NovaPACS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing right, arranged in a cascading manner. The profiles are depicted in black and are connected by flowing lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 28, 2017 Novarad Corporation % Mr. Doug Merrill Regulatory and Compliance Manager 752 East 1180 South #200 AMERICAN FORK UT 84003 Re: K171754 Trade/Device Name: NovaPACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2017 Received: June 13, 2017 Dear Mr. Merrill: 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 D. 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}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171754 Device Name NovaPACS #### Indications for Use (Describe) NovaPACS is intended for the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, including mammography. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography or fMRI. Mobile devices are used for diagnosis of medical images from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual. While NovaPACS full workstation provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application. NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context. 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) {3}------------------------------------------------ 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 Drug 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." {4}------------------------------------------------ #### 510(K) SUMMARY #### Submitter Novarad Corporation 752 East 1180 South, Suite 200 American Fork, UT 84003 E-mail: doug.merrill(@novarad.net Phone: 801-642-1001 Contact Person: Doug Merrill Date Summary Prepared: 9 January 2015 #### Device Name Trade Name: NovaPACS Common Name: PACS Classification Name: System, Imaging Processing, Radiological #### Predicate Devices | K160371 | NovaPACS | Novarad Corporation | |---------|------------------------|---------------------| | K133910 | nordicBrainEx Software | NordicNeuroLab AS | #### Indication for Use NovaPACS is intended for the viewing, archiving, analysis, annotation, distribution, editing, fusion, and processing of digital medical images and data acquired from diagnostic imaging devices and all DICOM devices, including mammography. NovaPACS is intended for use by trained healthcare professionals, including radiologists, physicians, technologists, clinicians, and nurses. NovaPACS allows the end user to display, manipulate, archive, and evaluate images. Mobile devices are not intended to replace a full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography or fMRI. Mobile devices are used for diagnosis of medical #### Novarad 510(k) Submission | 2017 {5}------------------------------------------------ images from different modalities including CT, MR, US, CR/DX, NM, PT, and XA. For a list of compatible mobile platforms see NovaPACS Diagnostic Viewer User Manual. While NovaPACS full workstation provides tools to assist the healthcare professional determine diagnostic viability, it is the user's responsibility to ensure quality, display contrast, ambient light conditions, and to confirm image compression ratios are consistent with the generally accepted standards of the clinical application. NovaPACS is intended for providing analysis and visualization of functional MRI data of the human brain, presenting derived properties and parameters in a clinically useful context. # Device Description NovaPACS is a picture archiving and communication system software that retrieves, archives, and displays images and data from all common modalities. NovaPACS uses a variety of workstations, including a Technologist Workstation, Enterprise Radiologist Workstation, Cardio Viewer and Workstation, NovaMG Workstation, and NovaWeb Web Viewer. The NovaPACS software makes images and data available in digital format from all common modalities. The images are viewed on a computer monitor or portable device. NovaPACS tools/features include the following: window, level, zoom, pan, digital subtraction, ejection, cross localization, note-taking ability, voice dictation, and other similar tools. It includes the capability to measure distance and image intensity values, such as standardized uptake value. NovaPACS displays measurement lines, annotations, regions of interest, and fusion blending control functionality. Advanced features include 3D image rendering, virtual fly-through, time domain imaging, vessel analysis, and blood oxygen level dependent (BOLD) fMRI. BOLD fMRI analysis is used to highlight small susceptibility changes in the human brain in areas with altered bloodflow resulting from neuronal stimulation. The Functional Processing Software includes features such as scalp stripping, 3D motion correction, smoothing, coregistration, normalize images to MNI templates, and warping. Images and data are stored on a digital archive with multiple redundances; images and data are available on-site and off-site. Novarad provides all software, including third party software (i.e. Windows® OS). NovaPACS software resides on third party hardware, which may vary depending on the client's PACS needs. All hardware is connected to the radiology department local area network. NovaPACS integrates with NovaRIS and may integrate with any other third party RIS software that has HL7 interface capabilities. NovaPACS integrates with Novarad Mobile Rad application and web viewers to display data on 3rd party mobile platforms. Mobile devices are not intended to replace full workstation and should be used only when there is no access to a workstation. They are not to be used for mammography or fMRI. {6}------------------------------------------------ ### Substantial Equivalence Research and testing data provide evidence that NovaPACS is substantially equivalent to the represented predicate devices: NovaPACS, a class II device under 21 CFR 892.2050 and nordicBrainEx Software, a class II device under 892.2050. NovaPACS and all predicate devices are Radiological Image Processing Systems which retrieve, store, and display images from DICOM compliant medical imaging modalities and/or systems. All are intended to be used in healthcare settings, such as hospitals and clinics, on 3d party off-the-shelf hardware, and connected to a local area network. All are intended to provide qualified medical professionals with a variety of tools and software for the viewing, analysis, and annotation of medical images. The new version of NovaPACS for which this submission is an upgraded version of the predicate NovaPACS device. The new version of NovaPACS software differs from the NovaPACS predicate software in intended use by providing algorithms designed to analyze functional MRI data of the brain. Although this feature was not available in the previous version of NovaPACS, this similar feature is already available in other predicate device listed. Performance testing results show that the fMRI software features of NovaPACS operate correctly and safely and meet equivalent objectives and perform equivalent functions as those represented in the predicate devices. Performance testing also shows that the unique combination of safety features represented in NovaPACS does not raise any additional safety concerns. There are no clinical tests to compare Noval ACS and predicate devices, as they are software products that send and store images and information. # Performance Testing Functional MRI software testing has been performed for NovaPACS to safety and efficacy of the device. Nineteen test cases were run on the NovaPACS to fulfill the fMRI requirements. All 19 test cases passed. We believe that the testing performed so far is sufficient to conclude that the features and functionality of NovaPACS fMRI software is substantially equivalent to that of the predicate devices, and that it does not rasse any new safety concerns. Verification and validation activites are performed on NovaPACS during software development prior to release, and in an ongoing manner for any updates. NovaPACS software passes all performance requirements and meets all specifications prior to release, including: - All requirements in the iteration have a test case and the test case has run and passed a. - b. All Acceptance tests have passed - All Current tests have passed C. - All high-impact bugs have been corrected and verified by Quality Assurance d. - e. Any unresolved anomalies have been assessed in a risk meeting, and it has been found that they do not pose a safety risk to the end user (or their patients) and do not substantially affect the performance of NovaPACS software.