TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA

K132544 · Tomtec Imaging Systems GmbH · LLZ · Nov 25, 2013 · Radiology

Device Facts

• Record ID: K132544
• Device Name: TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA
• Applicant: Tomtec Imaging Systems GmbH
• Product Code: LLZ · Radiology
• Decision Date: Nov 25, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K132544 · Nov 25, 2013	TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA	Tomtec Imaging Systems GmbH	Published clinical literature	A clinical evaluation based on a literature review was conducted to assess the benefits and risks of the device. The published data were used to demonstrate that the device is safe and effective for its intended use in diagnostic review, quantification, and reporting of cardiovascular, fetal, and abdominal structures.	Literature review; Clinical evaluation; Risk-benefit assessment

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical evaluation via literature review; Literature review	Patients with suspected cardiovascular, fetal, and abdominal disease	Not applicable for this study	Safety and performance of the device under normal conditions of use

Indications for Use

TomTec-Arena software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities. TomTec-Arena is not intended to be used for reading of mammography images. Indications for use of TomTec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.

Device Story

TomTec-Arena 1.0 is a clinical software package for reviewing, quantifying, and reporting multi-dimensional digital medical data. It operates on high-performance PCs running Microsoft Windows. The software integrates various clinical application packages (CAPs) for cardiovascular, fetal, and abdominal analysis. It functions as a platform for database management, import/export, and statistical quantification. Clinicians use the software to analyze medical images; outputs assist in diagnostic review and clinical decision-making regarding patient structures and function. The device is intended for clinical environments where medical imaging data is processed.

Clinical Evidence

No clinical data or studies were used to determine substantial equivalence. Evidence is based on non-clinical bench testing (module and system level) and a literature-based clinical evaluation assessing the benefits and risks of the device. Testing verified all requirements, including measurement verification and functional performance.

Technological Characteristics

Software-based clinical application package for multimodal/multidimensional medical data analysis. Runs on standard high-performance PC platforms (Microsoft Windows). Connectivity includes database, import, and export services. Software is modular, consisting of various CAPs for cardiac, fetal, and abdominal analysis.

Indications for Use

Indicated for diagnostic review, quantification, and reporting of cardiovascular, fetal, and abdominal structures and function in patients with suspected disease. Prescription use only.

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

• Image-Arena Applications, Research-Arena Applications: 4D RV-Function 1.0, 4D Cardio-View 2.0, 4D LV-Function 2.0 (K071232)
• Image-Arena 4.0 and Image-Arena Applications: 2D Cardiac Performance Analysis 1.0 (K090461)
• 4D MV-Assessment 2.0 (K103782)
• 4D Sono-Scan 1.0 (K110595)
• Image-Arena and Image-Arena Applications Image-Arena 4.5, Echo-Com 4.5, Image-Com 4.5 (K110667)
• 4D LV-Analysis 3.0 (K110746)
• 2D Cardiac Performance Analysis MR 1.0 (K120135)
• Image-Com 5.0 (K122289)

Submission Summary (Full Text)

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NOV 2 5 2013

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K132544
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TomTec Imaging Systems, GmbH Edisonstrasse 6 85716 Unterschleissheim

# Traditional 510(k) Summary

- TomTec-Arena 1.0 .
# Owner's Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

## Contact Person

Mrs. Christine Klein [phone] Phone Fax [phone]

#### Common, Classification & Proprietary Names

| Common Name: | Various Image Analysis System Software |
|----------------------|---------------------------------------------------------------------------------|
| Classification Name: | Picture Archiving and communications system<br>Programmable diagnostic computer |

TomTec-Arena 1.0 Proprietary Name:

## Predicate Devices

| Predicate Device 1 | K071232 | Image-Arena Applications, Research-<br>Arena Applications : 4D RV-Function 1.0,<br>4D Cardio-View 2.0, 4D LV-Function 2.0 |
|--------------------|---------|---------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K090461 | Image-Arena 4.0 and Image-Arena<br>Applications: 2D Cardiac Performance<br>Analysis 1.0 |
| Predicate Device 3 | K103782 | 4D MV-Assessment 2.0 |
| Predicate Device 4 | K110595 | 4D Sono-Scan 1.0 |
| Predicate Device 5 | K110667 | Image-Arena and Image-Arena<br>Applications Image-Arena 4.5, Echo-Com<br>4.5, Image-Com 4.5 |
| Predicate Device 6 | K110746 | 4D LV-Analysis 3.0 |
| Predicate Device 7 | K120135 | 2D Cardiac Performance Analysis MR 1.0 |
| Predicate Device 8 | K122289 | Image-Com 5.0 |

summary

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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 to represent the company's brand.

# Device Description

TomTec-Arena is a clinical software package for reviewing, quantifying and reporting digital medical data. TomTec-Arena runs on high performance PC platforms based on Microsoft Windows operating system standards. The software is compatible with different TomTec Image-Arena™ platforms, their derivatives or third party platforms.

Platforms enhance the workflow by providing the database, import, export and other services. All analyzed data and images will be transferred to the platform for archiving, reporting and statistical quantification purposes.

Tom Tec-Arena consists of the following optional clinical application packages:

- Image-Com .
- . 4D LV-Analysis/Function
- 4D RV-Function .
- 4D Cardio-View ●
- . 4D MV-Assessment
- . Echo-Com
- 2D Cardiac-Performance Analysis .
- . 2D Cardiac-Performance Analysis MR
- . 4D Sono-Scan

## Indications for use and Intended use

TomTec-Arena software is a clinical software package designed for review, quantification and reporting of structures and function based on multi-dimensional digital medical data acquired with different modalities.

TomTec-Arena is not intended to be used for reading of mammography images. Indications for use of TomTec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.

## Technological Characteristics Comparison

The Subject Device "TomTec-Arena 1.0" contains clinical application packages (CAPs) for analysis of medical studies containing multimodal and multidimensional medical data.

The actual submission combines the advantages of the FDA cleared TomTec Imaging Systems software products:

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 a company that specializes in imaging technology.

TomTec Imaging Systems, GmbH Edisonstrasse 6 85716 Unterschleissheim

| Predicate Device 1 | K071232 | Image-Arena Applications, Research-Arena<br>Applications: 4D RV-Function 1.0, 4D<br>Cardio-View 2.0, 4D LV-Function 2.0 |
|--------------------|---------|-------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K090461 | Image-Arena 4.0 and Image-Arena<br>Applications: 2D Cardiac Performance<br>Analysis 1.0 |
| Predicate Device 3 | K103782 | 4D MV-Assessment 2.0 |
| Predicate Device 4 | K110595 | 4D Sono-Scan 1.0 |
| Predicate Device 5 | K110667 | Image-Arena and Image-Arena Applications<br>Image-Arena 4.5, Echo-Com 4.5, Image-<br>Com 4.5 |
| Predicate Device 6 | K110746 | 4D LV-Analysis 3.0 |
| Predicate Device 7 | K120135 | 2D Cardiac Performance Analysis MR 1.0 |
| Predicate Device 8 | K122289 | Image-Com 5.0 |

The Subject Device incorporates all functionalities within dedicated clinical application packages (CAPs) with the goal of enhancing the workflow when analysing multimodal and multidimensional medical data. The underlying technology of the Subject Device is identical to the Predicate Devices listed above.

## 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.

The test procedure was performed according to the Project Quality Plan.

Test results were reviewed by designated technical professionals before software proceeded to release.

All requirements have been verified by tests or other appropriate methods.

The incorporated OTS Software is considered validated either by particular tests or implied by the absence of OTS SW related abnormalities during all other V&V activities.

The summary conclusions state that:

- । all automated tests were reviewed and passed
- feature complete test completed without deviations -
- functional tests are completed
- measurement verification is completed without deviations -
- multilanquage tests are completed without deviations -
- all non-verified bugs have been evaluated and are rated as minor deviations. They are deferred to the next release.

summary

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#### Discussion according clinical performance data testing

Substantial equivalence determination of this subject device was not based on clinical data or studies.

The overall product concept was clinically accepted and supports the conclusion that the device is as safe as effective, and performs as well as or better than the predicate devices.

A clinical evaluation following the literature route based on the assessment of benefits, associated with the use of the device, was performed. The clinical evaluation shows that the published data are relevant and applicable to the relevant characteristics of the device under assessment and the medical procedure for which the device is intended.

Risk analysis aspects were treated in the risk management report. Based on this document the existing applied methods in the literature and the newly described techniques of the product (which are considered in the risk analysis) were evaluated.

No further risks were identified.

#### Conclusion from the analysis of the literature review

- . The Risk-Benefit Assessment concludes that the benefit is superior to the risk, whereas the risk is low. The product TomTec-Arena is therefore harmless for patient and user and the advantages overbalance the probable risks of injury or illness for the patient.
- The data are sufficient to demonstrate compliance with the essential . requirements covering safety and performance of the device in question under normal conditions of use.
- The claims made in the device labeling are substantiated by the clinical data. .

#### 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 devices.

No reportable events or problems for the predicate devices exist.

The overall product concept was clinically accepted and the test results support the conclusion that the subject device is as safe as effective and performs as well as the predicate devices.

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . د. ان الان الان القارة التأت J. Waldinger

October 31, 2013

J. Waldin-
CTO

summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2013

TOMTEC IMAGING SYSTEM. GmbH % CHRISTINE KLEIN QM & RA ASSISTANT EDISONSTRASSE 6 UNLERSCHLEISSHEIM 85716 GERMANY

Re: K132544 Trade/Device Name: TomTec Arena 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 23, 2013 Received: October 28, 2013

Dear Ms. Klein:

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 mav, 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. Ilsting 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.

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Page 2-Ms. Klein

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (21CFR 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/dcfault.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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Smh.7):

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

for

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K132544

Device Name TomTec-Arena 1.0

Indications for Use (Describe)

Indications for use of TomTec-Arena software are diagnostic review, quantification and reporting of cardiovascular, fetal and abdominal structures and function of patients with suspected disease.

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page.

#### PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Sm.h.7).

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