K Number

Device Name

SYNGO, CT LIVER ANALYSIS

Manufacturer

SIEMENS MEDICAL SOLUTIONS, INC.

Date Cleared

2014-11-13

(351 days)

Product Code

JAK 90J LLZ

Regulation Number

892.1750

Intended Use

syngo. CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories. Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver. The following evaluation tools are provided: - · Computation and manual correction of liver volumes - · Computation and manual correction of tumor volumes and extent - · Computation and manual correction of liver vessel tree structure - · Computation of territories based on vessel branches - · Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels) - · Manual definition of separation plane proposals - · Computation of volume of liver parts - · Combination of information from different CT and MR phase volumes syngo. CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation. You can use syngo.CT Liver Analysis to create a DICOM Structured Report.

Device Description

synqo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories. The syngo.CT Liver Analysis Software is designed to operate on the most recent syngo.via platform. The task is organized as a linear workflow providing the following task steps (several task steps can be skipped to allow fast processing in cases with limited clinical needs): · Assignment of CT phase volumes relevant for anatomical information · Manual rigid registration of CT phase volumes · Automatic segmentation of liver, interactive manual correction of result · Semi-automatic seqmentation of lesions, interactive manual correction of result · Semi-automatic seqmentation of vasculature, interactive manual correction of result · Manual anatomical classification of vascular objects, calculation and visualization of vascular territories · Interactive definition of parts of the liver and calculation of partial volumes · Inspection of results (2D/3D): · Reporting

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

K061696, K071310

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

Unknown
The document mentions "Automatic segmentation" and "Semi-automatic segmentation" which could potentially utilize AI/ML, but it does not explicitly state that AI/ML is used. The description of the test set mentions testing the "semi-automatic segmentation algorithm," but again, doesn't specify the underlying technology. Without explicit mention of AI, ML, or related terms like neural networks or deep learning, it's impossible to confirm.

Therapeutic

No
The device is an image analysis software used for evaluating liver and vessel structures, calculating volumes, and creating reports. It is a diagnostic tool, not a therapeutic device that treats or cures a disease.

Diagnostic

Yes

The software analyzes CT volume data sets of the liver and its intrahepatic vessel structures, computes and corrects liver and tumor volumes, and defines tumor position in relation to vessels. These functions provide quantitative and visual information that helps clinicians assess and understand the disease status (e.g., changes in liver and tumor volume), which is a key component of diagnosis or monitoring disease progression. While it indicates no direct diagnosis, providing such analytical tools for "image analysis" to "evaluate the liver volume and examine the vessels of the liver" and "facilitates reporting" points towards a diagnostic aid role.

SaMD (Software as a Medical Device)

Yes

The device is described as "image analysis software" and "software for CT volume data sets." The description focuses entirely on software functionalities and its operation on a software platform (syngo.via). There is no mention of accompanying hardware components that are part of the medical device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that syngo.CT Liver Analysis is an image analysis software that processes CT and MR volume data sets. These are medical images, not biological samples.
The analysis is performed on existing medical images. The software analyzes pre-acquired CT and MR scans of the liver and its vessels. It does not involve any testing or analysis of biological specimens.

The device is a medical image analysis software intended to assist clinicians in evaluating and quantifying anatomical structures and lesions within the liver based on imaging data. This falls under the category of medical devices, but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver.

The following evaluation tools are provided:

· Computation and manual correction of liver volumes
· Computation and manual correction of tumor volumes and extent
· Computation and manual correction of liver vessel tree structure
· Computation of territories based on vessel branches
· Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels)
· Manual definition of separation plane proposals
· Computation of volume of liver parts
· Combination of information from different CT and MR phase volumes

syngo. CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation.

You can use syngo.CT Liver Analysis to create a DICOM Structured Report.

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

JAK

Device Description

The task is organized as a linear workflow providing the following task steps (several task steps can be skipped to allow fast processing in cases with limited clinical needs):

· Assignment of CT phase volumes relevant for anatomical information
The user has to decide which anatomical structures need to be evaluated and on which CT series the necessary structures have to be segmented. To assign a CT series to an anatomical structure, the user has to drag and drop a series from the Series Navigator on the anatomical series segment. Wrongly assigned series can also be unassigned if needed. For up to 6 anatomical structures, a proper selection of phase volumes is requested:

1. liver (LIV)
1. tumor (TUM)
1. portal vein (PV)
1. hepatic vein (HV)
1. hepatic artery (HA) and
1. bile ducts (BD) or MR data (view only).

· Manual rigid registration of CT phase volumes
In case more than one CT (or MR) series has been selected, the series have to be manually aligned to each other to match up the liver anatomy, using the manual alignment tool.

· Automatic segmentation of liver, interactive manual correction of result
An automatic segmentation of the liver can be corrected interactively. The outer contour of the liver is displayed. For correcting the automatic segmentation, the user can draw splices where the contour of the segmentation needs to be aligned. Two tools are available to propagate the splices to the liver segmentation.
1. 2D splicing the contour will follow the newly drawn splices on the given slice only. This option gives full control for complex changes.
1. 3D splicing the contour will follow the newly drawn splices and is propagated to neighboring slices. This option is recommended for simple changes to have less correction steps.
· Semi-automatic seqmentation of lesions, interactive manual correction of result
Multiple lesions can be seqmented. All lesions will be listed in the Findings Navigator with name and given volume. To start an initial segmentation, a stroke has to be drawn across the lesion at its largest extent. A 3D segmentation is now computed automatically. To correct the given contour of a lesion, the 3D splicing tool introduced in the liver segmentation step can be used.
· Semi-automatic seqmentation of vasculature, interactive manual correction of result
Up to four vascular objects can be segmented in this task step. The initial segmentation is performed by setting a seed point into the corresponding main vessel entering the liver. The system now automatically starts to segment the whole intrahepatic vascular object. In case many vessels have been misleadingly added, a cut off value can be adjusted interactively. Some vessels still might be missed or misleadingly added by the initial segmentation. To correct this, the user can manually add or delete vessels. By moving the mouse cursor over a subtree of the vascular object, the whole subtree is high-lighted for easier exploration of the segmented structures. This is giving a preview of which subtree would be deleted or reclassified by the corresponding tool. The following tools are available for this feature:
Single click add The user can add additional vessel by setting one seed 1. point into the missing vessel in any orthogonal view in "local" mode.
1. Multi click add - The user starts segmenting a vascular branch by setting one or more seed points into a missing vessel. After setting the first seed point, an interactive line will show where the course of the newly added vessel would be. The last seed point has to be set by making a double click.
1. In cases where HV and PV need to be separated from each other, the tools for adding HV or PV vessels can be used to correct the classification of the vessels. Delete – Any vessel or vessel subtree can be deleted by using the deletion tool.
· Manual anatomical classification of vascular objects, calculation and visualization of vascular territories

The vascular territories can be calculated based on the segmentation of the vascular objects. The calculation will be based on an anatomical labeling of the vascular structure which is provided by the user. The user has to label the subtrees of the segmented vascular objects. Each label also has a predefined color. By moving the mouse cursor over a subtree of the vascular object, the whole subtree is high-lighted. This is giving a preview of which subtree would be colored with the corresponding label. Up to 16 labels can be selected. After all necessary vascular subtrees have been labeled; calculation and visualization of vascular territories can be started.

· Interactive definition of parts of the liver and calculation of partial volumes
The user can inspect the results and interactively define up to three independent separation proposals. A separation proposal can be defined by drawing a contour in one of the orthogonal views or on the 3D liver surface in the VRT segment. After that, two tools are provided to interpolate a separation surface through the given contours. The separation surface can be further adapted by the user by deforming or smoothing it.

· Inspection of results (2D/3D):

At any time the segmented structures and separation surfaces can be reviewed in orthogonal 2D displays and 3D displays. Safety margin around given tumors can also be displayed in 2D and 3D. The margin size can be chosen interactively.

· Reporting

All findings generated by the user as well as calculated volumes and 3D images of the structures are summarized in one report.

Mentions image processing

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

CT, MR

Anatomical Site

Liver

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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

To ensure performance of the semi-automatic segmentation algorithm, the algorithms were tested on clinical data sets. The datasets used were based on variations that can appear for a qiven anatomic structure.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance tests were conducted to test the functionality of the syngo.CT Liver Analysis post processing application. These tests have been performed to test the ability of the included features of syngo.CT Liver Analysis. The results of these tests demonstrate that this application performs as intended. The result of all conducted testing was found acceptable to support the claim 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.

K061696, K071310

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

Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an emblem consisting of three stylized human profiles facing to the right, with flowing lines extending from the profiles.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 13, 2014

Siemens Medical Solutions, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355

Re: K133643

Trade/Device Name: syngo.CT Liver Analysis Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 4, 2013 Received: November 5, 2013

Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

for

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

Enclosure

Indications for Use

510(k) Number (if known) K133643

Device Name syngo.CT Liver Analysis

Indications for Use (Describe)

Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver.

The following evaluation tools are provided:

· Computation and manual correction of liver volumes
· Computation and manual correction of tumor volumes and extent
· Computation and manual correction of liver vessel tree structure
· Computation of territories based on vessel branches
· Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels)
· Manual definition of separation plane proposals
· Computation of volume of liver parts
· Combination of information from different CT and MR phase volumes

syngo. CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation.

You can use syngo.CT Liver Analysis to create a DICOM Structured Report.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The text is a light blue color. The background is white.

510(K) SUMMARY FOR SYNGO.CT LIVER ANALYSIS Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355 Date Prepared: November 7, 2014

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. General Information: Importer/Distributor Establishment: Registration Number: 2240869 Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
  Manufacturing Facility:

Siemens AG; Medical Solutions Henkestraße 127 D-91052 Erlangen, Germany Establishment Registration Number: 3002808157

2. Contact Person:

Ms. Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-4912 Fax: (610) 448-1787 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

Product Name: syngo.CT Liver Analysis Propriety Trade Name: syngo.CT Liver Analysis Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: 90JAK

SIEMENS

1. Legally Marketed Predicate Device: Product Name: IQQA Liver Software Propriety Trade Name: IQQA Liver Software Classification Name: Picture Archiving and Communications System Classification Panel: Radiology CFR Section: 21 CFR §892.2050 Device Class: Class II Product Code: LLZ
  Product Name: syngo.CT Oncology Proprietv Trade Name: svngo.CT Oncology Classification Name: Computed Tomography X-ray System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II Product Code: JAK

5. Indications for Use:

Using syngo.CT Liver Analysis, you can evaluate the liver volume and examine the vessels of the liver.

The following evaluation tools are provided:

Computation and manual correction of liver volumes ●
Computation and manual correction of tumor volumes and extent ●
Computation and manual correction of liver vessel tree structure ●
Computation of territories based on vessel branches ●
Tumor position in relation to vessels (i.e. 3D visualization of liver, tumor and vessels)
Manual definition of separation plane proposals ●
Computation of volume of liver parts ●
Combination of information from different CT and MR phase volumes ●

syngo.CT Liver Analysis facilitates reporting by using of appropriate reporting tools, for example, volume statistics and key image creation.

You can use syngo.CT Liver Analysis to create a DICOM Structured Report.

Image /page/6/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in a light blue color. The background is white, which makes the word stand out.

Substantial Equivalence: 6.

Siemens syngo.CT Liver Analysis post processing software package is substantially equivalent to the following medical devices in commercial distribution as listed in Table 1:

Table 1: Predicate Devices

Manufacturer	Predicate Device	510(k) #	Clearance Date
EDDA	IQQA-Liver Software	K061696	November 13, 2006
Siemens	syngo.CT Oncology Software Package	K071310	June 08, 2007

7. Device Description

The task is organized as a linear workflow providing the following task steps (several task steps can be skipped to allow fast processing in cases with limited clinical needs):

· Assignment of CT phase volumes relevant for anatomical information

The user has to decide which anatomical structures need to be evaluated and on which CT series the necessary structures have to be segmented. To assign a CT series to an anatomical structure, the user has to drag and drop a series from the Series Navigator on the anatomical series segment. Wrongly assigned series can also be unassigned if needed. For up to 6 anatomical structures, a proper selection of phase volumes is requested:

1. liver (LIV)
1. tumor (TUM)
1. portal vein (PV)
1. hepatic vein (HV)
1. hepatic artery (HA) and
1. bile ducts (BD) or MR data (view only).

· Manual rigid registration of CT phase volumes

In case more than one CT (or MR) series has been selected, the series have to be manually aligned to each other to match up the liver anatomy, using the manual alignment tool.

· Automatic segmentation of liver, interactive manual correction of result An automatic segmentation of the liver can be corrected interactively. The outer contour of the liver is displayed. For correcting the automatic segmentation, the user can draw splices where the contour of the segmentation needs to be

Image /page/7/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The background is white.

aligned. Two tools are available to propagate the splices to the liver segmentation.

1. 2D splicing the contour will follow the newly drawn splices on the given slice only. This option gives full control for complex changes.
1. 3D splicing the contour will follow the newly drawn splices and is propagated to neighboring slices. This option is recommended for simple changes to have less correction steps.
· Semi-automatic seqmentation of lesions, interactive manual correction of result

Multiple lesions can be seqmented. All lesions will be listed in the Findings Navigator with name and given volume. To start an initial segmentation, a stroke has to be drawn across the lesion at its largest extent. A 3D segmentation is now computed automatically. To correct the given contour of a lesion, the 3D splicing tool introduced in the liver segmentation step can be used.

· Semi-automatic seqmentation of vasculature, interactive manual correction of result
Up to four vascular objects can be segmented in this task step. The initial segmentation is performed by setting a seed point into the corresponding main vessel entering the liver. The system now automatically starts to segment the whole intrahepatic vascular object. In case many vessels have been misleadingly added, a cut off value can be adjusted interactively. Some vessels still might be missed or misleadingly added by the initial segmentation. To correct this, the user can manually add or delete vessels. By moving the mouse cursor over a subtree of the vascular object, the whole subtree is high-lighted for easier exploration of the segmented structures. This is giving a preview of which subtree would be deleted or reclassified by the corresponding tool. The following tools are available for this feature:
Single click add The user can add additional vessel by setting one seed 1. point into the missing vessel in any orthogonal view in "local" mode.
1. Multi click add - The user starts segmenting a vascular branch by setting one or more seed points into a missing vessel. After setting the first seed point, an interactive line will show where the course of the newly added vessel would be. The last seed point has to be set by making a double click.
1. In cases where HV and PV need to be separated from each other, the tools for adding HV or PV vessels can be used to correct the classification of the vessels. Delete – Any vessel or vessel subtree can be deleted by using the deletion tool.
· Manual anatomical classification of vascular objects, calculation and visualization of vascular territories

Image /page/8/Picture/0 description: The image contains the word "SIEMENS" in all capital letters. The text is displayed in a teal color. The font appears to be sans-serif and bolded.

color. By moving the mouse cursor over a subtree of the vascular object, the whole subtree is high-lighted. This is giving a preview of which subtree would be colored with the corresponding label. Up to 16 labels can be selected. After all necessary vascular subtrees have been labeled; calculation and visualization of vascular territories can be started.

· Interactive definition of parts of the liver and calculation of partial volumes
The user can inspect the results and interactively define up to three independent separation proposals. A separation proposal can be defined by drawing a contour in one of the orthogonal views or on the 3D liver surface in the VRT segment. After that, two tools are provided to interpolate a separation surface through the given contours. The separation surface can be further adapted by the user by deforming or smoothing it.

· Inspection of results (2D/3D):

· Reporting

All findings generated by the user as well as calculated volumes and 3D images of the structures are summarized in one report.

Summary of Technical Characteristics of the Subject Device as Compared 8. with the Predicate Device:

syngo.CT Liver Analysis application is designed to be operated on the syngo.via platform in a single or multi user environment. syngo.CT Liver Analysis software package provides the same evaluation tools and functionality as the predicate devices. syngo.CT Liver Analysis does not have significant changes in technological characteristics when compared to the predicate devices. The intended use is the same and the scientific technology is similar; therefore Siemens believes that syngo.CT Liver Analysis is substantially equivalent to the predicate devices. Table 2 below provides a comparison of the main features of syngo.CT Liver Analysis in comparison to the predicate devices.

| Property | syngo.CT Liver
Analysis | IQQA Liver
Software | Syngo CT
Oncology
Package | | |
|--------------------|-------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------|--|--|
| Organ Segmentation | Pre-Processing for
complete liver
segmentation and
manual corrections
of liver
segmentation. | Interactive
segmentation of
the liver. | N/A | | |

Table 2: Summary of Differences between Subject Device and Legally Marketed Predicate Devices

SIEMEN

| Property | syngo.CT Liver
Analysis | IQQA Liver
Software | Syngo CT
Oncology
Package |
|---------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Lesion Segmentation | Semi-automated
segmentation of
liver lesions. | Interactive
segmentation of
lesions. | Segmentation and
volumetric
evaluation of
suspicious lesions
including
dedicated tools for
lung, liver and
lymph node
assessment. |
| Segmentation of
Tubular Structures | Semi-automated
segmentation of
arterial, portal
venous and
venous vascular
bile ducts tree. | Interactive
segmentation of
vascular
structures. | N/A |
| Organ Territories | 3D semi-
automated
mapping of
vascular territories
onto liver tissue. | Interactive
segmentation of
liver segments. | N/A |
| Organ Separation | Virtual separation
planes and
subsequent
volumetric
calculation of liver
parts. | Virtual separation
planes and
subsequent
volumetric
calculation of liver
parts. | N/A |
| Primary Organ
Displayed | Liver | Liver | lesions with focus
on lung, liver and
lymph nodes |

9. Nonclinical Testing:

syngo.CT Liver Analysis 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
(Digital Imaging and Communications in Medicine) Standard: · DICOM 2008DICOM conformity is fully covered by syngo.via implementations.

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This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests were conducted for syngo.CT Liver Analysis during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

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.

Software Verification and Validation

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.

Summary

10. 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.

11. Conclusion as to Substantial Equivalence:

The syngo.CT Liver Analysis has a similar indication for use as the predicate devices. syngo.CT Liver Analysis is an image analysis software for CT volume data sets. It analyses the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver. These regions can be evaluated by exploring the volume of the liver and its vascular territories, patient radiology images, or data by the clinician using the same functionalities as the cleared predicate.

Image /page/11/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The text is a light blue color, and the background is white. The word is written in all capital letters and is centered in the image.

It is Siemens opinion, that the syngo.CT Liver Analysis Software is substantially equivalent to the predicate devices listed in Table 1. The modifications included in the comparison table and described throughout this submission do not alter the Intended use or fundamental scientific technology of the legally marketed predicate devices. The differences between the legally marketed predicate devices and the subject device have been assessed via Verification and Validation as well as Risk Management. Any differences in technological characteristics are accompanied by information within this submission that demonstrates the device is as safe and effective as the predicate devices and do not raise different questions of safety and effectiveness than the predicate.