FACT Medical Imaging Sysytem

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by a flowing line. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 2, 2015 Dexin Medical Imaging Technology Co., Ltd. % Mr. Leon Lu Director of Ouality and Regulatory Affairs MEDevice Services. LLC 3500 South Dupont Highway DOVER DE 19901 Re: K143586 Trade/Device Name: FACT Medical Imaging System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 18, 2015 Received: August 4, 2015 Dear Mr. Lu: 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. Michael O'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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K143586 Device Name FACT Medical Imaging System Indications for Use (Describe) The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography. In addition, the FACT Medical Imaging System has the following indications: (1) Pulmonary Review and Analysis Application Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow. The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime. (2) Vessel Review and Analysis Application Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries. Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <div> </div> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary #### Summary Prepared Date: 8/28/2015 #### Submission Sponsor (Manufacturer): Dexin Medical Imaging Technology Co., Ltd. 227 Chongye Street, Weinan High-tech Zone, Weinan, Shaanxi, China 714000 Contact Person Name: Wanq, Yu Title: QA Manager ## Submission Correspondent (Agent): Mr. Anthony Hopkins Regulatory Affairs Specialist Mr. Leon Lu Director of Quality and Regulatory Affairs MEDevice Services, LLC 3500 South Dupont Highway Dover, Delaware 19901 USA Email: info@medeviceservices.com www.medeviceservices.com MEDevice China, Ltd. 12F Weiya Building, No.29 Suzhou Street, Haidian District Beijing, China 100080 Email: info@medevicechina.com www.medevicechina.com Trade/Device Name: FACT Medical Imaging System Device Class: II Classification Name: Medical Image Processing Software Regulation Number: 21 CFR. 892.2050 {4}------------------------------------------------ #### Product Code: LLZ Review Panel: Radiology Predicate Device: - K071331 . Vital Images, Inc. Vitrea, version 4.0 Medical Image processing Software - K120484 . Mevis Medical Solutions Visia™ Oncology - K083227 . VIDA Diagnostics VIDA Pulmonary Workstation 2 (PW2) #### Device Description: The FACT Medical Imaging System is self-contained, non-invasive medical image processing software. It can be marketed as software only, as well as packaged with standard off-the-shelf PC hardware. It can operate as a stand-alone workstation or in a distributed server-client configuration across a computer network. The FACT Medical Imaging System allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from a variety of imaging devices. This device addresses physicians' needs through various application options for pulmonary and vessel applications. Over the counter use: No Duration and type of contact: N/A Single use: No Sterile: No {5}------------------------------------------------ #### Indication for Use: The FACT Medical Imaging System is a medical software application that allows the processing, review, analysis, communication and media interchange of multidimensional digital images acquired from a variety of imaging devices. The FACT Medical Imaging System is not meant for primary image interpretation in mammography. In addition. the FACT Medical Imaging System has the following indications: (1) Pulmonary Review and Analysis Application Pulmonary Review and Analysis application is an option that is intended for supporting physicians in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from pulmonary CT images. Three-Dimensional seqmentation and isolation of sub-compartments, volumetric analysis, density evaluations, and reporting tools are combined with a dedicated workflow. The automated image registration facilitates the synchronous display and navigation of multiple datasets for viewing data and easy follow-up comparison. The summary report of findings helps the user to track findings and note changes, such as shape, size, or overtime. (2) Vessel Review and Analysis Application Vessel Review and Analysis application is an option intended for viewing the anatomy and pathology of a patient's coronary arteries. Physicians can select any artery to view the following anatomical references: the highlighted vessel in 3D, curved MPR vessel view, and straightened MPR view with cross sections of the vessel. Physicians can semi-automatically stenosis measurements, and maximum and minimum lumen diameters. In addition, physicians can also measure vessel dimensions along the centerline in curved MPR view and examine Hounsfield unit or signal intensity statistics. #### Software Development: The FACT Medical Imaging System was designed, developed, tested and validated according to written procedures. These procedures specify individuals within the orqanization responsible for developing and approving product specifications, coding and testing, validation testing and maintenance. {6}------------------------------------------------ ## Comparison to Predicate Devices: | Indications For Use Statement | | | | | | | | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------|-----------------------|--------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 1 | Acquiring images from a<br>variety of imaging devices | Same | Same | Same | Similar | Same | | | 2 | Processing, review,<br>analysis, communication<br>and media interchange of<br>multi-dimensional digital<br>images | Same | Same | Same | Similar | Same | | | 3 | To be used for supporting<br>physicians in the<br>diagnosis and<br>documentation of<br>pulmonary tissue images<br>(e.g., abnormalities) from<br>pulmonary CT images. | Same | None | Similar | Same | Same | | | 4 | To be used for viewing<br>the anatomy and<br>pathology of a patient's<br>coronary arteries | Same | Same | None | None | Same | | | | | | Standards Met | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 5 | Conforms to the essential<br>requirements of the<br>DICOM standard for data<br>exchange (PS 3.3 - PS<br>3.12) | Same | Same | Same | Same | Same | | | | | | Design | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 6 | Software device that<br>operates on off-the-shelf<br>hardware | Same | Same | Same | Same | Same | | | 7 | Device is a system<br>composed of multiple<br>components that work<br>stand-alone and in<br>concert | Same | Same | Same | Partial, stand-alone<br>only | Same | | | 8 | Web-based client | Same | None | None | None | N/A.<br>But this<br>web-based<br>feature has<br>been<br>included by<br>many<br>PACS, such<br>as K131424<br>(Product<br>name:<br>miPlatform<br>medical<br>imaging<br>suite,<br>Company<br>name:<br>Hinacom | | | | | | | | | Software<br>and<br>Technology<br>Ltd. Co.).<br>This new<br>feature | | | | | | | | | won't affect<br>the safety<br>and<br>effectivenes<br>s of the | | | | | | | | | subject<br>device. | | | 9 | Operating System | Windows | Windows | Windows | Linux | Same | | | | | Functions and Capabilities - General Functions | | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 10 | DICOM Image Import/<br>Export (Support DICOM<br>Storage, Query/Retrieve,<br>and Print) | Same | Same | Same | Partial, PW2 support<br>DICOM Image<br>Import | Same | | | 11 | Present a study list | Same | Same | Same | Same | Same | | | 12 | 2D image reading<br>(Support image<br>annotation, measurement<br>and cine) | Same | Same | Same | Same | Same | | | 13 | Synchronized stacking | Same | Same | Same | None | Same | | | 14 | 3D visualization (Support<br>MPR, MIP, volume<br>rendering) | Same | Same | Same | Same | Same | | | | Functions and Capabilities - Pulmonary Review and Analysis Application | | | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 15 | Segmentation of left /<br>right lungs | Same | None | Same | Same | Same | | | 16 | Segmentation of<br>pulmonary fissures/ lobes | Same | None | None | Same | Same | | | 17 | Segmentation of<br>pulmonary airways tree | Same | None | Same | Same | Same | | | 18 | Segmentation of<br>pulmonary vessels | Same | None | Same | Same | Same | | | 19 | Segmentation of<br>suspicious nodules | Same | None | Same | None | Same | | | 20 | Export reports (including<br>key image and<br>measurement ) | Same | Same | Same | Partial. Export<br>measure-ment only | Same | | | 21 | Automated image<br>registration of two<br>datasets for follow-up<br>comparison | Same | None | Same | None | Same | | | 22 | Virtual fly-through the<br>airways | Same | None | None | Same | Same | | | 23 | 3D visualization of<br>pulmonary sub-<br>compartments | Same | None | Same | Same | Same | | | 24 | Volumetric analysis<br>(Support size, density,<br>volume) | Same | None | Same | Same | Same | | | 25 | airway lumen and wall<br>thickness measurements | Same | None | None | Same | Same | | | | | Functions and Capabilities - Vessel Review and Analysis Application | | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | 26 | Segmentation of coronary<br>vessels | Same | Same | None | None | Same | | | 27 | 3D visualization of<br>coronary vessels | Same | Same | None | None | Same | | | 28 | Vessel centerline review | Same | Same | None | None | Same | | | 29 | Curved MPR vessel view | Same | Same | None | None | Same | | | 30 | Measurement of vessel<br>dimensions | Same | Same | None | None | Same | | | 31 | Measurement of stenosis | Same | Same | None | None | Same | | | 32 | Exporting reports | Same | Same | None | None | Same | | | Other Areas of Comparison | | | | | | | | | | | Subject Device | Predicate<br>Device 1 | Predicate Device<br>2 | Predicate Device 4 | Discussion | | | | | FACT Medical<br>Imaging System | Vitrea, version<br>4.0 | Visia™ Oncology | VIDA Pulmonary<br>Workstation 2 (PW2) | N/A | | | 33 | Target population | No restriction | Same | Same | Same | Same | | | 34 | Intended user | to be used by<br>trained<br>professional-s<br>only | Same | Same | Same | Same | | | 35 | Energy used and/or<br>delivered | Electric power<br>supply to<br>computer<br>hardware only | Same | Same | Same | Same | | | 36 | Materials | N/A | N/A | N/A | N/A | N/A | | | 37 | Biocompatibility | N/A | N/A | N/A | N/A | N/A | | | 38 | Compatibility with<br>environment and other<br>devices | Interoperation<br>with other<br>devices based<br>on consensus<br>standards on<br>data exchange<br>(DICOM) | Same | Same | No direct interface<br>with any CT or data<br>collection equipment | Same | | {7}------------------------------------------------ {8}------------------------------------------------ ## Section5 510(k) Summary The proposed FACT Medical Imaging System has similar intended use as the predicate devices, Vitrea Medical Image processing software (k071331), Visia™ Oncology (K120484), and VIDA Pulmonary Workstation 2 (PW2) (k083227). The FACT Medical Imaging System is similar in overall design, principal of operation and configuration compared to the predicate devices. These devices are medical application software and they all provide 2D & 3D image visualization and manipulation tools for medical image analysis. The FACT Medical Imaging System and its predicate device, Vitrea Medical Image processing software, both allow for the analysis, communication and media interchange of digital images acquired from a variety of acquisition devices, support the DICOM protocol for communication of images with other medical imaging devices, and support the workflows, UI, and functions for vessel analysis scope. The FACT Medical Imaging System and its predicate devices, Visia™ Oncology and VIDA Pulmonary Workstation 2 (PW2) support the workflows, UI, and functions for pulmonary analysis scope. {9}------------------------------------------------ No new issues of safety or effectiveness are introduced by using this proposed device. In summary, this proposed device is substantially equivalent to the predicate devices in the areas of technical characteristics, general function, application, and intended use. This device does not raise any new potential safety risks and is equivalent in performance to the predication devices. ## Discussion of Non-Clinical Tests Performed: The following non-clinical tests have been performed: - Functional test ● - Functional regression test ● - Performance test ● - Portability test ● - Graphical user interface test ● - Usability test ● - Interoperability test ● - Measurement accuracy evaluation and validation: ● - Accuracy of pulmonary segmentation and measurements - Accuracy of fissure seqmentation and measurements - Accuracy of airway segmentation and measurements - Accuracy of vessel segmentation and measurements The FACT Medical Imaging System was tested successfully with reference to its Software Requirements Specification, as well as design verification and validation documents and Traceability Matrix document. Verification, validation, and testing activities established the performance, functionality, and reliability characteristics of this device, which is found to be safe and effective and substantially equivalent to the currently-cleared predication devices. Pass/Fail criteria were based on the requirements and intended use of the proposed device. Test results showed that all tests successfully passed. #### Discussion of Clinical Tests Performed: None #### General Safety and Effectiveness Concerns: The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. It is the user's responsibility to ensure that display quality, environmental lighting and other {10}------------------------------------------------ possible distractions are consistent with the clinical environment. The hardware components specified are all 'off the shelf' computer components. #### Conclusion: The proposed device is as safe and effective as the predicate devices. The proposed device has the same intended uses and indications, similar technological characteristics, and principles of operation as its predicate device. The minor differences between the proposed device and its predicate devices raise no new issues of safety or effectiveness. Thus, the proposed device is considered to be substantially equivalent to its predicate devices.