(53 days)
CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
CW60N LCD Monitor is intended to display 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 and reviewing 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.
EzCal is packed with the display.
Here's an analysis of the provided text regarding the CW60N LCD Monitor, focusing on the acceptance criteria and the study proving compliance:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a formal table of acceptance criteria with corresponding performance results directly tied to the "acceptance criteria" language. Instead, it lists a series of bench tests performed and then concludes that the device "meets the acceptance criteria." The performance evaluation is implied through the successful completion of these tests as per the FDA guidance document.
Below is an attempt to create a table based on the information provided, inferring acceptance criteria from the tests performed and the statement about meeting them.
| Acceptance Criteria Category (Inferred from Test Item) | Reported Device Performance (Inferred from "meets acceptance criteria") |
|---|---|
| Pixel Defects & Artifacts | Successfully passed (no unacceptable pixel defects or artifacts) |
| Luminance | Successfully passed (met specified luminance requirements) |
| Reflection | Successfully passed (met specified reflection requirements) |
| Luminance Uniformity | Successfully passed (met specified luminance uniformity requirements) |
| Veiling Glare | Successfully passed (met specified veiling glare requirements) |
| Color Uniformity | Successfully passed (met specified color uniformity requirements) |
| Luminance Response | Successfully passed (met specified luminance response requirements) |
| Luminance at 30° and 45° (horizontal & vertical) | Successfully passed (met specified luminance at angles requirements) |
| Temporal Performance | Successfully passed (met specified temporal performance requirements) |
| Color Tracking | Successfully passed (met specified color tracking requirements) |
| Gray Tracking | Successfully passed (met specified gray tracking requirements) |
| MTF (Modulation Transfer Function) | Successfully passed (met specified MTF requirements) |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1 |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document refers to "bench tests" performed on "the CW60N," implying that at least one physical unit of the device was tested. It does not provide the number of units or repeated measurements.
- Data Provenance: The tests were performed following the instructions in the FDA's "Display Devices for Diagnostic Radiology - Guidance for Industry and Food and Drug Administration Staff" (October 2, 2017). This indicates the tests were conducted specifically for regulatory submission, likely prospective in nature, as they were performed on the CW60N device. There is no information regarding the country of origin of the data beyond the manufacturer being in the Republic of Korea.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Number of Experts: Not applicable. The "ground truth" for the performance tests of a medical display monitor typically refers to established technical specifications and industry standards (like DICOM Part 14 GSDF or the FDA guidance document itself) rather than expert human interpretation of medical images. The tests evaluate the physical display characteristics.
- Qualifications of Experts: Not applicable. The tests are objective measurements against technical standards. While engineers or technicians with specific expertise in display calibration and testing would perform these, their qualifications in terms of medical image interpretation (e.g., radiologist experience) are not relevant here.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable. As mentioned above, the tests are objective measurements against established technical specifications. There is no subjective human adjudication process described or required for these types of device performance tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Readers Improvement with AI vs. without AI Assistance:
- No, an MRMC comparative effectiveness study was not done.
- This device is an LCD monitor for displaying medical images, not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- No, a standalone (algorithm only) performance study was not done.
- This device is a hardware display monitor. Its performance is evaluated based on its physical characteristics and ability to accurately render images according to standards, not as a standalone algorithm.
7. The Type of Ground Truth Used:
- The "ground truth" for the device's performance is based on technical specifications, industry standards (e.g., DICOM Part 14 GSDF), and regulatory guidance documents (FDA's "Display Devices for Diagnostic Radiology"). These documents define the expected objective performance characteristics of a medical display monitor.
8. The Sample Size for the Training Set:
- Not applicable. This device is a hardware monitor, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for a hardware display monitor.
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Image /page/0/Picture/0 description: The image contains 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" in a stacked format.
WIDE Corporation % Josh Baker Consultant OT Consulting Inc. 33781 Bayside Lane DANA POINT CA 92629
October 31, 2022
Re: K222722
Trade/Device Name: CW60N Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: PGY Dated: September 8, 2022 Received: September 8, 2022
Dear Josh Baker:
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.
Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: 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) K222722
Device Name CW60N
Indications for Use (Describe)
CW60N LCD Monitor is intended to be used in displaying digital medical images for review by trained medical practitioners. It 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
[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)]
06/13/2022
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 |
| 510(k) Contact Person | Josh Baker – Consultant, OT Consulting Inc.33781 Bayside Lane, Dana Point, California 92629 USA |
| Tel: 714-788-8152 | |
| Email: josh@otconsulting.tech |
3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]
| Model Name: | CW60N |
|---|---|
| Common Name: | TFT LCD Medical Monitor System |
| Classification Name: | Medical image management and processing system |
| 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: | K163335 |
|---|---|
| Applicant: | EIZO CORPORATION |
| Model Name: | 6MP Color LCD Monitor, RadiForce RX660, RX660-AR |
| Common Name: | 6MP Color LCD Monitor |
510(k) Summary 1/4
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Classification Name: Display, Diagnostic Radiology Regulation Number: 21 CFR 892.2050 Product Code: PGY Device Class: 2
5. Description of the Device [21 CFR 807.92(a) (4)]
CW60N LCD Monitor is intended to display 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 and reviewing 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.
EzCal is packed with the display.
6. Intended Use [21 CFR 807.92(a) (5)]
CW60N LCD Monitor is intended to be used in displaying and viewing digital medical images for review by trained medical practitioners. It does not support the display of mammography images for diagnosis.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
The table below presents comparisons between the subject device (CW60N) and the predicate device (K163335):
| Attributes | Predicate Device | Subject Device | DiscussionofDifferences |
|---|---|---|---|
| Product | RadiForce RX660,RadiForce RX660-AR | CW60N | - |
| Screentechnology | TFT ColorLCD Panel (IPS) | TFT ColorLCD Panel (IPS) | - |
| Viewing angle (H, V) | H: 176°, V: 176° | H: 176°, V: 176° | - |
| Resolution | 6MP (3,280 x 2,048) | 6MP (3,280 x 2,048) | - |
| Aspect ratio | 16 : 10 | 16 : 10 | - |
| Active screen size | 645.5 mm x 403.0 mm | 645.504 mm x403.0464 mm | Provided by the panelmanufacturers. |
| Pixel pitch | 0.1968 mm x 0.1968mm | 0.197 mm x 0.197Mm | Provided by the panelmanufacturers. |
| Maximum luminance | 1,000 cd/m² | 1,300 cd/m² | Provided by the panelmanufacturers. |
| DICOM calibratedluminance | 500 cd/m² | 500 cd/m² | - |
| Contrast ratio(typical) | 1500 : 1 | 2000 : 1 | Provided by the panelmanufacturers. |
| ResponseTime(typical) | 25ms (On/Off) | 28ms (On/Off) | Provided by the panelmanufacturers. |
| Backlighting | LED | LED | - |
| Display Colors | From a palette of 68billion colors:- 10-bit (DisplayPort): | From a palette of 68billion colors:- 10-bit : 1.07 billion | - |
| 1.07 billion colors(maximum)- 8-bit colors: 16.77 million colors | colors (maximum) | ||
| Luminance Non-uniformitycompensation | Digital UniformityEqualizer | Luminance UniformityCorrection | It is only a difference interms of eachmanufacturer, but thefunctions are similar. |
| Input video signals | DVI-D (dual link) x 1,DisplayPort x 2 | DisplayPort x 1 | Differences bymanufacturers. |
| Output video signals | DisplayPort x 1 (daisychain) | - | Differences bymanufacturers. |
| Scanning Frequency(H / V) | 31 - 127 kHz / 22 - 61 Hz(VGA Text: 69 - 71Hz)Frame synchronousmode:29.5 - 30.5 Hz, 59 - 61Hz | DisplayPort115.5KHz, 55Hz | : Differences bymanufacturers. |
| PowerRequirements | AC 100 - 240 V:50 / 60 Hz | AC 100 - 240 V:50 / 60 Hz | - |
| PowerConsumption /Save Mode | 190 W / Less than 1.6W | 180 W / Less than 20W | Differences bymanufacturers. |
| PowerManagement | DVI DMPM,DisplayPort 1.2a | DisplayPort 1.2a | - |
| QC software | RadiCS | EzCal | It is only a difference interms of eachmanufacturer, but thefunctions are similar. |
| Sensors | Backlight Sensor,Integrated FrontSensor,Presence Sensor,Ambient Light Sensor | IQ Sensor,Human Sensor,Ambient Light Sensor | It is only a difference interms of eachmanufacturer, but thefunctions are similar. |
| USB Ports /Standard | 2 upstream,3 downstream / Rev.2.0 | 1 upstream,2 downstream / Rev.3.0 | Differences bymanufacturers. |
| Dimensions(W x H x D) | 682.5 x 441 x 88 mm(w/o stand) | 692.0 x 642.7 x 283.0mm(w stand) | Different housingdesign. |
510(k) Summary 2/4
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CW60N Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, indications for use, and safety and effectiveness.
8. Summary of Non-Clinical Data
CW60N comply with the following international and FDA-recognized consensus standards:
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| 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 -Requirements And Tests |
The bench tests below were performed on the CW60N 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, Veiling Glare, Color Uniformity, Luminance Response, Luminance at 30° and 45° in horizontal, and vertical directions, Temporal Performance Test, Color Tracking, Gray Tracking, MTF
9. Summary of Clinical Data
No clinical studies were considered necessary and performed.
10. Conclusion [21 CFR 807.92(b) (3)]
Subject Device is substantially equivalent to the currently marketed and predicate devices in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.
Additionally, the safety of the subject device was validated through tests including ANSI/AAMI ES 60601-1 and IEC 60601-1-2. The effectiveness of the device was validated through bench tests.
The results of these tests demonstrate that CW60N 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).