(30 days)
Not Found
No
The document describes a standard image management system and clinical application packages for reviewing and reporting medical images. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
The device is described as an image management system and software for reviewing, measuring, and reporting digital medical data, specifically mentioning stress echo studies. While it assists in clinical decision-making by processing diagnostic information, it does not directly apply therapy to a patient.
No
The device is described as an "image management system," a "general purpose digital medical image processing tool," and software for "reviewing and measuring of digital medical data." While it handles medical images, its primary stated function is data management and processing, not providing a medical diagnosis. The Echo-Com component reviews stress echo studies and supports wall motion scoring, which is part of analysis, but the system as a whole does not perform diagnosis.
No
The device description explicitly states that Image-Arena runs on an "integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards," indicating it includes hardware components.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device's intended use: The primary intended use of the Image-Arena platform and its associated software (Image-Com, Echo-Com) is for the management, review, and processing of digital medical images acquired from various modalities (like ultrasound for stress echo).
- No mention of specimen analysis: The description focuses entirely on handling and analyzing images, not on analyzing biological specimens.
The device is clearly intended for use in a clinical setting (physician practices and hospitals) for managing and reviewing medical images, which falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Image-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. .
Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Image-Arena is an SQL database based image management system that provides the capability to import, export, store, retrieve and report digital studies.
lmage Arena is developed as a common interface platform for TomTec - and commercially available analysis and quantification tools (= clinical application packages) that can be connected to Image-Arena through the Generic Clinical Application Package interface (= Generic CAP Interface)
lmage-Arena manages different digital medical data from different modalities except digital mammography.
Image-Arena is suited as stand-alone workstation as well as networked multisystem server / client installations.
Image-Arena runs on an integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Image-Arena provides the possibility to create user defined medical reports.
The system does not produce any original medical images.
Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Echo-Com is a clinical application package software for reviewing and reporting of digital stress echo data. Echo-Com is either embedded in Image-Arena Platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
different modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician practices and hospitals.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white. The word "TOMTEC" is in large, bold letters, with the "M" stylized to look like a mountain. Below the word "TOMTEC" are the words "IMAGING SYSTEMS" in smaller letters.
February 10th, 2011
Traditional 510(k) Summary
APR - 8 2011
Image-Arena and Image-Arena Applications Image-Arena 4.5 Echo-Com 4.5 Image-Com 4.5
Additional Marketing Name: IQ Workstation
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
Various Image Analysis System Common Name: Software Classification Name: Picture archiving and communications system Proprietary Name(s): Image-Arena and Image-Arena Applications
Image-Arena 4.5 Image-Com 4.5 Echo-Com 4.5
summary
page 1 of 6
1
Image /page/1/Picture/0 description: The image shows a logo for TOMTEC Imaging Systems. The logo is in black and white and features a stylized font. The word "TOMTEC" is in large, bold letters, with a line above the "TEC" portion. Below the main word, in smaller letters, it says "IMAGING SYSTEMS".
Predicate Devices
| Predicate Device 1 | K083348 | Image-Arena Platform 4.0, Server
Manager 4.0, Echo-Com 4.0,Image-Com
4.0, TomTec Imaging Systems GmbH |
|--------------------|---------|-------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K061995 | Xcelera, Philips Medical Systems North
America CO. |
Device Description
Image-Arena is an SQL database based image management system that provides the capability to import, export, store, retrieve and report digital studies.
lmage Arena is developed as a common interface platform for TomTec - and commercially available analysis and quantification tools (= clinical application packages) that can be connected to Image-Arena through the Generic Clinical Application Package interface (= Generic CAP Interface)
lmage-Arena manages different digital medical data from different modalities except digital mammography.
Image-Arena is suited as stand-alone workstation as well as networked multisystem server / client installations.
Image-Arena runs on an integrated Intel Pentium high performance computer system based on Microsoft™ Windows standards. Communication and data exchange are done using standard TCP/IP, DICOM and HL7 protocols.
Image-Arena provides the possibility to create user defined medical reports.
The system does not produce any original medical images.
Image-Com is a clinical application package software for reviewing and measuring of digital medical data. Image-Com is either embedded in Image-Arena platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Echo-Com is a clinical application package software for reviewing and reporting of digital stress echo data. Echo-Com is either embedded in Image-Arena Platform or can be integrated into Third Party platforms, such as PACS or CVIS.
Image /page/1/Picture/13 description: The image shows a pattern of small, black, right-angle shapes arranged in a slightly curved line. The shapes are oriented in different directions, creating a dynamic and somewhat chaotic visual effect. The overall impression is one of movement and complexity within a simple geometric form.
summary
2
Image /page/2/Picture/0 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.
Indications for use and Intended use
The Image-Arena software platform is intended to import, export, store, retrieve and report digital studies. The Image-Arena software is based on a SQL database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools.
Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
Technological Characteristics Comparison
The proposed and the predicate devices are software devices that run on high performance computer system to receive, store, display and digital process of medical images.
The Image-Arena Application software tool package is modular structured and consists of different software modules, combining the advantages of the previously FDA cleared software products:
summary
page 3 of 6
3
Image /page/3/Picture/0 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, and it is likely used to represent the company's brand.
| Predicate Device 1 | K083348 | Image-Arena Platform 4.0, Server
Manager 4.0, Echo-Com 4.0,Image-Com
4.0, TomTec Imaging Systems GmbH |
|--------------------|---------|-------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K061995 | Xcelera, Philips Medical Systems North
America CO. |
.
.
:
summary
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page 4 of 6
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ਦੇ 8
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.
Predicate Devices:
TomTec Image-Arena and Image-Arena
Applications
Image /page/4/Figure/4 description: The image shows a diagram of the Image-Arena platform 4.0. The diagram shows the different components of the platform, including Image-Arena Applications, Echo-Com 4.0, Image-Com 4.0, and Third Party Applications. The diagram also shows the Generic Interface, Database and Data Management System, Dicom Services, Import and Export Functions, Report and Archive Functions, and Basic Image Viewer.
・・ IA 3.0
applications
New Device: TomTec Image-Arena 4,5 and Image-Arena
Image /page/4/Figure/7 description: The image contains the word "Applications" in bold, black font. The word is presented in a simple, straightforward manner. The text appears to be isolated without any surrounding context or additional elements.
Image /page/4/Figure/8 description: The image shows a diagram of a software architecture. The architecture consists of several layers, including Image-Arena Applications, Echo-Com 4.5, Image-Com 4.5, TomTec Clinical Application Packages, and Third Party Applications. These applications are built on top of a Generic Interface, which in turn is built on top of a Database and Data Management System Imtproof. The database system provides Dicom Services, Import and Export Functions, Report and Archive Functions, and a Basic Image Viewer.
Predicate
Devices:
Image /page/4/Figure/10 description: The image shows the text "K083348" in a simple, sans-serif font. The text is black against a white background, providing a clear contrast. The numbers and letters are evenly spaced and easily readable.
TomTec ImageArena Platfrom 4.0,
Server Manager
Server Manager Server Manager
4.0, EchoCom 4.0, Image-Com 4.0
Xcelera
New Device:
TomTec Image-
Arena 4.5 and
Image-Arena
Applications
summary
5
Image /page/5/Picture/0 description: The image is a logo for TOMTEC Imaging Systems. The logo is black and white and features 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.
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, February 10th, 2011
J. Heald
Inge Scheidt OM & RA Officer
Image /page/5/Picture/10 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 background is plain white, which helps to emphasize the black shapes.
summary
6
Image /page/6/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a bold, sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room – WO66-G609 Silver Spring, MD 20993-0002
Mr. Inge Scheidt QM & RA Officer TomTec Imaging Systems GmbH Edisonstrasse 6 Unterschleissheim, Bavaria, D-85716 GERMANY
APR - 8 2011
Re: K110667
Trade/Device Name: Imag-Arena Image.Arena Applications: Image-Arena 4.5; Echo-Com 4.5; Image-Com 4.5 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: LLZ Dated: February 10, 2011
Received: March 9, 2011
Dear Mr. 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 class II (Special Controls). it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
7
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Mary S Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
Indications for Use
510{k) Number (if known): کای 0 (6 6 7
Device Name:
lmage-Arena and Image-.Arena Applications Image-Arena 4.5 Echo-Com 4.5 Image-Com 4.5
Additional Marketing Name: IQ Workstation
Indications for Use:
The Image-Arena software platform is intended to import, export, store; retrieve and report digital studies. The Image-Arena software is based on a SQL - database and is intended as an image management system. The Image-Arena software can import certain digital 2D or 3D image file formats of different modalities.
Image-Arena offers a Generic Clinical Application Package interface in order to connect TomTec applications as well as commercially available analysis and quantification tools to the Image-Arena platform.
The software is suited for stand-alone workstations as well as for networked multisystem installations and therefore is an image management system for physician practices and hospitals. It is intended as a general purpose digital medical image processing tool.
Image-Arena is not intended to be used for reading of mammography images.
Image-Com software is intended for reviewing and measuring of digital medical data of different modalities. It can be driven by Image-Arena or other third party platforms and is intended to launch other commercially available analysis and quantification tools. .
Echo-Com software is intended to serve as a versatile solution for Stress echo examinations in patients who may not be receiving enough oxygen because of blocked arteries. Echo-Com software is intended for reviewing, wall motion scoring and reporting of stress echo studies.
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) | |
|---|---|
Division Sign Off
Division of Technologycal Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
દત
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