(47 days)
21.3 inch (54 cm) Color 3M pixel LCD Monitor, CCL358i2 (CL21358) is intended to be used in displaying and viewing medical images for diagnosis by trained medical practitioners. It is not meant to be used for digital mammography.
CCL358i2 (CL21358) is a 21.3-inch (54 cm) Color LCD monitor whose display resolution is 1536 x 2048 (landscape), 2048 x 1536 (portrait) supporting DVI (digital visual interface) and Display Port.
This document describes the K133185 submission for the TOTOKU CCL358i2 (CL21358) 21.3 inch (54 cm) Color LCD Monitor. It outlines the device's technical specifications and compares them to a predicate device, CCL356i2 (K112604), to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document lists "Technical Specification" as desired criteria (SPEC) and uses the comparison to a predicate device and internal testing to claim equivalence. The document doesn't explicitly state "acceptance criteria" and "reported device performance" in separate columns, but rather outlines specifications it aims to meet and then discusses how the device meets them, primarily through comparison to a predicate and general testing. I will interpret "SPEC" as the acceptance criteria and the surrounding text as the performance.
| Acceptance Criteria (SPEC) | Reported Device Performance/Verification |
|---|---|
| 1. Luminance uniformity: Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminance uniformity data. | The document states "Refer to actual Luminance uniformity data" which implies data was collected and met this specification. It further claims that the CCL358i2 has "equivalent display performances" to the predicate due to shared characteristics and specific technical details, including the same DICOM calibrated luminance values (410 cd/m2) and typical maximum luminance values (800 cd/m2). The employment of LED backlight is noted to help maintain high luminance constantly and deteriorate more slowly. |
| 2. Pixel Defects / Fault: Class II or more. ISO13406-2. | The document implies compliance with this standard by not marking any deviation or issue with pixel defects and claiming overall equivalent display performance and safety/EMC validation. |
| 3. Artifacts (phase/clock issues flicker, miscellaneous including ringing, ghosting, image sticking): By visible check, no flicker, ringing, ghosting and image sticking. | The document doesn't explicitly detail the "visible check" for artifacts but concludes that "None of the tests revealed behaviors inconsistent with the expected performance," which would encompass artifact checks. It asserts "equivalent display performances" to the predicate device. |
| 4. Chromaticity Measurement of 5%, 50%, 95% Level: SPEC data. | The document states "Refer to Chromaticity actual data" which implies data was collected and met this specification. It also mentions that the devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode and lookup tables. It does state "Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4". |
| 5. Chromaticity: Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4. Refer to Chromaticity actual data. | This is directly stated as a specification, and the document implies that "actual data" would show compliance. It also notes that the devices display images in accordance with DICOM GSDF by default utilizing factory calibrated display mode and lookup tables. |
| Additional Implied Criteria/Performance: | |
| DICOM calibrated luminance values | Same as predicate: 410 cd/m2 |
| Typical maximum luminance values | Same as predicate: 800 cd/m2 |
| Contrast Ratio | 1400:1 (for CCL358i2) |
| Safety Standards | ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B). "The overall design of the CCL358i2 (CL21358) was validated in accordance with internationally recognized Safety and EMC standards by third-party certifiers." |
| System and performance tests | "JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the CCL358i2 (CL21358) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not detail specific sample sizes for test sets regarding the performance criteria (luminance, pixel defects, artifacts, chromaticity). The "study" appears to be a technical comparison and internal testing rather than a clinical study with a defined test set of medical images or patient data. The data provenance is not specified beyond being generated by JVC KENWOOD Corporation, which is based in Japan. The type of study is a technical validation, not a clinical trial, and does not involve patient data, so "retrospective or prospective" is not applicable in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The device is a medical display monitor, and the "ground truth" for its performance relates to its technical specifications, not medical diagnoses. Therefore, the "experts" would likely be engineers or display calibration specialists, but their number and specific qualifications are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of adjudication method is used in medical image interpretation studies, not for the technical validation of a display monitor.
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
Not applicable. The device is a medical display monitor, not an AI-powered diagnostic tool. No MRMC comparative effectiveness study was performed or is relevant to this device's validation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is hardware (a display monitor), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is its adherence to technical specifications and industry standards (e.g., AAPM-TG18, ISO13406-2, DICOM GSDF, safety/EMC standards). This is based on objective measurements and verified through internal testing and third-party certifications, rather than clinical ground truth like pathology or outcomes data.
8. The sample size for the training set
Not applicable. This device is a display monitor, not a machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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TOTOKU
K133185
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510(k) SUMMARY
| Submitted Information: | JVC KENWOOD CORPORATION3-12, MORIYA-CHO, KANAGAWA-KU,YOKOHAMA-SHI, KANAGAWA, 221-0022 JAPANDEC 0 3 2013 |
|---|---|
| Contact Person: | Tsukasa Tashiro, General ManagerEmail: tashiro.tsukasa@jvckenwood.comTel: +81.258.24.6611Fax: +81.258.24.6617 |
| Date Prepared: | October 4, 2013 |
| Device Name: | 21.3 inch (54 cm) Color LCD Monitor CCL358i2 (CL21358) |
| Common Name: | CCL358i2, CL21358 |
| Classification Name: | Class II(Part 892 Radiology DevicesSec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 21.3 inch (54 cm) Col or LCD Monitor CCL35 6i2 (CL21356)(K112604) |
| Device Description: | CCL358i2 (CL21358) is a 21.3-inch (54 cm) Color LCD monitorwhose display resolution is 1536 x 2048 (landscape), 2048 x 1536(portrait) supporting DVI (digital visual interface) and Display Port. |
| Intended Use: | 21.3 inch (54 cm) Color 3M pixel LCD Monitor, CCL358i2 (CL21358)is intended to be used in displaying and viewing medical imagesfor diagnosis by trained medical practitioners. It is not meant to beused for digital mammography. |
| Substantial Equivalence: | CCL358i2 (CL21358) shares the same characteristics with ourpredicate device CCL356i2 (K112604) except for the LCD paneland power supply. |
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| Technical Specification | |
|---|---|
| 1. Luminance uniformity[SPEC] Less than 30% based on AAPM-TG18 4.4. Refer to actual Luminanceuniformity data | |
| 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[SPEC] data | |
| 5. Chromaticity[SPEC] Delta (u', v') ≤ 0.01 measured at 80% Lmax based on AAPM-TG18 4.8.4Refer to Chromaticity actual data |
.
.
:
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| CCL33662 (CL21356) K112601ali: 433.152mm, Vertical: 324.864ml K112601ali: 433.152mm, Vertical: 324.864ml Donali: 433.152mm, Video Signal, DisplayPort 25361x 2048.0048.dets By | CCL358i2 (CL21358 | |
|---|---|---|
| 10(k) Mumber Taxilay Area Taxilay Area Taxilay Area Taxilmin Displi Ixel Pitch | K133185 | |
| Horizontal: 433.152mm, Vertical: 324.864mm OVI-D Digital Video Signal, DisplayPort | ||
| 36 x 2048 dots 115 x 0.2115mr | ||
| DVI | ||
| anning Freque | ||
| aximum Luminan | ||
| tware: Medivisor Nx | ||
| uminance Calibratio Iptional) | ivisor Nx nsor (Optional): Chroma5 (X-Ri | Calibration Sensor (Optional): Chroma5 (X-Ri |
| ontrast Ratio Prial Communicatic | 1400:1 | |
| fety Standar | ||
| USB: upstream port (x 1), downstream port (x 2) ANSI/AAMI ES60601-1, CAN/CSA C22.2 No.60601-1, FCC (Class B), MDD/CE, VCCI-B (Class B) | ||
| Net: 12kg | ||
| 000 22737) x 468.4 - 529.9(H) x 220(D) mm (Landscape) | ||
| eight & Dimensi | ||
| wer Supp | 730: Lipstream port (x 1), downstream port (x 3), download. Modi 1774: No.68 (x) = 32, Mo.60 1, FC (dass B); Modi 1774: V = 33, 4(r) > 320, Min (kantaispa) Mar 177, M = | 00-240V AC, 50/60Hz |
Substantial Equivalence Comparison
Similarities: CCL358i2 (CL21358) employs the same front bezel, back enclosure and tilt stand as predicate device CCL35612 (K112604)
Differences
Differences:
CCL358i2 (CL21358) employs a different LCD panel and power supply
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K133185
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CCL358i2 (CL21358) can be considered to have equivalent display performances to those of the predicate device CCL356i2 (K112604) due to the following reasons:
- a. The maximum display sizes (1536*2048) and the active area sizes (433.152mm (H) x 324.864mm (V)) used for the both devices are the same.
- b. The DICOM calibrated luminance values of the both devices are the same (410 cd/m2 and the typical maximum luminance values are also same (800 cd/m2) between both devices. The high luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- 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. Both devices support Digital Visual Interface (DVI) and DisplayPort.
As for the maintenance, the same OC software is used for both devices have Front Sensor to stabilize the luminance.
As for built-in sensors, both devices have 2 (two) kinds of common sensors, Front Sensor and Ambient Light Sensor. Front Sensor is related to the maintenance or calibration and Ambient Light Sensor is used to measure the ambient light by lx. Front sensor enables automatic grayscale calibration by measuring the luminance at the screen surface. Without Front sensor, the gravscale calibration process requires human intervention and the use of and external sensor. The accuracy data of the calibration with external sensors and that with Front Sensor is included in section 9 "Verification & Validation" in "Application".
The overall design of the CCL358i2 (CL21358) 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 CCL358i2 (CL21358) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 3M pixel Color LCD Monitor, CCL358i2 (CL21358) 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.
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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of two main elements: the HHS symbol and the department's name. The HHS symbol is a stylized representation of a human figure embracing three abstract shapes, which are meant to symbolize the department's mission of providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WOod-GMB Silver Spring, MD 20993-0002
December 3, 2013
JVC KENWOOD Corporation % Mr. Tsukasa Tashiro General Manager 3-12 Moriva-cho, Kanagawa-ku Yokohama-shi. Kanagawa, 221-0022 JAPAN
Re: K133185
Trade/Device Name: 21.3 inch (54 cm) Color LCD Monitor CC1.35812 (C1.21358) Regulation Number: 21 CFR 892,2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 1.1.7. Dated: October 4. 2013 Received: October 17, 2013
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 docs 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 cither 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. FIDA 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); 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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Page 2-Mr. Tashiro
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.lda.gov/Medicall.cevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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,
for
Janine M. Morris 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
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
Indications for Use
510(k) Number (if known) KIJ3185
Device Name CC1.358i2 (CL21358)
Indications for Use (Describe)
21.3 inch (54 cm) Color 3M pixel 1.C1.358) 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 munimography.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
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| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
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| [Signature] |
FORM FDA 3881 (9/13)
liki Matidung Kanners (10)) | レト付加 | 【EF
§ 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).