Mammo Tomosynthesis (MDMG-5221)
Device Facts
| Record ID | K161229 |
|---|---|
| Device Name | Mammo Tomosynthesis (MDMG-5221) |
| Applicant | Barco N.V. |
| Product Code | PGY · Radiology |
| Decision Date | May 18, 2016 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
Indications for Use
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis by trained medical practitioners. It is specially designed for breast tomosynthesis applications.
Device Story
The Barco Mammo Tomosynthesis (MDMG-5221) is a medical-grade display system for digital mammography and breast tomosynthesis. It consists of a 21.3-inch TFT AMLCD grayscale display with LED backlight technology, driven by a display controller board installed in a PACS workstation. The device incorporates QA software to maintain DICOM compliance. It is used by radiologists and trained medical practitioners in clinical settings to view high-resolution diagnostic images. The system features Uniform Luminance Technology (ULT), Per Pixel Uniformity (PPU), Ambient Light Compensation (ALC), and an I-Guard sensor to ensure image consistency and quality. By providing accurate, calibrated grayscale visualization, the device assists clinicians in the review and diagnosis of breast imaging, potentially improving diagnostic accuracy for breast tomosynthesis.
Clinical Evidence
Bench testing only. No clinical or animal data were performed. Bench tests included DICOM calibration, luminance uniformity, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2) testing to validate the transition to LED backlight technology and firmware updates.
Technological Characteristics
21.3" TFT AMLCD grayscale display; 2048 x 2560 resolution; 0.165 mm pixel pitch; LED backlight; 2100 cd/m² max luminance; 950:1 contrast ratio; 15 ms response time. Features: Uniform Luminance Technology (ULT), Per Pixel Uniformity (PPU), Ambient Light Compensation (ALC), I-Guard sensor. Connectivity: DP, DVI, USB 2.0. Power: 125W nominal. Software: QA software for DICOM compliance.
Indications for Use
Indicated for trained medical practitioners to display and view digital images, including standard and multi-frame digital mammography, for review, analysis, and diagnosis, specifically for breast tomosynthesis applications.
Regulatory Classification
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.
Special Controls
*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).
Predicate Devices
- Mammo Tomosynthesis 5MP (MDMG-5221) (K090603)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 18, 2016
Barco N.V. % Mr. Lieven De Wandel Regulatory Officer President Kennedypark 35 Kortrijk, 8500 BELGIUM
Re: K161229
Trade/Device Name: Mammo Tomosynthesis (MDMG-5221) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: PGY Dated: April 25, 2016 Received: May 2, 2016
Dear Mr. De Wandel:
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)
K161229
Device Name
Mammo Tomosynthesis (MDMG-5221)
Indications for Use (Describe)
The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in displaying and viewing digital images, including standard and multi-frame digital mammography, for review, and diagnosis by trained medical practitioners.
It is specially designed for breast tomosynthesis applications.
Note: There are no changes to the indications for use statement from that of the unmodified device
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)
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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary (in accordance with 21 CFR 807.92) | | | |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|----------------------------------------|
| 1. Company | Barco N.V.<br>Healthcare Division<br>35 President Kennedypark<br>B-8500 Kortrijk<br>BELGIUM | | |
| 2. Contact<br>person | Lieven De Wandel<br>Regulatory Affairs Officer | | |
| 3. Date of<br>submission | 25 April 2016 | | |
| 4. Device<br>information | Trade name/model: Mammo Tomosynthesis 5MP (MDMG-5221)<br>Common name: MDMG-5221<br>Classification name: System, image processing, Radiological<br>Classification code: LLZ<br>Regulation number: 892.2050 | | |
| 5. Predicate<br>device | Mammo Tomosynthesis 5MP (MDMG-5221) cleared under 510(K) K090603 | | |
| 6. Device<br>description | MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP<br>display, specifically addressing the requirements of the emerging modality of Digital<br>Breast Tomosynthesis (DBT) and QA software.<br>The display controller board is installed in a PACS workstation computer, connected to the<br>display. The QA software helps to make and keep the displays DICOM compliant.<br>The display uses LED backlight technology. | | |
| 7. Intended Use<br>of the Device | The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used in<br>displaying and viewing digital images, including standard and multi-frame digital<br>mammography, for review, analysis, and diagnosis by trained medical practitioners. It is<br>specially designed for breast tomosynthesis applications. | | |
| 8. Comparison<br>of technological<br>characteristics | Specification | MDMG-5221 (new device) | MDMG-5221 (predicate device) |
| | Screen technology | TFT AMLCD Dual Domain IPS<br>grayscale | TFT AMLCD Dual Domain IPS<br>grayscale |
| | Active screen size (diagonal) | 540.9 mm (21.3") | 540.9 mm (21.3") |
| | Active screen size (H x V) | 422.4 x 377.9 mm (16.6 x 13.3") | 422.4 x 377.9 mm (16.6 x 13.3") |
| | Aspect ratio (H:V) | 4:5 | 4:5 |
| | Resolution | 2048 x 2560 | 2048 x 2560 |
| | Pixel pitch | 0.165 mm (0.0065") | 0.165 mm (0.0065") |
| | Color imaging | No | No |
| | Gray imaging | Yes | Yes |
| | Viewing angle (H, V) | 176° (at 10:1 contrast) | 176° (at 10:1 contrast) |
BARCO
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| | Uniform Luminance<br>Technology (ULT) | | | | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|--|-----------------------------|--|
| | Per Pixel Uniformity (PPU) | Yes | | Yes | |
| | Ambient Light Compensation<br>(ALC) | Yes | | Yes | |
| | Backlight Output Stabilization<br>(BLOS) | No | | No | |
| | I-Guard | Yes | | Yes | |
| | Maximum luminance | 2100 cd/m² | | 2100 cd/m² | |
| | DICOM calibrated luminance<br>(ULT off) | 1000 cd/m² | | 1000 cd/m² | |
| | Contrast ratio (typical) | 950:1 | | 950:1 | |
| | Response time (Tr + Tf) | 15 ms (typical) | | 15 ms (typical) | |
| | Video input signals | DP, DVI | | DP, DVI | |
| | USB ports | 1 upstream,<br>2 downstream | | 1 upstream,<br>2 downstream | |
| | USB standard | 2.0 | | 2.0 | |
| | Power consumption<br>(nominal) | 125W | | 125W | |
| | Power save mode | Yes | | Yes | |
| | Net weight with stand | 15.4 kg | | 15.4 kg | |
| | Net weight w/o stand | 10.9 kg | | 10.9 kg | |
| 9. Performance<br>testing | The bench tests mentioned below were performed to validate the device characteristics<br>that differ from the predicate device: | | | | |
| | Modification to device | Test performed | | | |
| | LED backlight instead of CCFL | DICOM calibration and Luminance<br>Uniformity tests | | | |
| | Updated firmware | Firmware tests | | | |
| | Additional tests performed: Electrical Safety test (IEC 60601-1), EMC test (IEC 60601-1-2)<br>The tests showed that the device has similar or superior characteristics compared to the<br>predicate device and did not reveal new issues of safety and performance. | | | | |
| | Animal or clinical testing have not been performed. | | | | |
| 10. Conclusion | The Mammo Tomosynthesis (MDMG-5221) was found to be substantially equivalent to<br>the predicate device, due to the following reasons: | | | | |
| | a) Device and predicate device have the same intended use<br>b) The technological characteristics differences from the predicate device do not<br>affect safety or effectiveness<br>c) Bench testing showed that the device has similar or superior characteristics<br>compared to the predicate device and did not reveal new issues of safety and<br>performance. | | | | |
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