4D SONO-SCAN 1.0
Device Facts
| Record ID | K110595 |
|---|---|
| Device Name | 4D SONO-SCAN 1.0 |
| Applicant | Tomtec Imaging Systems GmbH |
| Product Code | LLZ · Radiology |
| Decision Date | Apr 7, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
4D Sono-Scan 1.0 is intended to analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing. The 4D Sono-Scan 1.0 reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for subsequent 3D/4D tomographic reconstruction and rendering. It is intended as a general purpose digital 3D/4D ultrasound image processing tool.
Device Story
4D Sono-Scan 1.0 is a clinical software application for Windows-based PCs; processes digitized ultrasound B-mode images acquired from external ultrasound machines (e.g., Toshiba Aplio XG, Zonare Z.ONE). Software performs analysis, storage, retrieval, reconstruction, and rendering of 3D/4D datasets; enables basic measurements (areas, distances, volumes). Used in clinical settings for offline analysis; integrates with TomTec Image-Arena platforms via Generic CAP Interface for reporting and statistical quantification. Healthcare providers use the output to assist in clinical decision-making by providing quantitative data from ultrasound images. Benefits include enhanced workflow for 3D/4D image processing and standardized measurement capabilities.
Clinical Evidence
No clinical trial data provided. Safety and effectiveness supported by non-clinical software verification and validation testing performed at module and system levels according to internal protocols. The product concept was clinically accepted.
Technological Characteristics
Software-based clinical application for Windows PC platforms. Functions as a general-purpose digital 3D/4D ultrasound image processing tool. Features include database management, import/export, and tomographic reconstruction/rendering. Connectivity via Generic CAP Interface for data exchange with TomTec Image-Arena platforms. No hardware components; standalone software application.
Indications for Use
Indicated for reviewing 3D/4D ultrasound data sets and performing basic 3D measurements.
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
- Sono-Scan, Sono-Scan Pro, Cardio-Scan, TomTec Imaging Systems GmbH (K020561)
- 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, 4D Cardio-View 2.x component only, TT Imaging Systems GmbH (K071232)
Submission Summary (Full Text)
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K11C595
Image /page/0/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is black and white. The word "Tomtec" is in large, bold letters. Below the word "Tomtec" is the phrase "Imaging Systems" in smaller letters.
APR - 7 2011
March 23吋, 2011
# Traditional 510(k) Summary
# 4D Sono-Scan 1.0
# Owner's Name and Address
TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim
## Contact Person
Inge Scheidt QM & RA Officer ++49-89-32175-515 Phone Fax ++49-89-32175-750
# Common, Classification & Proprietary Names
| Common Name: | Various ultrasound Image Analysis System<br>Software |
|----------------------|------------------------------------------------------|
| Classification Name: | Programmable diagnostic computer |
| Proprietary Name(s): | 4D Sono-Scan 1.0 |
# Predicate Devices:
| Predicate Device 1 | K020561 | Sono-Scan, Sono-Scan Pro, Cardio-Scan,<br>TomTec Imaging Systems GmbH |
|--------------------|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K071232 | Image-Arena Platform 3.0, Research Arena<br>Platform 2.0, Echo-Com 3.x, Image-Com<br>3.x, 4D Cardio-View 2.x, 4D LV-Analysis<br>2.5x, 4D RV-Function 1.x, 4D MV-<br>Assessment 1.x and 4D LV-Function 2.x,<br>4D Cardio-View 2.x component only,<br>TT Imaging SystemsGmbH |
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summary
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Image /page/1/Picture/0 description: The image shows the word "OMTEC" in a bold, sans-serif font. The letters are black and the background is white. Below the word "OMTEC" is the phrase "IMAGING SYSTEMS" in a smaller font. The letters in "IMAGING SYSTEMS" are also black and the background is white.
#### Device Description
The 4D Sono-Scan 1.0 is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 4D Sono-Scan 1.0 is proprietary software for the analysis, storage, retrieval, reconstruction and rendering of digitized ultrasound B-mode images. The data can be acquired by ultrasound machines that are able to acquire and store 4D datasets (i.e. Toshiba Aplio XG or Zonare Z.ONE). The digital 3D/4D data can be used for basic measurements like areas, distances and volumes.
4D Sono-Scan 1.0 is compatible to different TomTec Image-Arena platforms and their derivatives (i.e. Zonare IQ Workstation) for offline analysis. The platform enhances the workflow by providing the database, import, export and other advanced high-level research functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes via the Generic CAP Interface.
The Generic CAP (= clinical application packages) Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.
#### Intended Use
4D Sono-Scan 1.0 is intended to analyze digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.
The 4D Sono-Scan 1.0 reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for subsequent 3D/4D tomographic reconstruction and rendering. It is intended as a general purpose digital 3D/4D ultrasound image processing tool.
#### Indications for use
4D Sono-Scan 1.0 intended as software for reviewing 3D/4D data sets and perform basic measurements in 3D.
### Technological Characteristics Comparison
For detailed comparison of all software functionalities of the subject device and the predicate devices refer to Chapt. 12: Substantial Equivalent discussion.
## Discussion according non-clinical performance data testing
summary
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Image /page/2/Picture/0 description: The image contains a sequence of alphanumeric characters. The characters are 'K11c595'. The characters are written in a cursive style.
Image /page/2/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 on top. 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.
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. Please refer to Chapter 16: Software, Verification and Validation Documentation.
#### Discussion according clinical performance data testing
The overal! product concept was clinically accepted and the clinical test results support the conclusion that the subject device is as safe as effective, and performs as well as the predicate devices. Please refer to Chapter 16: Software, Verification and Validation Documentation.
#### Test Conclusions of non-clinical and clinical performance data
Test results support the conclusion, that the subject device is as safe as effective, and performs as well as or better than the predicate devices. Please refer to Chapter 16: Software, Verification and Validation Documentation.
Munich, March 23'd, 2011
Inge Scheidt QM & RA Officer
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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with its wings spread, and 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 Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Inge Scheidt QM & RA Officer TomTec Imaging Systems GmbH Edisonstrasse 6 Unterscheissheim, Bavaria, D-85716 GERMANY
-- 7 2011 APR
Re: K110595
Trade/Device Name: 4D Sono-Scan 1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 31, 2011 Received: March 2, 2011
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 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 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 (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/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 (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
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Indications for Use 1105 510(k) Number (if known):
Device Name:
#### 4D Sono-Scan 1.0
Indications for Use:
4D Sono-Scan 1.0 intended as software for reviewing 3D/4D data sets and perform basic measurements in 3D.
Prescription Use X (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)
Mary S Patel
ion Sian-Off) . . : Office of દાભા રાભ
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