HEALTHMYNE

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, arranged in a cascading manner. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 15, 2016 HealthMyne, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313 Re: K153289 Trade/Device Name: HealthMyne Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 31, 2015 Received: January 4, 2016 Dear Mr. Job: 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'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) K153289 Device Name HealthMyne #### Indications for Use (Describe) The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the product automatically and semiautomatically segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings. Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-----------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### 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 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." {3}------------------------------------------------ # Summary of Safety and Effectiveness/510k Summary This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h). | Company | HealthMyne, Inc.<br>918 Deming Way<br>Madison, WI 53717 | |------------------|-----------------------------------------------------------------------------------------------------------------------| | Contact | Sigrid Schoepel<br>Director of Regulatory Affairs<br>Telephone: 608-833-2610<br>Email: sigrid.schoepel@healthmyne.com | | Preparation Date | October 26, 2015 | | Trade Name | HealthMyne | | Classification | Class II per 21 CFR 892.2050<br>Picture Archiving and Communications System | | Product Code | LLZ | ### Marketed Devices HealthMyne is a software-only medical device that can manage OEM medical diagnostic images that are compatible with the DICOM standard. It performs functions similar to those currently available in the VitreaAdvanced software cleared for marketing via 510(k) K121213 by Vital Images, Inc. ### Device Description HealthMyne accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports. The system can automatically segment and register data sets, and calculate metrics on clinician-identified nodules. When a clinician identifies a seed point for a nodule, the system automatically finds the extent of the nodule. Regions of interest (organs and nodules) can be viewed on the 2D data sets as contours and as 3D models. Metrics can be used to aid in analysis of a study, including the American College of Radiology RADS standards, and specifically with this release the LungRADs categories. #### Intended Use The HealthMyne software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the HL7 and DICOM (including DICOM-RT) standards, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements, and export the information. The product automatically and semi-automatically {4}------------------------------------------------ segments normal structures and abnormal structures (for example, nodules and lesions), and provides metrics for the structures. The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information (for example, image analysis) that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings. ### Comparison with Predicate HealthMyne performs many diagnostic image management picture archiving and communications functions available in the predicate device as shown in the following comparison chart. Its intended uses are similar to those of the predicate. | Element | Submission - HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6<br>(K121213) | |----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------| | Device Name | HealthMyne | VitreaAdvanced* | | 510(k) owner | HealthMyne, Inc. | Vital Images, Inc. | | Supports<br>mammography | No. | No. | | Operating<br>System | Windows, Linux | Windows | | Platform | Client-server | Client-server | | JPG/JPG 2000 | Supported using third-party Kakadu<br>tool. ISO 10918/15444 | Supported. See DICOM conformance<br>statement at vitalimages.com. | | Images are<br>stored/<br>compressed/<br>uncompressed | Both. Lossy used to indicate<br>loading/for display only and lossless<br>loaded simultaneously, unless DICOM<br>contains lossy only. | Both. Users can choose to compress<br>images. | | Local archive:<br>Server level/<br>archive level | No separate archive due to software-<br>only product. Redundant data storage<br>recommended to the customer. | Yes. Available as a separate product. | | DICOM<br>compliant | Yes. See conformance statement. | Yes. See conformance statement at<br>vitalimages.com. | | HL7 support | Yes. See conformance statement. | No reference to HL7. | | Study lists | Yes. | Yes. | | Ability to filter<br>and search<br>study list | Yes. Can set up custom filters.<br>Dynamic (freeform) search and<br>matching. Also customizable, indexed<br>search parameters. | Yes. Can set up custom filters. Search and<br>matching. | | View study-<br>related<br>documents | Yes. Presentation states and regions of<br>interest/nodules. | Yes. Presentation states and regions of<br>interest/nodules. | | Manage<br>pushed studies | Yes. This product supports only<br>pushed studies. No studies originate<br>within this product. | Yes. This product can import and export<br>using DICOM. | | Element | Submission - HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6<br>(K121213) | | View current<br>and prior<br>studies at the<br>same time | Yes. Called current study and prior<br>study. Prior studies have a large<br>"PRIOR" label in each viewport. | Yes. Can select series from different<br>studies for the same patient. | | Re-organize<br>series in a<br>study (for<br>viewing) | Yes. Has a thumbnail view with the<br>ability to drag and drop the thumbnail<br>into a viewport. Cannot save the<br>order. | Yes. Can drag and drop a viewport image<br>to another viewport. | | Create<br>separate<br>displays | Yes. Can display a viewport as a single<br>viewport, can select a viewport layout<br>and add series to it. | Yes. Can display a viewport as a single<br>viewport, can select a viewport layout and<br>add series to it. | | Cycle through<br>series | Yes. Can show the "next" and<br>"previous" sets of series. | Yes. Can show the "next" and "previous"<br>sets of series. | | Image display<br>modes | Yes. Static and manual cine. | Yes. Static and manual cine. | | Display color<br>images | Yes. | Yes. | | Select images | Yes. There is an active image indicator.<br>The active image can be chosen or is<br>automatically set based on tool use. | Yes. Select images to group and/or<br>perform functions. | | Delete images | Yes. Only with PACS admin privileges<br>and from the admin console. | Yes. Can delete images from the viewer<br>window. | | Sort images | Yes. Sorting and grouping are by<br>system-defined rules. | Yes. Sorting and grouping are by system-<br>defined rules. | | Scrolling<br>through slices | Yes. Linked series are scrolled<br>together. Can "swipe" on a scroll bar<br>to move through slices quickly. Can<br>lock/unlock scrolling through every<br>image. | Yes. Grouped series are scrolled together. | | Zoom in/out | Yes. Default settings and can zoom<br>interactively. | Yes. Default settings and can zoom<br>interactively. | | Pan an image | Yes. | Yes. | | Rotate an<br>image | Yes. In 3D. | Yes. Can flip 2D images and rotate 2D and<br>3D images. | | 3D images | Yes. | Yes. | | 3D MIP | No. | Yes. | | Create oblique<br>planes | No. | Yes. | | Standard<br>viewport<br>layouts | Yes. Viewport layouts that are<br>independent of any modality or<br>common features of series. | Yes. Viewport layouts that are<br>independent of any modality or common<br>features of series. | | Custom<br>layouts | No. Viewport layouts and hanging<br>protocols are factory-default. | Yes. Viewport layouts can be set by the<br>user. | | Element | Submission - HealthMyne 2015 Rel 2 | Predicate – VitreaAdvanced 6.6<br>(K121213) | | Labels | Yes. There are labels in the viewport for patient, study, and image information. | Yes. There are labels in the viewport for patient, study, and image information. | | Orientation labels | Yes. | Yes. | | Cross-reference indicator | Yes. There is a cutline in linked viewports to indicate intersection. | No. Use of cross-hair markers. | | Location indicator | Yes. There is a cross-hair tool to show a point of interest. | Yes. There is a cross-hair tool to show a point of interest, also used to change the axis in 3D rotation. | | View DICOM data | Yes. You can view the DICOM information about the patient, study, and current image. | Yes. You can view the DICOM information about the patient, study, and current image. | | Create MPR images | Yes. MPRs from the external source are supported/displayed and can create multi-planar reconstructions of 2D images. | Yes. Can create multi-planar reconstructions of 2D images and set options for display. | | Window/level across series | Yes. W/L settings are applied to the active image and any linked images. | Yes. Must group series to link W/L. | | Window/level presets | Yes. Factory default. | Yes. Factory defaults and can save window/level settings. | | Adjust window/level | Yes. Can interactively adjust the window and level. | Yes. Can interactively adjust the window and level. | | Post-processing of images | Yes. Can create multi-planar reconstructions of 2D images and 3D views of contours. | Yes. Can create multi-planar reconstructions of 2D images and 3D views. | | Annotation | Yes. User can display annotations and can add and edit callouts. | Yes. User can display annotations and can add and edit callouts. | | Measuring tools | Yes. Pixel intensity/location and ruler. | Yes. Ruler. | | Metrics | Yes. Image analysis metrics. | Yes. Image analysis metrics. | | ACR RADS categories | Yes. Architecture in place to display RADS categories, initial implementation is for LungRADS. | Yes. References the Fleischner society guidelines. LungRADS's risk stratification is based on the Fleischner society guidelines. | | Store presentation states | Yes. Can save certain visualization settings. | Yes. Can save certain visualization settings. | | Detect image/patient issues | Yes. Can view patients and studies with errors. | Yes. Can view patients and studies with errors. | | Print reports | No. | Yes. Can export and print reports. | | Element | Submission – HealthMyne 2015 Rel 2 | Predicate - VitreaAdvanced 6.6<br>(K121213) | | Custom<br>hanging<br>protocols | No. Comes with factory-default<br>hanging protocols. | No. Comes with factory-default layouts. | | Custom filters | Yes. Can set filters to affect the studies<br>listed. | Yes. Can set filters to affect the studies<br>listed. | | Set reading<br>state | Yes. Can mark a study as read. | Yes. Can mark a study as read. | | Custom search<br>groups | Yes. Can set "codes" to index<br>elements for searching (for example,<br>referring physician or sets of exam<br>types) for faster auto-complete during<br>search. | Yes. Can set searches using matches and<br>ranges on the column headings. | | Display RTP<br>structures | Yes. Supports DICOM RT structures. | Yes. Supports DICOM RT structures. | | Register<br>images | Yes. Can automatically and/or<br>manually register images. | Yes. Can manually synchronize datasets in<br>viewers. Only applies to MPRs and 3D<br>images. | | Segment<br>regions of<br>interest (ROIs) | Yes. Can automatically generate ROIs<br>and also manually identify nodules for<br>automatic generation of nodule ROIs. | Yes. Can automatically generate ROIs and<br>also manually identify nodules for<br>automatic generation of nodule ROIs. | | Edit ROIs | Yes. Can edit the shape of nodules in<br>three dimensions. | Yes. Can edit ROIs in three dimensions. | | Manual nodule<br>detection | Yes. Manual click to identify nodules,<br>automatic segmentation of the<br>volume. | Yes. Manual click to identify nodules,<br>automatic segmentation of the volume. | | Automatic<br>nodule<br>detection | No. | Yes. Automatic detection of nodules in<br>current study if nodules identified in<br>previous studies, and the reverse. | | Nodule display<br>modes | Yes. View nodules independently or in<br>reference to other anatomy. | Yes. View nodules independently or in<br>reference to other anatomy. | | Image fusion | No. | Yes. Create a fused 3D image by<br>combining series. | | Timeline<br>comparison | No. | Yes. Compare between nodules in studies<br>of elapse time between scans, doubling<br>time, percent growth | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ### Summary of Studies The HealthMyne software has undergone verification and validation to confirm its functional performance. Non clinical testing conformance to the following FDA recognized industry standards applicable to PACS devices: DICOM standard for medical diagnostic images, HL7 standard for patient information, SMPTE display, and the JPEG2000 image standard. {8}------------------------------------------------ ### Conclusion It is the opinion of HealthMyne, Inc. that the HealthMyne software is substantially equivalent to similar image management options available in the predicate device. HealthMyne does not include any new indications for use with regards to the management of medical diagnostic image information, nor does use of this software result in any new potential hazards.