(48 days)
Not Found
No
The summary describes a data management and analysis platform for ultrasound images, focusing on standard image processing and measurement tools. There is no mention of AI, ML, or related concepts.
No
The device is a software platform intended for data management and analysis of ultrasound images, not for providing therapy.
Yes
The "Intended Use / Indications for Use" states that the software is used for "analysis of the left ventricle in heart failure patients", "to analyze pathologies related to the Mitral Valve", and "for analysis of the right ventricle in all patients with a need of right heart function diagnosis." These are all diagnostic purposes, specifically aiding in the diagnosis of heart conditions.
Yes
The device description explicitly states it is a "software tool package" and details its functions related to analysis, documentation, and archiving of ultrasound studies, without mentioning any accompanying hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is a "data management platform for clinical application packages" and that the clinical application packages are for "analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle". This describes a device used for analyzing medical images and data from the patient, not for performing tests on samples taken from the patient (which is the core definition of an IVD).
- Device Description: The description focuses on image analysis, documentation, archiving, and importing various image formats. It describes a tool for working with medical imaging data, not a device that performs diagnostic tests on biological samples.
- Input Modality: The input modality is ultrasound imaging, which is a non-invasive imaging technique performed on the patient, not a method for analyzing biological samples.
IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information for diagnosis, monitoring, or screening. This device is clearly focused on the analysis and management of medical images obtained directly from the patient.
N/A
Intended Use / Indications for Use
The Image-Arena/Research-Arena Applications software tool package is intended to retrieve, store, 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.
The Image-Arena and Research-Arena Platform Software is intended to serve as a data management platform for clinical application packages.
As the Image-Arena and Research-Arena Applications software tool package is modular structured, the clinical applications packages are indicated as software packages for analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle in all patients with a need of right heart function diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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 line Image-Arena Applications and Research-Arena Applications. 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 new 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-, GE-,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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound studies, digital 2D, 3D and 4D (dynamic 3D) image formats, analogue video acquisition, 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.
Anatomical Site
left ventricle, Mitral Valve, right ventricle, heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical researcher or routine oriented physician, 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/2 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.
Jan. 29th, 2007
Special 510(k) Summary
Image-Arena Platform 3,x Research-Arena Platform 2 x Echo-Com 3.x lmage-Com 3.x 4D Cardio-View 2.x 4D LV-Analysis 2.5x 4D RV-Function 1.x 4D MV-Assessment 1.x 4D LV-Function 2.x
Owner's Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
Contact Person
Inge Scheidt QM & RA Manager ++49-89-32175-515 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 |
| Proprietary Name(s): | Image-Arena and Research-Arena Applications |
Image-Arena Platform 3.x Research-Arena Platform 2.x Echo-Com 3.x Image-Com 3.x 4D Cardio-View 2.x 4D LV-Analysis 2.5x 4D RV-Function 1.x 4D MV-Assessment 1.x 4D LV-Function 2.x
Image /page/0/Picture/13 description: The image shows a collection of black, angled lines arranged in a somewhat curved pattern. The lines are short and thick, and they are oriented at various angles, creating a sense of disarray. The overall arrangement of the lines gives the impression of a winding path or a scattered collection of objects. The lines are all black, and the background is white.
page 1 of 5
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" 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
TomTec K040546
Image-Arena Applications Research-Arena Applications
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 line Image-Arena Applications and Research-Arena Applications. 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 new 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-, GE-,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 retrieve, store, 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.
Image /page/1/Picture/11 description: The image shows a collection of black, angled lines arranged in a somewhat curved formation. The lines are of similar length and thickness, and they are positioned close together, creating a dense pattern. The overall impression is abstract, with the lines resembling a series of connected, angular shapes.
summary
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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.
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 product:
Image-Arena Applications Research-Arena Applications K040546
Image /page/2/Picture/4 description: The image shows a series of black, right-angle shapes arranged in a curved line. The shapes are oriented in a way that suggests movement or direction, creating a dynamic visual effect. The arrangement of the shapes gives the impression of a winding path or a chain of interconnected elements. The overall composition is simple yet visually engaging due to the repetition and pattern of the shapes.
3
Image /page/3/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The logo is 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.
Image /page/3/Figure/1 description: The image shows a diagram of the predicate devices and a new device. The predicate devices include Image-Arena Applications and Research-Arena Applications on Image-Arena Platform 3.x and Research-Arena Platform 1.x. The new device includes Image-Arena Applications and Research-Arena Applications on Image-Arena Platform 3.x and Research-Arena Platform 2.x. The diagram also shows the generic interface, database and data management system, and device modification.
0016
page 4 of 5
summary
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" 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.
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, Jan. 2981, 2007
J. Sibert
Image /page/4/Picture/10 description: The image shows a collection of black, angled lines arranged in a somewhat curved pattern. The lines are short and thick, and they appear to be clustered together. The overall impression is abstract, with no clear objects or figures discernible.
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summary
5
Image /page/5/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The background is white. The text is centered in the image.
Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized abstract symbol resembling a bird or a person reaching upwards. The symbol is positioned to the right of the text, which is arranged in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Inge Scheidt QM & RA Manager TomTec Imaging Systems GmbH Edisonstrasse 6 Unterschleissheim, Bavaria D-85716 GERMANY
Re: K071232
Trade/Device Name: Image-Arena Platform 3.0; Research-Arena Platform 2.0; Echo-Com 3.x; Image-Com 3.x; 4D Cardio-View 2.x; 4D LV-Analysis 2.5x; 4D RV-Function 1.x; 4D MV-Assessment 1.x; and, 4D LV-Function 2.x Regulation Number: 21 CFR §892.2050
Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: April 19, 2007 Received: May 7, 2007
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 Aot 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 (Premarket Approval), 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.
Image /page/5/Picture/11 description: The image is a circular logo or emblem. The text "1906-2006" is at the top, and the letters "FDA" are in the center. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo. The text around the circle says "FDA Centennial: A Century of Protecting the Public Health".
Protesting and Promoting Public Health
6
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.xxxxx 21 CFR 884.xxxx 21 CFR 892 xxxxx Other
(Gastroenterology/Renal/Urology) (Obstetrics/Gynecology) (Radiology);
240-276-0115 240-276-0115 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
| Indications for Use | |
|---|---|
| 10(k) Number (if known): | K071232 |
Device Name:
5
Image-Arena Platform 3.0 Research-Arena Platform 2.0 Echo-Com 3.x Image-Com 3.x 4D Cardio-View 2.x 4D LV-Analysis 2.5 x 4D RV-Function 1.x 4D MV-Assessment 1.x 4D LV-Function 2.x
Indications for Use:
The Image-Arena and Research-Arena Platform Software is intended to serve as a data management platform for clinical application packages.
As the Image-Arena and Research-Arena Applications software tool package is modular structured, the clinical applications packages are indicated as software packages for analysis of the left ventricle in heart failure patients, to analyze pathologies related to the Mitral Valve and for analysis of the right ventricle in all patients with a need of right heart function diagnosis.
Hulbert
(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number .
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)
0012