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.

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

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.

AI/ML Overview

The provided text does not contain specific acceptance criteria or details of a study designed to prove the device meets said criteria.

The document is a 510(k) premarket notification for a Picture Archiving and Communication System (PACS) named JiveX. It primarily focuses on establishing substantial equivalence to previously cleared predicate devices. While it mentions "Verification and validation is done through all development phases" and lists various testing activities (review of requirements, software design, automated tests, manual test cases, evaluation with customers, impact testing), it does not provide quantitative acceptance criteria or a detailed study report with results for the JiveX system itself.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details.

The document indicates that JiveX is considered substantially equivalent to the following:

Predicate Device 1: JiveX (K053183) by VISUS Technology Transfer GmbH
Predicate Device 2: syngo.plaza VB10A (K132532) by SIEMENS AG, Medical Solutions

The rationale for substantial equivalence is based on:

Equivalent intended use
Shared technological characteristics
Similar feature set

The submission states that JiveX "does not raise any new issues of safety and efficacy," implying that the safety and effectiveness are supported by the predicate devices and the general development and testing processes mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

June 26, 2015

VISUS Technology Transfer GmbH % Mr. Axel Schreiber Vice President Research and Development Universitatsstrasse 136 Bochum 44797 GERMANY

Re: K142750

Trade/Device Name: JiveX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 11, 2015 Received: June 15, 2015

Dear Mr. 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,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K142750

Device Name JiveX

Indications for Use (Describe)

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)
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Commercial and/or Industrial PPE Vehicle Registration	Non-Commercial and/or Non-Industrial PPE Vehicle Registration
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|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

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. 13644799 Bochum, Germany
Registration Number	3007667119
Contact Person	Axel Schreiber, MD, PhDVice President R&DTelephone +49 234 93693-0Email: schreiber@visus.com
Date Prepared	June 03, 2015
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

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It supports the physician in diagnosis.

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.

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

Technological Characteristics

JiveX is a software only medical device.

The following table compares JiveX with the predicate devices syngo.plaza and JiveX

	SE: syngo.plaza	SE: JiveX	JiveX
510(k) number	K132532	K053183
	SIEMENS AG,Medical Solutions	VISUS TechnologyTransfer GmbH	VISUS TechnologyTransfer GmbH
Design /Architecture	client / server	client / server	client / server
Operatingsystems	MS Windows	Server: Win 2000/XP,Solaris, Linux 2Client: Win 9x/ME/2000/NT/XP, Solaris, Linux 2	Server: Win. XP/7/8.1/Srv. 2003/2008/ 2012Client: Win. XP/7/8.1
Imagecommunication	TCP/IP, DICOM,proprietary internalimage transfer protocol	TCP/IP, DICOM,proprietary internalimage transfer protocol	TCP/IP, DICOM,proprietary internalimage transfer protocol
Accepted ImageFormats	DICOM data	DICOM image data	DICOM data + dataaccepted as non DICOMand converted toDICOM for storage:PDF, standard andproprietary ECG formats
	SE: syngo.plaza	SE: JiveX	JiveX
Supported storagesolutions	Internal storage onRAID. External storageon NAS and anyDICOM long termarchive	Local storage onHDD/RAID/DVD,Network: SAN, HSM,long term storagesolutions	Local storage onHDD/RAID/DVD,Network: NAS, SAN,long term storagesolutions
Image datacompression	JPEG lossless, JPEG2000 lossless. Displayas received: JPEGlossy, RLE, MPEG-2	JPEG 2000 lossless &lossy, ZIP, JPEG lossyfor web clientsDisplay as received:JPEG lossless & lossy,RLE, MPEG-2	JPEG 2000 lossless &lossy, ZIP, JPEG lossyfor web clientsDisplay as received:JPEG lossless & lossy,RLE, MPEG-2
Web based access	Yes	Yes	Desktop & mobiledevices (not intended forreading)
Virtualization	Yes, VMware	No	Yes, VMware
User administr.	Centralized	Centralized	Centralized
RIS/HISintegration	Via standards HL7 andDICOM, aligned toIHE Framework	Image Call Up from RIS,Patient InformationReconciliation, InstanceAvailability. SupportedStandards: HL7, IHE	Image Call Up fromRIS, Patient InformationReconciliation, InstanceAvailability. SupportedStandards: HL7, IHE
Hardware	Windows based,manufacturerindependentworkstations	Windows/Linux/Solarisbased, manufacturerindependent hardware	Windows based,manufacturerindependent server,workstations and clienthardware, iPAD
Image ProcessingAlgorithms	- Zoom, Pan, Rotate,Flip- GeometricalMeasurements- ROI statistics- Region Calculationfor Mammography- 3D Cross Reference	- Zoom, Pan, Rotate,Flip, Magnify- Geometrical Measure-ments- ROI statistics	- Zoom, Pan, Rotate,Flip, Magnify- Geometrical Measure-ments- ROI statistics- Mammography autoshutter- 3D Cross Reference- ECG measurements
	- Interpolation: nearestneighbor, bilinear & bi-cubic- Windowing and LUTmapping- Image subtraction forDigital SubtractionAngiography	- Interpolation: nearestneighbor, bilinear- Filters: sharpen,- Windowing and LUTmapping	- Interpolation: nearestneighbor, bilinear- Filters: sharpen,CLAHE- Windowing and LUTmapping
	SE: syngo.plaza	SE: JiveX	JiveX
Image ProcessingAlgorithms 3D	Voxar module:- MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- Shaded SurfaceDisplay	Voxar module:- MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering	- MPR- Max. Int. Projection- Min. Int. Projection- Volume Rendering- MIP for tomosynthesisdata (not for diagnosticuse)- 3D image registration
Hangingprotocols	Yes	Yes	Yes
Bookmarks	Yes. FindingsNavigator	No	Yes: Captures

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TRADITIONAL 510(k) PREMARKET NOTIFICATION SUBMISSION

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TRADITIONAL 510(k) PREMARKET NOTIFICATION SUBMISSION

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	K053183
SIEMENS AG, Medical Solutions	syngo.plaza VB10A	K132532

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.

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).