4D MV Assessment is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

4D MV Assessment 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 for cardiology.

4D MV-Assessment 2.0 is intended as software to analyze pathologies related to the mitral valve.

Device Description

4D MV-Assessment® is a clinical application package for high performance PC platforms based on Microsoft® Windows® operating system standards. 4D MV-Assessment is software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images and Color Doppler images. The data is acquired by ultrasound machines that are able to store compatible 3D/4D datasets. The digital 3D/4D data can be used for comprehensive morphological and functional assessment of the mitral valve.

4D MV-Assessment is compatible with different Tom Tec Image-ArenaTM 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 MV-Assessment is designed for 2-, 3- and 4-dimensional morphological and functional analysis of mitral valves (MV). Based on an easy and intuitive workflow the application package generates models of anatomical structures such as MV annulus, leaflet and the closure line. Automatically derived parameters allow quantification of pre- and post-operative valvular function and comparison of morphology.

4D MV-Assessment improves the presentation of anatomy and findings to surgeons and cardiologists and visualizes the complex morphology and dynamics of the mitral valve.

The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.

AI/ML Overview

The provided text from the 510(k) summary for the "4D MV-Assessment 2.0" device does not contain detailed information regarding specific acceptance criteria, study methodologies, or performance results in the way requested by the prompt.

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

However, it explicitly refers to "Chapter 16: Software, Verification and Validation Documentation" for details, which is not included in the provided text. Therefore, I cannot extract the specific information requested in the table and detailed study aspects.

Based only on the provided text, I can state that:

Acceptance Criteria and Reported Device Performance: This information is not provided in the given summary. The document generally states that the device was found to be "as safe as effective, and performs as well as or better than the predicate devices" based on non-clinical and clinical performance data, but specific metrics or criteria are not detailed.
Sample size for the test set and data provenance: Not mentioned.
Number of experts used to establish ground truth and qualifications: Not mentioned.
Adjudication method: Not mentioned.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not mentioned. The document focuses on the device's standalone capabilities and its comparison to predicate devices, but no human-in-the-loop study with effect sizes is described.
Standalone (algorithm-only) performance: The device is described as "software for the retrieval, reconstruction, rendering and analysis of digitized ultrasound B-mode images and Color Doppler images" and performs "3- and 4-dimensional morphological and functional analysis of mitral valves." This implies a standalone algorithmic function, but specific performance metrics for this standalone mode are not provided in the summary.
Type of ground truth used: Not explicitly stated. The document refers to "clinical test results" and "morphological and functional assessment," which implies comparison against clinical observations or established diagnostic criteria, but the precise nature of the ground truth (e.g., expert consensus, pathology, outcome data) is not specified.
Sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

Summary

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K103782 P1/3

Image /page/0/Picture/1 description: The image shows the logo for TOMTEC IMAGING SYSTEMS. The logo is in black and white. The word "TOMTEC" is in large, bold letters, with the "O" stylized to look like a circle with a line through it. Below the word "TOMTEC" is the phrase "IMAGING SYSTEMS" in smaller letters.

December 10th, 2010

Special 510(k) Summary

JAN 2 7 2011

4D MV-Assessment 2.0

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 AnalysisSoftware
Classification Name:	Programmable diagnostic computer
Proprietary Name(s):	4D MV-Assessment 2.0

Predicate Devices:

Predicate Device 1	K071232	Image-Arena Platform 3.0; Research-Arena Platform 2.0; Echo-Com 3.0; Image-Com 3.0; 4D Cardio-View 2.0; 4D LV-Analysis 2.5; 4D RV-Function 1.0; 4D MVAssessment 1.2; 4D LV-Function 2.0Only 4D MV-Assessment 1.2component and 4D LV-Analysis 2.5component, TomTec Imaging SystemsGmbH
Predicate Device 2	K090461	Image-Arena 4.0 and Image-ArenaApplications with 2D Cardiac PerformanceAnalysis 1.0TomTec Imaging Systems GmbH

Image /page/0/Picture/14 description: The image shows a series of black, angled lines arranged in a somewhat curved pattern. The lines are short and thick, and they are oriented at various angles, creating a sense of movement or direction. The overall effect is abstract and geometric, with the lines appearing to be stacked or layered on top of each other. The pattern is dense and compact, with little space between the lines.

summary

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K103782 P2/3

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" 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.

Device Description

4D MV-Assessment improves the presentation of anatomy and findings to surgeons and cardiologists and visualizes the complex morphology and dynamics of the mitral valve.

The Generic CAP Interface is used to connect clinical application packages (=CAPs) to platforms to exchange digital medical data.

Intended Use

4D MV Assessment is intended to retrieve, analyze and store digital ultrasound images for computerized 3-dimensional and 4-dimensional (dynamic 3D) image processing.

Indications for use

4D MV-Assessment 2.0 is intended as software to analyze pathologies related to the mitral valve.

Image /page/1/Picture/13 description: The image shows a series of black, angled lines arranged in a somewhat curved pattern. The lines are short and thick, and they are oriented at various angles, creating a sense of movement or flow. The overall impression is abstract and geometric, with the lines forming a dynamic composition. The lines are close together, creating a dense and textured effect.

page 2 of 3

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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. 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.

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

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, December 10th, 2010

Inae Scheidt OM & RA Officer

Image /page/2/Picture/12 description: The image shows a series of black, angled lines arranged in a somewhat circular or spiral pattern. The lines are thick and appear to be of uniform width. The overall impression is abstract, with the lines creating a sense of movement or rotation. The lines are arranged close together, creating a dense and visually complex pattern.

summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle emblem. The eagle is depicted with three wing-like shapes, creating a sense of movement and flight. The overall design is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

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

TomTec Imaging Systems GmbH c/o Ms. Inge Scheidt QM & RA Officer Edisonstrasse 6 85716 Unterschleissheim Unterschleissheim, Germany D-85716

JAN 2 7 201

Re: K103782

Trade/Device Name: 4D MV-Assessment 2.0 Regulation Number: 21 CFR 870.1425 Regulation Name: Programmable Diagnostic Computer Regulatory Class: Class II (two) Product Code: DQK Dated: December 10, 2010 Received: December 27, 2010

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 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.

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Page 2 - Ms. Inge Scheidt

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _ K103782

Device Name:

4D MV-Assessment 2.0

Indications for Use:

MV-Assessment 2.0 is intended as software to analyze pathologies. related to the mitral valve.

Prescription Use
(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)

(Division Sign-Off) 1127/2011 Division of Cardiovascular Devices 510(k) Number_K103782

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).