(87 days)
Not Found
Yes
The document explicitly states that the device includes an "AI-based algorithm" and that the algorithm for brain and pelvis synthetic CTs has been changed to a "deep-learning algorithm."
No.
This device is an image analysis software used for visualization, manipulation, and contouring of medical images, which aids in the preparation of treatments but does not directly perform or deliver therapy.
No
The device is a visualization, manipulation, and contouring tool used for the preparation of treatments, specifically radiation therapy. It processes medical images and assists in treatment planning but does not make a diagnosis or directly identify diseases.
Yes
The device is described as "image analysis software" and "software for viewing, manipulation, 3D and 4D visualization, comparison of medical images". While it interacts with medical images from various modalities, the core device itself is the software performing these functions. There is no mention of accompanying hardware that is part of the device itself.
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 preparation of radiation therapy treatments. It works with existing medical images, not biological samples.
- Intended Use: The intended use is focused on image visualization, manipulation, and contouring for treatment planning, not on diagnosing conditions based on biological samples.
The device is a medical imaging software tool used in the planning and preparation of radiation therapy, which falls under a different regulatory category than In Vitro Diagnostics.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found".
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 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines the following digital image processing and visualization tools:
- Multi-modality viewing and contouring of anatomical, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
- 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
- Automated Contouring on CT images
- Creation of contours on images supported by the application 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 multi-modality image fusion
- Visualization and contouring of moving tumors and organs
- Management of points of interest including but not limited to the isocenter
- Creation of simple geometric treatment plans
- Generation of a synthetic CT based on multiple pre-define MR acquisitions
Product codes
MUJ
Device Description
The subject device with the current software version SOMARIS/8 VB60 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 in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for 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.
For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:
- Reference Point Management
- Patient Marking
- Contouring / Routine Contouring
- Structure Set Management
- Synthetic CT
- Basic Feature of syngo.via RT Image Suite
Mentions image processing
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines the following digital image processing and visualization tools:
- Multi-modality viewing and contouring of anatomical, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
- 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
- Automated Contouring on CT images
- Creation of contours on images supported by the application 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 multi-modality image fusion
- Visualization and contouring of moving tumors and organs
- Management of points of interest including but not limited to the isocenter
- Creation of simple geometric treatment plans
- Generation of a synthetic CT based on multiple pre-define MR acquisitions
Mentions AI, DNN, or ML
The algorithm for brain and pelvis synthetic CTs has been changed from Atlas based to a deep-learning algorithm.
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac CBCT images.
Anatomical Site
Regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Moving tumors and organs. Brain and pelvis.
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
The AI-based algorithm was tested on independent data for geometric fidelity and HU accuracy using automated bench tests.
Summary of Performance Studies
The subject device syngo.via RT Image Suite VB60 includes an AI-based algorithm for the creation of synthetic CT images from MR images to be used in the preparation of radiation therapy treatment planning.
The AI-based algorithm was tested on independent data for geometric fidelity and HU accuracy using automated bench tests.
The subject device algorithm demonstrated very good geometric accuracy with average deviations in the body outline smaller than 1 mm, which is below the voxel resolution and therefore not clinically relevant. The HU accuracy of the subject device algorithm was well within 50 HU (200 HU) for soft (bone) tissue.
In comparison to the predicate device, the subject device algorithm showed equal performance in geometric accuracy and superior performance in HU accuracy.
Key Metrics
Geometric accuracy: average deviations in the body outline smaller than 1 mm.
HU accuracy: well within 50 HU (200 HU) for soft (bone) tissue.
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.
Not Found
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
July 30, 2021
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
Siemens Medical Solutions USA Inc. % Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932
Re: K211379
Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: MUJ Dated: May 3, 2021 Received: May 4, 2021
Dear Clayton Ginn:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K211379
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 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines the following digital image processing and visualization tools:
- · Multi-modality viewing and contouring of anatomical, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, Linac CBCT images
- · 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
- · Automated Contouring on CT images
- · Creation of contours on images supported by the application 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 multi-modality image fusion
- · Visualization and contouring of moving tumors and organs
- · Management of points of interest including but not limited to the isocenter
- · Creation of simple geometric treatment plans
- · Generation of a synthetic CT based on multiple pre-define MR acquisitions
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
Traditional: 510(k): syngo.via RT Image Suite
K211379
Section 5 510(k) Summary
Identification of the Submitter I.
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
Submitter Contact Person:
Clayton Ginn Regulatory Affairs Specialist 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 Email: clayton.ginn@siemens-healthineers.com
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 |
| Device Class: | Class II |
| Product Code: | MUJ |
III. Predicate Device
| Trade Name: | syngo.via RT Image Suite |
|---|---|
| 510(k) Number: | K201444 |
| Clearance Date: | 08/13/2020 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
4
Healt
IV. Device Description
The subject device with the current software version SOMARIS/8 VB60 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 in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for 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.
For the current software version SOMARIS/8 VB60 the following already cleared features have been modified:
- . Reference Point Management
- Patient Marking ●
- Contouring / Routine Contouring
- Structure Set Management ●
- Synthetic CT
- Basic Feature of syngo,via RT Image Suite
V. Indications for Use
syngo.via RT Image Suite is a 3D and 4D image visualization, multi-modality manipulation and contouring tool that helps the preparation 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 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 simple geometric treatment plans. Contours, images and treatment plans can subsequently be exported to a Treatment Planning System.
The software combines the 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 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
- Automated Contouring on CT images
- . Creation of contours on images supported by the application 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 multi-modality image fusion
- . Visualization and contouring of moving tumors and organs
- Management of points of interest including but not limited to the isocenter ●
- Creation of simple geometric treatment plans ●
- Generation of a synthetic CT based on multiple pre-define MR acquisitions ●
The Indications for Use is unchanged from that of the predicate device.
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VI. Comparison of Technological Characteristics with the Predicate Device
As with the predicate device syngo.via RT Image Suite SOMARIS/8 VB50, the subject device supports viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and the segmentation of turnors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy.
At a high-level a tabular summary of the subject and predicate device's technological differences is provided as Table 4 below for the software version SOMARIS/8 VB60:
| Feature | Description and Comparison of the Subject Device to the Predicate Device |
|---|---|
| Reference | |
| Point | |
| Management | Reference Point Management allows to edit the position, color, and type |
| of Points of Interest (POI). |
Modification:
The workflow for POI creation and editing has been slightly adapted to improve
usability without modification of the functionality. |
| Patient
Marking | Transmission of reference points with the offset details to a movable laser system
for patient marking.
Modification:
• Saving of sent POIs
• Removal of default value for laser calibration offset
• Consistency checks for laser calibration offset (only for integrated laser)
• Minor usability improvements |
| Contouring
(Routine
Contouring) | With Contouring, the user can create, delete, and edit Volumes of Interest (VOIs).
Modification:
The routine contouring feature has been enhanced for the subject device to
include a tool to cut a structure at a user-defined axial level. |
| 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.
Modifications:
The Structure Set Management provides a set of improvements to optimize the
workflow including:
• Structure Set approval
• Enhanced color picker
• Structure sorting by type
• Manual and automated merging of structure sets
• Streamlined rapid results configuration
• Filter for auto-contourable structures
• Merge / expand structure via structure templates |
| Synthetic CT | The synthetic CT feature provides functionality to create a CT-density equivalent
image series out of multiple MR-image-series.
Modification:
The algorithm for brain and pelvis synthetic CTs has been changed from Atlas
based to a deep-learning algorithm. |
| Basic Feature
of syngo.via
RT Image Suite | The set provides basic feature of the subject device.
Modification:
For the subject device the Parallel Image Display feature as well as the general
workflow have been improved. |
6
T
Image /page/6/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. There are also some orange dots to the right of the word "SIEMENS".
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VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
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. 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.
Non-Clinical Testing
This submission contains performance tests (Non-clincal test reports) to demonstrate continued 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. 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.
Summary of the Performance Evaluation of the Algorithm
The subject device syngo.via RT Image Suite VB60 includes an Al-based algorithm for the creation of synthetic CT images from MR images to be used in the preparation of radiation therapy treatment planning.
The Al-based algorithm was tested on independent data for geometric fidelity and HU accuracy using automated bench tests.
The subject device algorithm demonstrated very good geometric accuracy with average deviations in the body outline smaller than 1 mm, which is below the voxel resolution and therefore not clinically relevant. The HU accuracy of the subject device algorithm was well within 50 HU (200 HU) for soft (bone) tissue.
In comparison to the predicate device, the subject device algorithm showed equal performance in geometric accuracy and superior performance in HU accuracy.
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.
Siemens hereby certifies that syngo.via RT Image Suite meets the following voluntary standards covering electrical and mechanical safety listed below:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set; PS 3.1 ">– 3.20 | 06/27/2016 | NEMA |
| 13-79 | Software | Medical Device Software ">– Software Life Cycle
Processes; 62304:2015-06 (Edition 1.1) | 01/14/2019 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informatics | Medical devices ">– Application of risk
management to medical devices; 14971 Second
Edition 2007-03-01 | 06/27/2016 | ISO |
8
Image /page/8/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of several orange dots arranged in a circular pattern.
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognition | Standards
Development
Organization |
|-----------------------|----------------------|----------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------|
| 5-114 | General I
(QS/RM) | Medical devices - Part 1: Application of
usability engineering to medical devices
IEC 62366-1:2015 | 12/23/2016 | IEC |
VIII. Conclusion
syngo.via RT Image Suite (software version SOMARIS/8 VB60) has the same intended use and same indication for use as the predicate device (software version SOMARIS/8 VB50). The fundamental technological characteristics are the same as the predicate device. The result of all testing conducted was found acceptable to support the claim of substantial equivalence. The comparison of technological characteristics, non-clinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate device that is currently marketed for the same intended use. For the subject device, syngo.via RT Image Suite, Siemens used the same testing with the same workflows as used to clear the predicate device. Siemens considers syngo.via RT Image Suite to be as safe, as effective and with performance substantially equivalent to the commercially available predicate devices.