MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE

{0}------------------------------------------------ ## K120734 Microsoft Corporation Traditional 510(k) Premarket Submissio Microsoft® Amalga™ UIS Image Processing Module AUG 2 2012 # Section 5 - 510(k) Summary for # Microsoft® Amalga™ UIS Image Processing Module ### 1. Submission Sponsor Microsoft Corporation 1 Microsoft Way Redmond, WA 98052 USA Phone: 301.771.8624 Contact: Michael Willingham, VP, Quality Assurance & Regulatory Affairs ### Submission Correspondent 2. Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: 262-290-0023 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Adrienne Lenz, Senior Consultant, QA & RA Email: project.management@emergogroup.com ### Date Prepared 3. 17 July 2012 ### Device Name 4. Trade/Proprietary Name: Microsoft® Amalga™ UIS Image Processing Module Common/Usual Name: Picture Archiving and Communication System Classification Name: Picture archiving and communications system Classification Regulation: 892.2050 Classification Panel: Radiology Product Code: LLZ Device Class: 2 ### FDA Establishment Registration #: 3007734659 .. 43.11px app SILE 1.5 ) 1. 1.11 11 ุก จากร รอบคว้างในอัลบั้ม {1}------------------------------------------------ Microsoft Corporation Traditional 510(k) Premarket Submission Microsoft® Amalga™ UIS image Processing Module ### 5. Predicate Devices K061214 AquariusAPS Server, TeraRecon, Inc. K011142 AquariusAPS Workstation, TeraRecon, Inc. ### 6. Device Description The Microsoft® Amalga™ UIS Image Processing Module (IPM) is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ UIS Medical Imaging Module (MIM). These two software products (Amalga™ UIS and Amalga™ MIM) are Class 1 devices that perform consolidation of disparate health information (Amalga™ UIS) and medical image communication (Amalga™ MIM). Amalga™ IPM enables healthcare providers to rapidly navigate across images by selecting tagged organs and to review these images using multi-planar reconstruction (MPR). Amalga™ IPM delivers a basic MPR rendering platform that constructs a three-dimensional view from a set of CT, MR, or PET images. Amalga™ IPM also enables organ label based navigation through DICOM CT scans both in 2D image display and MPR viewing mode. ### Intended Use The Microsoft® Amalga™ UIS Image Processing Module is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ Medical Imaging Module to receive medical images from acquisition devices and imaging systems adhering to DICOM protocol. Medical images received from volumetric or planar imaging modalities are processed to derive certain information. The information thus derived is transmitted using the DICOM or HTTP protocol to other devices supporting these standard protocols. The IPM enables physicians and other healthcare providers to rapidly navigate across images by selecting tagged organs and review them through multi-planar reconstruction (MPR). IPM is not intended to be used for primary diagnosis. This device is not intended to be used for mammography. ### 7. Technological Characteristics and Substantial Equivalence 11791111111111111111 The following table compares the features of the Microsoft® Amalga™ UIS Image Processing Module to the AquariusAPS Server and Workstation, providing the basis of substantial equivalence. {2}------------------------------------------------ # K120734 Page 3 of 5 Microsoft Corporation Traditional 510(k) Premarket Submission Microsoft® Amalga™ UIS Image Processing Module ## Comparison Table ・ | Trade Name | Amalga™ UIS IPM | AquariusAPS Server | AquariusAPS<br>Workstation | |---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|---------------------------------------------------| | 510(k) Number | | K061214 | K011142 | | Product Code | LLZ | LLZ | LLZ | | Regulation Number | 21 CFR 898.2050 | 21 CFR 898.2050 | 21 CFR 898.2050 | | Regulation Name | Picture archiving and<br>communications<br>system | Picture archiving and<br>communications<br>system | Picture archiving and<br>communications<br>system | | Platform | Amalga UIS 2009 R2<br>SP3 and Medical<br>Imaging Module | TeraRecon | TeraRecon | | Intended for use in primary<br>diagnostic workflow | No | Yes | Yes | | Receive images using DICOM<br>protocol | Yes | Yes | Yes | | Send images using DICOM<br>protocol | Yes | Yes | Yes | | MPR Visualization<br>(Axial/Sagittal/Coronal) | Yes | No | Yes | | MPR Visualization<br>(oblique) | Yes | No | Yes | | Modalities supported for<br>MPR review | CT, MR, PET | CT, MR, PET | CT, MR, PET | | Trade Name | Amalga™ UIS IPM | AquariusAPS Server | AquariusAPS | | | | | Workstation | | Identify locations of | Yes. The list of the | Yes. The list of | Yes (manual) | | anatomical structures | structures are: | structures are: | | | | Abdomen,<br>�<br>Adrenal Gland<br>●<br>(Left/Right),<br>Femoral Neck<br>and head<br>(Left/Right),<br>Heart (Atrium<br>and ventricle)<br>(Left/Right),<br>Kidney<br>(Left/Right),<br>Liver,<br>Lung (Left/Right),<br>Pelvis,<br>●<br>Spleen,<br>Stomach,<br>Thorax | Brain<br>●<br>Heart<br>Heart vasculature<br>●<br>Liver<br>Lung | | | Modalities supported for<br>identification of anatomical<br>structures | CT | СТ | ст | | Manual review of identified<br>anatomical structures and<br>correction tools | Yes | Yes | Yes | | Ability to navigate to an<br>image displaying an<br>identified anatomical<br>structure | Yes | Yes | Yes | | Align and review two or<br>more sets of images side by<br>side | Yes. Link by image<br>number for two<br>series | Yes | Yes | | Performing actions and<br>image set navigation based<br>on DICOM and other data<br>identified from the DICOM<br>image set | Yes · | Yes | No | Page 3 of 5 - . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. · ﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ ﺍﻟﻤﺘﻮﺍﺻﻞ *** 1 - 114 - 11 - 11 {3}------------------------------------------------ K\20734 Page 4 of 5 ## Microsoft Corporation Traditional 510(k) Premarket Submission Microsoft® Amalga™ UIS Image Processing Module : {4}------------------------------------------------ Microsoft Corporation Traditional 510(k) Premarket Submission Microsoft® Amalga™ UIS Image Processing Module ### 8. Non-Clinical Testing Support for the substantial equivalence of the Microsoft® Amalga™ UIS Image Processing Module was provided as a result of risk management and software validation, which confirmed all features of the Microsoft® Amalga™ UIS Image Processing Module were compliant with the software requirements: The Microsoft® Amalga™ UIS Image Processing Module operates properly for multiplanar reconstruction and navigation using semantic tagging of organs. ### 9. Clinical Testing Validation of the image tagging algorithm was completed using human images from a variety of databases. These databases comprise patients with a wide variety of medical conditions and body shapes and the scans exhibit large differences in image cropping, resolution, scanner type and use of contrast agents. Comparison between physician identified and software identified boundaries confirmed suitable accuracy and efficiency of the image tagging algorithm. Sensitivity, specificity, accuracy and precision were determined for each of the 21 organs. Accuracy ranged between 84% and 99%, exceeding the predetermined threshold of 81%. ### 10. Conclusion It has been shown in this 510(k) submission that the difference between the Microsoft® Amalga™ UIS Image Processing Module and the predicate device does not raise any questions regarding its safety and effectiveness. The conclusions drawn from the nonclinical tests demonstrate equivalent performance of the Microsoft® Amalga™ UIS Image Processing Module and the predicate devices. The Microsoft® Amalga™ Image Processing Module, as designed and manufactured is determined to be substantially equivalent to the referenced predicate devices. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is a stylized eagle emblem. The eagle is depicted with its wings spread, and its body is formed by three curved lines. # DEPARTMENT OF HEALTH & HUMAN SERVICES ### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring. MD 20993-0002 Caradigm % Ms. Adrienne Lenz Senior Consultant, QA and RA Emergo Group 611 West 5th Street, Third Floor AUSTIN TX: 78701 Re: K120734 Trade/Device Name: Microsoft® Amalga™ UIS Image Processing Module Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 17, 2012 Received: July 18, 2012 ## Dear Ms. Lenz: 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. If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of ^ AUG 2 2012 1 22-7 {6}------------------------------------------------ medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely Yours, Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health Enclosure {7}------------------------------------------------ Microsoft Corporation Traditional 510(k) Premarket Submission Microsoft® Amalga™ UIS Image Processing Module # Section 4 - Indications for Use Statement 510(k) Number (if known): Not Assigned Device Name: Microsoft® Amalga™ UIS Image Processing Module ### Indications for Use: The Microsoft® Amalga™ UIS Image Processing Module (IPM) is used in conjunction with Microsoft® Amalga™ UIS and Microsoft® Amalga™ UIS Medical Imaging Module to receive medical images from acquisition devices and imaging systems adhering to DICOM protocol. Medical images received from volumetric or planar imaging modalities are processed to derive certain information. The information thus derived is transmitted using the DICOM or HTTP protocol to other devices supporting these standard protocols. The IPM enables physicians and other healthcare providers to rapidly navigate across images by selecting tagged organs and review them through multi-planar reconstruction (MPR). IPM is not intended to be used for primary diagnosis. This device is not intended to be used for mammography. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD) Office of In Vitro Diagnostic Device Evaluation and Safe 510(k) K120734 Page 1 of 3, 11, 11: 11: 11: Silie-1 19 32.11 1 ally 1000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ้ายเฉปลาวเมว)