(16 days)
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.
MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MP display, specifically addressing the requirements of the emerging modality of Digital Breast Tomosynthesis (DBT) and QA software.
The display controller board is installed in a PACS workstation computer, connected to the display. The QA software helps to make and keep the displays DICOM compliant.
The display uses LED backlight technology.
The provided text describes a 510(k) Summary for the Barco Mammo Tomosynthesis (MDMG-5221) device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, rather than proving a new device meets specific acceptance criteria through extensive clinical studies.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify formal "acceptance criteria" in the sense of performance thresholds for a clinical study (e.g., a specific sensitivity or specificity target). Instead, it compares the technical specifications and performance of the new device to its predicate. The "acceptance criteria" can be inferred as demonstrating comparable or superior performance in key technical aspects and safety as the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (New MDMG-5221) | Predicate Device (MDMG-5221 cleared under K090603) |
|---|---|---|
| Similar or superior technological characteristics | ||
| Screen technology | TFT AMLCD Dual Domain IPS grayscale | TFT AMLCD Dual Domain IPS 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) |
| Per Pixel Uniformity (PPU) | Yes | Yes |
| Ambient Light Compensation (ALC) | Yes | Yes |
| Backlight Output Stabilization (BLOS) | No | No |
| I-Guard | Yes | Yes |
| Maximum luminance | 2100 cd/m² | 2100 cd/m² |
| DICOM calibrated luminance (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, 2 downstream | 1 upstream, 2 downstream |
| USB standard | 2.0 | 2.0 |
| Power consumption (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 |
| Safety and Effectiveness not affected by modifications | Bench tests confirmed similar or superior characteristics, no new safety/performance issues. | |
| (Specific for LED backlight and firmware update) | DICOM calibration and Luminance Uniformity tests passed. Firmware tests passed. Electrical Safety (IEC 60601-1) and EMC (IEC 60601-1-2) tests passed. |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Animal or clinical testing have not been performed." Therefore, there is no test set of patient data, sample size, or data provenance from a clinical study to report. The "testing" referred to in the document is bench testing of the display device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no clinical test set with medical images requiring expert ground truth was used in this submission.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
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. This device is a display monitor, not an AI-powered diagnostic tool. The submission does not involve an MRMC study or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a display monitor, not an algorithm.
7. The Type of Ground Truth Used
Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for the technical performance tests would be the established engineering specifications and measurement standards.
8. The Sample Size for the Training Set
Not applicable. As this is a display monitor submission demonstrating substantial equivalence via technical bench testing, there is no "training set" in the context of an algorithm or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set mentioned or implied in this submission for this device.
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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)
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)
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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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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| 510(k) Summary (in accordance with 21 CFR 807.92) | |||
|---|---|---|---|
| 1. Company | Barco N.V.Healthcare Division35 President KennedyparkB-8500 KortrijkBELGIUM | ||
| 2. Contactperson | Lieven De WandelRegulatory Affairs Officer | ||
| 3. Date ofsubmission | 25 April 2016 | ||
| 4. Deviceinformation | Trade name/model: Mammo Tomosynthesis 5MP (MDMG-5221)Common name: MDMG-5221Classification name: System, image processing, RadiologicalClassification code: LLZRegulation number: 892.2050 | ||
| 5. Predicatedevice | Mammo Tomosynthesis 5MP (MDMG-5221) cleared under 510(K) K090603 | ||
| 6. Devicedescription | MDMG-5221, system name Barco Mammo Tomosynthesis, is an update of the 5MPdisplay, specifically addressing the requirements of the emerging modality of DigitalBreast Tomosynthesis (DBT) and QA software.The display controller board is installed in a PACS workstation computer, connected to thedisplay. The QA software helps to make and keep the displays DICOM compliant.The display uses LED backlight technology. | ||
| 7. Intended Useof the Device | The Barco Mammo Tomosynthesis (MDMG-5221) device is intended to be used indisplaying and viewing digital images, including standard and multi-frame digitalmammography, for review, analysis, and diagnosis by trained medical practitioners. It isspecially designed for breast tomosynthesis applications. | ||
| 8. Comparisonof technologicalcharacteristics | Specification | MDMG-5221 (new device) | MDMG-5221 (predicate device) |
| Screen technology | TFT AMLCD Dual Domain IPSgrayscale | TFT AMLCD Dual Domain IPSgrayscale | |
| 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 LuminanceTechnology (ULT) | |||||
|---|---|---|---|---|---|
| Per Pixel Uniformity (PPU) | Yes | Yes | |||
| Ambient Light Compensation(ALC) | Yes | Yes | |||
| Backlight Output Stabilization(BLOS) | No | No | |||
| I-Guard | Yes | Yes | |||
| Maximum luminance | 2100 cd/m² | 2100 cd/m² | |||
| DICOM calibrated luminance(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,2 downstream | 1 upstream,2 downstream | |||
| USB standard | 2.0 | 2.0 | |||
| Power consumption(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. Performancetesting | The bench tests mentioned below were performed to validate the device characteristicsthat differ from the predicate device: | ||||
| Modification to device | Test performed | ||||
| LED backlight instead of CCFL | DICOM calibration and LuminanceUniformity tests | ||||
| Updated firmware | Firmware tests | ||||
| Additional tests performed: Electrical Safety test (IEC 60601-1), EMC test (IEC 60601-1-2)The tests showed that the device has similar or superior characteristics compared to thepredicate 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 tothe predicate device, due to the following reasons: | ||||
| a) Device and predicate device have the same intended useb) The technological characteristics differences from the predicate device do notaffect safety or effectivenessc) Bench testing showed that the device has similar or superior characteristicscompared to the predicate device and did not reveal new issues of safety andperformance. |
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§ 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).