(64 days)
No
The summary describes standard image processing and visualization techniques for cardiac CT data analysis and does not mention AI or ML.
No
The device is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets, designed to support physicians in determining functional parameters and evaluating myocardial enhancement defects. It does not exert any direct therapeutic action on the patient.
Yes
The "Intended Use / Indications for Use" section states that the software is designed to support physicians in "determining the functional parameters of the left and right ventricles, confirming the presence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding" and to "help the physician classify conspicuous regions of tissue." These functions are directly related to identifying and characterizing medical conditions, which falls under the definition of a diagnostic device.
Yes
The device is explicitly described as an "image analysis software package" and its functions are solely related to processing and analyzing existing CT image data. There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: Syngo.CT Cardiac Function is an image analysis software package that processes imaging data (CT angiography). It does not analyze biological samples taken from the body.
- Intended Use: The intended use is to support physicians in evaluating cardiac CT images, calculating functional parameters, and assessing myocardial enhancement defects. This is based on interpreting visual information from the images, not on analyzing biological markers in a sample.
Therefore, while it is a medical device used for diagnosis and evaluation, it falls under the category of medical imaging software rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac.CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.
These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.
Product codes
90 JAK
Device Description
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.
These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT)
Anatomical Site
Cardiac, Left and right ventricles, Myocardium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / Not Found
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)
Non clinical tests are conducted for syngo. CT Cardiac Function software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K063762, K092519, K073153, K073138
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
KI10366
SIEMENS
510(k)
Section 8
APR 1 2 2011
510(k) - Summarv
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
l. GENERAL INFORMATION
· 1. Device Name and Classification
Product Name: syngo.CT Cardiac Function Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology 21 CFR §892:1750 CFR Section: Device Class: Class II Product Code: 90 JAK
2: lmporter/Distributor Establishment: Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
3. Manufacturing Facility:
Siemens AG Medical Solutions Henkestrasse 127
D-91052 Erlangen, Germany
4. Contact Person:
Mr. Ralf Hofmann Regulatory Affairs Specialist Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-8170 Fax: +49 9191 18-9782
-
- Date of Preparation of Summary: Mar. 23d 2011
510(k) submission for SIEMENS ' syngo.CT Cardiac Function (CT-CFA)
- Date of Preparation of Summary: Mar. 23d 2011
1
SIEMENS
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
6. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
7. Device Description and Intended Use:
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.
These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.
8. Substantial Equivalence:
syngo.CT Cardiac Function software package, designed for post processing images that have been continuously acquired with computed tomography (CT) imaging systems which meet certain minimal requirements, is substantially equivalent to the following devices:
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens AG | syngo® Circulation | K063762 | 01/05/2007 |
| 2. Siemens AG | syngo®.x | K092519 | 08/27/2009 |
| 4. GE Medical Systems | CardIQ Function Xpress | K073153 | 02/26/2008 |
| 5. GE Medical Systems | CardIQ Xpress 2.0 | K073138 | 02/26/2008 |
, Ki
2
SIEMEN
ல் Summary of Technological Characteristics of the Principle Device as Compared with the Predicate Devices
syngo.CT Cardiac Function is a post-processing software package which provides a combination of functionality similar to functionality provided by one or more of the predicate devices as listed below. It uses the same data for evaluation as the predicate devices and provides results in the same format as the predicate devices.
As basis for data viewing, syngo. CT Cardiac Function uses basic reader and image display functionality as provided by syngo .x. In addition to basic viewing capabilities, syngo.CT Cardiac Function provides tools for visualization, analysis and reporting of cardiac function conditions. These tools are based on segmentation of cardiovascular structures such as coronary arteries and heart chambers. Accordingly, syngo.CT Cardiac Function has equivalent technological characteristics as the predicate devices. Moreover, syngo:CT Cardiac Function uses current image processing algorithms, in order to provide results that are substantially equivalent to those obtained with one or more of the predicate devices.
| syngo.CT
Cardiac Function | Description | Comparison to predicate
devices |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Basic Reading
Functionality | Conventional navigation on 2D and 3D views,
change of layouts, adapt window values | Same |
| Cardiac, Aortic Valve
and Mitral Valve
Planes | Rotate MPR planes to short/long axis, aortic or
mitral plane views | Extended. Additional planes for
aortic and mitral valve. |
| Review Marker | Functionality for setting location of a clinical finding
on any view | Extended. Additional bookmarking
functionality. |
| Integrated Reporting
(Reporting Tools) | Functionality for editing values of clinical findings
such as location, pathology, etc | Same |
| Heart Isolation | Masking of structures around the heart | Same |
| 4D Movie and Movie
Series | Start/stop movie and adjust all views. Select MPR
views for movie series | Extended. Storage for movie
series added. |
| 4D Chamber Modeling
and Contouring | Contouring of heart chambers contours, edit and
correction of contouring | Extended. Added editing
functions. |
| 4D Left Ventricle
Analysis | Volumetry of left ventricle over complete heart
cycle. Selection of volumetry mode. | Extended. Added support for dual
analysis mode. |
| Dynamic Volume
Graph | Volume graph over heart cycle. | Same |
| Functional Parameters | Measurement of global and local cardiac function
parameters. | Extended. Additional display
options. |
| Polar Maps | Bulls-eye plots for display of local cardiac function
parameters. | Same |
| 4D Right Ventricular
Analysis | Volumetry of right ventricle over complete heart
cycle. | Same |
| Vizualization of relative
Enhancement in
Myocardium | Colouring of left ventricular myocardium based on
relative HU enhancement. | Same . |
| Delayed Relative
Enhancement View | Colouring of left ventricular myocardium based on
HU enhancement. | Same |
| Hybrid View | VRT visualization of coronary anatomy combined
with local functional parameters in a single view. | Extended. Left ventricular
epicardial model added to VRT. |
| DICOM compatible | | Same |
3
SIEMENS
Siemens is of the opinion that syngo.CT Cardiac Function software package is intended for the same indications for use as the predicate devices. It does not introduce any new potential safety risk and is substantial equivalent to and performs as well as the predicate devices.
10. Summary of non-clinical and/or clinical testing
syngo.CT Cardiac Function is designed to fulfill the requirements of following standards
- IEC 60601-1-6 : 2006; Medical electrical equipment Part 1-6: General requirements . for basic safety and essential performance - Collateral Standard: Usability
- . IEC 62304 Ed. 1.0, "Medical Device Software - Software Lifecycle Processes"
- ISO 14971:2007; Medical devices Application of risk management to medical devices .
- DICOM (Digital Imaging and Communications in Medicine) Standard: 2008 . DICOM conformity is fully covered by syngo x implementations.
Non clinical tests are conducted for syngo. CT Cardiac Function software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.
Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font. 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
Siemens AG Medical Solutions % Mr. Norbert Stuiber Responsible Third Party Official, 510(k) TPR Program Manager TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K110366
APR 1 2 2011
Trade/Device Name: syngo.CT Cardiac Function Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 4, 2011 Received: April 7, 2011
Dear Mr. Stuiber:
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
5
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. Pastel
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
6
Indication for use
510(k) Number (if known):
Device Name:
syngo.CT Cardiac Function
Syngo.CT Cardiac Function is an image analysis software package for evaluating cardiac.CT angiography (CTA) volume data sets. Combining digital image processing and visualization tools (multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP) thin/thick, inverted MIP thin/thick, volume rendering technique (VRT)), evaluation tools (left and right ventricular (LV/RV) volume calculation, left ventricular myocardial wall calculation and visualization of myocardial enhancement by color coding of hypo-/hyperdense areas) and reporting tools (finding location, finding characteristics and key images), the software package is designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence of physician-identified myocardial enhancement defects and evaluation, documentation and follow-up of any such finding.
These visualization/evaluation tools allow for quantification of functional parameters and characterization of myocardial enhancements defects over time, helping the physician to assess any changes. It is also designed to help the physician classify conspicuous regions of tissue.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (Part 21 CFR 801 Subpart C)
(Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
DRH, Office of In Vitro Diagnostic Devices (OIVD)
uy S. Patel
Office of In Vitro Diagnostic Devic
510(k) K110366
Section 2