(275 days)
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No
The document describes a standard PACS system with image processing capabilities but makes no mention of AI or ML technologies.
No
Explanation: The device is a Picture Archiving and Communication System (PACS) software that displays, processes, stores, and archives medical data to support physician diagnosis. It does not provide any treatment or therapy.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections both explicitly state, "It supports the physician in diagnosis." Additionally, it mentions "For primary image diagnosis in Mammography..." and "When using FDA cleared monitors diagnosis on digital mammography images is possible."
Yes
The device description explicitly states "JiveX is a software only medical device."
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The description of JiveX clearly states its purpose is to display, process, store, and archive medical data, primarily images (DICOM) and bio signals. It does not mention analyzing biological samples like blood, urine, or tissue.
- The intended use is for image diagnosis. The document explicitly states that JiveX supports the physician in diagnosis, particularly through the use of medical images. This is a key characteristic of medical imaging software, not IVDs.
- The inputs are imaging and bio signal data. The inputs are described as DICOM or HL7 data, including mammographic images and bio signals. These are not biological specimens.
Therefore, JiveX falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
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.
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.
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
- Zoom, Pan, Rotate, Flip
- Geometrical Measurements
- ROI statistics
- Region Calculation for Mammography
- 3D Cross Reference
- Interpolation: nearest neighbor, bilinear & bi-cubic
- Windowing and LUT mapping
- Image subtraction for Digital Subtraction Angiography
- Sharpen filters
- CLAHE
- MPR
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering
- Shaded Surface Display
- MIP for tomosynthesis data
- 3D image registration
- Mammography auto shutter
- ECG measurements
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
Typical users of this system are trained professionals, including but not limited to physicians, radioal technicians, and assistants.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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).
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§ 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).
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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.
1
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)
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) |
|---|
| ------------------------------------------------- |
| Commercial and/or Industrial PPE Vehicle Registration | Non-Commercial and/or Non-Industrial PPE Vehicle Registration |
|---|---|
| -------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------- |
|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
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 | 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.
4
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, | |||
| Medical Solutions | VISUS Technology | ||
| Transfer GmbH | VISUS Technology | ||
| Transfer GmbH | |||
| Design / | |||
| Architecture | client / server | client / server | client / server |
| Operating | |||
| systems | MS Windows | Server: Win 2000/XP, | |
| Solaris, Linux 2 | |||
| Client: Win 9x/ME/2000/ | |||
| NT/XP, Solaris, Linux 2 | 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 | TCP/IP, DICOM, | ||
| proprietary internal | |||
| image transfer protocol | TCP/IP, DICOM, | ||
| proprietary internal | |||
| image transfer protocol | |||
| Accepted Image | |||
| Formats | DICOM data | DICOM image data | DICOM data + data |
| accepted as non DICOM | |||
| and converted to | |||
| DICOM for storage: | |||
| PDF, standard and | |||
| proprietary ECG formats | |||
| SE: syngo.plaza | SE: JiveX | JiveX | |
| Supported storage | |||
| solutions | Internal storage on | ||
| RAID. External storage | |||
| on NAS and any | |||
| DICOM long term | |||
| archive | Local storage on | ||
| HDD/RAID/DVD, | |||
| Network: SAN, HSM, | |||
| long term storage | |||
| solutions | Local storage on | ||
| HDD/RAID/DVD, | |||
| Network: NAS, SAN, | |||
| long term storage | |||
| solutions | |||
| Image data | |||
| compression | JPEG lossless, JPEG | ||
| 2000 lossless. Display | |||
| as received: JPEG | |||
| lossy, RLE, MPEG-2 | 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 | Yes | Yes | Desktop & mobile |
| devices (not intended for | |||
| reading) | |||
| Virtualization | Yes, VMware | No | Yes, VMware |
| User administr. | Centralized | Centralized | Centralized |
| RIS/HIS | |||
| integration | Via standards HL7 and | ||
| DICOM, aligned to | |||
| IHE Framework | Image Call Up from RIS, | ||
| Patient Information | |||
| Reconciliation, Instance | |||
| Availability. Supported | |||
| Standards: HL7, IHE | Image Call Up from | ||
| RIS, Patient Information | |||
| Reconciliation, Instance | |||
| Availability. Supported | |||
| Standards: HL7, IHE | |||
| Hardware | Windows based, | ||
| manufacturer | |||
| independent | |||
| workstations | Windows/Linux/Solaris | ||
| based, manufacturer | |||
| independent hardware | Windows based, | ||
| manufacturer | |||
| independent server, | |||
| workstations and client | |||
| hardware, iPAD | |||
| Image Processing | |||
| Algorithms | - Zoom, Pan, Rotate, | ||
| Flip |
- Geometrical
Measurements - ROI statistics
- Region Calculation
for 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 auto
shutter - 3D Cross Reference
- ECG measurements |
| | - Interpolation: nearest
neighbor, bilinear & bi-
cubic - Windowing and LUT
mapping - Image subtraction for
Digital Subtraction
Angiography | - Interpolation: nearest
neighbor, bilinear - Filters: sharpen,
- Windowing and LUT
mapping | - Interpolation: nearest
neighbor, bilinear - Filters: sharpen,
CLAHE - Windowing and LUT
mapping |
| | SE: syngo.plaza | SE: JiveX | JiveX |
| Image Processing
Algorithms 3D | Voxar module: - MPR
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering
- Shaded Surface
Display | Voxar module: - MPR
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering | - MPR
- Max. Int. Projection
- Min. Int. Projection
- Volume Rendering
- MIP for tomosynthesis
data (not for diagnostic
use) - 3D image registration |
| Hanging
protocols | Yes | Yes | Yes |
| Bookmarks | Yes. Findings
Navigator | No | Yes: Captures |
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TRADITIONAL 510(k) PREMARKET NOTIFICATION SUBMISSION
6
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.