IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS
Device Facts
| Record ID | K040546 |
|---|---|
| Device Name | IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS |
| Applicant | Tomtec Imaging Systems GmbH |
| Product Code | LLZ · Radiology |
| Decision Date | Apr 27, 2004 |
| 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/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies. The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering. The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore 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, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
Device Story
Image-Arena/Research-Arena Applications are modular software tools for ultrasound image management and analysis. Inputs include digital 2D, 3D, and 4D ultrasound images (DICOM, HPSONOS, TomTec formats) and analog video. The system performs tomographic reconstructions, surface rendering, and offline measurements (B-mode, M-mode, Doppler, DTI). It operates on Windows-based PCs in standalone or networked configurations. Physicians and researchers use the output for documentation, reporting, and clinical decision-making across multiple medical specialties. The system facilitates data archiving and standardized reporting, aiming to improve workflow efficiency and diagnostic utility of ultrasound studies.
Clinical Evidence
Bench testing only. Software validation and testing were conducted at the module and system level according to internal protocols. No clinical data was required or provided.
Technological Characteristics
Modular software package running on Intel Pentium-based PCs with Windows XP or 2000 Professional. Features SQL-based database for image management. Supports 2D/3D/4D tomographic reconstruction and surface rendering. Connectivity via DICOM and proprietary file formats. Standalone or networked deployment.
Indications for Use
Indicated for acquisition, storage, retrieval, analysis, and reporting of digital ultrasound studies in cardiology, radiology, neurology, gastroenterology, urology, surgery, obstetrics, and gynecology. Used in physician practices and hospitals for research and routine clinical applications.
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
- TomTec Echo-View (K022824)
- TomTec Echo-Com (K001592)
- Siemens Sequoia Diagnostic Ultrasound System Signature II, Axius SW Applications (K022567)
- Siemens Sequoia Diagnostic Ultrasound System, Axius SW Applications (K032114)
Submission Summary (Full Text)
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K040 546
APR 2 7 2004
Image /page/0/Picture/2 description: The image shows the logo for Tomtec Imaging Systems. The logo is in black and white and features 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.
Feb. 12th, 2004
# Traditional 510(k) Summary
Image-Arena Applications Research-Arena Applications
Image-Arena Platform 3.x Research-Arena Platform 1.x 4D Cardio-View 2.x 4D LV-Analysis 2.x 4D Surgical-View 2.x 4D Echo-View 6.x 4D Easy-View 3.x 4D Omni-View 3.x 4D Parametric-View 1.x Echo-Com 3.x Image-Com 3.x Doku-Com 3.x Axius Quantitative Strain Rate Imaging (Axius QSI) Axius M-Mode DTI (Axius M-Mode DTI) Axius Advanced Contrast Quantification (Axius ACQ) Axius Edge Assisted Ejection Fraction (Axius Edge Assisted EF)
#### Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
#### Contact Person
Ralf Janitz QM & RA Manager ++49-89-32175-830 Phone Phone ++49-89-32175-750 Fax
#### Common, Classification & Proprietary Names Common Name: Various Ultrasound Image Analysis Software & System
Classification Name:
Ultrasonic Pulsed Echo Imaging System
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summarv
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TOMTEC
IMAGING SYSTEMS
Proprietary Name(s):
### Image-Arena Applications Research-Arena Applications
Image-Arena Platform 3.x Research-Arena Platform 1.x 4D Cardio-View 2.x 4D LV-Analysis 2.x 4D Surgical-View 2.x 4D Echo-View 6.x 4D Easy-View 3.x 4D Omni-View 3.x 4D Parametric-View 1.x Echo-Com 3.x Image-Com 3.x Doku-Com 3.x Axius Quantitative Strain Rate Imaging (Axius QSI) Axius M-Mode DTI (Axius M-Mode DTI) Axius Advanced Contrast Quantification (Axius ACQ) Axius Edge Assisted Ejection Fraction (Axius Edge Assisted EF)
#### Predicate Device
| Tom Tec | Echo-View | K022824 |
|---------|-------------------------------------------------------------------------------|---------|
| TomTec | Echo-Com | K001592 |
| Siemens | Sequoia™ Diagnostic Ultrasound System Signature II,<br>Axius™ SW Applications | K022567 |
| Siemens | Sequoia™ Diagnostic Ultrasound System<br>Axius™ SW Applications | K032114 |
#### Device Description
The hardware requirements are based on an Intel Pentium high performance computer system and Microsoft® Windows XP Professional™ or Microsoft® Windows 2000 Professional™ Operating System standards. The Image-Arena/Research-Arena Applications are a software tool package designed for analysis, documentation and archiving of ultrasound studies in multiple dimensions. The Image-Arena/Research-Arena Applications software tools are modular structured and consist of different software modules, combining the advantages of the previously FDA 510(k) cleared TomTec software product lines Echo-View and Echo-Com and Siemens Axius™ software applications.The
Image /page/1/Picture/8 description: The image contains a series of black, angled lines that resemble arrows or chevrons. These lines are arranged in a somewhat curved or winding pattern, creating a sense of movement or direction. The lines are closely spaced together, forming a dense and visually dynamic composition. The overall effect is abstract and geometric.
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summarv
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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" 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.
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/Research-Arena Applications offer features to import different digital 2D, 3D and 4D (dynamic 3D) image formats based on defined file format standards (DICOM-, HPSONOS-, TomTec- file formats) as well as analogue video acquisition 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 B-mode, 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.
#### Intended Use
The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL database intended as image management system especially for medical ultrasound studies.
The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.
The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore 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, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
#### Technological Characteristics Comparison
The Image-Arena/Research-Arena Applications software tool package is modular structured and consists of different software modules, combining the advantages of the previously FDA cleared software products:
TomTec Echo-View, K022824
TomTec Echo-Com, K001592
Siemens Sequoia™ Diagnostic Ultrasound System Signature II, Axius™ SW Applications K022567 and K032114.
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summan
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Image /page/3/Figure/0 description: This image shows a diagram of the TomTec imaging systems. The diagram shows the different product lines, including the TomTec Echo-Com Product Line, the TomTec Echo-View Product Line, and the Siemens Sequola Product Line. The diagram also shows the different applications that are available for each product line, as well as the different interfaces that are available.
From single programs to a modular structured tool package
Image /page/3/Picture/2 description: The image shows a series of black, angled lines arranged in a curved pattern. The lines are oriented in a similar direction, creating a sense of movement or flow. The overall composition is abstract and lacks a clear focal point, with the lines appearing to be randomly distributed along the curve.
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summary
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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" 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.
The Image-Arena/Research-Arena Applications software is the combined modified modular structured version and follow-up product and has been transferred to Microsoft® Windows XP Professional™ operating system standards. The graphic user interface has been improved for faster and easier application. The Image-Arena Platform/Research-Arena Platform based on SQL – database has a generic interface that enables the professional practitioners to combine the Image-Arena/Research-Arena Applications software very easy and generate image management systems especially for medical ultrasound studies.
#### Test Discussion
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.
#### Test Conclusions
Test results support the conclusion that actual device performance satisfies the design intent. Actual device performance as tested internally conforms to the system performance specifications.
Munich, Feb. 12th 2004
Ralf Janitz
QM & RA Manager
Image /page/4/Picture/8 description: The image shows a series of right angle symbols that are connected together. The symbols are all black and are arranged in a curved line. The symbols are all facing the same direction, with the open end of the angle pointing to the right. There are approximately 10-15 symbols in the image.
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summary
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## APR 2 7 2004
Mr. Ralf Janitz Manager, Regulatory Affairs TomTec Imaging Systems Edisonstr.6, D-85716 Unterschleissheim GERMANY
Re: K040546
Trade/Device Name: Image-Arena Applications, Research-Arena Applications Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892. 1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: 90 LLZ, IYN, and IYO Dated: February 27, 2004 Received: March 9, 2004
Dear Mr. Janitz:
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 111 (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.
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
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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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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### Indications for use
510(k) Number (if known): K040546
Device Name: Image-Arena Applications, Research-Arena Applications
Indications For Use:
#### Intended Use Summary for Image-Arena/Research-Arena Applications
The Image-Arena/Research-Arena Applications software tool package is intended to acquire, store, retrieve, analyze and report digital ultrasound studies. The Image-Arena Platform and the Research-Arena Platform are based on a SQL - database intended as image management system especially for medical ultrasound studies.
The Image-Arena/Research-Arena Applications software can import certain digital 2D or 3D image file formats for 2D/3D and 4D tomographic reconstructions and surface rendering.
The software is suited to stand-alone workstations as well as networked multisystem installations and is therefore 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, radiology, neurology, gastroenterology, urology, surgery, obstetrics and gynecology.
Prescription Use V (Per 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Of+fice of Device Evaluation (ODE)
David R. Seymore
Division Sign-Off) Sision of Reproductive. Abdominal ans Radiological Devices 510 k) Number
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