syngo.CT Clinical Extensions by Siemens Medical Solutions USA, Inc.

syngo.CT Clinical Extensions is a software bundle that offers tools to support special clinical evaluations. syngo.CT Clinical Extensions can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners). syngo.CT Clinical Extensions is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Extended Functionality and includes the following modifications in comparison to the primary predicate device:

1. New Marketing Name: syngo.CT Clinical Extensions
1. Modified Indications for Use Statement
1. Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Vascular Tool modification:
  - i. Modified Coronary Vessel Tracing Support
  - ii. Heart and Coronary Tree Isolation Tools
  - iii. Support of MR data
  - iv. Support of additional workflow improvement visualization tools
- b. Oncology Tool modification:
  - i. Support of Mean Diameter Value
  - ii. Support of Lung Lesion Segmentation Tool
- ﻥ Support of Dual Energy Tool
- Support of Endoscopic View Tool ರ
- Editing of Pre-generated Results e.

AI/ML Overview

The provided text is a 510(k) summary for the syngo.CT Clinical Extensions device, which is a software bundle for advanced visualization and measurement of medical images. Based on the document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of quantitative acceptance criteria for device performance. Instead, it states that "The testing supports that all software specifications have met the acceptance criteria" and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence."

The device's performance is reported in a comparative manner, asserting substantial equivalence to predicate devices based on:

Functionality: The subject device offers an extension of previously cleared post-processing application software, including modifications to the Vascular Tool and Oncology Tool, and support for additional functionalities like Dual Energy Tool and Endoscopic View Tool.
Technological Characteristics: The subject device uses the same or similar technological characteristics as the predicate devices, with differences noted as not raising "different questions of safety and effectiveness."
Safety and Effectiveness: "Test results show that the subject device, syngo.CT Clinical Extensions are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness."

Summary of Reported Performance (Qualitative, based on stated substantial equivalence):

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence (to predicate device, with enhancements)	The device performs all functionalities of the predicate syngo.CT Extended Functionality, with added features such as modified Coronary Vessel Tracing Support, Heart and Coronary Tree Isolation Tools, support for MR data in Vascular Tool, Mean Diameter Value and Lung Lesion Segmentation in Oncology Tool, and support for Dual Energy Tool and Endoscopic View Tool.
Safety (no new safety concerns compared to predicate)	No new safety concerns are raised compared to the predicate device. Risk analysis was completed, and risk controls were implemented to mitigate identified hazards. Conforms to relevant safety standards.
Effectiveness (as safe and effective as predicate)	As effective as the predicate devices for its intended use, providing advanced visualization and measurement tools for diagnostic purposes.
Software Specifications Adherence	All software specifications have met the acceptance criteria.
Conformance to Standards	Conformance to various industry standards (DICOM, IEC 62304, ISO 14971, IEC 62366-1, AAMI / ANSI ES60601-1) is claimed.
Adherence to Cybersecurity Requirements	Conforms to cybersecurity requirements as per FDA guidance.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size (number of images or cases) used for the test set.

Data provenance is also not explicitly stated in terms of country of origin or whether it was retrospective or prospective. The statement "The subject device is also tested using the same methods as used for the predicate devices" implies that similar types of data as used for predicate devices (likely retrospective clinical images) were utilized for testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not mention the number of experts used or their specific qualifications for establishing ground truth for the test set. It describes the device as supporting "trained technicians or physicians in diagnosis," implying that the expected users are medical professionals, but it doesn't detail how the ground truth for testing was established. Given the nature of a 510(k) for a software update/bundle, it's possible that the "ground truth" was established by comparing the software's output with existing, clinically accepted measurements or visualizations, rather than through independent expert consensus on raw images.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1) for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The document does not mention an MRMC comparative effectiveness study comparing human readers with AI vs. without AI assistance. The submission focuses on the software's performance against its own specifications and its equivalence to predicate devices, rather than a human-in-the-loop performance study.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) was Done

The testing described appears to be primarily focused on the standalone performance of the algorithm/software functionalities. "Non-clinical tests (integration and functional) were conducted... Performance tests were conducted to test the functionality... The results of these tests demonstrate that the subject device performs as intended." This implies testing the software's ability to process images, perform measurements, and generate visualizations accurately, which is a standalone evaluation of its capabilities.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used. However, given the device's function (advanced visualization and quantitative measurements), the ground truth for the "functional" and "performance" tests would likely involve:

Reference Measurements: Comparing the software's quantitative measurements (e.g., vessel diameter, lesion mean diameter, bone mineral content) against established or known values, or measurements performed by validated methods/tools.
Visual Fidelity: Assessing the accuracy and clinical utility of the advanced visualizations in comparison to a reference standard.
Software Specifications: Meeting predefined software specifications for each tool's output and behavior.

It is unlikely to be pathology or outcomes data, as this device primarily focuses on image processing and measurement for diagnosis assistance rather than direct disease detection or prognosis.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This is typical for a 510(k) for a software platform that bundles existing functionalities and adds incremental updates. While the underlying algorithms within these functionalities might have been developed using training data, this specific 510(k) submission does not detail the training set for the syngo.CT Clinical Extensions bundle itself. The changes described (e.g., "Semi-automatic vessel tracing tool that allows tracing with less user-interaction") suggest algorithmic improvements, which would benefit from training data, but the specifics are not provided in this summary.

9. How the Ground Truth for the Training Set Was Established

Since a training set is not mentioned, the method for establishing its ground truth is also not described.

Summary

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March 8, 2018

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Blvd., 65-1A MALVERN PA 19355

Re: K173625

Trade/Device Name: syngo.CT Clinical Extensions Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 30, 2018 Received: February 1, 2018

Dear Ms. Mangum:

We have reviewed vour 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 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Robert Sauer

for Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K173625

Device Name

syngo.CT Clinical Extensions

Indications for Use (Describe)

An interface shall enable the connection between the syngo.CT Clinical Extensions software package and the interconnected CT Scanner system.

Result images created with the syngo. CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY FOR SYNGO.CT CLINICAL EXTENSIONS Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: March 6, 2018

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. Submitter

Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number 2240869

Manufacturing Site

Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen, Germany Establishment Registration Number 3004977335

Contact Person

Kimberly Manqum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com

II. Device Name and Classification

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

III. Predicate Device Primary Predicate Device:

Trade Name:	syngo.CT Extended Functionality
510(k) Number:	K163341
Clearance Date:	02/09/2017
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	This predicate has not been subject to a design-related recall

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Secondary Predicate Device:

Trade Name:	syngo.CT Single Source Dual Energy
510(k) Number:	K150745
Clearance Date:	08/11/2015
Classification Name:	System, Image Processing, Radiological
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	This predicate has not been subject to a design-related recall

Secondary Predicate Device:

Trade Name:	syngo Fly Through
510(k) Number:	K971717
Clearance Date:	09/03/1997
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	This predicate has not been subject to a design-related recall

Secondary Predicate Device:

Trade Name:	syngo.MR Vascular Analysis
510(k) Number:	K130749
Clearance Date:	08/20/2013
Classification Name:	System, Image Processing, Radiological
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.2050
Device Class:	Class II
Product Code:	LLZ
Subsequent Product Code	LNH
Recall Information:	This predicate has not been subject to a design-related recall

Reference Device:

Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:

syngo.PET&CT Oncology K093621 02/23/2010 System, Image Processing, Radiological Radiology 21 CFR § 892.2050 Class II LLZ This reference device has not been subject to a design-related recall

Reference Device:

Trade Name: 510(k) Number: Clearance Date: Classification Name: Classification Panel: CFR Section: Device Class: Product Code: Recall Information:

syngo.CT Coronary Analysis K100637 05/26/2010 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 Class II JAK This reference device has not been subject to a design-related recall

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IV. Device Description

1. New Marketing Name: syngo.CT Clinical Extensions
1. Modified Indications for Use Statement
1. Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Vascular Tool modification:
  - i. Modified Coronary Vessel Tracing Support
  - ii. Heart and Coronary Tree Isolation Tools
  - iii. Support of MR data
  - iv. Support of additional workflow improvement visualization tools
- b. Oncology Tool modification:
  - i. Support of Mean Diameter Value
  - ii. Support of Lung Lesion Segmentation Tool
- ﻥ Support of Dual Energy Tool
- Support of Endoscopic View Tool ರ
- Editing of Pre-generated Results e.

Depending on the clinical question, the user can select functionality which supports the explicit clinical fields as listed below. The syngo.CT Clinical Extensions software package is designed to operate on syngo-compatible post-processing platforms, software version SOMARIS/8 VB30 or later. Table 1 below provides a listing of all tools as well as the modification status in comparison to the predicate devices for this software version:

Table 1: syngo.CT Clinical Extensions Tool Packages

Tool	Description	Modification Status
VascularTool	Provides tools and layouts for vascular assessment. Thisfeature has been modified from the predicate primary deviceto support the following:Semi-automatic vessel tracing tool that allowstracing with less user-interaction Heart and Coronary Tree isolation tools that allowremoval and isolation of myocardial structures Support of MR Angiography data Workflow improvement tools that allow managementand documentation of measurements	Modified from theprimary predicatedevice
OncologyTool	Provides tools for localization and evaluation of nodules. Thisfeature has been modified from the predicate primary deviceto support the following:Mean Diameter Value Tool that allows display of themean diameter of a lesion Lung Lesion Segmentation Tool that allows semi-automatic segmentation of solid and sub-solidnodules. The unmodified Lung LesionSegmentation Tool was cleared in a referencedevice under K093621.	Modified from theprimary predicatedevice
Osteo Tool	Provides a set of routine tools for the assessment of bonemineral content.	Unmodified from theprimary predicatedevice

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Tool	Description	Modification Status
Neuro DSATool	Provides a set of tools for assessment of the cerebralvasculature by removing interfering bone structures.	Unmodified from theprimary predicatedevice
Dual EnergyTool	Provided tools for the Evaluation of low/high kV images fromdual energy data.	Newly supported butunmodified from thesecondary predicatedevice
EndoscopicView Tool	Provides the possibility to interactively fly through tubularstructures which are either filled by low-intensity (e. g. air-filled) or high-intensity (blood filled) material.	Newly supported butunmodified from thesecondary predicatedevice
ROI HUThresholdTool	Supports the user in the evaluation of HU value distributionswithin a user defined region of interest.	Unmodified from theprimary predicatedevice

V. Indications for Use

syngo.CT Clinical Extensions is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners). An interface shall enable the connection between the syngo.CT Clinical Extensions software package and the interconnected CT Scanner system. Result images created with the syngo.CT Clinical Extensions software package can be used to assist trained technicians or physicians in diagnosis.

VI. Comparison of Technological Characteristics with the Predicate Device

As with the primary predicate device, the subject device is a bundle software package consisting of previously cleared unmodified and modified software applications that provide advanced visualization and measurement tools. Software version SOMARIS/8 VB30 supports additional post-processing application features for MR datasets, dual energy images, and endoscopic visualization tools. At a high-level, the subject and predicate devices are based on the following same or similar technological characteristics as listed in Table 2 below:

Feature	Subject Devicesyngo.CT Clinical Extensions	Predicate Deviceand SupportedFunctionality	Comparison Result
SoftwareVersion	SOMARIS/8 VB30	Primary Predicate Device:K163341, clearance date2/9/2017SOMARIS/8 VB20	Modified to supportadditionalfunctionality
VascularTool	The Vascular Tool provides tools andlayouts for vascular assessment.Additionally, the subject device VascularTool supports additional tools for vascularassessment and support of MR data.	Primary Predicate Device:K163341, clearance date2/9/2017	Modified to supportadditionalassessment toolsand MR data

	Table 2: Technological Characteristic Comparison
		The Vascular Tool providestools and layouts forvascular assessment andCT data.
OncologyTool	The oncology Tool offers tools forlocalization and evaluation of nodules.Additionally, the subject device providesthe possibility to calculate the meandiameter value and supports lung lesionsegmentation tools.	Primary Predicate Device:K163341, clearance date2/9/2017The oncology extensionoffers tools for localizationand evaluation of nodules.	Modified to supportmean valuecalculation and lunglesion segmentationtools
OsteoTool	The Osteo extension is used for theevaluation of Bone Mineral Density (BMD)values (mg CA-HA/ml) of the lumbar spinebased on Osteo CT scans.	Primary Predicate Device:K163341, clearance date2/9/2017.The Osteo extension is usedfor the evaluation of BoneMineral Density (BMD)values (mg CA-HA/ml) of thelumbar spine based onOsteo CT scans.	Unmodified from theprimary predicatedevice
NeuroDSA Tool	Bone removal tool from a CT angiographydataset.	Primary Predicate Device:K163341, clearance date2/9/2017.Bone removal tool from a CTangiography dataset.	Unmodified from theprimary predicatedevice
DualEnergyTool	Evaluation of low/high kV images fromdual energy data.	Secondary PredicateDevice:K150745, clearance date8/11/2015Evaluation of low/high kVimages from dual energydata.	Unmodified from thesecondary predicatedevice K150745
Endoscopic ViewTool	Fly through tubular structures which areeither filled by low-intensity (e.g. air-filled)or high-intensity (e.g. blood-filled)material.	Secondary PredicateDevice:K971717, clearance date9/3/1997Fly through tubularstructures which are eitherfilled by low-intensity (e.g.air-filled) or high-intensity(e.g. blood-filled) material.	Unmodified from thesecondary predicatedevice K971717
ROI HUThreshold	Evaluation of HU value distributions withina user defined region of interest.	Primary Predicate Device:K163341, clearance date2/9/2017.	Unmodified from theprimary predicatedevice
		Evaluation of HU valuedistributions within a userdefined region of interest
Pre-generatedresults	Support of pre-generated results and theability to edit pre-generated results	Primary Predicate Device:K163341, clearance date2/9/2017.	Modified from theprimary predicatedevice to supportediting of pre-generated results
		Support of pre-generatedresults

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Anv differences in technological characteristics do not raise different questions of safety and effectiveness. Siemens believes that the subject device is substantially equivalent to the predicate devices. Testing and validation is completed. Test results show that the subject device, syngo.CT Clinical Extensions are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VII. Performance Data

Non-Clinical Testing Summary

Non-clinical tests (integration and functional) were conducted for syngo.CT Clinical Extensions during product development. Performance tests were conducted to test the functionality of the syngo.CT Clinical Extensions. The modifications described in this Premarket Notification were supported with verification/validation testing. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence. Siemens claims conformance to the following performance standards listed in Table 3:

RecognitionNumber	ProductArea	Title of Standard	PublicationDate	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 – 3.20	06/27/2016	NEMA
13-32	Software	Medical Device Software -Software LifeCycle Processes; 62304:2006 (1stEdition)	08/20/2012	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971Second Edition 2007-03-01	08/20/2012	ISO
5-95	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	06/27/2016	IEC
19-4	General II(ES/EMC)	AAMI / ANSI ES60601-1:2005/(R)2012and A1:2012, Medical electricalequipment - part 1: general requirementsfor basic safety and essentialperformance (IEC 60601-1:2005, mod)	07/09/2014	AAMI, ANSI

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. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed and risk control implemented to mitigate

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identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation supports the claim of substantial equivalence.

Siemens Healthcare conforms to the Cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with quidance document "Content of Premarket Submissions for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.

Summary

This subject device combines seven advanced visualization and measurement tools into one software bundle package. The fundamental software technology which is provided within the scope of the advanced tools is already cleared and remains unchanged in comparison to the predicate devices. The Indications for Use for the subject device has been adapted to provide a more specific description of the subject device syngo.CT Clinical Extensions functionality, but does not represent a new intended use in comparison to the predicate devices. The modifications described in this Premarket Notification were supported with verification and validation testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards.

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. syngo.CT Clinical Extensions is designed to fulfill the requirements of the applicable safety and performance standards as listed above.

VIII. Conclusions

The predicate devices were cleared based on non-clinical testing including verification and validation, and supportive literature. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The subject device is also tested using the same methods as used for the predicate devices. The comparison of technological characteristics, nonclinical performance data, and software validation included in this submission demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use. Since both devices were tested using the same methods, Siemens believes that the data generated from the syngo.CT Clinical Extensions testing supports a finding of substantial equivalence.

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.