(24 days)
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 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.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the Canon DP-M3010 Mammography Color Display and its substantial equivalence to a predicate device, the RadiForce RX840-MG (K120451). The acceptance criteria are implicitly defined by the performance characteristics of the predicate device and the recommended tests for display accessories for full-field digital mammography systems.
| Feature | Acceptance Criteria (Implied by Predicate/Guidance) | Reported Device Performance (DP-M3010) |
|---|---|---|
| Display Performance / Specification | ||
| Screen technology | TFT Color LCD panel(IPS) | TFT Color LCD panel(IPS) |
| Screen surface | Anti-Glare (Predicate) | Anti-Reflection |
| Viewing angle (Horizontal, Vertical) | Horizontal:176°, Vertical:176° (CR > 10) (Predicate) | Horizontal:170°, Vertical:170° (CR > 50) |
| Active screen size | 817.1 x 430.9 mm (Predicate) | 645.12 x 403.2 mm |
| Resolution | 8MP (4,096 x 2,160) (Predicate) | 10.5 MP (4,096 x 2,560) |
| Aspect ratio | 17:9 (Predicate) | 16:10 |
| Pixel pitch | 0.1995 x 0.1995 mm (Predicate) | 0.1575 x 0.1575 mm |
| Maximum luminance | 700 cd/m² (Predicate) | 500 cd/m² |
| DICOM calibrated luminance | 500 cd/m² (Predicate) | 500 cd/m² |
| Contrast ratio | 1000:1 (Predicate) | 1000:1 |
| Backlighting | LED (Predicate) | LED |
| Gradation | 8 bit, 10 bit (Predicate) | 10 bit |
| Luminance non-uniformity compensation | Yes (Predicate) | Yes |
| Response speed | 25 ms (black-white-black) (Predicate) | 20 ms (black-white-black) |
| Video Signal Input | ||
| Input video signals | DVI-D(Dual Link) x2, DisplayPort x 2 (Predicate) | DisplayPort 1.1a x 4 |
| Scanning Frequency(V) | 29.5 - 61Hz (Predicate) | 59.922 - 60.317Hz |
| Dot Clock | DVI-D: 310MHz, DisplayPort: 290MHz (Predicate) | 174.25MHz x4 |
| Power Related Specifications | ||
| Power Requirements | AC 100 - 120V, 200 - 240V : 50/60Hz (Predicate) | AC 100 - 240V : 50/60Hz |
| Power Consumption Save Mode | 350W / 6W (Predicate) | 325W / 2W |
| Power Management | DVI DMPM, DisplayPort 1.1a (Predicate) | DisplayPort 1.1a |
| Miscellaneous Features/ Specifications | ||
| QC software | Yes (Predicate) | Yes |
| Sensors | Backlight Sensor, Integrated Front Sensor, Presence Sensor, Ambient Light Sensor (Predicate) | Backlight Sensor, Front Sensor, Ambient Light Sensor |
| USB Ports / Standard | 1 upstream, 2 downstream / Rev. 2.0 (Predicate) | 1 upstream, 2 downstream / Rev. 2.0 |
| Dimensions w/o stand (W x H x D) | 896 x 527 x 157 mm (Predicate) | 707 x 465 x 106 mm |
| Contrast Enhancer (Darkening image Background) | No (Predicate) | Yes |
| Presence Sensor | Yes (Predicate) | No |
| Bench Tests (recommended by FDA Guidance) | All tests meet performance similar to or better than the predicate, demonstrating no new safety/effectiveness concerns. | Results showed display performance is equivalent to the RadiForce (K120451). |
| Electrical Safety | Compliance with IEC 60601-1 | Tests performed, results indicate no concern. |
| EMC | Compliance with IEC 60601-1-2 | Tests performed, results indicate no concern. |
Study Proving Device Meets Acceptance Criteria:
The study conducted to prove the Canon DP-M3010 meets the acceptance criteria was a non-clinical bench test study comparing it to a legally marketed predicate device, the RadiForce RX840-MG (K120451).
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical "sample size" in terms of patient cases or images, as this was a display device assessment. The "test set" implicitly refers to the physical DP-M3010 display unit itself and its components, upon which the bench tests were performed.
- Data Provenance: The tests were performed on the DP-M3010 model itself. The country of origin for the device is Japan (Canon Inc. - Hiratsuka Development Center). The study was prospective in the sense that specific tests were conducted on the newly developed device to assess its performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable as the study was a non-clinical bench test of a display device, not an AI or diagnostic algorithm requiring expert ground truth for interpretation of medical images. The "ground truth" for the display's performance was established by technical specifications and adherence to recognized standards for display quality.
4. Adjudication Method for the Test Set:
This information is not applicable as the study was a non-clinical bench test. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or AI output review, which is not the case here.
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, an MRMC comparative effectiveness study was not done. This document pertains to a display device, not an AI or diagnostic algorithm that assists human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable as the document describes a display device, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the device's performance was established by:
- Technical specifications and performance characteristics of the legally marketed predicate device (RadiForce RX840-MG).
- Industry standards and guidelines for medical displays, specifically "Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions," which recommended the specific bench tests performed (e.g., Luminance response, resolution, chromaticity, electrical safety, EMC).
8. The Sample Size for the Training Set:
This information is not applicable. There was no "training set" as this is a physical display device, not a machine learning model.
9. How the Ground Truth for the Training Set was Established:
This information is not applicable for the same reason as above.
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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.
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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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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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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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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 |
| Maximumluminance | 500 cd/m² | 700 cd/m² |
| DICOM calibratedluminance | 500 cd/m² | 500 cd/m² |
| Contrast ratio | 1000:1 | 1000:1 |
| Backlighting | LED | LED |
| Gradation | 10 bit | 8 bit, 10 bit |
| Luminancenon-uniformitycompensation | 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 |
| ScanningFrequency(V) | 59.922 - 60.317Hz | 29.5 - 61Hz |
| Dot Clock | 174.25MHz x4 | DVI-D: 310MHzDisplayPort: 290MHz |
| Power Related Specifications | ||
| PowerRequirements | AC 100 - 240V : 50/60Hz | AC 100 - 120V, 200 - 240V :50/60Hz |
| PowerConsumptionSave Mode | 325W / 2W | 350W / 6W |
| PowerManagement | 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, IntegratedFront 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/ostand(W x H x D) | 707 x 465 x 106 mm | 896 x 527 x 157 mm |
| Contrast Enhancer(Darkening imageBackground) | Yes | No |
Table 6-1. Comparison Table of Technological Characteristics
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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).
§ 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).