are largely defined by these comparative specifications and compliance with standards, rather than specific performance metrics directly measured against a predefined threshold in clinical studies for this particular device.
However, based on the provided text, we can infer some "acceptance criteria" and the reported performance as demonstrated through bench testing and comparison to the predicate.
| Acceptance Criteria (Implied/Derived) | Reported Device Performance (R190/R191) | Reference |
|---|---|---|
| Display Performance | ||
| Resolution | 1280x1024 (Matches the general capability of the predicate, though listed differently due to viewing directions) | Comparison Table |
| Screen Technology | 19" Monochrome TFT LCD Panel (Same as predicate) | Comparison Table |
| Viewing Angle (H, V) | Horizontal 176°, Vertical 176° (Comparable to predicate's 170°, 170°) | Comparison Table |
| Contrast Ratio | 1000:1 (Better than predicate's 800:1, deemed not to affect use) | Comparison Table |
| Response Time | 16ms (Better than predicate's 18ms) | Comparison Table |
| Recommended Luminance | 800cd/m² (Comparable to predicate's 1000cd/m², "difference is not large and does not affect the use" after curve correction) | Comparison Table |
| Pixel Pitch | 0.2928x0.2928mm (Comparable to predicate's 0.294x0.294mm) | Comparison Table |
| Backlight | LED (Same as predicate) | Comparison Table |
| DICOM LUT | 10-bit:1024 (Predicate 12-bit:4096. "Both devices use grayscale extension technology, and the final display effect is not much different, which does not affect the use of the product.") | Comparison Table |
| Luminance Calibration | Built-in calibration sensor provided (Same as predicate) | Comparison Table |
| Safety and Electrical | ||
| Electrical Safety | Complies with IEC 60601-1:2012 | Bench Testing Summary |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2:2014, EN 60601-1-2:2015 | Bench Testing Summary |
| Functional/Performance | ||
| Angular dependency of luminance response | Bench tested and met performance standards | Bench Testing Summary |
| Luminance non-uniformity | Bench tested and met performance standards as specified in TGI18 guideline | Bench Testing Summary |
| Chromaticity non-uniformity | Bench tested and met performance standards as specified in TG18 guideline | Bench Testing Summary |
| Small-spot contrast ratio | Bench tested and met performance standards | Bench Testing Summary |
| Temporal response | Bench tested and met performance standards | Bench Testing Summary |
| Luminance stability | Bench tested and met performance standards | Bench Testing Summary |
The study that "proves the device meets the acceptance criteria" is the non-clinical bench testing and the comparison to the predicate device as outlined. The FDA's issuance of the 510(k) clearance signifies their agreement that these tests and comparisons demonstrate substantial equivalence and thus meet the necessary criteria for safe and effective use.
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for the Test Set: Not applicable. This submission relies on bench testing of the device itself and comparison to a predicate device's established performance, rather than a test set of patient cases.
- Data Provenance: Not applicable for a patient data test set. The data provenance for the technical specifications is from the manufacturer's own testing and specifications for both the proposed device and the predicate device (as reported in K061303).
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 with ground truth established by experts was used for this submission. The device is a display monitor, and its performance is evaluated based on technical specifications and adherence to standards, not its ability to interpret medical images.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set requiring adjudication was used.
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
- No. An MRMC study was not done. This device is a medical display monitor and does not involve AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a display monitor and does not involve an algorithm with standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of clinical images. The "ground truth" for this device's performance is based on engineering measurements and compliance with established technical international standards for medical displays (e.g., luminance, contrast, resolution, DICOM conformance, safety standards).
8. The Sample Size for the Training Set
- Not applicable. The device is a medical display monitor and does not employ machine learning or AI that would require 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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510(k) Summary K183494
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | Dec 3, 2018 |
|---|---|
| Submitter: | Nanjing Jusha Display Technology Co., Ltd |
| Add: 8A, Block 1. Nanjing International Service OutsourcingMansion, No. 301, Hanzhongmen street, Nanjing, China. | |
| Contact Person: | Zilong Liang |
| Certification Manager | |
| Nanjing Jusha Display Technology Co., Ltd | |
| Tel: +86-25- 83305050 | |
| Fax: +86-25-5878 3273 | |
| Device Trade Name: | R190 LCD Monitor,R191 LCD Monitor |
| Common/Usual Name: | 1MP Monochrome LCD Monitor |
| Classification Name: ProductCode: | Display, Diagnostic Radiology 21CFR 892.2050PGY |
| Predicate Device(s): | MDM 1900-1NR AND MDM 1900-1NR; K061303 |
| Device Description: | R190/R191 LCD Monitor is the display system with the resolution(1280*1024), high luminance (800cd/m2), and can present up to 1.07billion colors(1024 grayscale), 1 DICOM look up table inside.R190/R191 uses luminance stabilization mechanism to ensurebrightness stability in the product service time.The product is consisted of the following components:-19inches, Mono-TFT LCD Panel- M150M/P38 motherboard/FR-4- R190/R191 LCD Monitor software- Power cable- Data Cable.The LCD Monitor is designed, tested, and will be manufactured inaccordance with both mandatory and voluntary standards. |
| Intended Use: | 1. IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance2. IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests |
| Intended Use: | R190/R191 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: | R190/R191 LCD Monitor is the display system with the resolution monitor (1 megapixels) with electronic capabilities for evaluation of high resolution medical images,the resolution $(1280*1024)$ , high luminance (800cd/m²), and can present up to 1.07 billion colors(1024 grayscale), 1 DICOM look up table inside. R190/R191 uses luminance stabilization mechanism to ensure brightness stability in the product service time. |
| Determination of Substantial Equivalence: | Summary of Non-Clinical Tests:The LCD Monitor complies with voluntary standards as following:1. IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance2. IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and testsR190/R191 is substantially equivalent to MDM 1900-1NR.R190/R191 employs the maximum resolution values same as that of MDM 1900-1NR. Comparison table of the principal characteristics of 2 devices is shown in the Attachment 1.Attachment 1The following quality assurance measures were applied to the development of the system:• Risk Analysis• Requirements Reviews• Design Reviews• Raw materials 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 R190/R191 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 R190/R191 LCD Monitor device to the legally marketed predicate CHILIN MDM 1900-1NR LCD Monitor device to which substantial equivalency is claimed.
| Attributes | Predicate Device | Proposed Device | Proposed Device | Discussion of Differences |
|---|---|---|---|---|
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | - |
| 510(k) Number | K061303 | K183494 | K183494 | - |
| Display Performance/Specifications | ||||
| Screen technology | 19" Monochrome TFT LCD Panel | 19" Monochrome TFT LCD Panel | 19" Monochrome TFT LCD Panel | Same |
| Viewing angle (H, V) | Horizontal 170°,Vertical 17 0° | Horizontal 176°,Vertical 176° | Horizontal 176°,Vertical 176° | - |
| AttributeS | Predicate Device | Proposed Device | Proposed Device | Discussion ofDifferences |
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | |
| 510(k)Number | K061303 | K183494 | K183494 | |
| Resolution | 1024 x 1280 | 1280*1024 | 1280*1024 | The differencebetween the twodevices is due tothe differentviewing directionsand does not affectperformance. |
| Displayarea | 376.32 (H) x301.056(V) mm | 374.7840 (H) x299.8272(V) mm | 374.7840 (H) x299.8272(V) mm | Same |
| ContrastRatio | 800:1 | 1000:1 | 1000:1 | - |
| ResponseTime | 18ms | 16ms | 16ms | - |
| Scanningfrequency (H; V) | 75kHz;63.4~79.78Hz | 52 | 52 | This differencebetween the twodevice is caused bythe different nodisplay areadefined bydifferentmanufacturers ,nothing to do withthe displayfunction |
| RecommendedLuminance | 1000cd/m2 | 800cd/m2 | 800cd/m2 | This item is themaximumbrightness of theLCD panel. Afterthe curve iscorrected, thedifference is notlarge and does notaffect the use. |
| PixelPitch | 0.294x0.294 mm | 0.2928x0.2928mm | 0.2928x0.2928mm | - |
| Backlight | LED | LED | LED | Same. |
| Attribute | Predicate Device | Proposed Device | Proposed Device | Discussion ofDifferences |
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | |
| 510(k)Number | K061303 | K183494 | K183494 | |
| DICOMLUT | 12-bit : 4096 | 10-bit:1024 | 10-bit:1024 | Both devices usegrayscale extensiontechnology, and thefinal display effectis not muchdifferent, whichdoes not affect theuse of the product. |
| Luminancecalibration | Built in calibrationsensor provided | Built in calibrationsensor provided | Built in calibrationsensor provided | Same |
| Video Signal Input | ||||
| Inputsignals | DVI standardD-Sub | DVI-DDisplayPortHDMIDVI-A | DVI-DDisplayPortHDMISOG | |
| Inputterminational | DVI-D (dual link) x1,D-Sub x 1 | DVI-D (dual link) x 1,DisplayPort x 1HDMI x1DVI-A x 1 | DVI-D (dual link) x1, DisplayPort x 1HDMI x1SOG x 1 | - |
| Displaycontroller | Off the shelf | Off the shelf | Off the shelf | Same |
| Power Related Specification | ||||
| PowerRequirement | AC 100~240V | AC 100~240V | AC 100~240V | Same |
| PowerConsumption/SaveMode | 47W/less than 0.5W | 25W/less than 0.5W | 25W/less than 0.5W | - |
| Attributes | Predicate Device | Proposed Device | Proposed Device | Discussion ofDifferences |
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | |
| 510(k)Number | K061303 | K183494 | K183494 | |
| PowerManagement | DVI DMPMDisplayPort | DVI DMPMDisplayPort | DVI DMPMDisplayPort | - |
| Miscellaneous Features/Specifications | ||||
| Serviceinterface | RS232 | USB | USB | This interface isonly used tocommunicate withthe host, does notaffect theperformance of thedisplay. |
| Dimensions w/o stand(W x H x D) | Without stand:344mmx418mmx82.5mm | Without stand:419mm x343mmx71mm | Without stand:419mm x343mmx71mm | Different housingdesign due to thedifferent panel size. |
| With stand:344mmx433mmx227 mm | With stand:419mm x379mmx198mm | With stand:419mm x379mmx198mm |
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| Attributes | Predicate Device | Proposed Device | Proposed Device | Discussion of Differences |
|---|---|---|---|---|
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | |
| 510(k)Number | K061303 | K183494 | K183494 | |
| Indication for use | MDM 1900-1NRMonitor is intendedto be used indisplaying andviewing digitalimages for diagnosisof X-ray or MRI,etc. by trainedmedicalpractitioners. Thedevice does notsupport the displayof mammographyimages fordiagnosis. | R190 LCD Monitor isintended to be used indisplaying andviewing digitalimages for diagnosisof X-ray or MRI, etc.by trained medicalpractitioners. Thedevice does notsupport the display ofmammographyimages for diagnosis. | R191 LCD Monitoris intended to beused in displayingand viewing digitalimages fordiagnosis of X-rayor MRI, etc. bytrained medicalpractitioners. Thedevice does notsupport the displayof mammographyimages fordiagnosis. | Same |
| Attributes | Predicate Device | Proposed Device | Proposed Device | Discussion of Differences |
| Product | CHILIN MDM1900-1NR | R190 LCD Monitor | R191 LCD Monitor | |
| 510(k) Number | K061303 | K183494 | K183494 | |
| Applicable standard | 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. | 1.IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance2.IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and tests | 1.IEC 60601-1:2012,Medical electrical equipment-Part 1:General requirements for basic safety and essential performance2.IEC 60601-1-2:2014,EN 60601-1-2:2015,Medical electrical equipment-Part 1-2:General requirements for basic safety and essential performance-Collateral Standard:Electromagnetic disturbances-Requirements and 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 R190/R191 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 R190/R191 The device complies with the IEC 60601-1:2012 standard for safety and the IEC 60601-1:2012 and EN 60601-1-2:2015 standard for EMC.
Animal and clinical study
The subject of this premarket submission,R190/R191, does not require animal or clinical studies to support substantial equivalence.
CONCLUSIONS
R190/R191 Medical Monitor 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 R190/R191 Medical Monitor does not raise any new issues of safety or effectiveness.
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Image /page/9/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. % Zilong Liang Certification Manager Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St. Nanjing, Jiangsu 210036 CHINA
April 5, 2019
Re: K183494
Trade/Device Name: R190/R191 LCD Monitor Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2019 Received: January 11, 2019
Dear Zilong Liang:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, subject to the general controls provisions of the Act. Although this letter refers to your products as devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA), they may be subject to additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your devices 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 devices comply 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Mills, Ph.D. 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
510(k) Number (if known)
Device Name
R190/R191 LCD Monitor
Indications for Use (Describe)
R190/R191 LCD Monitor is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRJ, 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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Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of Nanjing Jusha Display Technology Co., Ltd and as such may not be disclosed to others not employed by Nanjing Jusha Display Technology Co., Ltd. All rights reserved.
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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).