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.

4D Sono-Scan 1.0 intended as software for reviewing 3D/4D data sets and perform basic measurements in 3D.

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.

AI/ML Overview

The provided text describes the 4D Sono-Scan 1.0 device, its intended use, and a general statement about its testing. However, it does not explicitly define acceptance criteria in a quantifiable table format, nor does it detail a specific study with statistical results to prove the device meets such criteria.

The document refers to verification and validation documentation (Chapter 16), which would typically contain such information, but these chapters are not included in the provided text.

Based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

No explicit table of acceptance criteria or specific quantifiable performance metrics are provided in the given text. The document generally states that "The overall 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."

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not specified.

4. Adjudication Method for the Test Set:

Not specified.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No mention of an MRMC study or any effect size comparing human readers with and without AI assistance is provided. The device is software for analyzing existing ultrasound images and performing measurements, not directly an AI-assisted diagnostic tool for human readers in the sense of improving their diagnostic accuracy.

6. Standalone (Algorithm Only) Performance:

The document states, "Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted." This implies standalone testing of the software's functionality (e.g., ability to reprocess, reconstruct, render, and perform basic measurements), rather than a clinical performance study with human subjects. However, no specific performance metrics for this standalone testing are provided beyond the general statement that test results support its safety and effectiveness compared to predicates.

7. Type of Ground Truth Used:

While not explicitly stated, for a device performing basic measurements on ultrasound images, the "ground truth" for testing would likely involve:

Comparison of software measurements against manually performed measurements (e.g., by experts) on the same images.
Comparison of software-generated 3D/4D reconstructions against expected anatomical structures or other validated reconstruction methods.
Verification of the software's ability to accurately read and reprocess different 3D/4D image file formats.

8. Sample Size for the Training Set:

Not applicable. The 4D Sono-Scan 1.0 is described as a "clinical application package" and "proprietary software for the analysis, storage, retrieval, reconstruction and rendering of digitized ultrasound B-mode images." It performs "basic measurements like areas, distances and volumes." There is no indication that this device uses machine learning or AI models that require a separate "training set" in the conventional sense. It appears to be a rule-based or algorithmic software for image processing and quantification.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no indication of a training set for machine learning. The software's functionality would have been developed and verified against known principles of image processing, geometry, and engineering specifications.

Summary

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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 SystemSoftware
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,TomTec Imaging Systems GmbH
Predicate Device 2	K071232	Image-Arena Platform 3.0, Research ArenaPlatform 2.0, Echo-Com 3.x, Image-Com3.x, 4D Cardio-View 2.x, 4D LV-Analysis2.5x, 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 SystemsGmbH

Image /page/0/Picture/14 description: The image contains 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 overall impression is that of a stylized, abstract design.

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 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.

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

Image /page/2/Picture/9 description: The image contains a series of black, right-angled shapes arranged in a somewhat curved line. The shapes are oriented in different directions, creating a dynamic and somewhat chaotic pattern. The shapes are closely spaced, with some overlapping, which adds to the complexity of the overall composition.

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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

Page 1 of 1

Regulation Number and Section

§ 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).