(16 days)
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No
The document describes a medical monitor for displaying images and does not mention any AI/ML capabilities or image processing features.
No
The device is a monitor intended for displaying medical images for diagnosis, not for treating conditions.
Yes
Explanation: The device is a monitor used for "displaying and viewing medical images for diagnosis," which directly supports diagnostic activities by medical practitioners.
No
The device description explicitly states it is a 20.1-inch Monochrome 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 to display and view medical images for diagnosis. This involves interpreting images generated from the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is a monitor, which is a display tool. IVD devices are typically instruments or reagents used to perform tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any processes related to in vitro testing.
Therefore, the ME205 (ML20205) monitor falls under the category of medical imaging display devices, not IVD devices.
N/A
Intended Use / Indications for Use
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) 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.
Product codes
PGY
Device Description
ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome 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
Not Found
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)
JVC KENWOOD Corporation performed a range of system and performance tests to ensure that the ME205 (ML20205) 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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 12, 2014
JVC KENWOOD CORPORATION % Mr. Tsukasa Tashiro Senior Manager 3-12 Moriya-cho, Kanagawa-ku Yokohama-shi, Kanagawa, 221-0022 JAPAN
Re: K143076
Trade/Device Name: 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: October 24, 2014 Received: October 27, 2014
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
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
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known) Not known K143076 Device Name ME205 (ML20205)
Indications for Use (Describe)
20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor ME205 (ML20205) 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)
区 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
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
PSC Publishing Services (301) 443-6740 EF
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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, Senior Manager
Email: tashiro.tsukasa@jvckenwood.com
Tel: +81.258.24.6611
Fax: +81.258.24.6617 |
| Date Prepared: | October 24, 2014 |
| Device Name: | 20.1 inch (51 cm) Monochrome LCD Monitor ME205 (ML20205) |
| Common Name: | ME205, ML20205 |
| Classification Name: | Class II
(Part 892 Radiology Devices
Sec. 892.2050 Picture Archiving and Communication System) |
| Predicate Device: | 20.1 inch (51 cm) Monochrome LCD Monitor ME201 (MDL2006A)
(K021738) |
| Device Description: | ME205 (ML20205) is a 20.1-inch (51 cm) Monochrome 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: | 20.1 inch (51 cm) Monochrome 2M pixel LCD Monitor, ME205
(ML20205) 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. |
| Substantial Equivalence: | ME205 (ML20205) shares the same technical characteristics,
application and intended use with our predicate device ME201
(K021738). |
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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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| ME201L (MDL2006A) | ME205 (ML20205) | |
|---|---|---|
| 10(k) Number | K021738 | Not Known |
| Display Area | Horizontal: 408.0mm, Vertical: 306.0mm | Horizontal: 408.0mm, Vertical: 306.0mm |
| Pixel Pitch | 0.255 mm x 0.255mm | 0.255 mm x 0.255mm |
| Input Signal | Video signal-analog 0.7Vpp/75 Ω | |
| DVI-D digital video signal | DVI-I 29-pin connector, DisplayPort connector | |
| Maximum Resolution | 1600 x 1200 at landscape display | 1200 x 1600 at portrait display |
| 1600 x 1200 at landscape display | ||
| Scanning Frequency | Horizontal: 31 – 80kHz | |
| Vertical: 55 – 85Hz | Horizontal: 30 – 75kHz | |
| Vertical: 55 – 60Hz | ||
| Maximum Image Clock | 162MHz | 162MHz |
| Maximum Luminance | 410 cd/m² DICOM calibrated | |
| 700 cd/m² typ. As LCD component | 410 cd/m² DICOM calibrated | |
| 1000 cd/m² typ. As LCD component | ||
| Luminance Calibration | ||
| (Optional) | Software | Software |
| Photo Sensor (optional): DTP92(X-Rite) | Photo Sensor (optional): X-Rite Chroma 5 | |
| Contrast Ratio | Typ. 1000:1 | Typ. 1000:1 |
| Serial Communication | RS-232C | USB |
| Safety Standards | Medical Safety: UL2601-1, CSA No. 601-1 | |
| EN60601-1 | 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: 10.8kg | |
| 453(w) x 466(H) x 251(D) mm (landscape) | ||
| 353(w) x 520(H) x 251(D) mm (portrait) | ||
| Packed: 14kg | ||
| 470(W) x 680(H) x 340(D) mm | Net: 9.6kg | |
| 453(w) x 462 – 523(H) x 220(D) mm (landscape) | ||
| 353(w) x 512 – 573(H) x 220(D) mm (portrait) | ||
| Packed: 12.5kg | ||
| 470(w) x 675(H) x 347(D) mm | ||
| Power Supply | 100-240V AC, 50/60Hz | 100-240V AC, 50/60Hz |
bstantial Equivalence Compari
E205 (ML20205) employs a different LCD panel, power supply, and main board from the predicate devi
lE201L (K021738). Differences:
- E205 (ML20205) employs the same front bezel and tilt stand as those employed on the predicate device ME20
K021738). The back enclosures of both devices are similar to each ot similarities:
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ME205 (ML20205) can be considered to have equivalent display performances to those of the predicate device ME201L (K021738) due to the following reasons:
- a. The active sizes (408.0mm x 306.0mm) and the maximum display resolution (1600 x 1200) used for the both devices are the same.
- b. The DICOM calibrated luminance values of the both devices are the same (410cd/m2). In regard to the maximum luminance, the value of the predicate device ME201L (K021738) is 700cd/m2, whereas that of ME205 (ML20205) is set to a higher value of 700cd/m2. Additionally ME205 (ML20205) realizes high luminance at constantly stable level by adopting LED backlight, which lasts longer than conventional CCFL backlights do.
- The LED backlight was newly employed instead of CCFL backlight because it is ﻥ 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.
- The both devices display images in accordance with DICOM GSDF by default utilizing d. the factory calibrated display mode stored in lookup tables inside of them.
- The predicate device ME201L (K021738) supports DVI-D (digital interface) and D-Sub e. (analog interface), whereas ME205 (ML20205) 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 ME205 (ML20205) 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 ME205 (ML20205) performs in accordance with its specifications. None of the tests revealed behaviors inconsistent with the expected performance.
Conclusion
The 2M pixel Monochrome LCD Monitor, ME205 (ML20205) 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.