(28 days)
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No
The document describes a medical display monitor and does not mention any AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML algorithms.
No
The device is a monitor intended for displaying medical images for diagnosis, not for providing therapy or treatment.
No
The device is a monitor used for displaying medical images, not for performing diagnostic analysis itself. Its intended use is for trained medical practitioners to view images for diagnosis.
No
The device description explicitly states it is a 21.3-inch Color LCD monitor, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "displaying medical images for diagnosis by trained medical practitioners." This describes a device that displays visual information, not a device that performs tests on biological samples (which is the core function of an IVD).
- Device Description: The description details a monitor, which is a display device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
Therefore, the CCL210 (CL21210) is a medical image display device, not an IVD.
N/A
Intended Use / Indications for Use
21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
Product codes
PGY
Device Description
CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-I (both digital and analog interface) and DisplayPort (digital interface).
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
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The overall design of the CCL210 (CL21210) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL210 (CL21210) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of human profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi 221-0022 JAPAN
Re: K151134
Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 28, 2015 Received: April 29, 2015
Dear Mr. Tashiro:
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151134
Device Name
21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)
Indications for Use (Describe)
21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) is intended to be used in displaying medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital 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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TOTOKU
510(k) SUMMARY
| Submitted Information: | JVC KENWOOD CORPORATION
3-12, MORIYA-CHO, KANAGAWA-KU,
YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPAN |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Tsukasa Tashiro, Engineering Specialist
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | April 28, 2015 |
| Device Name: | 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) |
| Common Name: | CCL210, CL21210 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.1 inch (51 cm) Color LCD Mo
nitor CCL208 (CDL2013A)
(K092728) |
| Device Description: | CCL210 (CL21210) is a 21.3-inch (54 cm) Color LCD monitor
whose display resolution is 1600 x 1200 (landscape), 1200 x 1600
(portrait) supporting DVI-I (both digital and analog interface) and
DisplayPort (digital interface). |
| Intended Use: | 21.3 inch (54 cm) Co lor 2M pixel LCD M
onitor, CCL210
(CL21210) is intended to be used in displaying
and viewin g
medical images for diagnosis by trained medical practitioners. It is
not meant to be used in digital mammography. |
| Substantial Equivalence: | CCL210 (CL21210) shares the same technical characteristics,
application and intended use with our predicate device CCL2 08
(K092728) |
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Technical Specification
-
- Luminance uniformity
- [SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data
-
- Pixel Defects / Fault [SPEC] Class II or more. ISO13406-2
-
- Artifacts
- · phase/clock issues flicker
- miscellaneous including ringing, ghosting, image sticking [SPEC] By visible check, no flicker, ringing, ghosting and image sticking
-
- Chromaticity Measurement of 5%, 50%, 95% Level [SPEC] Refer to actual data.
-
- Chromaticity
[SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 Refer to Chromaticity actual data
-
- Power On Luminance Drift [SPEC] Refer to actual data.
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| CCL208 (CDL2013A) | CCL210 (CL21210) | |
|---|---|---|
| 510(k) Number | K092728 | Not Known |
| Display Area | Horizontal: 408.0mm, Vertical: 306.0mm | Horizontal: 432.0mm, Vertical: 324.0mm |
| Input Signal | Mini D-sub 15-pin connector (same connector) | |
| DVI-I 29-pin connector | DVI-I 29-pin connector, DisplayPort connector | |
| Maximum Resolution | 1200 x 1600 at portrait display | |
| 1600 x 1200 at landscape display | 1200 x 1600 at portrait display | |
| 1600 x 1200 at landscape display | ||
| Pixel Pitch | 0.255 mm x 0.255mm | 0.270 mm x 0.270 mm |
| Scanning Frequency | Horizontal: 30 – 75kHz | |
| Vertical: 55 – 60Hz | Horizontal: 30 – 75kHz | |
| Vertical: 55 – 60Hz | ||
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 120 cd/m² DICOM calibrated | |
| 300 cd/m² typ. As LCD component | 250 cd/m² DICOM calibrated | |
| 440 cd/m² typ. As LCD component | ||
| Luminance Calibration | ||
| (Optional) | Software | |
| Photo Sensor (optional): X-Rite Chroma 5 | Software | |
| Photo Sensor (optional): X-Rite Chroma 5 | ||
| Contrast Ratio | 800:1 | Typ 1500:1 |
| Serial Communication | DDC-ci | USB |
| Safety Standards | Medical Safety: MET (for US)/MET-C (for C | |
| anada), | ||
| IEC60601-1, IEC60601-1-2, IEC60950-1, FC | ||
| VCCI-B, MDD/CE | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. | |
| 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B), ICES-003 | ||
| (Class B) | ||
| Weight & Dimension | Net: 10.7kg | |
| 453(w) x 462 - 523(H) x 220(D) mm | ||
| Packed: 15.5kg | ||
| 470(w) x 685(H) x 345(D) mm | Net: 10.7kg | |
| 473(w) x 476.4 – 537.9(H) x 220(D) mm | ||
| Packed: 15.5kg | ||
| 470(w) x 675(H) x 347(D) mm | ||
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
bstantial Equivalence Compari
.210 (CL21210) employs a different LCD panel, power supply, and main board from predicate device CCL208 (K0927 ifferences:
CL210 (CL21210) employs the same tilt stand as that employed on the predicate device CCL208 (K09278). Th
zel and back enclosure of CCL210 (CL21210) are slightly larger but cl Similarities
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CCL210 (CL21210) can be considered to have equivalent display performances to those of the predicate device CCL208 (K092728) due to the following reasons:
- a. The active area of CCL210 (CL21210) differs from that of the predicate device CCL208 (K092728) in size: 432.0mm x 324.0mm for CCL210 and 408.0mm x 305.0mm for the predicate device. Both devices, however, have the same maximum display resolution of 1600 x 1200.
- b. The DICOM calibrated luminance value of the predicate device CCL208 (K092728) is 120cd/m2, whereas that of CCL210 (CL21210) is set to a higher value of 250cd/m2. In regard to the maximum luminance, CCL210 (CL21210) also achieves superior value of 400cd/m2 compared to the predicate device CCL208 (K092728) with 300cd/m2. Additionally CCL210 (CL21210) realizes high luminance at constantly stable level by adopting LED backlight, which lasts longer than conventional CCFL backlights do.
- c. The LED backlight was newly employed instead of CCFL backlight because it is mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to "Technical Data" where several image quality characteristics of the proposed device are compared with those of the predicate device.
- d. The both devices display images in accordance with DICOM GSDF by default utilizing the factory calibrated display mode stored in lookup tables inside of them.
- e. The predicate device CCL208 (K092728) supports DVI-D (digital interface) and D-Sub (analog interface), whereas CCL210 (CL21210) supports DVI-I (both digital and analog interface) and DisplayPort (digital interface).
As for the maintenance, the same QC software is used for both devices. Both devices have Backlight Sensor to stabilize the luminance.
The overall design of the CCL210 (CL21210) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL210 (CL21210) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Color LCD Monitor, CCL210 (CL21210) is substantially equivalent to the predicate device with respect to technical characteristics, application and intended use. The specifications of the primary component employed by the proposed device are the same to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.