JiveX (Model Number / Release: 5.4)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. VISUS Health IT GmbH Axel Schreiber Vice President Process & Agile Services Gesundheitscampus-Sued 15 Bochum, 44801 Germany July 14, 2023 #### Re: K231041 Trade/Device Name: JiveX (Model Number / Release: 5.4) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: June 9, 2023 Received: June 9, 2023 Dear Axel Schreiber: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Jessica Lamb Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K231041 Device Name JiveX, Release 5.4 #### Indications for Use (Describe) JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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}------------------------------------------------ # Section 5 "510(k) Summary" of the Traditional 510(k) Premarket Notification Submission for the medical device JiveX, release 5.4 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92 ### Submitter | Manufacturer (Owner) | VISUS Health IT GmbH,<br>Gesundheitscampus 15<br>44801 Bochum, Germany | |----------------------|-------------------------------------------------------------------------------------------------------------------------------| | Registration Number | 3007667119 | | Contact Person | Axel Schreiber, MD, PhD<br>Vice President Process & Agile Services<br>Telephone +49 234 93693-0<br>Email: schreiber@visus.com | | Date Prepared | June 9th, 2023 | ### Device | 510(k) Number | K231041 | |----------------------|---------------------------------------------------| | Trade Names | JiveX | | Common Name | Picture Archiving and Communication System (PACS) | | Classification Panel | Radiology | | CFR Section | 21 CFR §892.2050 | | Device Class | Class II | | Product Code | LLZ | ### Predicate Device | Predicate Device | K212321 | |----------------------|---------------------------------------------------| | Trade Names | JiveX | | Common Name | Picture Archiving and Communication System (PACS) | | Classification Panel | Radiology | | CFR Section | 21 CFR §892.2050 | | Device Class | Class II | | Product Code | LLZ | {4}------------------------------------------------ # Device Description JiveX is a PACS software, with a Moderate level of concern. A Communication Server is communicating, storing, converting, and archiving images, documents and signal data via DICOM. HL7 and proprietary interfaces. It also renders images for the web-based image distribution. The fat clients can be used as workstations for medical reading and reporting. They provide extensive functions for image display and image processing. The reporting of digital mammography images is also supported. The web-based clients are mainly intended for image distribution on personal computers and mobile devices. They offer less functions than the fat clients. As far as the functions allow for it, the web clients can also be used for reading and reporting on personal computers. # Indications for Use JiveX is a software only Picture Archiving and Communication System intended to display, process, read, report, communicate, distribute, store, and archive medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals. JiveX also converts case related non-image documents, archives them as DICOM data and serves as a vendor neutral archive. It supports the physician in diagnosis. For primary image diagnosis in Mammography only uncompressed or non-lossy compressed images must be used. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants. Note: Web-based image distribution and mobile device display of mammographic images are not intended for diagnostic purposes. For users in the United States of America: Mobile device display is not intended for diagnostic purposes. Note: the indications for use have not changed compared to the predicate device. ### Comparison of Technological Characteristics The subject device and the predicate device have identical technological characteristics: JiveX is a software only medical device (SaMD). The communication server and the fat clients for radiology reading are implemented in Java. The web clients are implemented in java script / type script, HTML and CSS. The software is run on the customer's own hardware. Clients run on personal computers with MS windows operating systems. Alternatively, clients may be run on a server (-farm) and can be distributed using Citrix. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines. {5}------------------------------------------------ | | Subject Device (K231041) | Predicate Device (K212321) | |------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Name, Release | JiveX 5.4 | JiveX 5.3 | | Manufacturer | VISUS Health IT GmbH | Same | | Indications for use | JiveX is a software only Picture<br>Archiving and Communication<br>System intended to display, process,<br>read, report, communicate,<br>distribute, store, and archive<br>medical data which is available as<br>DICOM or HL7 data, including<br>mammographic images, and bio<br>signals. JiveX also converts case<br>related non-image documents,<br>archives them as DICOM data and<br>serves as a vendor neutral archive.<br>It supports the physician in<br>diagnosis.<br>For primary image diagnosis in<br>Mammography only uncompressed<br>or non-lossy compressed images<br>must be used.<br>Typical users of this system are<br>trained professionals, including but<br>not limited to physicians,<br>radiologists, nurses, medical<br>technicians, and assistants.<br>Note: Web-based image distribution<br>and mobile device display of<br>mammographic images are not<br>intended for diagnostic purposes.<br>For users in the United States of<br>America: Mobile device display is<br>not intended for diagnostic purposes. | Same | | Prescr./OTC | Prescription | Same | | Design /<br>Architecture | client / server | Same | | Software only | Yes. Software as a Medical Device<br>(SaMD) | Same | | Operating<br>systems | Server: Win. 10/11 Srv. 2012/2016/<br>2019/2022; Client: Win. 8.1/10/11;<br>iOS 14/15/16 | Server: Win. 10 Srv. 2012/2016/<br>2019<br>Client: Win. 8.1/10; iOS 13, 14 | | Image and<br>document<br>communication | TCP/IP, DICOM, HL7, IHE XDS,<br>WADO-URI, proprietary internal<br>data transfer protocols, proprietary<br>interface to accept JPEG from an<br>iPhone via web interface | Same | | | Subject Device (K231041) | Predicate Device (K212321) | | Accepted Image<br>Formats | DICOM data + data accepted as non<br>DICOM and converted to DICOM<br>for storage: PDF, JPG, TIFF,<br>standard and proprietary ECG<br>formats | Same | | Supported<br>storage solutions | Local storage on HDD/RAID/DVD,<br>Network: NAS, SAN, long term<br>storage solutions | Same | | Image data<br>compression | JPEG 2000 lossless & lossy, ZIP,<br>LZ4, JPEG lossy for web clients<br>Display as received: JPEG lossless<br>& lossy, RLE, MPEG-2 | Same | | Web based<br>access | Desktop (not intended for<br>mammography reading). Mobile<br>devices (not intended for reading) | Same | | Virtualization &<br>Citrix support | Yes, VMware. Java and web clients<br>can be distributed via Citrix. | Same | | User administr. | Centralized | Same | | Workflow<br>support,<br>RIS/HIS<br>integration | Image Call Up from RIS, Patient<br>Information Reconciliation,<br>Instance Availability, receive<br>documents via HL7 MDM.<br>Supported Standards: HL7, IHE.<br>PACS driven reading workflow. | Same | | IHE XDS | XDS-Consumer, Integrated Source<br>Repository, XDS Repository | Same | | Hardware | Windows based, manufacturer<br>independent server, workstations<br>and client hardware, iPAD | Same | | Image<br>Processing<br>Algorithms | - Zoom, Pan, Rotate, Flip, Magnify<br>- Geometrical Measurements<br>- ROI statistics<br>- Mammography auto shutter<br>- 3D Cross Reference<br>- 4D Navigation<br>- ECG measurements<br>- Interpolation: nearest neighbor, bi-<br>linear, bi-cubic, Lanczos, b-spline<br>- Filters: sharpen, CLAHE<br>- Windowing and LUT mapping | Same | | | Subject Device (K231041) | Predicate Device (K212321) | | Image<br>Processing<br>Algorithms 3D | - MPR, curved MPR<br>- Max. Int. Projection<br>- Min. Int. Projection<br>- Volume Rendering<br>- MIP for tomosynthesis data (not<br>for diagnostic use)<br>- 3D image registration<br>- fused display, SUV calculation | Same | | Hanging<br>protocols | Yes | Same | | Bookmarks | Yes: Captures | Same | #### Tabular comparison of subject and predicate device: {6}------------------------------------------------ {7}------------------------------------------------ Table 1: Tabular comparison of features and specifications ### Performance Data #### Summary of Non-Clinical Testing Verification and validation is done through all development phases and includes - review of requirements, software design, code - Review and acceptance of newly implemented functionality - Daily build of the (intermediate) product and performance of automated tests on unit. . component, x-component and UI level - Verification / validation of "off the shelf software" ● - . Evaluation of selected software functionality with customers - Formal test run of all manual test cases pertaining to new or modified functionality ● - Impact testing for all changes that had been introduced ● - Extensive regression testing. including full regression testing of all inacceptable hazards. ● Based on the non-clinical performance testing the subject device was found to have a safety and effectiveness profile that is similar to the predicate device. ### Conclusions While there are some differences between JiveX 5.4 and its predicate device, these differences are very minor and do not affect device substantial equivalence. JiveX 5.4 has the same basic operational principles and technical characteristics as its predicate device and it functions in the same manner. Additionally, it has the same indications for use. It is as safe, as effective, and performs as well as or better than its predicate device. Therefore, JiveX 5.4 is substantially equivalent to the predicate device cited within this submission