syngo.via RT Image Suite

K173635 · Siemens Medical Solutions USA, Inc. · MUJ · Jan 12, 2018 · Radiology

Device Facts

• Record ID: K173635
• Device Name: syngo.via RT Image Suite
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Jan 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device

Intended Use

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. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans 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 multi-parametric images such as but not limited to CT, PET, PET/CT, MRI. Linac Cone Beam CT (CBCT) images and dose distributions · Multiplanar reconstruction (MPR) think 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, 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 - · Management of points of interest including but not limited to the isocenter - · Management of simple treatment plans - · Generation of a synthetic CT based on multiple pre-define MR acquisitions

Device Story

syngo.via RT Image Suite is a software tool for radiation therapy planning; inputs include multi-modality medical images (CT, PET, PET/CT, MRI, CBCT) and dose distributions. It performs 3D/4D visualization, multiplanar reconstruction (MPR), volume rendering (VRT), and image registration (rigid/deformable). It enables manual and semi-automatic contouring of regions-of-interest (targets, organs-at-risk) and generation of synthetic CT from MR acquisitions. Used in clinical settings by medical professionals (physicians, dosimetrists) to prepare treatment plans and assess response. Outputs include contoured images, points of interest (isocenter), and simple treatment plans for export to external Treatment Planning Systems. Benefits include efficient workflow for contouring and improved visualization of anatomical/functional data for radiation therapy preparation.

Clinical Evidence

Bench testing only. Verification and validation testing confirmed functionality of modified features (synthetic CT, beam placement, contouring tools). Supportive literature provided for synthetic CT tissue classification method. No clinical trials performed.

Technological Characteristics

Software-based image processing suite; platform SOMARIS/8 VB30. Features: multi-modality visualization (MPR, MIP, VRT), rigid/deformable registration, synthetic CT generation, and contouring tools. Conforms to DICOM (PS 3.1-3.20), IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 60601-1-6 (usability), and IEC 60601-1-4 (programmable electrical medical systems).

Indications for Use

Indicated for 3D/4D image visualization, multimodality manipulation, and contouring to assist in radiation therapy preparation and response assessment (e.g., Brachytherapy, Particle Therapy, External Beam Radiation Therapy). Applicable to patients requiring contouring of body regions, targets, and organs-at-risk, and creation/modification of simple treatment plans.

Regulatory Classification

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.

Predicate Devices

• syngo.via RT Image Suite (K162370)
• syngo VSim (K151887)
• Biograph mMR with syngo MR E11P system software (K163234)

Reference Devices

• syngo.CT Single Source Dual Energy (twin beam) (K163289)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Libertv Blvd. MALVERN PA 19355

January 12, 2018

Re: K173635

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, LLZ Dated: November 17, 2017 Received: November 24, 2017

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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}------------------------------------------------

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 mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara 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

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K173635

Device 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. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans 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 multi-parametric images such as but not limited to CT, PET, PET/CT, MRI. Linac Cone Beam CT (CBCT) images and dose distributions

· Multiplanar reconstruction (MPR) think 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, 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
- · Management of points of interest including but not limited to the isocenter
- · Management of simple treatment plans
- · Generation of a synthetic CT based on multiple pre-define MR acquisitions

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 [e-mail]

"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 (7/17)

PSC Publishing Services [phone]

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

# 510(K) SUMMARY FOR SYNGO.VIA RT IMAGE SUITE

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 17, 2017

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.

### I. Submitter

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

Establishment Registration Number 2240869

#### Manufacturing Site

Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany

Establishment Registration Number 3004977335

#### Contact Person

Kimberly Mangum Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Phone: [phone] Fax: [phone] Email: [e-mail]

## II. Device Name and Classification

Product Name: Proprietv Trade Name: Classification Name: Classification Panel: CFR Section: Subsequent CFR Section: Device Class: Product Code: Subsequent Product Code: LLZ

syngo.via RT Image Suite syngo.via RT Image Suite System, Planning, Radiation Therapy Treatment Radiology 21 CFR §892.5050 21 CFR §892.2050 Class II MUJ

# III. Predicate Device

#### Primary Predicate Device:

Trade Name: syngo.via RT Image Suite 510(k) Number: K162370 Clearance Date: 10/25/2016 Classification Name: System, Planning, Radiation Therapy Treatment Classification Panel: Radiology CFR Section: 21 CFR §892.5050 Subsequent CFR Section: 21 CFR §892.2050

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

# SIEMENS

Device Class: Class II Product Code: MUJ Subsequent Product Code: LLZ Recall Information: There have been no recalls for this device

#### Secondary Predicate Device:

| Trade Name: | syngo VSim |
|-----------------------|-----------------------------------------------|
| 510(k) Number: | K151887 |
| Clearance Date: | 09/16/2015 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Recall Information: | There have been no recalls for this device |

#### Secondary Predicate Device:

| Trade Name: | Biograph mMR with syngo MR E11P system software |
|--------------------------|----------------------------------------------------------------------------------------------|
| 510(k) Number: | K163234 |
| Clearance Date: | 02/28/2017 |
| Classification Name: | Tomographic Imager Combining Emission Computed Tomography with<br>Nuclear Magnetic Resonance |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.1200 |
| Device Class: | Class II |
| Product Code: | OUO |
| Subsequent Product Code: | KPS, LNH, LNI |
| Recall Information: | There have been no recalls for this device |

#### Reference Device:

| Trade Name: | syngo.CT Single Source Dual Energy (twin beam) |
|-----------------------|------------------------------------------------|
| 510(k) Number: | K163289 |
| 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 |

# IV. Device Description

syngo.via RT Image Suite is an image analysis software for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. The subject device syngo.via RT Image Suite with software version SOMARIS/8 VB30 is a further extension of the previously cleared primary predicate device syngo.via RT Image Suite with software version SOMARIS/8 VB20 and supports the following modifications:

- 1) Modified Indications for Use Statement
- 2) Support of software version SOMARIS/8 VB30 which supports the following functionality:
- a. Support of Beam Placement
- Support of Synthetic CT b.
- Support of modified contouring tools c.
- i. Routine Contouring
- ii. Advanced Contouring
- iii. Rapid Results Technology
- d. Support of modified structure management

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, sending isocenter points to an external laser system, 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.

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

# SIEMENS

syngo.via RT Image Suite provides dedicated tools, which help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk. The software application works in a similar fashion on any officially supported imaging modality, for example, native contouring is supported on CT but also on MR or PET images.

# V. Indications for Use

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. It also provides functionalities to create and modify simple treatment plans. Contours, images and treatment plans 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 multi-parametric ● images such as but not limited to CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions
- 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 ●
- Management of points of interest including but not limited to the isocenter ●
- Management of simple treatment plans
- Generation of a synthetic CT based on multiple pre-define MR acquisitions .

# VI. Comparison of Technological Characteristics with the Predicate Device

As with the primary predicate device, the subject device supports: viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and the segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy. Software version SOMARIS/8 VB30 supports additional beam placement, synthetic CT, and modified contouring tools and structure management tools.

At a high level, the subject and predicate devices are based on the following same technological characteristics:

- . Software operating platform SOMARIS/8
- Multi-modality Image Manipulation
- Multi-modality 3D and 4D visualization of images
- . Comparison of medical images from multiple imaging modalities and the segmentation of tumors and organs-at-risk prior to dosimetric planning and response assessment in radiation therapy

The following technological differences exist between the subject device and the primary predicate device:

- Software version SOMARIS/8 VB30
- . Support of synthetic CT feature
- Support of beam placement ●
- Support of modified contouring tools ●
- . Support of additional structure management tools
- Rapid Results Technology 0

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

Image /page/6/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, which makes the text stand out.

A tabular summary of the subject and predicate device technological differences is provided as Table 4 below:

Table 1 Differences and Similarities in Technical Characteristics

| Feature | Subject Device<br>syngo.via RT Image<br>Suite | Primary Predicate Device<br>syngo.via RT Image<br>Suite | Secondary Predicate<br>Device<br>syngo VSim | Secondary<br>Predicate Device<br>Biograph mMR<br>with syngo MR<br>E11P system<br>software | Comparison<br>Results |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Software | SOMARIS/8 VB30 | SOMARIS/8 VB20 | syngo VSim VA10A | N/A | Modified from the<br>primary predicate<br>device to support<br>additional<br>functionality |
| Beam<br>Placement | Creation of new<br>geometric treatment<br>plans for photon<br>radiotherapy | N/A | Creation of new<br>geometric treatment<br>plans for photon and<br>electron radiotherapy | N/A | Modified from the<br>secondary<br>predicate device to<br>be more user<br>intuitive |
| Synthetic CT | Generation of CT-<br>density image series out<br>of multiple MR-image<br>series | N/A | N/A | Generation of MR-<br>density image<br>series out of<br>multiple MR-image<br>series | Modified form the<br>secondary<br>predicate device to<br>support generation<br>of CT density<br>images |
| Contouring | Routine Contouring,<br>Advanced Contouring,<br>Contouring on 4D Image<br>Data, Routine Structure<br>Operations, Duplication<br>of Structures and POIs.<br>Rapid Results<br>Technology | Routine Contouring,<br>Advanced Contouring,<br>Contouring on 4D Image<br>Data, Routine Structure<br>Operations, Duplication<br>of Structures and POIs | Routine Contouring,<br>Advanced Contouring,<br>Routine Structure<br>Operations, Duplication<br>of Structures and POIs | N/A | Modified from the<br>primary predicate<br>device to support<br>modified routine<br>and advanced<br>contouring tools |
| Structure Set<br>Management | Loading and storing of<br>DICOM RT structure<br>sets, creating, editing<br>and deletion of structures<br>and POIs.<br>Creating, editing and<br>deletion of structure<br>templates.<br>Customize predefined<br>structure database with<br>mapping to international<br>nomenclature schemes. | Loading and storing of<br>DICOM RT structure<br>sets, creating, editing<br>and deletion of structures<br>and POIs.<br>Creating, editing and<br>deletion of structure<br>templates. | Loading and storing of<br>DICOM RT structure<br>sets, creating, editing<br>and deletion of structures<br>and POIs.<br>Creating, editing and<br>deletion of structure<br>templates.<br>Customize predefined<br>structure database. | N/A | Modified from the<br>predicate devices to<br>support additional<br>tools for contouring<br>and structure<br>management |
| Reference<br>Point<br>Management | Reference point creation<br>and management | Reference point creation<br>and management | Reference point creation<br>and management | N/A | Same as the<br>predicate devices |
| Basic<br>Features | Routine Reading<br>Functionality, Parallel<br>Image Display, Routine<br>Annotation Functionality | Routine Reading<br>Functionality, Parallel<br>Image Display, Routine<br>Annotation Functionality | Routine Reading<br>Functionality | N/A | Same as the<br>primary predicate<br>device |
| Patient<br>Marking | Sending of reference<br>points with offset details<br>to a laser system | Sending of reference<br>points with offset details<br>to a laser system | Sending of reference<br>points with offset details<br>to a laser system | N/A | Same as the<br>primary predicate<br>device |
| Alignment<br>Tools | Rigid Alignment,<br>Deformable Alignment | Rigid Alignment,<br>Deformable Alignment | Rigid Alignment | N/A | Same as the<br>primary predicate<br>device |
| Feature | Subject Device<br>syngo.via RT Image<br>Suite | Primary Predicate Device<br>syngo.via RT Image<br>Suite | Secondary Predicate<br>Device<br>syngo VSim | Secondary<br>Predicate Device<br>Biograph mMR<br>with syngo MR<br>E11P system<br>software | Comparison<br>Results |
| Dose<br>Evaluation | Loading of any existing<br>dose files; addition or<br>subtraction of two dose;<br>shows Dose Volume<br>Histograms | Loading of any existing<br>dose files; addition or<br>subtraction of two dose;<br>shows Dose Volume<br>Histograms | N/A | N/A | Same as the<br>primary predicate<br>device |

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

# VII. Performance Data

# Non-Clinical Testing Summary

Non-clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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. Supportive articles were provided to support specific device functionality and claims, including the Synthetic CT feature. The supportive articles provided for the synthetic CT feature demonstrates the classification of tissues for brain acquisitions method used for the synthetic CT feature included in this submission.

Siemens claims conformance to the following performance standards:

| Product<br>Area | Title of Standard | Reference<br>Number and Date | Publication<br>Date | Standards<br>Development<br>Organization |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set | PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| Software | Medical device software - Software life<br>cycle processes | 62304 First edition<br>2006-05 | 08/20/2012 | IEC |
| General | Medical devices – Application of risk<br>management to medical devices | 14971 Second<br>Edition 2007-03-<br>01 | 06/27/2016 | ISO |
| General | Medical electrical equipment - Part 1-6:<br>General requirements for basic safety<br>and essential performance - Collateral<br>Standard: Usability | 60601-1-6 Edition<br>3.0 | 07/09/2014 | IEC |
| General | Medical electrical equipment - Part 1-4:<br>General requirements for safety -<br>Collateral standard Programmable<br>electrical medical systems, Edition 1.1 | 60601-1-4:2000,<br>Consol. Ed. 1.1 | 09/08/2009 | IEC |

# 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" May 11, 2005 is also included as part of this submission. issued on 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 identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support 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 guidance document "Content of Premarket Submissions

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

for Management of Cybersecurity Medical Devices issues on October 2, 2014" is included within this submission.

#### Summary

This subject device provides tool designed help the medical professional in contouring and evaluating volumes of interest, for example gross target volumes, or organs-at-risk. The fundamental software technology which is provided within the scope of the subject device 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.via RT Image Suite functionality, but does not represent a new intended use. 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.via RT Image Suite 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. phantom tests, 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, non-clinical 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.via RT Image Suite testing supports a finding of substantial equivalence.