JiveX

K142750 · Visus Technology Transfer GmbH · LLZ · Jun 26, 2015 · Radiology

Device Facts

• Record ID: K142750
• Device Name: JiveX
• Applicant: Visus Technology Transfer GmbH
• Product Code: LLZ · Radiology
• Decision Date: Jun 26, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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 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.

Device Story

JiveX is a software-only PACS; functions as a vendor-neutral archive for DICOM/HL7 medical data, including mammographic images and bio signals. Input data is stored, processed, and rendered for clinical review. System comprises a communication server and client workstations (fat clients for diagnostic reading; web/mobile clients for distribution). Physicians and technicians use fat clients on Windows PCs for primary diagnosis; requires FDA-cleared mammography monitors for mammographic images. Web/mobile clients are for distribution only, not diagnosis. Device supports clinical decision-making by providing image manipulation, measurement, and visualization tools (e.g., MPR, volume rendering, 3D registration). Benefits include centralized access to patient data, improved workflow efficiency, and diagnostic support through standardized image processing.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including requirements review, software design/code review, automated unit/component/UI testing, informal/formal manual test runs, and impact testing for changes. Risk analysis was performed to identify and control potential hazards.

Technological Characteristics

Software-only client/server architecture implemented in Java. Server runs on MS Windows (Server 2003/2008/2012); clients run on MS Windows (XP/7/8.1) or iPad. Connectivity via TCP/IP, DICOM, and HL7. Supports virtualization (VMware). Image processing includes zoom, pan, rotate, flip, magnify, geometrical measurements, ROI statistics, mammography auto-shutter, 3D cross-reference, ECG measurements, interpolation (nearest neighbor, bilinear), filters (sharpen, CLAHE), and windowing/LUT mapping. 3D capabilities include MPR, Max/Min Intensity Projection, Volume Rendering, and 3D image registration.

Indications for Use

Indicated for trained professionals, including physicians, radiologists, nurses, medical technicians, and assistants, to display, process, read, report, communicate, distribute, store, and archive medical data (DICOM/HL7), including mammographic images and bio signals. Web-based and mobile display are not for diagnostic use.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• JiveX (K053183)
• syngo.plaza VB10A (K132532)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <label><input checked="true" type="checkbox"/> Commercial and/or Industrial PPE Vehicle Registration</label> | <label><input type="checkbox"/> Non-Commercial and/or Non-Industrial PPE Vehicle Registration</label> |
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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,<br>Universitätsstr. 136<br>44799 Bochum, Germany |
|----------------------|----------------------------------------------------------------------------------------------------------|
| Registration Number | 3007667119 |
| Contact Person | Axel Schreiber, MD, PhD<br>Vice President R&D<br>Telephone [phone]<br>Email: [e-mail] |
| 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

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.

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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 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 with the predicate devices syngo.plaza and JiveX

| | SE: syngo.plaza | SE: JiveX | JiveX |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | K132532 | K053183 | |
| | SIEMENS AG,<br>Medical Solutions | VISUS Technology<br>Transfer GmbH | VISUS Technology<br>Transfer GmbH |
| Design /<br>Architecture | client / server | client / server | client / server |
| Operating<br>systems | MS Windows | Server: Win 2000/XP,<br>Solaris, Linux 2<br>Client: Win 9x/ME/2000/<br>NT/XP, Solaris, Linux 2 | Server: Win. XP/7/8.1/<br>Srv. 2003/2008/ 2012<br>Client: Win. XP/7/8.1 |
| Image<br>communication | TCP/IP, DICOM,<br>proprietary internal<br>image transfer protocol | TCP/IP, DICOM,<br>proprietary internal<br>image transfer protocol | TCP/IP, DICOM,<br>proprietary internal<br>image transfer protocol |
| Accepted Image<br>Formats | DICOM data | DICOM image data | DICOM data + data<br>accepted as non DICOM<br>and converted to<br>DICOM for storage:<br>PDF, standard and<br>proprietary ECG formats |
| | SE: syngo.plaza | SE: JiveX | JiveX |
| Supported storage<br>solutions | Internal storage on<br>RAID. External storage<br>on NAS and any<br>DICOM long term<br>archive | Local storage on<br>HDD/RAID/DVD,<br>Network: SAN, HSM,<br>long term storage<br>solutions | Local storage on<br>HDD/RAID/DVD,<br>Network: NAS, SAN,<br>long term storage<br>solutions |
| Image data<br>compression | JPEG lossless, JPEG<br>2000 lossless. Display<br>as received: JPEG<br>lossy, RLE, MPEG-2 | JPEG 2000 lossless &<br>lossy, ZIP, JPEG lossy<br>for web clients<br>Display as received:<br>JPEG lossless & lossy,<br>RLE, MPEG-2 | JPEG 2000 lossless &<br>lossy, ZIP, JPEG lossy<br>for web clients<br>Display as received:<br>JPEG lossless & lossy,<br>RLE, MPEG-2 |
| Web based access | Yes | Yes | Desktop & mobile<br>devices (not intended for<br>reading) |
| Virtualization | Yes, VMware | No | Yes, VMware |
| User administr. | Centralized | Centralized | Centralized |
| RIS/HIS<br>integration | Via standards HL7 and<br>DICOM, aligned to<br>IHE Framework | Image Call Up from RIS,<br>Patient Information<br>Reconciliation, Instance<br>Availability. Supported<br>Standards: HL7, IHE | Image Call Up from<br>RIS, Patient Information<br>Reconciliation, Instance<br>Availability. Supported<br>Standards: HL7, IHE |
| Hardware | Windows based,<br>manufacturer<br>independent<br>workstations | Windows/Linux/Solaris<br>based, manufacturer<br>independent hardware | Windows based,<br>manufacturer<br>independent server,<br>workstations and client<br>hardware, iPAD |
| Image Processing<br>Algorithms | - Zoom, Pan, Rotate,<br>Flip<br>- Geometrical<br>Measurements<br>- ROI statistics<br>- Region Calculation<br>for Mammography<br>- 3D Cross Reference | - Zoom, Pan, Rotate,<br>Flip, Magnify<br>- Geometrical Measure-<br>ments<br>- ROI statistics | - Zoom, Pan, Rotate,<br>Flip, Magnify<br>- Geometrical Measure-<br>ments<br>- ROI statistics<br>- Mammography auto<br>shutter<br>- 3D Cross Reference<br>- ECG measurements |
| | - Interpolation: nearest<br>neighbor, bilinear & bi-<br>cubic<br>- Windowing and LUT<br>mapping<br>- Image subtraction for<br>Digital Subtraction<br>Angiography | - Interpolation: nearest<br>neighbor, bilinear<br>- Filters: sharpen,<br>- Windowing and LUT<br>mapping | - Interpolation: nearest<br>neighbor, bilinear<br>- Filters: sharpen,<br>CLAHE<br>- Windowing and LUT<br>mapping |
| | SE: syngo.plaza | SE: JiveX | JiveX |
| Image Processing<br>Algorithms 3D | Voxar module:<br>- MPR<br>- Max. Int. Projection<br>- Min. Int. Projection<br>- Volume Rendering<br>- Shaded Surface<br>Display | Voxar module:<br>- MPR<br>- Max. Int. Projection<br>- Min. Int. Projection<br>- Volume Rendering | - MPR<br>- Max. Int. Projection<br>- Min. Int. Projection<br>- Volume Rendering<br>- MIP for tomosynthesis<br>data (not for diagnostic<br>use)<br>- 3D image registration |
| Hanging<br>protocols | Yes | Yes | Yes |
| Bookmarks | Yes. Findings<br>Navigator | 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.