Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard PACS system with image processing capabilities but makes no mention of AI, ML, deep learning, or any related technologies.

Therapeutic

No

Explanation: The device is a Picture Archiving and Communication System (PACS) software designed to display, process, store, and archive medical data, and support physicians in diagnosis. It does not actively treat or alleviate a disease, nor does it restore, modify, or correct body function; therefore, it is not a therapeutic device.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states, "It supports the physician in diagnosis," and specifies, "For primary image diagnosis in Mammography only uncompressed images must be used." The "Device Description" also mentions "medical diagnostic and viewing workplaces" and that "diagnosis on digital mammography images is possible."

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "JiveX is a software only medical device." While it interacts with hardware like monitors, servers, and mobile devices, the submission clearly defines the regulated component as the software itself.

IVD (In Vitro Diagnostic)

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, such as 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 (DICOM, HL7, etc.). It supports physicians in diagnosis by providing access to and tools for viewing and manipulating these images.
Lack of Sample Analysis: JiveX does not perform any analysis on biological samples taken from a patient. It works with pre-existing medical data, primarily images.

Therefore, while JiveX is a medical device that supports diagnosis, it does so by managing and presenting imaging data, not by performing in vitro tests on biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

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.

Product codes (comma separated list FDA assigned to the subject device)

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.

A Communication Server is communicating, storing, and archiving DICOM data and also renders images for the web based image distribution.

Fat clients, rich in rendering and image manipulation functionality, are medical diagnostic and viewing workplaces. When using FDA cleared monitors diagnosis on digital mammography images is possible.

The web based clients are intended for image distribution on either personal computers or mobile devices.

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants.
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K142750

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or movement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 16, 2016

VISUS Technology Transfer GmbH % Axel Schreiber. M.D., Ph.D. Vice President Research and Development Universitaetsstrasse 136 Bochum, 44799 GERMANY

Re: K162008

Trade/Device Name: JiveX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 14, 2016 Received: July 20, 2016

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. 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.

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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

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Indications for Use

510(k) Number (if known) K162008

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, radioal technicians, and assistants.

Note: Web-based image distribution and mobile device display are 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."

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510(k) Summary

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 Technology Transfer GmbH,
Universitätsstr. 136
44799 Bochum, Germany |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Registration Number | 3007667119 |
| Contact Person | Axel Schreiber, MD, PhD
Vice President R&D
Telephone +49 234 93693-0
Email: schreiber@visus.com |
| Date Prepared | September 16th, 2016 |
| 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 |

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.

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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 are not intended for diagnostic purposes.

A Communication Server is communicating, storing, and archiving DICOM data and also renders images for the web based image distribution.

Fat clients, rich in rendering and image manipulation functionality, are medical diagnostic and viewing workplaces. When using FDA cleared monitors diagnosis on digital mammography images is possible.

The web based clients are intended for image distribution on either personal computers or mobile devices.

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.

	The following table compares JiveX 5.0 with the predicate devices JiveX 4.7
--	-----------------------------------------------------------------------------

	JiveX 5.0	SE: JiveX 4.7
510(k) number	K162008	K142750
Manufacturer	VISUS Technology Transfer GmbH	VISUS Technology Transfer GmbH
Design/Architect.	client / server	client / server
Operating
systems	Server: Win. 7/8.1/10 Srv. 2008/
2012
Client: Win. 7/8.1/10	Server: Win. XP/7/8.1/ Srv.
2003/2008/ 2012
Client: Win. XP/7/8.1
Image
communication	TCP/IP, DICOM, proprietary
internal image transfer protocol,
proprietary interface to accept JPEG
from an iPhone via web interface	TCP/IP, DICOM, proprietary
internal image transfer protocol
Accepted Image
Formats	DICOM data + data accepted as non
DICOM and converted to DICOM
for storage: PDF, standard and
proprietary ECG formats	DICOM data + data accepted as non
DICOM and converted to DICOM
for storage: PDF, standard and
proprietary ECG formats
Supported storage
solutions	Local storage on HDD/RAID/DVD,
Network: NAS, SAN, long term
storage solutions	Local storage on HDD/RAID/DVD,
Network: NAS, SAN, long term
storage solutions
Image data
compression	JPEG 2000 lossless & lossy, ZIP,
JPEG lossy for web clients
Display as received: JPEG lossless &
lossy, RLE, MPEG-2	JPEG 2000 lossless & lossy, ZIP,
JPEG lossy for web clients
Display as received: JPEG lossless
& lossy, RLE, MPEG-2
Web based access	Desktop & mobile devices (not
intended for reading)	Desktop & mobile devices (not
intended for reading)
Virtualization &
Citrix support	Yes, VMware. Java and web clients
can be distributed via Citrix.	Yes, VMware

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	JiveX 5.0	SE: JiveX 4.7
User administr.	Centralized	Centralized
RIS/HIS
integration	Image Call Up from RIS, Patient
Information Reconciliation, Instance
Availability, receive documents via
HL7 MDM. Supported Standards:
HL7, IHE	Image Call Up from RIS, Patient
Information Reconciliation, Instance
Availability. Supported Standards:
HL7, IHE
IHE XDS	XDS-Consumer	no
Hardware	Windows based, manufacturer
independent server, workstations and
client hardware, iPAD	Windows based, manufacturer
independent server, workstations
and client hardware, iPAD
Image Processing
Algorithms	- Zoom, Pan, Rotate, Flip, Magnify

Geometrical Measurements
ROI statistics
Mammography auto shutter
3D Cross Reference
ECG measurements
Interpolation: nearest neighbor,
bilinear
Filters: sharpen, CLAHE
Windowing and LUT mapping | - Zoom, Pan, Rotate, Flip, Magnify
Geometrical Measurements
ROI statistics
Mammography auto shutter
3D Cross Reference
ECG measurements
Interpolation: nearest neighbor,
bilinear
Filters: sharpen, CLAHE
Windowing and LUT mapping |
| Image Processing
Algorithms 3D | - MPR
Max. Int. Projection
Min. Int. Projection
Volume Rendering
MIP for tomosynthesis data (not for
diagnostic use)
3D image registration | - 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 |

Discussion of differences and explanation of important differences

JiveX in release 4.7 (K142750) is a predecessor of the device. Functionality has been enhanced and ported to current operating systems and hardware. The most notable enhancements are:

1. The JiveX review client based clients and the web clients can be distributed within the institution via Citrix.
1. New module JiveX Photo Documentation Gateway that provides a proprietary interface to mobile devices. An iPhone App e.g. can query patient demographic information and can send back JPEG images together with meta data including the patient demographic information. JiveX converts these images into DICOM images and imports them.
1. The module JiveX HL7 Gateway has been enhanced with the possibility to receive documents from an information system via HL7 MDM. Also the JiveX HL7 Gateway provides patient demographic information via the IHE PDQm profile. In order to better fit into multi sited institutions and regional healthcare networks the HL7 Gateway supports the issuer of patient ID (assigning authority).

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1. New module "JiveX XDS Consumer" that allows to query XDS registries and retrieve documents and images from an XDS repository or XDS source respectively. Plain text, PDF and CDA documents can be displayed.
  There are three main lines of development in JiveX 5.0 compared to JiveX 4.7.
Extend the integration of JiyeX into the customers IT environment. The four bullet . points mentioned above are accompanied by some smaller enhancements (e.g. improved handling of JPEG and PDF from mass-scanning, automated import of DICOM files from the file system, sending notification to the RIS also for archived or deleted studies)
. The complete user interface has been face lifted. The focus was on unifying the existing interfaces and giving a unique color scheme and graphical language. At the same time the pre-existing user interaction concepts have been maintained.
. Refactorings to improve uptime and data consistency: e.g. allowing services of the communication server to be restarted at runtime, replacing the data base engine, providing automated detection and repair functionality for inconsistent data (which was done manual before)

As a result JiveX 5.0 addresses more customer IT environments than JiveX 4.7 but basically provides the same services. This goes in-line with JiveX 5.0 having the same intended use as JiveX 4.7.

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
Additional impact testing for all changes after start of the formal test run

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.

Substantial Equivalence

JiveX is substantially equivalent to the following commercially available devices:

Manufacturer	Trade Name	510(k) number
VISUS Technology Transfer GmbH	JiveX 4.7	K142750

JiveX described in this 510(k) has an equivalent intended use, shares the technological characteristics and provides a similar feature set as the predicate devices.

JiveX does not raise any new issues of safety and efficacy.