(49 days)
Unknown
While the device description mentions "semi-automatic contouring" and "software assisted contouring," and the "Synthetic CT" feature is supported by articles demonstrating "classification of tissues," the summary does not explicitly state the use of AI or ML algorithms. The description of the testing focuses on functional and performance tests, not the typical validation required for AI/ML models (e.g., training/test sets, performance metrics like AUC). Without explicit mention of AI/ML or details about model training and validation, it's not possible to definitively confirm its presence.
No
This device is an image analysis software used for visualization, manipulation, and contouring, primarily for treatment preparation and response assessment in radiation therapy, rather than directly delivering therapy.
No
The device is described as a "preparation and response assessment" tool for treatments, particularly radiation therapy. It visualizes, manipulates, and contours images for tasks like creating and modifying simple treatment plans and exporting data to a Treatment Planning System. Its primary function is image processing and anatomical segmentation in support of planning and assessing treatment, rather than identifying or characterizing diseases or medical conditions.
Yes
The device description explicitly states "syngo.via RT Image Suite is an image analysis software" and details various software functionalities for image processing, visualization, and contouring. While it interacts with external systems (like laser systems and Treatment Planning Systems) and uses image data from hardware modalities, the device itself is described solely as software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that syngo.via RT Image Suite is an image analysis software used for viewing, manipulating, and contouring medical images (CT, PET, MRI, etc.) for the purpose of radiation therapy planning and response assessment. It works with images of the body, not with samples taken from the body.
- Intended Use: The intended use is focused on aiding in the preparation and assessment of treatments like radiation therapy, which involves external or internal radiation applied to the body, not laboratory testing of biological samples.
The device is a medical imaging software tool used in the clinical setting for treatment planning and assessment, not for diagnostic testing of biological specimens.
N/A
Intended Use / 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. 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
Product codes (comma separated list FDA assigned to the subject device)
MUJ, LLZ
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:
-
- Modified Indications for Use Statement
-
- 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT) images and dose distributions, MR acquisitions
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professional
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 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 (7/17)
PSC Publishing Services (301) 443-6740
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: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
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 |
| 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:
-
- Modified Indications for Use Statement
-
- 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
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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
syngo.via RT Image
Suite | Primary Predicate Device
syngo.via RT Image
Suite | Secondary Predicate
Device
syngo VSim | Secondary
Predicate Device
Biograph mMR
with syngo MR
E11P system
software | Comparison
Results |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Software | SOMARIS/8 VB30 | SOMARIS/8 VB20 | syngo VSim VA10A | N/A | Modified from the
primary predicate
device to support
additional
functionality |
| Beam
Placement | Creation of new
geometric treatment
plans for photon
radiotherapy | N/A | Creation of new
geometric treatment
plans for photon and
electron radiotherapy | N/A | Modified from the
secondary
predicate device to
be more user
intuitive |
| Synthetic CT | Generation of CT-
density image series out
of multiple MR-image
series | N/A | N/A | Generation of MR-
density image
series out of
multiple MR-image
series | Modified form the
secondary
predicate device to
support generation
of CT density
images |
| Contouring | Routine Contouring,
Advanced Contouring,
Contouring on 4D Image
Data, Routine Structure
Operations, Duplication
of Structures and POIs.
Rapid Results
Technology | Routine Contouring,
Advanced Contouring,
Contouring on 4D Image
Data, Routine Structure
Operations, Duplication
of Structures and POIs | Routine Contouring,
Advanced Contouring,
Routine Structure
Operations, Duplication
of Structures and POIs | N/A | Modified from the
primary predicate
device to support
modified routine
and advanced
contouring tools |
| Structure Set
Management | Loading and storing of
DICOM RT structure
sets, creating, editing
and deletion of structures
and POIs.
Creating, editing and
deletion of structure
templates.
Customize predefined
structure database with
mapping to international
nomenclature schemes. | Loading and storing of
DICOM RT structure
sets, creating, editing
and deletion of structures
and POIs.
Creating, editing and
deletion of structure
templates. | Loading and storing of
DICOM RT structure
sets, creating, editing
and deletion of structures
and POIs.
Creating, editing and
deletion of structure
templates.
Customize predefined
structure database. | N/A | Modified from the
predicate devices to
support additional
tools for contouring
and structure
management |
| Reference
Point
Management | Reference point creation
and management | Reference point creation
and management | Reference point creation
and management | N/A | Same as the
predicate devices |
| Basic
Features | Routine Reading
Functionality, Parallel
Image Display, Routine
Annotation Functionality | Routine Reading
Functionality, Parallel
Image Display, Routine
Annotation Functionality | Routine Reading
Functionality | N/A | Same as the
primary predicate
device |
| Patient
Marking | Sending of reference
points with offset details
to a laser system | Sending of reference
points with offset details
to a laser system | Sending of reference
points with offset details
to a laser system | N/A | Same as the
primary predicate
device |
| Alignment
Tools | Rigid Alignment,
Deformable Alignment | Rigid Alignment,
Deformable Alignment | Rigid Alignment | N/A | Same as the
primary predicate
device |
| Feature | Subject Device
syngo.via RT Image
Suite | Primary Predicate Device
syngo.via RT Image
Suite | Secondary Predicate
Device
syngo VSim | Secondary
Predicate Device
Biograph mMR
with syngo MR
E11P system
software | Comparison
Results |
| Dose
Evaluation | Loading of any existing
dose files; addition or
subtraction of two dose;
shows Dose Volume
Histograms | Loading of any existing
dose files; addition or
subtraction of two dose;
shows Dose Volume
Histograms | N/A | N/A | Same as the
primary predicate
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
Area | Title of Standard | Reference
Number and Date | Publication
Date | Standards
Development
Organization |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set | PS 3.1 - 3.20 | 06/27/2016 | NEMA |
| Software | Medical device software - Software life
cycle processes | 62304 First edition
2006-05 | 08/20/2012 | IEC |
| General | Medical devices – Application of risk
management to medical devices | 14971 Second
Edition 2007-03-
01 | 06/27/2016 | ISO |
| General | Medical electrical equipment - Part 1-6:
General requirements for basic safety
and essential performance - Collateral
Standard: Usability | 60601-1-6 Edition
3.0 | 07/09/2014 | IEC |
| General | Medical electrical equipment - Part 1-4:
General requirements for safety -
Collateral standard Programmable
electrical medical systems, Edition 1.1 | 60601-1-4:2000,
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.