IMAGE-COM 5.0

K122289 · Tomtec Imaging Systems GmbH · LLZ · Oct 24, 2012 · Radiology

Device Facts

• Record ID: K122289
• Device Name: IMAGE-COM 5.0
• Applicant: Tomtec Imaging Systems GmbH
• Product Code: LLZ · Radiology
• Decision Date: Oct 24, 2012
• 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
K122289 · Oct 24, 2012	IMAGE-COM 5.0	Tomtec Imaging Systems GmbH	Published clinical literature	A clinical evaluation based on a literature review was performed to assess the benefits and risks of the device, demonstrating that the device is as safe and effective as the predicate devices.	Literature review; Clinical evaluation; Risk-benefit assessment

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical evaluation following the literature route; Literature review	Patients relevant to the intended use of the device	Not applicable for this study	Safety and performance of the device under normal conditions of use

Indications for Use

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.

Device Story

Image-Com 5.0 is a clinical application software package for reviewing and measuring digital medical data. It functions as an integrated component of the Image-Arena platform or as a standalone integration within third-party PACS or CVIS environments. The device enables users to perform 2D, 3D, and 4D image analysis by combining functionalities previously separated in predicate software (2D analysis from Image-Com 4.5 and 3D/4D analysis from Cardio-View 2.x). Clinicians use the software to launch various analysis and quantification tools, facilitating more accurate assessments and reducing analysis time. The device is intended for professional clinical use to support diagnostic decision-making by providing quantitative measurements from medical images.

Clinical Evidence

No prospective clinical trials were conducted. Evidence consists of a clinical evaluation based on a literature review assessing the benefits of the device's measurement and analysis capabilities. The evaluation concluded that published data are relevant to the device's characteristics and intended medical procedures. Risk-benefit assessment indicates that benefits (improved accuracy and reduced analysis time) outweigh the low risks. Bench testing included software validation, functional testing, measurement verification, and multi-language testing, all of which passed without deviations.

Technological Characteristics

Clinical application software for 2D, 3D, and 4D medical image analysis. Operates as an integrated module within Image-Arena or third-party PACS/CVIS platforms. Software-based measurement and review tools. No specific hardware materials or energy sources; device is purely software-based.

Indications for Use

Indicated for the review and measurement of digital medical data across various modalities. No specific patient population, age, or gender restrictions are defined.

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 Platform 4.5, Echo-Com 4.5, Image-Com 4.5 (K110667)
• Image-Arena Applications; Research-Arena Applications : 4D Cardio-View 2.x (K071232)

Submission Summary (Full Text)

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K122289

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.

# Traditional 510(k) Summary

OCT 24 2012

Image-Com 5.0 .

# Owner's Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

## Contact Person

B. Mumm COO Phone [phone] Fax [phone]

#### Common, Classification & Proprietary Names

| Common Name: | Various Image Analysis System<br>Software | | |
|----------------------|---------------------------------------------|--|--|
| Classification Name: | Picture archiving and communications system | | |

Proprietary Name(s):

#### lmage-Com 5.0

## Predicate Devices

| Predicate Device 1 | K110667 | Image-Arena Platform 4.5, Echo-Com 4.5,<br>Image-Com 4.5 |
|--------------------|---------|--------------------------------------------------------------------------------|
| Predicate Device 2 | K071232 | Image-Arena Applications; Research-<br>Arena Applications : 4D Cardio-View 2.x |

Image /page/0/Picture/15 description: The image shows a series of black, angled lines arranged in a curved pattern. The lines are short and thick, and they are oriented at approximately 90-degree angles to each other. The overall arrangement of the lines creates a sense of movement or flow, as if they are following a curved path. The lines are closely spaced together, creating a dense and visually interesting pattern.

summary

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Image /page/1/Picture/0 description: The image shows the logo for TOMTEC Imaging Systems. The word "TOMTEC" is written in large, bold, black letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" written in smaller, black letters.

# Device Description

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.

#### Indications for use and Intended use

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.

#### Technological Characteristics Comparison

The Subject Device "Image-Com 5.0" is a CAP for analysis of medical studies containing 2D, 3D or 4D images.

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

| Predicate Device 1 | K110667 | Image-Arena Platform 4.5, Echo-Com 4.5, Image-Com 4.5 |
|--------------------|---------|-------------------------------------------------------------------------------|
| Predicate Device 2 | K071232 | Image-Arena Applications; Research-<br>Arena Applications: 4D Cardio-View 2.x |

The Subject Device includes the main functionalities as provided from Predicate Device 1 (Image-Com 4.6, TomTec Imaging Systems GmbH). The underlying technology of the Subject Device is identical to the predicate devices. It is a combined version of the Predicate Device 1 (Image-Com 4.5, TomTec Imaging Systems GmbH, for 2D analysis) and Predicate Device 2 (Cardio-View 2.x, TomTec Imaging Systems GmbH, for 3D/4D analysis) allowing the users to perform 2D, 3D and 4D image analysis within one software package.

#### 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.

summary

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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.

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

#### 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 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 that the Benefit is superior to the Risk. . Whereas the Risk is low. The benefit of the product is improving the accuracy of assessment and analyze-time. The product Image-Com 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.

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Image /page/3/Picture/0 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The word "TOMTEC" is in large, bold, black letters. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller, black letters. The logo is simple and professional.

# 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.

July 23, 2012

L. Ulli-

B. Mumm COO

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT
24
2012

Mr. Bernhard MUMM COO TomTech Imaging Systems GmbH Edisonstrasse 6 Unterschleissheim, Bavaria D-85716 GERMANY

Re: K122289

Trade/Device Name: Image-Com 5.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 23, 2012 Received: July 30, 2012

#### Dear Mr. MUMM:

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

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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 [phone]. 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/ReportaProblem/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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K122289

Device Name: Image-Com 5.0

Indications For Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D O'Hara

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(Division Sign Off) Division of Radiological Hea

Office of in Vitro Diagnostics and Ri

510/k