(27 days)
No
The summary describes a standard PACS system with image processing capabilities, but there is no mention of AI, ML, or related terms. The performance studies focus on software verification and validation, not AI/ML model performance.
No
The device is a Picture Archiving and Communication System (PACS) software used for displaying, processing, managing, and archiving medical data. It supports physicians in diagnosis but does not provide any direct therapeutic intervention or treatment. Its function is data management and display for diagnostic support, not therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states, "It supports the physician in diagnosis" and "For primary image diagnosis in Mammography only uncompressed images must be used."
Yes
The device description explicitly states "JiveX is a software only Picture Archiving and Communication System". While it interacts with hardware like monitors and printers, the device itself is described as solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- JiveX Functionality: JiveX is a Picture Archiving and Communication System (PACS). Its primary function is to display, process, store, and manage medical images and related data. It works with data that has already been generated by other medical devices (like imaging scanners).
- No Sample Analysis: JiveX does not perform any analysis on biological samples taken from a patient. It processes and displays data that is already in a digital format.
While JiveX supports the physician in diagnosis by providing access to and tools for viewing medical images, it does not perform the diagnostic test itself. The diagnostic test is performed by the imaging modality (e.g., MRI, CT, X-ray) or other devices that generate the data that JiveX manages.
N/A
Intended Use / 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 images must be used. Also monitors (displays) and printers which received FDA clearance for Mammography 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.
Product codes
LLZ
Device Description
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. Also monitors (displays) and printers which received FDA clearance for Mammography 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.
JiveX is a PACS software, with a Moderate level of concern.
A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM, HL7 and proprietary interfaces. It also renders images for the webbased image distribution.
The fat clients can be used as workstations for medical reading and reporting. They provide extensive functionality 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 functionality than the fat clients. As far as the functionality allows for it, the web clients can also be used for reading and reporting on personal computers.
JiveX in release 5.0.6 (K181964) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. The most notable enhancements are:
- Viewing clients:
- Fused image display
- Workflow support for manual spine labeling
- Creation of videos from image series and export into the file system
- Improvements for the maintenance of the system
- Interface for external software to retrieve information for status monitoring of the JiveX system
- Configuration of the web-clients for groups of users
- Enhancements of the Healthcare Content Management (HCM) include:
- Quality assurance workflow for documents
- The communication server can act as an integrated XDS source and repository: Incoming data is provided and registered in the document repository and can be registered at an XDS registry. Thus, XDS document consumers can retrieve the data.
- The new Module JiveX Connect allows for connectivity with patients and referring physicians: Patients get temporary access to their studies and can download the data. The access for referring physicians can be integrated into existing portal solutions.
- JiveX supports the IHE profile Imaging Object Change Management as the actor image manager (i.e. it receives and applies rejection notes for withdrawn objects). Withdrawn objects are no longer made available for the reading clients.
- Interface to a 3rd party web viewer for ecg reading. This web viewer (Cordiana DX) is a separate medical device. It can be called up from JiveX within the clinical context. Results are transferred back to JiveX. The correct transfer of the results is ensured by risk control measures.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found. The device is a Picture Archiving and Communication System (PACS) that handles medical data, including mammographic images and bio signals. It displays, processes, reads, reports, communicates, distributes, stores, and archives medical data available as DICOM or HL7 data.
Anatomical Site
Not Found. The device processes "medical data which is available as DICOM or HL7 data, including mammographic images, and bio signals".
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
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 and Human Services logo. To the right of that 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, M.D., Ph.D. Vice President, Process & Agile Services Gesundheitscampus-Sued 15-17 Bochum, 44801 GERMANY
April 14, 2020
Re: K200703
Trade/Device Name: JiveX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 13, 2020 Received: March 18, 2020
Dear Dr. 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 mediation-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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200703
Device Name JiveX
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. Also monitors (displays) and printers which received FDA clearance for Mammography 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.
| 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)
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3
510(k) Summary
K200703
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
General Information
| Manufacturer | VISUS Health IT GmbH,
Gesundheitscampus 13-15
44801 Bochum, Germany |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 3007667119 |
| Contact Person | Axel Schreiber, MD, PhD
Vice President Process & Agile Services
Telephone +49 234 93693-0
Email: schreiber@visus.com |
| Date Prepared | March 31st, 2020 |
| Subject Device | K200703 |
| Trade Names | JiveX |
| Common Name | Picture Archiving and Communication Systems (PACS) |
| Classification Panel | Radiology |
| CFR Section | 21 CFR §892.2050 |
| Device Class | Class II |
| Product Code | LLZ |
| Predicate Device | K181964 |
| Trade Names | JiveX |
| Common Name | Picture Archiving and Communication Systems (PACS) |
| Classification Panel | Radiology |
| CFR Section | 21 CFR §892.2050 |
| Device Class | Class II |
| Product Code | LLZ |
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Safety and Effectiveness Information for Determination of Substantial Equivalence
Device Description and Intended 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. Also monitors (displays) and printers which received FDA clearance for Mammography 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.
JiveX is a PACS software, with a Moderate level of concern.
A Communication Server is communicating, storing, and archiving images, documents and signal data via DICOM, HL7 and proprietary interfaces. It also renders images for the webbased image distribution.
The fat clients can be used as workstations for medical reading and reporting. They provide extensive functionality 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 functionality than the fat clients. As far as the functionality allows for it, the web clients can also be used for reading and reporting on personal computers.
JiveX in release 5.0.6 (K181964) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. The most notable enhancements are:
1. Viewing clients:
- o Fused image display
- o Workflow support for manual spine labeling
- Creation of videos from image series and export into the file system o
-
- Improvements for the maintenance of the system
- Interface for external software to retrieve information for status monitoring of the o JiveX system
- o Configuration of the web-clients for groups of users
-
- Enhancements of the Healthcare Content Management (HCM) include:
- o Quality assurance workflow for documents
5
- The communication server can act as an integrated XDS source and repository: o Incoming data is provided and registered in the document repository and can be registered at an XDS registry. Thus, XDS document consumers can retrieve the data.
- The new Module JiveX Connect allows for connectivity with patients and referring O physicians: Patients get temporary access to their studies and can download the data. The access for referring physicians can be integrated into existing portal solutions.
- JiveX supports the IHE profile Imaging Object Change Management as the actor image O manager (i.e. it receives and applies rejection notes for withdrawn objects). Withdrawn objects are no longer made available for the reading clients.
- Interface to a 3rd party web viewer for ecg reading. This web viewer (Cordiana DX) is O a separate medical device. It can be called up from JiveX within the clinical context. Results are transferred back to JiveX. The correct transfer of the results is ensured by risk control measures.
Technological Characteristics
JiveX is a client server solution that is mainly implemented in Java. Clients run on personal computers with MS windows operating systems. The mobile client runs on iPAD. The server also runs on MS Windows operating systems using server hardware either directly or via virtual machines.
JiveX is a software only medical device.
Discussion of differences
JiveX in release 5.0.6 (K181964) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. There are two main lines of development in JiveX 5.2 compared to JiveX 5.0.6
- Rounding off viewing functionality for the PACS and streamlining existing . workflows. New viewing functionality comprises e.g. image fusion. The preview panel, that gives an overview of loaded studies has been streamlined as well as the dialog to load additional studies. The performance for loading of multi frame data, especially the high resolution tomosynthesis data, has been greatly enhanced.
- The connectivity of the Healthcare Content Management System has been extended . to include communication partners outside the institutions. The system now fits into more customer environments, especially hospital networks.
As a result, JiveX 5.2 is more versatile than JiveX 5.0.6 but basically provides the same services. This goes in-line with JiveX 5.2 having the identical intended use as JiveX 5.0.6.
| JiveX 5.2 | SE: JiveX 5.0.6 | |
|---|---|---|
| 510(k) number | K200703 | K181964 |
| Manufacturer | VISUS Health IT GmbH | VISUS Health IT GmbH |
| Design / | ||
| Architecture | client / server | client / server |
| Operating | ||
| systems | Server: Win. 7/8.1/10 Srv. 2008/ | |
| 2012/2016/2019 | ||
| Client: Win. 7/8.1/10; iOS 12, 13 | Server: Win. 7/8.1/10 Srv. 2008/ | |
| 2012/2016 | ||
| Client: Win. 7/8.1/10; iOS 10, 11 | ||
| JiveX 5.2 | SE: JiveX 5.0.6 | |
| Image and | TCP/IP, DICOM, HL7, IHE XDS, | TCP/IP, DICOM, HL7, IHE XDS, |
| document | WADO-URI, proprietary internal | WADO-URI, proprietary internal |
| communication | image transfer protocol, proprietary | image transfer protocol, proprietary |
| interface to accept JPEG from an | interface to accept JPEG from an | |
| iPhone via web interface | iPhone via web interface | |
| Accepted Image | DICOM data + data accepted as non | DICOM data + data accepted as non |
| Formats | DICOM and converted to DICOM | DICOM and converted to DICOM |
| for storage: PDF, JPG, TIFF, | for storage: PDF, JPG, TIFF, | |
| standard and proprietary ECG | standard and proprietary ECG | |
| formats | formats | |
| Supported | Local storage on HDD/RAID/DVD, | Local storage on HDD/RAID/DVD, |
| storage solutions | Network: NAS, SAN, long term | Network: NAS, SAN, long term |
| storage solutions | storage solutions | |
| Image data | JPEG 2000 lossless & lossy, ZIP, | JPEG 2000 lossless & lossy, ZIP, |
| compression | LZ4, JPEG lossy for web clients | JPEG lossy for web clients |
| Display as received: JPEG lossless | Display as received: JPEG lossless | |
| & lossy, RLE, MPEG-2 | & lossy, RLE, MPEG-2 | |
| Web based | Desktop (not intended for | Desktop (not intended for |
| access | mammography reading). Mobile | mammography reading). Mobile |
| devices (not intended for reading) | devices (not intended for reading) | |
| Virtualization & | Yes, VMware. Java and web clients | Yes, VMware. Java and web clients |
| Citrix support | can be distributed via Citrix. | can be distributed via Citrix. |
| User administr. | Centralized | Centralized |
| RIS/HIS | Image Call Up from RIS, Patient | Image Call Up from RIS, Patient |
| integration | Information Reconciliation, Instance | Information Reconciliation, |
| Availability, receive documents via | Instance Availability, receive | |
| HL7 MDM. Supported Standards: | documents via HL7 MDM. | |
| HL7, IHE | Supported Standards: HL7, IHE | |
| IHE XDS | XDS-Consumer, Integrated Source | XDS-Consumer |
| Repository | ||
| Hardware | Windows based, manufacturer | Windows based, manufacturer |
| independent server, workstations | independent server, workstations | |
| and client hardware, iPAD | and client hardware, iPAD | |
| Image | - Zoom, Pan, Rotate, Flip, Magnify | - Zoom, Pan, Rotate, Flip, Magnify |
| Processing | - Geometrical Measurements | - Geometrical Measurements |
| Algorithms | - ROI statistics | - ROI statistics |
| - Mammography auto shutter | - Mammography auto shutter | |
| - 3D Cross Reference | - 3D Cross Reference | |
| - 4D Navigation | - 4D Navigation | |
| - ECG measurements | - ECG measurements | |
| - Interpolation: nearest neighbor, bi- | - Interpolation: nearest neighbor, bi- | |
| linear, bi-cubic, Lanczos, b-spline | linear | |
| - Filters: sharpen, CLAHE | - Filters: sharpen, CLAHE | |
| - Windowing and LUT mapping | - Windowing and LUT mapping | |
| JiveX 5.2 | SE: JiveX 5.0.6 | |
| Image | ||
| Processing | ||
| Algorithms 3D | - MPR, curved MPR |
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering
- MIP for tomosynthesis data (not
for diagnostic use) - 3D image registration
- fused display | - MPR, curved MPR
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering
- MIP for tomosynthesis data (not
for diagnostic use) - 3D image registration |
| Hanging
protocols | Yes | Yes |
| Bookmarks | Yes: Captures | Yes: Captures |
The following table compares JiveX 5.2 with the predicate device JiveX 5.0.6
6
7
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" ●
- Informal test run of newly developed manual test cases and of functionality on risk ●
- 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 ●
General Safety and Effectiveness Concerns
Using risk analysis potential hazards are identified. Potential hazards are controlled with design measures in the software and with verification and validation testing. The device labelling contains instructions for use and any necessary cautions and warnings for safe and effective use.
Conclusion
JiveX is substantially equivalent to the following commercially available device:
| Manufacturer: | VISUS Health IT GmbH |
|---|---|
| Trade Name: | JiveX 5.0.6 |
| 510(k) number: | K181964 |
JiveX described in this 510(k) has the identical intended use, shares the technological characteristics and provides a similar feature set as the predicate device.
JiveX does not raise any new issues of safety and efficacy.