4D MV-ASSESSMENT 2.0
Device Facts
| Record ID | K103782 |
|---|---|
| Device Name | 4D MV-ASSESSMENT 2.0 |
| Applicant | Tomtec Imaging Systems GmbH |
| Product Code | DQK · Cardiovascular |
| Decision Date | Jan 27, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 870.1425 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for 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. 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.
Device Story
4D MV-Assessment 2.0 is a clinical software application for high-performance PCs running Windows. It retrieves, reconstructs, renders, and analyzes digitized 3D/4D ultrasound B-mode and Color Doppler images. The software generates models of anatomical structures, including the mitral valve (MV) annulus, leaflets, and closure line. It provides automated quantification of valvular function and morphology for pre- and post-operative assessment. Used by cardiologists and surgeons in clinical settings, the software integrates with TomTec Image-Arena platforms via a Generic CAP Interface for database management, reporting, and statistical quantification. By visualizing complex mitral valve dynamics and anatomy, the device assists clinicians in evaluating valvular pathologies and making informed clinical decisions, potentially improving surgical planning and patient outcomes.
Clinical Evidence
No formal clinical trial data provided. The device's product concept was clinically accepted, and performance was validated through internal software verification and validation protocols at the module and system levels. Results support the conclusion that the device is as safe and effective as the predicate devices.
Technological Characteristics
Software-based application for high-performance PCs; Windows OS compatible. Utilizes Generic CAP Interface for data exchange. Performs 3D/4D tomographic reconstruction, rendering, and morphological/functional analysis of ultrasound datasets. Standalone software package; integrates with Image-Arena platforms. No specific hardware materials or energy sources; relies on host PC hardware.
Indications for Use
Indicated for the analysis of pathologies related to the mitral valve in patients undergoing ultrasound imaging.
Regulatory Classification
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.
Predicate Devices
- 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 MV Assessment 1.2; 4D LV-Function 2.0 (K071232)
- Image-Arena 4.0 and Image-Arena Applications with 2D Cardiac Performance Analysis 1.0 (K090461)
Submission Summary (Full Text)
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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 Analysis<br>Software |
|----------------------|-----------------------------------------------|
| 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-<br>Arena Platform 2.0; Echo-Com 3.0; Image-<br>Com 3.0; 4D Cardio-View 2.0; 4D LV-<br>Analysis 2.5; 4D RV-Function 1.0; 4D MV<br>Assessment 1.2; 4D LV-Function 2.0<br>Only 4D MV-Assessment 1.2<br>component and 4D LV-Analysis 2.5<br>component, TomTec Imaging Systems<br>GmbH |
|--------------------|---------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K090461 | Image-Arena 4.0 and Image-Arena<br>Applications with 2D Cardiac Performance<br>Analysis 1.0<br>TomTec Imaging Systems GmbH |
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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® 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.
#### 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.
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.
#### 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.
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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)
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(Division Sign-Off) 1127/2011 Division of Cardiovascular Devices 510(k) Number_K103782
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