K Number

Device Name

SYNGO, CT CARDIAC FUNCTION

Manufacturer

SIEMENS MEDICAL SOLUTIONS USA, INC.

Date Cleared

2012-12-20

(29 days)

Product Code

JAK SYN

Regulation Number

892.1750

Intended Use

syngo.CT Cardiac Function is an image analysis software package for evaluating CT images of the heart. Combining digital image processing and visualization tools (2D, 3D and 4D display of dynamic data), evaluation tools (structural and functional analysis of heart chambers and valves, and analysis of myocardial tissue) and reporting tools, the software package is designed to support the physician in determining the functional and morphological parameters of the heart chambers, heart valves and confirming the presence or absence of physician-identified myocardial disease and evaluation, documentation and follow-up of any such finding.

Device Description

syngo.CT-Cardiac Function is a dedicated application for cardiac and vascular post processing. Accordingly, syngo.CT-Cardiac Function has been designed in order to support diagnosis of cardiovascular lesions with a particular focus on conditions affecting cardiac function. syngo.CT Cardiac Function includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images, and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped into the following categories: Basic reading: commodity features that are commonly available on CT cardiac post-processing workstations. Advanced reading: additional features for increased user support during CT cardiac post-processing. If results are not as expected by the user (e.g. due to bad image quality caused by image artifacts, such as: noise, pacemaker artifacts, stair steps, wrong contrast timing, etc), he or she can easily modify the computations or discard them and do a manual diagnosis. The corresponding information will be kept in the reporting object which is stored in the syngo via database.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K110366, K112020, K113027

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes standard image processing and analysis tools without mentioning AI or ML. The user has full control and can manually modify or discard computations, which is not typical of autonomous AI/ML systems.

Therapeutic

No
The device is an image analysis software package designed to support physicians in diagnosis and evaluation of heart conditions, not for direct therapeutic intervention.

Diagnostic

Yes
The device is described as "designed to support the physician in determining the functional and morphological parameters of the heart chambers, heart valves and confirming the presence or absence of physician-identified myocardial disease and evaluation, documentation and follow-up of any such finding" and "designed in order to support diagnosis of cardiovascular lesions." These phrases clearly indicate its role in diagnosis.

SaMD (Software as a Medical Device)

Yes

The device is described as an "image analysis software package" and a "dedicated application" for post-processing CT images. The description focuses entirely on software features and functionalities for analyzing and visualizing cardiac CT data. There is no mention of any accompanying hardware components that are part of the device itself.

IVD (In Vitro Diagnostic)

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 description clearly states that syngo.CT Cardiac Function is an image analysis software package that processes CT images of the heart. It does not analyze biological samples.
Intended Use: The intended use is to support physicians in evaluating the structure and function of the heart based on imaging data, not laboratory test results.

Therefore, syngo.CT Cardiac Function falls under the category of medical imaging software, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

90JAK

Device Description

syngo.CT Cardiac Function includes tools that support the clinician at different steps during diagnosis, including reading and reporting. The user has full control of the reported measurements and images, and is able to choose the appropriate function suited for their clinical need. Features included in this software that aid in diagnosis can be grouped into the following categories:

. Basic reading: commodity features that are commonly available on CT cardiac post-processing workstations.
Advanced reading: additional features for increased user support . during CT cardiac post-processing.

If results are not as expected by the user (e.g. due to bad image quality caused by image artifacts, such as: noise, pacemaker artifacts, stair steps, wrong contrast timing, etc), he or she can easily modify the computations or discard them and do a manual diagnosis. The corresponding information will be kept in the reporting object which is stored in the syngo via database.

Mentions image processing

syngo.CT Cardiac Function uses current image processing algorithms in order to provide results that are substantially equivalent to those obtained with the predicate devices.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT images

Anatomical Site

heart

Indicated Patient Age Range

Not Found

Intended User / Care Setting

physician

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 were 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110366, K112020, K113027

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

Special 510(k) Submission: syngo.CT Cardiac Function

DEC 2 0 2012

510(K) SUMMARY FOR SYNGO. CT CARDIAC FUNCTION

Submitted by:

Siemens Medical Solutions USA, Inc.

51 Valley Stream Parkway

Malvern, PA 19355

Date Prepared: November 16, 2012

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.

1. Contact Person:

Mrs. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com

2. Device Name and Classification

Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

syngo.CT Cardiac Function syngo.CT Cardiac Function Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

Special 510(k) Submission: syngo.CT Cardiac Function

3. Substantial Equivalence:

Siemens syngo.CT Cardiac Function post processing software package is substantially equivalent to the following medical devices in commercial distribution:

| Predicate Device Name | FDA Clearance
Number | FDA Clearance Date |
|---------------------------------------|-------------------------|--------------------|
| Siemens syngo.CT Cardiac
Function | K110366 | 12/04/2011 |
| Siemens syngo.CT Vascular
Analysis | K112020 | 08/18/2011 |
| Siemens syngo. Aortic Valve Guide | K113027 | 11/22/2011 |

4. Device Description:

. Basic reading: commodity features that are commonly available on CT cardiac post-processing workstations.
Advanced reading: additional features for increased user support . during CT cardiac post-processing.

1. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
  syngo.CT Cardiac Function is a post-processing software package which provides a combination of functionality similar to functionality provided by

Special 510(k) Submission: syngo.CT Cardiac Function

the predicate devices. It uses the same data for evaluation as the predicate devices and provides results in the same format as the predicate devices.

As core functionality, syngo.CT Cardiac Function uses basic reading, image display and evaluation functionality as provided by the predicate device syngo.CT Cardiac Function (K110366, clearance date12/04/2011). In addition to this core functionality, syngo.CT Cardiac Function provides workflow improvements to support the user in repetitive tasks and provides extended support for the visualization of first pass relative enhancement. Similar to the predicate devices, syngo Aortic ValveGuide (K113027, clearance date 11/22/2011) and syngo.CT Vascular Analysis (K112020, clearance date 08/18/2011), syngo.CT Cardiac Function enables the user to visualize the aortic root allowing the measurement of its morphological characteristics.

Accordingly, synqo.CT Cardiac Function has similar technological characteristics as the predicate devices. syngo.CT Cardiac Function uses current image processing algorithms in order to provide results that are substantially equivalent to those obtained with the predicate devices.

syngo.CT Cardiac Function is designed to be operated on syngo.via VA20 platform in a single or multi user environment.

6. Nonclinical 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.via implementations.

Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

Special 510(k) Submission: syngo.CT Cardiac Function

7. Indications for Use:

8. 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 during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

க் Conclusion as to Substantial Equivalence

In summary, Siemens is of the opinion that the syngo.CT Cardiac Function software package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 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 is evenly spaced around the circle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 20, 2012

Siemens Medical Systems, Inc. % Mrs. Kimberly Mangum 51 Valley Stream Parkway Malvern, PA 19355

Re: K123585

Trade/Device Name: syngo.CT Cardiac Function Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 14, 2012 Received: November 21, 2012

Dear Mrs. Mangum:

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.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase of act hour 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 or any I vith 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 dorth 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.

Page 2 - Kimberly Mangum

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 Diagnostics and Radiological Health 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,

Janine M. Morris -S

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Special 510(k) Submission: syngo.CT Cardiac Function

510(k) Number (if known): _ K123585

Device Name:

syngo.CT Cardiac Function

Indications for Use:

syngo.CT Cardiac Function is an image analysis software package for evaluating CT images of the heart. Combining digital image processing and visualization tools (2D, 3D and 4D display of dynamic data), evaluation tools (structural and functional analysis of heart chambers and valves, and analysis of myocardial tissue) and reporting tools, the software package is designed to support the physician in determining the functional and morphological parameters of the heart chambers, heart valves and confirming the presence of physicianidentified myocardial disease and evaluation, documentation and follow-up of any such finding.

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 In Vitro Diagnostics and Radiological Health · (OIR)

Janine M. Morris -S 2012.12.20 18:59:33 -05.00