(53 days)
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No
The document describes a medical monitor and calibration software, with no mention of AI or ML capabilities.
No
The device is a medical monitor intended for displaying medical images, not for directly treating or diagnosing medical conditions.
No
The device is described as an LCD monitor for displaying digital medical images, not for performing diagnosis itself. Its purpose is to present images for review by practitioners, and it explicitly states it "does not support the display of mammography images for diagnosis." The EzCal software merely helps the display meet industry standards; it does not perform diagnostic analysis.
No
The device description explicitly states "CW60N LCD Monitor is intended to display high resolution color and grayscale medical imaging". This indicates a hardware component (the monitor) is the primary device, even though it includes accompanying software (EzCal ver.2).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The CW60N LCD Monitor is described as a device for displaying digital medical images. It does not perform any tests on biological samples. Its function is to present visual information to a medical practitioner.
- Intended Use: The intended use is for "displaying digital medical images for review by trained medical practitioners." This aligns with image viewing, not diagnostic testing of samples.
- Lack of IVD-related terms: The description does not mention any processes related to analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVDs.
Therefore, the CW60N LCD Monitor falls under the category of a medical image display device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench tests 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 Items: 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.
No clinical studies were considered necessary and performed.
The results of these tests demonstrate that CW60N meets the acceptance criteria and is adequate for this intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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).
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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
1
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 | Discussion
of
Differences |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Product | RadiForce RX660,
RadiForce RX660-AR | CW60N | - |
| Screen
technology | TFT Color
LCD Panel (IPS) | TFT Color
LCD 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 x
403.0464 mm | Provided by the panel
manufacturers. |
| Pixel pitch | 0.1968 mm x 0.1968
mm | 0.197 mm x 0.197
Mm | Provided by the panel
manufacturers. |
| Maximum luminance | 1,000 cd/m² | 1,300 cd/m² | Provided by the panel
manufacturers. |
| DICOM calibrated
luminance | 500 cd/m² | 500 cd/m² | - |
| Contrast ratio(typical) | 1500 : 1 | 2000 : 1 | Provided by the panel
manufacturers. |
| Response
Time(typical) | 25ms (On/Off) | 28ms (On/Off) | Provided by the panel
manufacturers. |
| Backlighting | LED | LED | - |
| Display Colors | From a palette of 68
billion colors:
- 10-bit (DisplayPort): | From a palette of 68
billion colors: - 10-bit : 1.07 billion | - |
| | 1.07 billion colors
(maximum) - 8-bit colors: 16.77 million colors | colors (maximum) | |
| Luminance Non-
uniformity
compensation | Digital Uniformity
Equalizer | Luminance Uniformity
Correction | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| Input video signals | DVI-D (dual link) x 1,
DisplayPort x 2 | DisplayPort x 1 | Differences by
manufacturers. |
| Output video signals | DisplayPort x 1 (daisy
chain) | - | Differences by
manufacturers. |
| Scanning Frequency
(H / V) | 31 - 127 kHz / 22 - 61 Hz
(VGA Text: 69 - 71
Hz)
Frame synchronous
mode:
29.5 - 30.5 Hz, 59 - 61
Hz | DisplayPort
115.5KHz, 55Hz | : Differences by
manufacturers. |
| Power
Requirements | AC 100 - 240 V:
50 / 60 Hz | AC 100 - 240 V:
50 / 60 Hz | - |
| Power
Consumption /
Save Mode | 190 W / Less than 1.6
W | 180 W / Less than 20
W | Differences by
manufacturers. |
| Power
Management | DVI DMPM,
DisplayPort 1.2a | DisplayPort 1.2a | - |
| QC software | RadiCS | EzCal | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| Sensors | Backlight Sensor,
Integrated Front
Sensor,
Presence Sensor,
Ambient Light Sensor | IQ Sensor,
Human Sensor,
Ambient Light Sensor | It is only a difference in
terms of each
manufacturer, but the
functions are similar. |
| USB Ports /
Standard | 2 upstream,
3 downstream / Rev.
2.0 | 1 upstream,
2 downstream / Rev.
3.0 | Differences by
manufacturers. |
| Dimensions
(W x H x D) | 682.5 x 441 x 88 mm
(w/o stand) | 692.0 x 642.7 x 283.0
mm
(w stand) | Different housing
design. |
510(k) Summary 2/4
5
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:
6
| IEC 60601-1: | Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2: | Medical Electrical Equipment - Part 1-2: General
Requirements 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.