4D LV-Analysis is intended to retrieve, analyze, and store digital ultrasound images for computerized dynamic 3-dimensional image analysis. 4D LV-Analysis reads certain digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format for analysis. It is intended as a digital 4D ultrasound image processing tool for cardiology.

4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.

Device Description

The 4D LV-Analysis® 3.0 software is a clinical application package for high performance PC platforms based on Microsoft Windows operating system standards. 4D LV-Analysis is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images. 4D LV-Analysis is compatible with different TomTec Image-Arena™ platforms, their derivatives or any other platform that provides and supports the Generic CAP Interface. Platforms enhance the workflow by providing the database, import, export and other functionalities. All analyzed data and images will be transferred to the platform for reporting and statistical quantification purposes. 4D LV-Analysis is designed for 2- and 3-dimensional morphological and functional analyses of the left ventricle. Based on three dimensional datasets a semi-automatic 3D surface model finding algorithm supports the calculation of a 4D model that represents the cavity of the LV.

From that model, global as well as regional volumetric changes can be derived. By looking at the timing of regional contractions, dyssynchrony of a ventricle can be quantified and visualized. For visualization, parametric maps are used that indicate areas with a delayed contraction.

Thus 4D LV-Analysis improves the functional analysis of the LV and presentation of findings to cardiologists and electro-physiologists and visualizes the contraction pattern of the LV to assess dyssynchrony.

AI/ML Overview

The submission K110746 for TomTec Imaging Systems GmbH's "4D LV-Analysis 3.0" device provides minimal details regarding specific acceptance criteria and detailed study results. The document largely defers to internal company procedures and a general statement of clinical acceptance.

Here's an analysis based on the provided text, highlighting what is presented and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance	Comments
Device is safe and effective	"safe as effective, and performs as well as the predicate devices."	Vague and lacking specific metrics or thresholds.
Performs as well as or better than predicate devices	"performs as well as or better than the predicate devices."	No specific performance metrics or statistical comparisons are provided.
Compliance with internal software testing and validation protocols	"Software testing and validation were done at the module and system level according to written test protocols established before testing was conducted."	This describes the process, not the outcome or specific acceptance criteria met.
Clinical acceptance of the overall product concept	"The overall product concept was clinically accepted"	This indicates a general positive reception but lacks quantifiable clinical endpoints or acceptance thresholds.

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

Sample Size for Test Set: Not specified. The document states "clinical test results support the conclusion," but no details about the number of cases or patients in the clinical performance testing are provided.
Data Provenance: Not specified. There is no information regarding the country of origin of the data or whether the clinical data was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

Was an MRMC study done? No, not explicitly mentioned. The document does not describe any study comparing human readers' performance with and without AI assistance.
Effect Size of Improvement: Not applicable, as no such study is described.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, implied. The device itself is software for analysis, and the claims about its performance relative to predicate devices would inherently involve evaluating its algorithmic output. However, no specific standalone performance metrics (e.g., accuracy, sensitivity, specificity for specific clinical endpoints) are provided.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified. The document refers to "overall product concept was clinically accepted" and "clinical test results," suggesting some form of clinical ground truth, but the specific nature (e.g., expert consensus, pathology, long-term outcomes, invasive measurements) is not detailed.

8. Sample Size for the Training Set

Sample Size for Training Set: Not specified. The document mentions the device uses a "semi-automatic 3D surface model finding algorithm," which implies machine learning or model training, but gives no details about the training data.

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

How Ground Truth Was Established: Not specified.

Summary of Deficiencies in Reporting:

The 510(k) summary for K110746, typical for submissions from that era and device type, is high-level and defers significant detail to internal documentation (Chapter 16: Software, Verification and Validation Documentation). It lacks specific, quantifiable acceptance criteria and detailed reporting of clinical performance data. Key information such as sample sizes, expert qualifications, ground truth methods, and statistical performance metrics which are common in more recent AI/ML device submissions, are not present in this public summary. The claims are generalized statements about safety and effectiveness in comparison to predicate devices, without providing the underlying evidence in this document.

Summary

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K110746

Image /page/0/Picture/1 description: The image shows the logo for TOMTEC Imaging Systems. The logo is in black and white and features a stylized font. The word "TOMTEC" is in large, bold letters, with the "O" slightly tilted. Below the main word, in smaller letters, it says "IMAGING SYSTEMS".

MAY 2 4 2011

March 23吋, 2011

Traditional 510(k) Summary

4D L.V-Analysis 3.0

Owner's Name and Address

TomTec Imaging Systems GmbH Edisonstrasse 6 D-85716 Unterschleissheim

Contact Person

Inge Scheidt QM & RA Officer Phone ++49-89-32175-515 ++49-89-32175-750 Fax

Common, Classification & Proprietary Names

Common Name:	Various Image Analysis SystemSoftware
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Classification Name: Programmable diagnostic computer

Proprietary Name(s): 4D LV-Analysis 3.0

Predicate Devices:

Predicate Device 1	K071232	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 MVAssessment 1.x; 4D LV-Function 2.xOnly 4D LV-Analysis 2.5x component,TomTec Imaging Systems GmbH
Predicate Device 2	K090461	Image-Arena 4.0 and Image-ArenaApplicationsOnly 2D Cardiac Performance Analysis1.0 component, TomTec ImagingSystems GmbH
Predicate Device 3	K082596	USWS-900A; UltraExtend UltrasoundWorkStation PackageOnly ACP componentToshiba America Medical Systems, Inc.

Image /page/0/Picture/16 description: The image contains a series of black, angled lines that are arranged in a somewhat linear fashion. The lines are oriented at different angles, creating a sense of movement or direction. The lines are clustered together, with some overlapping each other. The overall impression is abstract and geometric.

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Image /page/1/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" 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

Intended Use

Indications for use

4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.

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.

Image /page/1/Picture/12 description: The image shows a sequence of black shapes arranged in a line. The sequence starts with the number "12" on the left side of the image. The rest of the sequence is made up of a series of angled lines that resemble arrows or chevrons. The angled lines are arranged in a way that creates a sense of movement or direction from left to right.

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Image /page/2/Picture/1 description: The image shows the logo for Tomtec Imaging Systems. The logo is black and white and features the word "Tomtec" in a bold, sans-serif font. Below the word "Tomtec" is the phrase "Imaging Systems" in a smaller, sans-serif font. The logo is simple and modern.

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. Please refer to Chapter 16: Software, Verification and Validation Documentation.

Discussion according clinical performance data testing

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. 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/10 description: The image shows a sequence of black arrows and the number 13. The arrows are arranged in a line, with each arrow pointing in a slightly different direction. The number 13 is located at the beginning of the sequence of arrows. The arrows appear to be stylized and are not uniform in size or shape.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Inge Scheidt OM & RA Officer TomTec Imaging Systems GmbH Edisonstrasse 6 Unterschleissheim, Bavaria D-85716 GERMANY

MAY 2 4 2011

Re: K110746

Trade/Device Name: 4D LV-Analysis Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable diagnostic computer Regulatory Class: II Product Code: DOK and LLZ Dated: March 16, 2011 Received: March 17, 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 (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 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 K110746 510(k) Number (if known):

Device Name:

4D LV-Analysis 3.0

Indications for Use:

4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.

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)

Mary Stattl
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K110746

Regulation Number and Section

§ 870.1425 Programmable diagnostic computer.

(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).