(24 days)
Not Found
No
The description focuses on display hardware and basic image processing functions like contrast enhancement and ambient light correction. There is no mention of AI, ML, or any algorithms that learn from data.
No
The device is described as displaying and viewing digital images for review and analysis, not for treating or diagnosing a disease.
No
This device is a display system, not a diagnostic device. It is intended to display and view digital images for review and analysis by medical practitioners, but it does not perform any diagnostic function itself. The diagnostic function is performed by the medical practitioner who interprets the images.
No
The device description explicitly states that the DP-M3010 is "consisted of the DP-M3010 display and the application software". It then goes on to describe the hardware components of the display, including the LCD panel, front sensor, and ambient light sensor. The performance studies also include bench tests related to the physical characteristics of the display hardware.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners." This describes a device used for visualizing medical images, not for performing tests on biological samples.
- Device Description: The description focuses on the display technology, software for quality control and configuration, and features related to image display (hybrid view, contrast enhancer, sensors for calibration). It does not mention any components or processes related to analyzing biological specimens.
- Input: The input is "digital images," not biological samples.
- Performance Studies: The performance studies described are bench tests related to display characteristics (luminance, uniformity, resolution, etc.), electrical safety, and EMC. These are typical tests for medical imaging displays, not IVDs. There are no studies involving the analysis of biological samples or clinical outcomes based on such analysis.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is to present medical images for visual interpretation by a medical professional.
N/A
Intended Use / Indications for Use
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners.
Product codes (comma separated list FDA assigned to the subject device)
PGY
Device Description
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis. The DP-M3010 is consisted of the DP-M3010 display and the application software including Quality Control and Display Configuration Software. For the DP-M3010 display, 30-inch 10MP color LCD panel is used. The resolution is 10.5 megapixel (4096 x 2560). The DP-M3010 display has following two functions;
- . The hybrid view function: Monochrome compliant with the DICOM part 14 standard and color with non-DICOM gamma images are displayed on one screen at the same time.
- · The Contrast Enhancer function: Darkening the background of images.
The DP-M3010 has the built-in front sensor for monitoring display status. Using this front sensor allows for automatic correction of differences between the display characteristics that may change over time and the target image quality of the display. Also, The DP-M3010 has the ambient light correction function, namely correcting the luminance and gradation according to surrounding light by using the built-in ambient light sensor.
The Quality Control is software to be installed in a computer which controls the DP-M3010 display. The Quality Control software executes the calibration, runs tests compliant with various testing standards, creates test result reports, and monitors the DP-M3010 display conditions. The Display Configuration Software is used to perform the display settings. It is possible to save settings of the DP-M3010 Display on the computer. It is also possible to manually edit the areas for the hybrid view function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital mammography
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)
The following bench tests were performed on the DP-M3010: Luminance response, Luminance uniformity, Geometrical distortion, Display reflections including specular, diffuse, and haze components, Small-spot contrast ratio, Spatial resolution expressed as modulation transfer function (MTF), Noise expressed as noise power spectrum (NPS), Pixel aperture ratio, Chromaticity measured at the center of the screen at 5%, 50%, and 95% of the maximum luminance, Chromaticity uniformity, Pixel defect/faults, Artifacts, Temporal response, Stability of luminance.
Those test results showed that the display performance of the DP-M3010 is equivalent to that of the RadiForce (K120451).
In addition to those bench tests, electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2 tests were performed. Those test results indicate that the DP-M3010 does not raise concern.
No animal or clinical testing was performed on the DP-M3010.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
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 features a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The bird symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Canon Inc. - Hiratsuka Development Center % Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo, Bunkyo-ku, Tokyo, 113-0033 JAPAN
January 22, 2015
Re: K143718
Trade/Device Name: Mammography Color Display DP-M3010 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: December 19, 2014 Received: December 29, 2014
Dear Izumi Maruo:
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.
1
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
2
Indications for Use
510(k) Number (if known)
K143718
Device Name DP-M3010
Indications for Use (Describe)
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners.
Type of Use (Select one or both, as applicable)
2 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)
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Image /page/3/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly stylized. The word is written in all capital letters.
510(k) Summary
a. Owner/Company name, address CANON INC.- HIRATSUKA DEVELOPMENT CENTER 22-5, Tamura 9-chome, Hiratsuka-shi, Kanagawa 254-0013, Japan
" Contact person Masaki Tamura Project Manager 011- 81-463-54-2211 Phone: 011- 81-463-53-8931 Fax: tamura.masaki@canon.co.jp Email:
b. Contact/Application Correspondent
Izumi Maruo Senior Consultant MIC International Corp. 4-1-17 Hongo, Bunkyo-ku, Tokyo, 113-0033, Japan
Phone: 011-81-3-3818-8577 Fax: 011-81-3-3818-8573 Email: maruo@mici.co.jp
c. Date prepared
December 19, 2014
d. Name of device
| Trade Name: | Mammography Color Display DP-M3010 |
|---|---|
| Common Name: | System, Image Processing, Radiological |
| Classification Name: | Picture archiving and communications system |
| Classification Regulation: | 21 CFR 892.2050 |
| Product Code: | PGY |
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Image /page/4/Picture/0 description: The image shows the word "Canon" in red font. The font is bold and slightly stylized. The background is white.
e. Predicate devices
The Mammography Color Display DP-M3010 (hereinafter the DP-M3010) is substantially equivalent to the following legally marketed device:
| 510(k) Number | Trade name |
|---|---|
| K120451 | RadiForce RX840-MG |
The predicate device is hereinafter called "RadiForce (K120451)" in this application.
f. Description of the device
The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography, for review and analysis. The DP-M3010 is consisted of the DP-M3010 display and the application software including Quality Control and Display Configuration Software. For the DP-M3010 display, 30-inch 10MP color LCD panel is used. The resolution is 10.5 megapixel (4096 x 2560). The DP-M3010 display has following two functions;
- . The hybrid view function: Monochrome compliant with the DICOM part 14 standard and color with non-DICOM gamma images are displayed on one screen at the same time.
- · The Contrast Enhancer function: Darkening the background of images.
The DP-M3010 has the built-in front sensor for monitoring display status. Using this front sensor allows for automatic correction of differences between the display characteristics that may change over time and the target image quality of the display. Also, The DP-M3010 has the ambient light correction function, namely correcting the luminance and gradation according to surrounding light by using the built-in ambient light sensor.
The Quality Control is software to be installed in a computer which controls the DP-M3010 display. The Quality Control software executes the calibration, runs tests compliant with various testing standards, creates test result reports, and monitors the DP-M3010 display conditions. The Display Configuration Software is used to perform the display settings. It is possible to save settings of the DP-M3010 Display on the computer. It is also possible to manually edit the areas for the hybrid view function.
g. Indications for Use
The DP-M3010 is intended to be used in displaying digital images, including digital mammography for review and analysis by trained medical practitioners.
h. Statement of substantial equivalence
The DP-M3010 has the same intended use as the RadiForce (K120451) as shown in Table 6-1. Comparison Table of Technological Characteristics.
Regarding differences of technological features between the DP-M3010 and the RadiForce (K120451) in Table 6-1, the non-clinical testing demonstrates that those differences do not raise any new questions of safety or effectiveness (The summaries of the non-clinical testing are shown in next part in this section).
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Comparison Table of Technological Characteristics is shown below.
| Feature | DP-M3010 | RadiForce (K120451) |
|---|---|---|
| Classification | 892.2050 | 892.2050 |
| Intended Use | The DP-M3010 is intended to be used in displaying and viewing digital images, including digital mammography for review and analysis by trained medical practitioners. | The RadiForce RX840-MG is intended to be used in displaying and viewing digital images including those of digital mammography for review and analysis by trained medical practitioners. |
| Display Performance /Specification | ||
| Screen technology | TFT Color LCD panel(IPS) | TFT Color LCD panel(IPS) |
| Screen surface | Anti-Reflection | Anti-Glare |
| Viewing angle | ||
| (Horizontal, | ||
| Vertical) | Horizontal:170°, | |
| Vertical:170° | ||
| (CR > 50) | Horizontal:176°, | |
| Vertical:176° | ||
| (CR > 10) | ||
| Active screen size | 645.12 x 403.2 mm | 817.1 x 430.9 mm |
| Resolution | 10.5 MP(4,096 x 2,560) | 8MP(4,096 x 2,160) |
| Aspect ratio | 16:10 | 17:9 |
| Pixel pitch | 0.1575 x 0.1575 mm | 0.1995 x 0.1995 mm |
| Maximum | ||
| luminance | 500 cd/m² | 700 cd/m² |
| DICOM calibrated | ||
| luminance | 500 cd/m² | 500 cd/m² |
| Contrast ratio | 1000:1 | 1000:1 |
| Backlighting | LED | LED |
| Gradation | 10 bit | 8 bit, 10 bit |
| Luminance | ||
| non-uniformity | ||
| compensation | Yes | Yes |
| Response speed | 20 ms (black-white-black) | 25 ms (black-white-black) |
| Video Signal Input | ||
| Input video signals | DisplayPort 1.1a x 4 | DVI-D(Dual Link) x2, |
| DisplayPort x 2 | ||
| Scanning | ||
| Frequency(V) | 59.922 - 60.317Hz | 29.5 - 61Hz |
| Dot Clock | 174.25MHz x4 | DVI-D: 310MHz |
| DisplayPort: 290MHz | ||
| Power Related Specifications | ||
| Power | ||
| Requirements | AC 100 - 240V : 50/60Hz | AC 100 - 120V, 200 - 240V : |
| 50/60Hz | ||
| Power | ||
| Consumption | ||
| Save Mode | 325W / 2W | 350W / 6W |
| Power | ||
| Management | DisplayPort 1.1a | DVI DMPM, DisplayPort 1.1a |
| Miscellaneous Features/ Specifications | ||
| QC software | Yes | Yes |
| Sensors | Backlight Sensor, Front Sensor, | |
| Ambient Light Sensor | Backlight Sensor, Integrated | |
| Front Sensor, Presence Sensor, | ||
| Ambient Light Sensor | ||
| USB Ports / | ||
| Standard | 1 upstream, 2 downstream / Rev. | |
| 2.0 | 1 upstream, 2 downstream / Rev. | |
| 2.0 | ||
| Dimensions w/o | ||
| stand | ||
| (W x H x D) | 707 x 465 x 106 mm | 896 x 527 x 157 mm |
| Contrast Enhancer | ||
| (Darkening image | ||
| Background) | Yes | No |
Table 6-1. Comparison Table of Technological Characteristics
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Image /page/6/Picture/0 description: The image shows the word "Canon" in red. The font is bold and slightly stylized. The word is horizontally oriented and takes up most of the frame.
The DP-M3010 has the "Contrast Enhancer" function which can be used to darken the background of images, however, the RadiForce (K120451) does not have this function. Canon concluded that this function does not raise any new questions of safety or effectiveness because of following reasons:
- The Contrast Enhancer darkens background only.
- · User can set on or off the Contrast Enhancer as if necessary.
- · Device performance was not affected whether the Contrast Enhancer was on or off in performance testing.
The DP-M3010 does not have the presence sensor which is included in the RadiForce (K120451). The sensor only detects the presence of the user. Therefore, the display performance for clinical situation is unaffected by the presence sensor.
Based on the above, all the differences between the DP-M3010 and the RadiForce (K120451) do not raise any new concern. Thus, the DP-M3010 is substantially equivalent to the RadiForce (K120451).
Non-Clinical Performance Summary i.
The following bench tests were performed on the DP-M3010. Those tests are recommended in "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions''.
- Luminance response
- Luminance uniformity
- Geometrical distortion
- · Display reflections including specular, diffuse, and haze components
- Small-spot contrast ratio
DP-M3010 JUNE 25, 2014
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- Spatial resolution expressed as modulation transfer function (MTF)
- · Noise expressed as noise power spectrum (NPS)
- · Pixel aperture ratio
- Chromaticity measured at the center of the screen at 5%, 50%, and 95% of the maximum luminance
- Chromaticity uniformity
- Pixel defect/faults
- Artifacts
- Temporal response
- · Stability of luminance
Those test results showed that the display performance of the DP-M3010 is equivalent to that of the RadiForce (K120451).
In addition to those bench tests, electrical safety in accordance with IEC 60601-1 and EMC in accordance with IEC 60601-1-2 tests were performed. Those test results indicate that the DP-M3010 does not raise concern.
No animal or clinical testing was performed on the DP-M3010.
Conclusion i.
The DP-M3010 and the RadiForce (K120451) have the same intended use and the TFT Color LCD panel (IPS) screen. However, there are some different technological characteristics. Non-clinical tests showed that the different technological characteristics do not raise safety and effectiveness concern. Therefore, Canon concluded that the DP-M3010 is substantially equivalent to the RadiForce (K120451).