syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools:

· Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images
· Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
· Creation of contours on any type of images without prior assignment of a planning CT
· Manual and semi-automatic registration using rigid and deformable registration
· Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points. Supports the user in comparing images and contours of different patients
· Supports multi-modality image fusion
· Visualization and contouring of moving tumors and organs

Device Description

syngo.via RT Image Suite is an image analysis software used for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-atrisk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, registering images and exporting final results. syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation. The synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the syngo.via RT Image Suite, based on the provided document.

Important Note: The provided FDA 510(k) summary is a high-level overview. It describes the general V&V processes and states that acceptance criteria were met, but it does not provide specific acceptance criteria values or detailed performance metrics reported for the device. It primarily focuses on demonstrating substantial equivalence to predicate devices and meeting software safety standards.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Software Specifications	All software specifications have met the acceptance criteria.
Risk Analysis	Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all software specifications have met the acceptance criteria.
Verification & Validation	Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.
Functionality	Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence. syngo.via RT Image Suite performs as intended.
Safety	syngo.via RT Image Suite does not introduce any new potential safety risk.
Comparability	Device performance is comparable to the predicate devices that are currently marketed for the same intended use.
Cybersecurity	Siemens conforms to Cybersecurity requirements by implementing a process to prevent unauthorized access, modifications, misuse, or denial of use. (Note: Hospital's responsibility to comply with IEC 8001-1-2010 mentioned).
Standards Compliance	Designed to fulfill requirements of: - Digital Imaging and Communications in Medicine (DICOM) Set (PS 3.1 - 3.18) - Medical device software - Software life cycle processes (IEC 62304 First edition 2006-05) - Medical devices - Application of risk management to medical devices (ISO 14971 Second Edition 2007-03-01) - Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -- Collateral Standard: Usability (IEC 60601-1-6 Edition 3.0 2010-01) - Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems (IEC 60601-1-4:2000, Consol. Ed. 1.1)

Study Details

Sample size used for the test set and the data provenance:
The document states that "Integration and functional tests were conducted for syngo.via RT Image Suite during product development," and "Performance tests were conducted to test the functionality of the subject device." However, no specific sample sizes (e.g., number of cases, images) for the test set are provided. The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not specified in the provided document. The document describes the device as a "contouring tool" and mentions "software assisted contouring," implying human input. However, it does not detail how specific ground truth for quantitative evaluation would have been established or by whom.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not specified. The document focuses on verification and validation against software specifications and industry standards rather than a formal human-in-the-loop clinical adjudication study.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study is mentioned. The device is described as a "visualization, manipulation and contouring tool" that "helps the preparation and response assessment," and "supports the medical professional with tools." This indicates it's an assistive technology, but a formal study measuring the improvement of human readers with vs. without AI assistance is not detailed. The primary goal of this 510(k) submission is substantial equivalence to predicate devices.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The document focuses on the software as a device, and its functions are described as assisting the human professional. While the software has semi-automatic features (e.g., semi-automatic contouring, deformable registration), the submission does not present "standalone" performance metrics (e.g., sensitivity/specificity for a diagnostic task purely performed by the algorithm). Its role is described as a tool for "viewing, manipulation, ... and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning," suggesting it's designed to be used with human oversight and interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As details about specific performance evaluation studies are absent, the type of ground truth used is not explicitly stated. Given the device's function (contouring, image manipulation), it's highly probable that ground truth would involve expert-derived manual contours or measurements against which the software's outputs (e.g., semi-automatic contours, registration accuracy) would be compared. However, this is inferential.
The sample size for the training set:
Not specified. The document mentions software modifications like "Advanced Contouring" (freehand editing, 3D Nudge tools) and "Deformable Alignment" which might involve machine learning components requiring training data. However, details about training sets (size, composition, ground truth generation) are not included in this 510(k) summary.
How the ground truth for the training set was established:
Not specified. As the existence and details of a training set are not mentioned, the method for establishing its ground truth is also not provided.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines extending from the bottom of the profiles.

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

August 13, 2015

Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355

Re: K151380

Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ and LLZ Dated: May 21, 2015 Received: May 22, 2015

Dear Ms. Davis:

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.

{1}------------------------------------------------

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.

Michael D'Hara

For

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

Enclosure

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light teal. The letters are evenly spaced and fill the majority of the frame. The background is plain and white.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 See PRA Statement below. Indications for Use 510(k) Number (if known) 51380 levice Name syngo.via RT Image Suite Indications for Use (Describe) syngo via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools: · Multi-modality viewing and contounical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images · Multiplanar reconstruction (MPR) thingthick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique · Creation of contours on any type of mages without prior assignment of a planning CT · Manual and semi-automatic registration using rigid and deformable registration · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points Supports the user in comparing images and contours of different patients · Supports multi-modality image fusion · Visualization and contouring of moving tumors and organs

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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."

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Poblishing Services (101) 443-5740 EP

{3}------------------------------------------------

510(K) SUMMARY FOR syngo.via RT Image Suite

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: May 21, 2015

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: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Establishment Registration Number: 2240869

Manufacturing Site:

Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany

Establishment Registration Number: 3004977335

2. Contact Person:

Eve Davis Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mail Code D02 Malvern, PA 19355 Phone: (610) 219-7133 Fax: (610) 448-1787 Email: eve.davis@siemens.com

{4}------------------------------------------------

3.	Device Name and Classification
	Product Name:	syngo.via RT Image Suite
	Propriety Trade Name:	syngo.via RT Image Suite
	Classification Name:	system, planning, radiation therapy treatment
	Classification Panel:	Radiology
	CFR Section:	21 CFR §892.5050
	Device Class:	Class II
	Product Code:	MUJ
	Additional Product Code:	LLZ
	Legally Marketed Primary Predicate Device:
	Trade Name:	syngo® Dosimetrist Workspace v2.7
	510(k)#:	K101119
	Clearance Date:	June 16, 2010
	Classification Name:	System, Planning, Radiation Therapy Treatment
	Classification Panel:	Radiology
	Classification Regulation:	21 CFR §892.5050
	Device Class:	II
	Product Code:	MUJ
	Recall Information:	Recall 68395
	Legally Marketed Secondary Predicate Device:
	Trade Name:	syngo.PET&CT Oncology
	510(k)#:	K093621
	Clearance Date:	February 23, 2010
	Classification Name:	Picture Archiving and Communication Systems
	Classification Panel:	Radiology
	Classification Regulation:	21 CFR § 892.2050
	Device Class:	II
	Product Code:	LLZ
	Recall Information:	There have been no recalls for this device

4. Substantial Equivalence:

The subject device, syngo.via RT Image Suite, is substantially equivalent to following medical devices in commercial distribution:

Predicate Devices	FDA ClearanceNumber	FDA ClearanceDate
Primary Predicate Device:Siemenssyngo® Dosimetrist Workspace v2.7	K101119	June 16, 2010
Secondary Predicate Device:Siemenssyngo.PET&CT Oncology	K093621	February 23, 2010

{5}------------------------------------------------

5. Device Description:

syngo.via RT Image Suite supports the medical professional with tools to use during different steps in radiation therapy case preparation.

The synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support. Software information is located in Section 16.

The following modifications have been made to the previously cleared primary predicate device (syngo® Dosimetrist Workspace 2.7 K101119, clearance date June 16 2010) and the secondary predicate device (syngo.PET&CT Oncology K093621, clearance date February 23 2010).

1. A new software version SOMARIS/8 VB10 which supports the following:
- New post-processing software application "syngo.via RT Image . Suite" which has been designed for the new syngo.via platform (SOMARIS/8 VB10) and contains the following application modifications compared to the predicate devices:
  - o Advanced Contouring: offers freehand editing and 3D Nudge tools for editing in non-original image orientations. These two features are segmentation improvements to the already cleared feature "Advanced Segmentation" described in Premarket Notification K101119. clearance date 06/16/2010.
  - o Deformable Alignment: for cases where rigid alignment does not provide sufficient anatomical correspondence between secondary images and the reference image, deformable registration is an option. The deformable registration allows the user to map the corresponding anatomy captured in the two images. Rigid Alignment has been cleared within the Premarket Notification K093621, cleared date 02/23/2010.
  - Contouring on 4D CT: The subject device allows the user to o display a cine loop of images acquired through gated CT. This is a new feature supported by software testing.
1. An extended, more descriptive Indication for Use statement to include details of device functionality

{6}------------------------------------------------

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

syngo.via RT Image Suite has the same intended use and operating principle as the predicate devices. The synqo.via RT Image Suite application is designed to be operated on the syngo.via platform in a single or multi server environment.

syngo.via RT Image Suite does not have significant changes in technological characteristics when compared to the predicate devices. The subject device is the same to either one or both of the predicate devices in regards to:

Visualization ●
Routine Contouring .
Annotation
Reference Point Management ●
Structure Set Management ●
User Interface ●
Archiving/Storage ●
Hardware ●
Image Processing and Evaluation ●
Communication ●

The following table shows the differences in technological characteristics between the subject device and the predicate devices.

Feature	Subject Devicesyngo.via RTImage Suite	PrimaryPredicate DeviceSiemenssyngo®DosimetristWorkspace v2.7(K101119)	SecondaryPredicate DeviceSiemenssyngo.PET&CTOncology(K093621)	Comparison
AdvancedContouring	Freehandediting 3D	Random WalkerTools	N/A	The subject device offersfreehand 3D editing and 3DNudge tools for editing innon-original imageorientations. These twofeatures are segmentationimprovements to the 2Dtools cleared in K101119.
	Nudge 3D	Contour NudgeTool	N/A	Contour interpolation wascleared as part of both theprimary and secondarypredicate devices.
	Contourinterpolation	Contourinterpolation	Contourinterpolation
Alignment	Rigidalignment tools	Rigid alignmenttools	Rigid alignmenttools	The subject device containsthe same rigid alignmenttools as cleared in both theprimary and secondarypredicate devices

Table 1: Differences in technical characteristics

{7}------------------------------------------------

Feature	Subject Devicesyngo.via RTImage Suite	PrimaryPredicate DeviceSiemenssyngo®DosimetristWorkspace v2.7(K101119)	SecondaryPredicate DeviceSiemenssyngo.PET&CTOncology(K093621)	Comparison
	Deformablealignment tools	N/A	N/A	The Deformable alignmentused to map thecorresponding anatomycaptured on two registeredimages is an optional,additional feature for caseswhere rigid alignment doesnot provide sufficientanatomical correspondencebetween secondary imagesand the reference image.
Contouringon 4D CT	Present	N/A	N/A	The subject device allowsthe user to display a cineloop of images acquiredthrough gated CT. This is anew feature and was notavailable on the predicatedevices.

7. Nonclinical Testing:

syngo.via RT Image Suite is designed to fulfill the requirements of the following safety and performance standards:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
12-238	Radiology	Digital Imaging andCommunications in Medicine(DICOM) Set	PS 3.1 - 3.18	03/16/2012	NEMA
13-8	Software	Medical device software -Software life cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
5-40	General	Medical devices - Application ofrisk management to medicaldevices	14971 SecondEdition 2007-03-01	08/20/2012	ISO
5-85	General	Medical electrical equipment --Part 1-6: General requirementsfor basic safety and essentialperformance -- CollateralStandard: Usability	60601-1-6Edition 3.02010-01	1/30/2014	IEC
5-41	General	Medical electrical equipment -Part 1-4: General requirementsfor safety -- Collateral standard:Programmable electrical medicalsystems, edition 1.1	60601-1-4:2000, Consol.Ed. 1.1	09/08/2009	IEC

{8}------------------------------------------------

Verification and Validation

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Integration and functional tests were conducted for syngo.via RT Image Suite during product development.

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 test results show that all of the software specifications have me the acceptance criteria.

The risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results support 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.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. It is the hospital's responsibility to comply with IEC 8001-1-2010.

Summary

Performance tests were conducted to test the functionality of the subject device, syngo.via RT Image Suite. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

8. Indications for Use:

It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools:

· Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images
· Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)

{9}------------------------------------------------

· Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
· Creation of contours on any type of images without prior assignment of a planning CT
· Manual and semi-automatic registration using rigid and deformable registration
· Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points. Supports the user in comparing images and contours of different patients
· Supports multi-modality image fusion
· Visualization and contouring of moving tumors and organs

9. 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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence

The predicate devices were cleared based on non-clinical supportive information. The subject device was tested using the same non-clinical methods. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and Validation testing also demonstrates that syngo.via RT Image Suite performs as intended. The non-clinical test data demonstrates that syngo.via RT Image Suite device performance is comparable to the predicate devices that are currently marketed for the same intended use. In summary, Siemens is of the opinion that the syngo.via RT Image Suite does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.