(68 days)
Not Found
No
The description mentions a "semi-automatic 3D surface model finding algorithm" but does not use terms like AI, ML, deep learning, or neural networks, nor does it describe characteristics typically associated with AI/ML model development (training/test sets, performance metrics like AUC).
No.
The device is described as software for analyzing ultrasound images of the left ventricle to assess dyssynchrony, which is a diagnostic function, not a therapeutic one.
Yes
The device processes ultrasound images for analysis of the left ventricle to quantify dyssynchrony and improve functional analysis, which directly supports a medical diagnosis.
Yes
The device is described as a "software package" that runs on "high performance PC platforms based on Microsoft Windows operating system standards." It performs analysis of existing digital ultrasound images and does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The 4D LV-Analysis software processes and analyzes digital ultrasound images of the left ventricle. It does not analyze biological samples from the patient.
- Intended Use: The intended use is for analyzing ultrasound images for cardiology, specifically the left ventricle in heart failure patients. This is an image processing and analysis tool, not a diagnostic test performed on a biological sample.
Therefore, while it is a medical device used for diagnostic purposes in a clinical setting, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Intended Use: 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.
Indications for Use: 4D LV-Analysis 3.0 is intended as software for analysis of the left ventricle in heart failure patients.
Product codes
DOK, LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound B-mode images, digital 3D/4D image file formats for reprocessing to a proprietary 3D/4D image file format
Anatomical Site
left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
cardiologists and electro-physiologists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 System
Software |
| -------------- | ------------------------------------------- |
|---|
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 MV
Assessment 1.x; 4D LV-Function 2.x
Only 4D LV-Analysis 2.5x component,
TomTec Imaging Systems GmbH |
|--------------------|---------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate Device 2 | K090461 | Image-Arena 4.0 and Image-Arena
Applications
Only 2D Cardiac Performance Analysis
1.0 component, TomTec Imaging
Systems GmbH |
| Predicate Device 3 | K082596 | USWS-900A; UltraExtend Ultrasound
WorkStation Package
Only ACP component
Toshiba 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.
1
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
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.
Intended Use
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.
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.
2
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.
3
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
4
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
5
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)
i
(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