syngo.via RT Image Suite

K162370 · Siemens Medical Solutions USA, Inc. · MUJ · Oct 25, 2016 · Radiology

Device Facts

• Record ID: K162370
• Device Name: syngo.via RT Image Suite
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Oct 25, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: 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. 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, 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) 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, 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

Device Story

Software tool for radiation therapy planning; inputs include multi-modality medical images (CT, PET, MRI, CBCT) and dose distributions. Performs 3D/4D visualization, multiplanar reconstruction (MPR), volume rendering (VRT), and image registration (rigid/deformable). Enables manual and semi-automatic contouring of tumors and organs-at-risk; supports dose evaluation and isocenter management. Used in clinical settings by medical professionals (e.g., radiation oncologists, dosimetrists). Output consists of segmented structures, registered images, and points of interest exported to external Treatment Planning Systems. Assists clinicians in target definition and treatment preparation; facilitates improved workflow for contouring and dose assessment.

Clinical Evidence

Bench testing only. Non-clinical integration and functional testing performed to verify software modifications. Risk analysis and hazard mitigation implemented. Verification and validation testing confirmed device meets specifications and performs as intended.

Technological Characteristics

Software-based image analysis tool. Features: multi-modality viewing, MPR, MIP, VRT, rigid/deformable registration, and contouring. Connectivity: DICOM compliant. Standards: IEC 62304 (software lifecycle), ISO 14971 (risk management), IEC 60601-1-6 (usability), 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 treatment preparation and response assessment (e.g., Brachytherapy, Particle Therapy, External Beam Radiation Therapy). Applicable to patients requiring anatomical/functional image analysis (CT, PET, MRI, CBCT) for target and organ-at-risk segmentation.

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 (K151380)
• syngo Dosimetrist Workspace v2.7 (K101119)

Submission Summary (Full Text)

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

October 25, 2016

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

Re: K162370

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: August 12, 2016 Received: August 24, 2016

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Michael D'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

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# Indications for Use

510(k) Number (if known) K162370

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. 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, 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) 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, 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

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">X</span> Prescription Use (Part 21 CEB 801 Subpart D | Over-The-Counter Use (21 CER 801 Subpart C) |

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

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: August 12, 2016

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]

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# II. 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 |
| Subsequent CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Subsequent Product Code: | LLZ |

# III. Predicate Device

### Primary Predicate Device:

| Trade Name: | syngo.via RT Image Suite |
|--------------------------|-----------------------------------------------|
| 510(k) Number: | K151380 |
| Clearance Date: | August 13, 2015 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.5050 |
| Subsequent CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Subsequent Product Code: | LLZ |
| Recall: | There have been no recalls for this device |

#### Secondary Predicate Device:

| Trade Name: | syngo Dosimetrist Workspace v2.7 |
|-----------------------|-----------------------------------------------|
| 510(k) Number: | K101119 |
| Clearance Date: | October 9, 2010 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| Recall: | 68395 |

# 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.

syngo.via RT Image Suite combine 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.

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.

The following features have been modified:

- Routine Annotation Functionality (modified) ●
- Contouring Tools (modified)
- Patient Marking (modified)
- . Structure Set Management (modified)

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Image /page/5/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. The word is displayed horizontally and is the main focus of the image.

- Alignment Tools (modified)
- Dose Evaluation (new)

# 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 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 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 .

# VI. Comparison of Technological Characteristics with the Predicate Device

syngo.via RT Image Suite has the same intended use, operating principle as well as the image visualization and manipulation technological characteristics as the predicate devices. Evaluation and post-processing are the technological principles for both the subject and predicate devices. The fundamental features of this subject device are: 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. The indications for use are similar.

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Using a high-level comparison, the subject and predicate devices are based on the following same technological elements respectively have the following differences:

| | Subject Device | Primary Predicate Device | Secondary Predicate Device | Comparison |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|
| Feature | syngo.via RT Image<br>Suite | syngo.via RT Image<br>Suite | syngo Dosimetrist<br>Workspace v2.7 | |
| 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; Parallel<br>Image Display | Routine Annotation<br>Functionality<br>supports now a<br>finding feature |
| Contouring | 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>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 | Routine &<br>Contouring Tools<br>and Contouring on<br>4D Image Data<br>have been<br>improved |
| Patient<br>Marking | Transmission of POIs of<br>type isocenter to an<br>external laser system | n/a | Transmission of POIs of<br>type isocenter to an<br>external laser system | New feature in the<br>subject device but<br>is similar to the<br>secondary one |
| Alignment<br>Tools | Rigid Alignment and<br>Deformable Alignment | Rigid Alignment and<br>Deformable Alignment | Rigid Alignment | Rigid and<br>Deformable<br>Alignment tools<br>have been<br>improved to<br>provide a better<br>workflow |
| Dose<br>Evaluation | Loading of any existing<br>dose files: Addition or<br>Subtraction of two dose<br>files | n/a | n/a | new feature |

Table 4 Differences and Similarities in Technical Characteristics

# VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

This submission contains performance data to demonstrate conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo.via RT Image Suite during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.

### Risk Analysis

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

### Software Verification and Validation

Software Documentation for a Major 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.

### Non-Clinical Testing Summary

Performance tests were conducted to test the functionality of the syngo.via RT Image Suite. 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.

### 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

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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 following safety and performance standards:

| Recognition<br>Number | Product<br>Area | Title of Standard | Reference<br>Number and Date | Publication<br>Date | Standards<br>Development<br>Organization |
|-----------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in<br>Medicine (DICOM) Set | PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| N/A | Software | Medical device software - Software life<br>cycle processes | 62304 First edition<br>2006-05 | 08/20/2012 | IEC |
| 5-40 | General | Medical devices – Application of risk<br>management to medical devices | 14971 Second<br>Edition 2007-03-<br>01 | 06/27/2016 | ISO |
| 5-85 | 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 |
| N/A | 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 |

In this subject device six scientific articles are used to support the marketing claims provided in the product brochure.

# VIII. Conclusions

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. Furthermore, for the subject device, syngo.via RT Image Suite, Siemens used the same testing with the same workflows as was used to clear the predicate devices. 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.

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.