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.

Device Description

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.

AI/ML Overview

The provided text is a 510(k) Summary for the JiveX Picture Archiving and Communication System (PACS). This document does not contain a study that proves the device meets specific acceptance criteria for a diagnostic aid. Instead, it focuses on demonstrating substantial equivalence to a predicate device (JiveX 5.0.6) through a comparison of technological characteristics and intended use.

Therefore, many of the requested items (e.g., specific acceptance criteria, reported performance, sample sizes for test/training sets, expert qualifications, ground truth, MRMC studies, standalone performance) are not present in this type of regulatory submission.

However, I can extract information related to the device and its comparison to the predicate.

Here's what can be extracted from the document:

1. A table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or reported device performance in the context of a diagnostic accuracy study. The acceptance criteria for this submission are based on demonstrating "substantial equivalence" to a predicate device by showing similar intended use and technological characteristics, and that it raises no new issues of safety or effectiveness.

2. Sample size used for the test set and the data provenance:

Not Applicable: This document is a 510(k) summary demonstrating substantial equivalence for a PACS, not a diagnostic aid requiring a clinical performance study with a test set of medical cases. There is no mention of a test set with medical data for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable: As there is no test set for diagnostic performance, there is no mention of experts establishing ground truth for such a set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable: No test set for diagnostic performance is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No: The document does not describe an MRMC study. The JiveX PACS is a software system for archiving, displaying, and processing medical data, not an AI-powered diagnostic aid that assists human readers directly to improve diagnostic accuracy.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No: The JiveX PACS is not an algorithm for standalone diagnostic performance evaluation. Its purpose is to manage and display medical data for human interpretation.

7. The type of ground truth used:

Not Applicable: No ground truth for diagnostic performance is mentioned as this is not a diagnostic performance study.

8. The sample size for the training set:

Not Applicable: The JiveX PACS is a software system, not a machine learning algorithm that requires a training set of medical data for model development.

9. How the ground truth for the training set was established:

Not Applicable: As above, no training set is relevant to this submission.

Summary of Non-Clinical Testing (from the document):

The document mentions "Summary of Non-Clinical Testing" which details the verification and validation process for the software, demonstrating its safety and functionality as a PACS, rather than its diagnostic accuracy:

Review of requirements, software design, code.
Review and acceptance of newly implemented functionality.
Daily build of the product and performance of automated tests (unit, component, x-component, UI level).
Verification/validation of "off the shelf software."
Informal test runs of new manual test cases and 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 introduced.
Extensive regression testing.

Conclusion of the Study (from the document):

The "study" presented in this 510(k) summary is a comparative analysis for substantial equivalence against a predicate device (JiveX 5.0.6, K181964). The conclusion is that JiveX 5.2 is substantially equivalent to the predicate device because:

It has identical intended use.
It shares technological characteristics.
It provides a similar feature set.
It does not raise any new issues of safety and efficacy.

Key Differences and Enhancements of JiveX 5.2 compared to JiveX 5.0.6 (predicate device):

The document highlights enhancements in JiveX 5.2, but these are functional and architectural improvements, not related to diagnostic performance metrics:

Viewing clients: Fused image display, workflow support for manual spine labeling, creation of videos from image series, enhanced performance for loading multi-frame data (especially tomosynthesis).
System Maintenance: Interface for external software for status monitoring, configuration of web-clients for user groups.
Healthcare Content Management (HCM) Enhancements: Quality assurance workflow for documents, communication server acts as an integrated XDS source and repository, JiveX Connect module for patient/referring physician connectivity, supports IHE profile Imaging Object Change Management, interface to a 3rd party web viewer for ECG reading (Cordiana DX).
Technological Characteristics: Updated operating system support for server and client (e.g., Windows Server 2019, iOS 12, 13), enhanced image compression (LZ4), and extended image processing algorithms (e.g., additional interpolation methods like Lanczos, b-spline, and fused display for 3D image processing).

In essence, this document is a regulatory submission for a PACS, focusing on its functional capabilities and safety, rather than its performance in a diagnostic accuracy assessment.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K200703

Device Name JiveX

Indications for Use (Describe)

It supports the physician in diagnosis.

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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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 13-1544801 Bochum, Germany
Registration Number	3007667119
Contact Person	Axel Schreiber, MD, PhDVice President Process & Agile ServicesTelephone +49 234 93693-0Email: 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

It supports the physician in diagnosis.

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.

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
1. 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
1. Enhancements of the Healthcare Content Management (HCM) include:
- o Quality assurance workflow for documents

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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
Operatingsystems	Server: Win. 7/8.1/10 Srv. 2008/2012/2016/2019Client: Win. 7/8.1/10; iOS 12, 13	Server: Win. 7/8.1/10 Srv. 2008/2012/2016Client: 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
ImageProcessingAlgorithms 3D	- MPR, curved MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- MIP for tomosynthesis data (notfor diagnostic use)- 3D image registration- fused display	- MPR, curved MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- MIP for tomosynthesis data (notfor diagnostic use)- 3D image registration
Hangingprotocols	Yes	Yes
Bookmarks	Yes: Captures	Yes: Captures

The following table compares JiveX 5.2 with the predicate device JiveX 5.0.6

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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.

Regulation Number and Section

§ 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).