(59 days)
2MP Color LCD Monitor CCL214 (CL21214) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1600 x 1200 (landscape), 1200 x 1600 (portrait) supporting DVI-D (digital interface) and DisplayPort (digital interface).
This document is a 510(k) Summary for the JVC KENWOOD 2MP Color LCD Monitor CCL214 (CL21214). It does not describe a study involving an AI algorithm or analysis of medical images for diagnostic purposes by AI. Instead, it describes a medical display monitor. Therefore, many of the requested fields are not applicable.
Here's an analysis of the provided text based on your request, focusing on the device and its performance criteria:
Device: 2MP Color LCD Monitor CCL214 (CL21214)
Intended Use: To be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used in digital mammography.
Predicate Device: 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210) (K151134)
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Technical Specification) | Reported Device Performance (for CCL214 unless otherwise specified) |
|---|---|
| 1. Luminance uniformity | [SPEC] Less than 30% based on AAPM-TG18 4.4. (The document states this as the specification for the new device, implying it meets this.) |
| 2. Pixel Defects / Fault | [SPEC] Class II or more. ISO13406-2 (The document states this as the specification for the new device, implying it meets this.) |
| 3. Artifacts | [SPEC] By visible check, no flicker, ringing, ghosting and image sticking. (The document states this as the specification for the new device, implying it meets this.) |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level | (No specific performance value provided, but it's a measurement point that would be part of the test.) |
| 5. Chromaticity | [SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 (The document states this as the specification for the new device, implying it meets this.) |
| 6. Power On Luminance Drift | [SPEC] ΔLmax ≤ ±10% within 60 seconds. (The document states this as the specification for the new device, implying it meets this.) |
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm (Same as predicate) |
| Maximum Resolution | 1200 x 1600 at portrait display, 1600 x 1200 at landscape display (Same as predicate) |
| Pixel Pitch | 0.270 mm x 0.270 mm (Same as predicate) |
| Maximum Luminance (DICOM calibrated) | 250 cd/m² DICOM calibrated (Same as predicate) |
| Maximum Luminance (Typ. As LCD component) | 500 cd/m² typ. As LCD component (Superior to predicate's 440 cd/m²) |
| Contrast Ratio | Typ 1200:1 (Predicate: Typ 1500:1. This is a difference, but the document concludes it does not affect safety or effectiveness.) |
| Safety Standards | 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) (Same as predicate. Validated by third-party certifiers.) |
Study to prove device meets acceptance criteria:
The document states: "JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance."
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The testing would involve specific units of the CCL214 monitor. It's not a study on medical images but on the monitor itself.
- Data Provenance: Not applicable in the context of clinical data. The tests were performed by JVC KENWOOD Corporation to verify the monitor's performance against its specifications and international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a hardware specification and performance verification, not a clinical study involving experts determining ground truth on medical images. The "ground truth" here is adherence to technical specifications and international standards (e.g., AAPM-TG18, ISO13406-2, safety standards).
4. Adjudication method for the test set:
- Not applicable. This is a hardware verification, not a clinical study requiring adjudication of expert interpretations.
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. This is a medical display device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a medical display device, not an algorithm.
7. The type of ground truth used:
- The "ground truth" for this device's performance is objective technical specifications and adherence to international standards (e.g., luminance uniformity < 30% based on AAPM-TG18, Pixel Defects Class II or more per ISO13406-2, no visible artifacts, chromaticity Delta (u', v') ≤ 0.01 based on AAPM-TG18, Power On Luminance Drift ≤ ±10%). Safety and EMC standards outlined (ANSI/AAMI ES60601-1, CAN/CSA C22.2 No. 60601-1, FCC, MDD/CE, VCCI-B, ICES-003) also serve as part of the "ground truth" for regulatory compliance.
8. The sample size for the training set:
- Not applicable. This is a medical display device, not a machine learning model.
9. How the ground truth for the training set was established:
- Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 8, 2016
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro Engineering Specialist 3-12, Moriya-cho, Kanagawa-ku Yokohama. Kanagawa 221-0022 JAPAN
Re: K161895
Trade/Device Name: 2MP Color LCD Monitor CCL214 (CL21214) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: July 8, 2016 Received: July 11, 2016
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.
Michael D'Hara
For
Robert Ochs, 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
2MP Color LCD Monitor CCL214 (CL21214)
Indications for Use (Describe)
2MP Color LCD Monitor CCL214 (CL21214)
is intended to be used in displaying and viewing 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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510(k) SUMMARY
| Submitted Information: | JVC KENWOOD Corporation3-12, Moriya-cho, Kanagawa-ku,Yokohama-shi, Kanagawa, 221-0022 Japan |
|---|---|
| Contact Person: | Tsukasa Tashiro, Engineering SpecialistEmail: tashiro.tsukasa@jvckenwood.comTel: +81-258-24-6611Fax: +81-258-24-6617 |
| Date Prepared: | July 08, 2016 |
| Device Name: | 2MP Color LCD Monitor CCL214(CL21214) |
| Common Name: | CCL214 (CL21214) |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Color LCD Monitor CCL210 (CL21210)(K151134) |
| Device Description: | CCL214 (CL21214) is a 21.3-inch (54 cm) Color LCD monitorwhose display resolution is 1600 x 1200 (landscape), 1200 x 1600(portrait) supporting DVI-D (digital interface) and DisplayPort(digital interface). |
| Intended Use: | 21.3 inch (54 cm) Color 2M pixel LCD Monitor, CCL214(CL21214) is intended to be used in displaying and viewingmedical images for diagnosis by trained medical practitioners.It is not meant to be used in digital mammography. |
| Substantial Equivalence: | CCL214 (CL21214) shares the same technical characteristics,application, and intended use as our predicate device CCL210(CL21210 / K151134). |
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| Technical Specification |
|---|
| 1. Luminance uniformity[SPEC] Less than 30% based on AAPM-TG18 4.4. |
| 2. Pixel Defects / Fault[SPEC] Class II or more. ISO13406-2 |
| 3. Artifacts• phase/clock issues flicker• miscellaneous including ringing, ghosting, image sticking[SPEC] By visible check, no flicker, ringing, ghosting and image sticking. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level |
| 5. Chromaticity[SPEC] Delta (u', v') $\leq$ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4 |
| 6. Power On Luminance Drift[SPEC] $\triangle$ Lmax≤±10% within 60 seconds.$\triangle$ Lmax : the deviation between the target maximum luminance and the measured luminance. |
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| CCL210 (CL21210) | CCL214 (CL21214) | |
|---|---|---|
| 510(k) Number | K151134 | Not Known |
| Display Area | Horizontal: 432.0mm, Vertical: 324.0mm | Horizontal: 432.0mm, Vertical: 324.0mm |
| Input Signal | DVI-I 29-pin connector, DisplayPort connector | DVI-D 24-pin connector, DisplayPort connector |
| Maximum Resolution | 1200 x 1600 at portrait display1600 x 1200 at landscape display | 1200 x 1600 at portrait display1600 x 1200 at landscape display |
| Pixel Pitch | 0.270 mm x 0.270 mm | 0.270 mm x 0.270 mm |
| Scanning Frequency | Horizontal: 30 - 75kHzVertical: 55 - 60Hz | DVIHorizontal: 74.1KHz, Vertical: 60Hz (Landscape)Horizontal:98.1KHz, Vertical: 60Hz (Portrait)DisplayPortHorizontal: 75.0KHz, Vertical: 60Hz (Landscape)Horizontal:99.0KHz, Vertical: 60Hz (Portrait) |
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 250 cd/m² DICOM calibrated440 cd/m² typ. As LCD component | 250 cd/m² DICOM calibrated500 cd/m² typ. As LCD component |
| Luminance Calibration(Optional) | SoftwarePhoto Sensor (optional): X-Rite Chroma 5 | SoftwarePhoto Sensor (optional): X-Rite i1 Display |
| Contrast Ratio | Typ 1500:1 | Typ 1200:1 |
| Serial Communication | USB | USB |
| Safety Standards | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B),ICES-003 (Class B) | Medical Safety: ANSI/AAMI ES60601-1, CAN/CSA C22.2No. 60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B),ICES-003 (Class B) |
| Weight & Dimension | Net: 10.7kg473(w) x 476.4 – 537.9(H) x 220(D) mmPacked: 15.5kg470(w) x 675(H) x 347(D) mm | Net: 11.1kg367.0(w) x 521.9 – 583.4(H) x 220(D) mmPacked: Approx.14.0kg470(w) x 670(H) x 340.0(D) mm |
| Power Supply | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz |
antial Equivalence Compa
The LCD panel, the power supply, and the main board for CCL214 (CL21214) are different from those for CCL210 (Predicati
device). Differences
tilt stand for CCL214 (CL21214) is the same as CCL210 (K151134).
the sizes of front bezel and the rear cover are smaller than ones of CCL210 only sli Similarities:
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CCL214 (CL21214) can be considered to have equivalent performances to those of the predicate device CCL210 (K151134) due to the following reasons:
- a. CCL214 (CL21214) and the predicate device CCL210 (K151134) have the same active area whose size is 432.0mm x 324.0mm. Also, the maximum display resolution for both models is 1600 x 1200.
- b. As for the maximum luminance, CCL214 (CL21214) is superior to CCL210 (K151134). (CCL214 (CL21214): 500cd/m2 and CCL210 (K151134):440cd/m2) The maximum luminance by DICOM calibration at the factory default is 250cd/m2 for both CCL214 (CL21214) and the predicate device CCL210 (K151134).
- The LED backlight is equipped with CCL214 (CL21214) and the predicate device ﻥ CCL210 (K151134).
- As the factory default status, the both devices display images in accordance with DICOM ರ. GSDF which is stored in the lookup table inside the device.
- e. CCL214 (CL21214) supports DVI and DisplayPort as well as the predicate device CCL210 (K151134) .
As for the maintenance, the same QC software is used for both devices. CCL210 (K151134) has the backlight sensor to stabilize the luminance, but CCL214 (CL21214) has the front luminance sensor, which means the higher performance, to do so.
The overall design of the CCL214 (CL21214) has been validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers. Besides, JVC KENWOOD Corporation performed the system and performance tests to verify that the CCL214 (CL21214) performs in accordance with its specifications. None of the tests revealed behaviors which is inconsistent with the expected performance.
Conclusion
The 2M pixel Color LCD Monitor, CCL214 (CL21214) is substantially equivalent to the predicate device with respect to technical characteristics, its application, its intended use, and the specifications of the primary components.
And other differences have been independently validated.
But any differences between these two devices do not affect safety or effectiveness.
§ 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).