IMAGE-ARENA APPLICATIONS
Device Facts
| Record ID | K083348 |
|---|---|
| Device Name | IMAGE-ARENA APPLICATIONS |
| Applicant | Tomtec Imaging Systems GmbH |
| Product Code | LLZ · Radiology |
| Decision Date | Dec 23, 2008 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The Image-Arena software tool package is intended to retrieve, store, analyze and report digital ultrasound and XA studies. The Image-Arena platform is based on a SQL - database and is intended as an image management system for images of the modalities US and XA. The Image-Arena software can import certain digital 2D or 3D image file formats of the modalities US and XA. The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology.
Device Story
Image-Arena Platform 4.0 is a modular software suite for analysis, documentation, and archiving of ultrasound (US) and X-ray angiography (XA) studies. It functions as a common interface platform for TomTec and third-party clinical application packages (CAPs) via a generic interface. The system imports digital 2D, 3D, and 4D image formats (DICOM, HPSONOS, GE, TomTec) into a central SQL database. Operated by physicians or researchers in hospitals/clinics on standalone or networked workstations, it provides tools for offline measurements, report generation, and data management. Output includes processed images, measurements, and clinical reports, which assist clinicians in diagnostic decision-making for cardiac conditions. The modular design allows custom-tailored solutions for routine or research use.
Clinical Evidence
No clinical data provided. Performance supported by internal company procedures, including module and system-level software testing and validation conducted according to pre-established protocols.
Technological Characteristics
Software-based image management system; runs on Intel Pentium-based hardware with Windows XP Professional or Vista. Supports DICOM and proprietary file formats. Modular architecture with SQL database backend. Connectivity via networked multi-system installations or standalone workstations. No specific hardware materials or sterilization required as it is a software-only device.
Indications for Use
Indicated for clinical diagnosis and data management in cardiology. Used in physician practices and hospitals for research and routine clinical workflows. Echo-Com module indicated for stress echo examinations in patients with suspected arterial blockage. Image-Com module indicated for review, measurement, and reporting of cardiac US and XA DICOM data.
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
Submission Summary (Full Text)
{0}------------------------------------------------
K083348
Image /page/0/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
Sep 30", 2008
# Traditional 510(k) Summary
DEC 2 3 2008
Image-Arena Platform 4.0 / Server Manager 4.0 Echo-Com 4.0 Image-Com 4.0
# Owner's Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
# Contact Person
Inge Scheidt QM & RA Officer Phone ++49-89-32175-515 Fax ++49-89-32175-750
### Common, Classification & Proprietary Names
Common Name: Various Image Analysis System Software Classification Name: Picture archiving and communications system
Proprietary Name(s): Image-Arena Applications
> Image-Arena Platform 4.0 / Server Manager 4.0 Echo-Com 4.0 Image-Com 4.0
Image /page/0/Picture/14 description: The image shows a series of black, right-angle shapes arranged in a curved line. The shapes are oriented in different directions, creating a dynamic and somewhat chaotic pattern. The overall impression is that of a stylized, abstract design.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" are the words "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used on the company's website and marketing materials.
# Predicate Device
TomTec
Philips Medical Systems North America Co.
K071232
K061995
Image-Arena Applications Research-Arena Applications Xcelera
# Device Description
The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Vista™ Operating System standards.
It is suited as stand-alone workstations as well as networked multi-system installations. Image Arena is developed as a common interface platform for TomTec and 3rd party clinical application packages (CAPs) that can be connected to Image-Arena through the 30 party Interface. The different application packages have all access to the central database and can be enabled on a modular basis thus allowing custom tailored solutions of Image-Arena.
The Image-Arena Application is a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions and Xray angiography studies.
The Image-Arena Application software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product line Image-Arena Applications and Research-Arena Applications ( K071232) and Xcelera (K061995). The different modules can be combined on the demand of the users to fulfil the requirements of a clinical researcher or routine oriented physician.
The Image-Arena Application offers features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, GE-, TomTec- file formats) in one system, thus making image analysis independent of the ultrasound-device or other imaging devices used.
Offline measurements, documentation in standard report forms, the possibility to implement user-defined report templates and instant access to the stored data through digital archiving make it a flexible tool for image analysis and storage of different imaging modalities data including 2D, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) wave Doppler Mode, Power Amplitude Doppler Mode, Color Doppler Mode, Doppler Tissue Imaging and 3D/4D imaging modes.
Image /page/1/Picture/14 description: The image contains a series of black, angled lines arranged in a slightly curved formation. The lines are oriented in a way that they resemble arrows or chevrons, and they appear to be overlapping or closely spaced together. The overall impression is a pattern of directional shapes that create a sense of movement or flow.
summary
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" are the words "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
## Intended Use
The Image-Arena software tool package is intended to retrieve, store, analyze and report digital ultrasound and XA studies. The Image-Arena platform is based on a \$QL - database and is intended as an image management system for images of the modalities US and XA.
The Image-Arena software can import certain digital 2D or 3D image file formats of the modalities US and XA.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology.
### Technological Characteristics Comparison
The Image-Arena Applications software tool package is modular structured and consists of different software modules, combining the advantages of the previously FDA cleared software products:
K071232 Image-Arena Applications Research-Arena Applications K061995 Xcelera, Philips Medical Systems, North America Co.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white, with the word "Tomtec" in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
#### Predicate Devices:
Image /page/3/Figure/2 description: The image shows a diagram of the TomTec Image-Arena and Research-Arena applications. The diagram is split into two sections, with the top section showing the Image-Arena Platform 3.0 and Research-Arena Platform 2.0, and the bottom section showing the Image-Arena Platform 4.0. The diagram also shows the Generic Interface, Database and Data Management System, and the different applications that are available for each platform. The predicate devices K071232 and K061995 are also listed.
applications
> > >
summary
page 4 of 5
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white, with the word "TOMTEC" in large, bold letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller letters. The logo is simple and modern, and it is likely used to represent the company's brand.
# Discussion according non-clinical performance data testing
Testing was performed according to internal company procedures. Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted. Test results were reviewed by designated technical professionals before software proceeded to release.
### Discussion according clinical performance data testing
The overall product concept was clinically accepted and the clinical test results support the conclusion that the device is as safe as effective, and performs as well as or better than the predicate device.
# Test Conclusions of non-clinical and clinical performance data
Test results support the conclusion, that the device is as safe as effective, and performs as well as or better than the predicate device.
Munich, Sep 30th, 2008
J. I. Gesell
Inae Scheidt QM & RA Officer
{5}------------------------------------------------
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to promote health, well-being, and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
# DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2008
Ms. Inge Scheidt TomTec Imaging Systems, GmbH Edisonstrasse 6 D-85716 Unterschleissheim GERMANY
Re: K083348
Trade/Device Name: Image-Arena Applications (Image-Arena Platform 4.0 / Server Manager 4.0/ Echo-Com 4.0/ Image-Com 4.0)
Regulation Number: 21 CFR 892.2050
Regulation Name: Picture archiving and communications system Regulatory Class: Class II
Product Code: LLZ
Dated: October 30, 2008 Received: November 13, 2008
Dear Ms. Scheidt:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
{6}------------------------------------------------
### Page 2
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
loque In Whang
Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{7}------------------------------------------------
# Indications for Use
510(k) Number (if known):
Device Name:
Image-Arena Applications Image-Arena Platform 4.0 / Server Manager 4.0 Echo-Com 4.0 Image-Com 4.0
Indications for Use:
The Image-Arena Platform Software is intended to serve as a data management platform for clinical application packages. It provides information that is used for clinical diagnosis purposes.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for research and routine use in both physician practices and hospitals. It is intended as a general purpose digital medical image processing tool for cardiology.
As the Image-Arena Applications software tool package is modular structured. clinical applications packages with different indications for use can be connected.
Echo-Com software is intended to serve as a versatile solution for Stress Echo examinations in patients who may not be receiving enough blood or oxygen because of blocked arteries
Image-Com software is intended for reviewing, measuring and reporting of DICOM data of the cardiac modalities US and XA. It can be driven by Image-Arena or other third party platforms and is intended to launch other clinical applications.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vorat m why
(Division Sign-Off)
Division of Reproductive, Abdominal an Radiological Devices 510(k) Number
52
