(54 days)
The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
CX30N(CX30PQX) is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
CX30N is basic model and CX30PQX is identical to CX30N, except model name.
The provided text is a 510(k) summary for the CX30N (CX30PQX) medical display device. It describes the device's technical specifications, intended use, and a comparison with a predicate device to establish substantial equivalence. The document describes bench tests for performance, but it does not describe a study involving human readers, AI assistance, or the establishment of ground truth for diagnostic accuracy.
Therefore, many of the requested items (2-9) in the prompt cannot be answered from the provided text, as they pertain to clinical or standalone performance studies, which were not conducted or reported for this device based on the provided summary. The device in question is a medical monitor (hardware), not an AI algorithm or a diagnostic software.
Here's what can be extracted from the provided text regarding acceptance criteria and performance, as well as the limitations:
1. A table of acceptance criteria and the reported device performance
The document lists various "Test Items" that were performed, implying these are the parameters for which acceptance criteria would have been defined. However, the specific numerical acceptance criteria and the reported numerical performance values are not explicitly stated in the provided 510(k) summary. It only indicates that "CX30N(CX30PQX) meets the acceptance criteria."
| Test Item | Acceptance Criteria (Not explicitly stated in document) | Reported Device Performance (Not explicitly stated in document) |
|---|---|---|
| Pixel Defects | To meet specified standards | Meets acceptance criteria |
| Artifacts | To meet specified standards | Meets acceptance criteria |
| Luminance | To meet specified standards | Meets acceptance criteria |
| Reflection | To meet specified standards | Meets acceptance criteria |
| Luminance Uniformity | To meet specified standards | Meets acceptance criteria |
| Resolution | To meet specified standards | Meets acceptance criteria |
| Noise | To meet specified standards | Meets acceptance criteria |
| Veiling Glare | To meet specified standards | Meets acceptance criteria |
| Color Uniformity | To meet specified standards | Meets acceptance criteria |
| Luminance Response | To meet specified standards | Meets acceptance criteria |
| Luminance at 30° and 45° in diagonal, horizontal, and vertical directions | To meet specified standards | Meets acceptance criteria |
| Temporal Performance test | To meet specified standards | Meets acceptance criteria |
| Color Tracking | To meet specified standards | Meets acceptance criteria |
| Gray Tracking | To meet specified standards | Meets acceptance criteria |
Note: The phrase "meets the acceptance criteria" is a general statement. For a detailed understanding, the actual criteria (e.g., maximum allowable pixel defects, specific luminance range, etc.) and the measured values would be needed, which are not in this summary. The tests were performed "following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.'" This guidance would contain the specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the described tests are bench tests of a physical display device, not clinical or image-based studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable for the reasons stated above. Ground truth, in this context, would relate to image interpretation, not display performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable for the reasons stated above.
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
An MRMC study was not performed as this device is a medical monitor, not an AI-powered diagnostic tool. The document explicitly states "No clinical studies were considered necessary and performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study was not performed beyond the physical bench tests for the display's technical specifications. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable for the reasons stated above. For the bench tests, the "ground truth" would be the engineering specifications and calibrated measurement tools for display performance.
8. The sample size for the training set
This information is not applicable. This document describes a medical display monitor, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable. This document describes a medical display monitor, not a machine learning model.
In summary, the provided document focuses on the technical specifications and bench testing of a medical display monitor to prove its substantial equivalence to a predicate device. It explicitly states that "No clinical studies were considered necessary and performed," indicating that the device approval did not hinge on human reader studies or AI performance metrics.
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April 14, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wide Corporation % Mr. YeoJin Yun RA Manager 15F, The First Tower III, 602, Dongtangiheung-Ro Hwaseong-Si. Gyeonggi-Do 18469 REPUBLIC OF KOREA
Re: K210493
Trade/Device Name: CX30N (CX30PQX) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: PGY Dated: January 11, 2021 Received: February 19, 2021
Dear Mr. Yun:
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) K210493
Device Name CX30N(CX30PQX)
Indications for Use (Describe)
The CX30N(CX30PQX) LCD Monitor System is intended to be used in displaying and viewing digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
| 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
[As required by 21 CFR 807.92]
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR 807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
03/16/2021
2. Submitter's Information [21 CFR 807.92(a) (1)]
| Name of Sponsor: | WIDE Corporation. |
|---|---|
| Address: | 15F, The First Tower III, 602, Dongtangiheung-Ro,Hwaseong-Si, Gyeonggi-Do 18469, Republic of Korea |
| Contact Name: | YeoJin Yun |
| Telephone #: | +82-31-218-1675 |
| Fax #: | +82-31-376-9600 |
| Email: | yyjin@widecorp.com |
| Registration Number: | 3004082357 |
| Name of Manufacturer: | Same as Sponsor |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)|
Model Name: CX30N(CX30PQX) TFT LCD Medical Monitor System Common Name: Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2 Review Panel: Radiology
4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]
| 510(k) Number: | K153354 |
|---|---|
| Applicant: | EIZO CORPORATION |
| Model Name: | 3MP Color LCD Monitor, RadiForce RX350 |
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Display, Diagnostic Radiology |
| Regulation Number: | 21 CFR 892.2050 |
| Product Code: | PGY |
| Device Class: | 2 |
510(k) Summary 1/4
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5. Description of the Device [21 CFR 807.92(a) (4)]
CX30N(CX30PQX) is intended to provide high resolution color and grayscale medical imaging for PACS and Radiology system. This Medical Monitor is intended to be used by trained medical practitioners for displaying, reviewing, and analysis of medical images.
EzCal ver.2 is a software solution which enables the user to modify display output to meet DICOM Part 14 GSDF and other key industry standards.
CX30N(CX30PQX) is being provided with the calibration software EzCal v.2 (developed by Qubyx Inc.) when requested by the customer.
CX30N is basic model and CX30PQX is identical to CX30N, except model name.
6. Intended Use [21 CFR 807.92(a) (5)]
CX30N(CX30PQX) is intended to be used to display and view digital medical images for review and analysis by trained medical practitioners. The display is not intended for mammography.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
The device is an image display system which consists of computer software and components. The device does not contact the patient, nor does it control any life sustaining devices. A physician or trained medical practitioner provides ample opportunity for competent human intervention to interpret images and information being displayed.
| Attributes | Predicate Device | Subject Device | DiscussionofDifferences |
|---|---|---|---|
| Product | RadiForce RX340 | CX30N(CX30PQX) | - |
| Screentechnology | IPS TFT Color LCDPanel | Dual domain IPS TFTColor LCD Panel | - |
| Viewingangle (H, V) | H: 170°, V: 170° | H: 178°, V: 178° | Provided by the panelmanufacturers. |
| Active screensize | 323.7 mm x 431.6 mm | 324.86 mm x 433.15 mm | Provided by the panelmanufacturers. |
| Resolution | 3MP (1,536 x 2,048) | 3MP (1,536 x 2,048) | - |
| Aspect ratio | 3 : 4 | 3:4 | - |
| Pixel pitch | 0.21075 mm x 0.21075mm | 0.2115 mm x 0.2115mm | Provided by the panelmanufacturers. |
| Maximumluminance | 1,000 cd/m² | 1,000 cd/m² | - |
| DICOMcalibratedluminance | 400 cd/m² | 450 cd/m² | Differences bymanufacturers. |
| Contrast ratio | 1400 : 1 | 1500 : 1 | Provided by the panelmanufacturers. |
| Backlighting | LED | LED | - |
| DisplayColors | From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07 | From a palette of 68billion colors:- 10-bit input(DisplayPort): 1.07 | - |
8. Substantial Equivalence [21 CFR 807.92(b) (1) and 807.92]
510(k) Summary 2/4
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| billion colors(maximum)- 8-bit input: 16.77million colors | billion colors(maximum)- 8-bit input: 16.77million colors | ||
|---|---|---|---|
| Luminancenon-uniformitycompensation | Digital UniformityEqualizer | LuminanceUniformityControl | It is only a difference interms of eachmanufacturer, but thefunctions are similar. |
| Input videosignals | DVI-D (dual link) x 1,DisplayPort x 1 | DVI-D (dual link) x 1,DisplayPort x 1 | - |
| ScanningFrequency(H, V) | 31 - 127 kHz, 29 - 61Hz(VGA Text: 69 - 71 Hz)Frame synchronousmode: 29.5 - 30.5 Hz,59 - 61 Hz | 96KHz, 60Hz | Differences bymanufacturers. |
| PowerRequirements | AC 100 - 120 V,200 - 240 V: 50 / 60 Hz | AC 100~240 V: 50 / 60HzDC +24V, 2.4A | Differences bymanufacturers. |
| PowerConsumption/ Save Mode | 125 W / Less than 3 W | 75 W / Less than 2 W | Differences bymanufacturers. |
| PowerManagement | DVI DMPM,DisplayPort 1.1a | DVI DMPM,DisplayPort 1.1a | - |
| QC software | RadiCS | EzCal | It is only a difference interms of eachmanufacturer, but thefunctions are similar. |
| Sensors | Backlight Sensor,Presence Sensor,Integrated FrontSensor,Ambient Light Sensor | Backlight Sensor,IQ Sensor,Ambient Light Sensor | It is only a difference interms of eachmanufacturer, but thefunctions are similar.but Integrated FrontSensor is not used. |
| USB Ports /Standard | 1 upstream,2 downstream / Rev.2.0 | 1 upstream,3 downstream / Rev.3.0 | Differences bymanufacturers. |
| Dimensionsw/o stand(W x H x D) | 376 x 505 x 98 mm | 366 x 476 x 65.5 mm | Different housingdesign due to thedifferent panel size |
CX30N(CX30PQX) Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.
9. Summary of Non-Clinical Data
CX30N(CX30PQX) comply with the following international and FDA-recognized consensus standards:
| IEC 60601-1: | Medical Electrical Equipment -- Part 1: GeneralRequirements For Basic Safety And Essential Performance |
|---|---|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And Essential Performance --Collateral Standard: Electromagnetic Compatibility - |
| 510(k) Summary 3/4 |
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Requirements And Tests
The bench tests below were performed on the CX30N(CX30PQX) following the instructions in 'Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff, issued on October 2, 2017.
· Test Item
Pixel Defects, Artifacts, Luminance, Reflection, Luminance Uniformity, Resolution, Noise, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in diagonal, horizontal, and vertical directions, Temporal Performance test, Color Tracking, Gray Tracking
10. Summary of Clinical Data
No clinical studies were considered necessary and performed.
11. Conclusion [21 CFR 807.92(b) (3)]
Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.
Additionally, the safety of the subject device was validated through tests including IEC60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests.
The results of these tests demonstrate that CX30N(CX30PQX) meets the acceptance criteria and is adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing demonstrates that the device is as safe and effective as the predicate device and performs as well as the predicate device.
§ 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).