SYNGO.CT CARDIAC FUNCTION

K110366 · Siemens AG · JAK · Apr 12, 2011 · Radiology

Device Facts

• Record ID: K110366
• Device Name: SYNGO.CT CARDIAC FUNCTION
• Applicant: Siemens AG
• Product Code: JAK · Radiology
• Decision Date: Apr 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

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 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.

Device Story

Software package for post-processing cardiac CT angiography (CTA) volume data; utilizes digital image processing, multiplanar reconstruction (MPR), maximum/minimum intensity projection (MIP), and volume rendering (VRT). Performs left/right ventricular volume calculation, myocardial wall analysis, and color-coded visualization of hypo-/hyperdense myocardial areas. Used by physicians in clinical settings to quantify cardiac function, characterize enhancement defects, and classify tissue regions. Output includes functional parameters, polar maps, and clinical reports to assist in diagnosis, documentation, and longitudinal follow-up of cardiac conditions.

Clinical Evidence

Bench testing only. Software verification and validation testing conducted to ensure compliance with software specifications and risk control measures. No clinical data presented.

Technological Characteristics

Post-processing software package; DICOM compatible. Features include MPR, MIP, VRT, and segmentation of cardiovascular structures. Operates on standard CT imaging data. Adheres to IEC 62304 (software lifecycle), IEC 60601-1-6 (usability), and ISO 14971 (risk management).

Indications for Use

Indicated for use by physicians to evaluate cardiac CT angiography volume data sets, determine functional parameters of left and right ventricles, confirm myocardial enhancement defects, and document/follow-up findings.

Regulatory Classification

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.

Predicate Devices

• syngo® Circulation (K063762)
• syngo®.x (K092519)
• CardIQ Function Xpress (K073153)
• CardIQ Xpress 2.0 (K073138)

Submission Summary (Full Text)

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## 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: [phone] Fax: [phone]

- 5. Date of Preparation of Summary: Mar. 23d 2011
510(k) submission for SIEMENS ' syngo.CT Cardiac Function (CT-CFA)

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# 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

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## 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<br>Cardiac Function | Description | Comparison to predicate<br>devices |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Basic Reading<br>Functionality | Conventional navigation on 2D and 3D views,<br>change of layouts, adapt window values | Same |
| Cardiac, Aortic Valve<br>and Mitral Valve<br>Planes | Rotate MPR planes to short/long axis, aortic or<br>mitral plane views | Extended. Additional planes for<br>aortic and mitral valve. |
| Review Marker | Functionality for setting location of a clinical finding<br>on any view | Extended. Additional bookmarking<br>functionality. |
| Integrated Reporting<br>(Reporting Tools) | Functionality for editing values of clinical findings<br>such as location, pathology, etc | Same |
| Heart Isolation | Masking of structures around the heart | Same |
| 4D Movie and Movie<br>Series | Start/stop movie and adjust all views. Select MPR<br>views for movie series | Extended. Storage for movie<br>series added. |
| 4D Chamber Modeling<br>and Contouring | Contouring of heart chambers contours, edit and<br>correction of contouring | Extended. Added editing<br>functions. |
| 4D Left Ventricle<br>Analysis | Volumetry of left ventricle over complete heart<br>cycle. Selection of volumetry mode. | Extended. Added support for dual<br>analysis mode. |
| Dynamic Volume<br>Graph | Volume graph over heart cycle. | Same |
| Functional Parameters | Measurement of global and local cardiac function<br>parameters. | Extended. Additional display<br>options. |
| Polar Maps | Bulls-eye plots for display of local cardiac function<br>parameters. | Same |
| 4D Right Ventricular<br>Analysis | Volumetry of right ventricle over complete heart<br>cycle. | Same |
| Vizualization of relative<br>Enhancement in<br>Myocardium | Colouring of left ventricular myocardium based on<br>relative HU enhancement. | Same . |
| Delayed Relative<br>Enhancement View | Colouring of left ventricular myocardium based on<br>HU enhancement. | Same |
| Hybrid View | VRT visualization of coronary anatomy combined<br>with local functional parameters in a single view. | Extended. Left ventricular<br>epicardial model added to VRT. |
| DICOM compatible | | Same |

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## 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.

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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

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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 [phone]. 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 [phone] or [phone] 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

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### Indication for use

510(k) Number (if known):

K110366

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