(73 days)
Not Found
Yes
The document explicitly mentions "software assisted contouring" and "automated organ segmentation algorithm," and the performance studies focus on evaluating this algorithm, which is a strong indicator of AI/ML being used for image analysis and segmentation tasks. The "Mentions AI, DNN, or ML" field is also marked as "Yes".
No.
The device is a visualization and contouring tool used for the preparation of treatments, not for directly administering treatment or therapy.
No
The device is described as a "visualization, multi-modality manipulation and contouring tool" to help "preparation of treatments" and specifically "prior to dosimetric planning in radiation therapy." While it processes images and assists in identifying regions of interest, its primary stated purpose is pre-treatment planning and not to diagnose diseases or conditions.
Yes
The device description explicitly states it is "an image analysis software" and details its functionalities as software tools for viewing, manipulation, and analysis of medical images. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, 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 this device is an image analysis software for viewing, manipulating, and contouring medical images (CT, PET, MRI, etc.) for the purpose of preparing for radiation therapy. It works with images of the body, not with samples taken from the body.
- Intended Use: The intended use is focused on image visualization, manipulation, and contouring to aid in treatment planning, specifically radiation therapy. This is a diagnostic imaging and treatment planning tool, not a test performed on biological samples.
Therefore, the syngo.via RT Image Suite, as described, falls under the category of medical imaging software and is not an In Vitro Diagnostic device.
No
The input document explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", indicating no mention of PCCP authorization.
Intended Use / 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, functional, 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
Product codes
MUJ
Device Description
The subject device with the current software version SOMARIS/8 VB50 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.
The following already cleared features in the previous version of syngo via RT Image Suite (SOMARIS/8 VB40) have been modified:
- Contouring
- Routine Contouring
- Advanced Contouring
- Structure Set Management
- Deformable Alignment
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac CBCT images, MR
Anatomical Site
Regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Pelvic and head/neck regions, thoracic.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professional. Not specified as to care setting, but likely clinical (e.g., hospital, radiation oncology center) given the intended use for radiation therapy planning.
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 segmentation algorithm of the subject device was evaluated on a test set of 112 subjects. The detection rates for the subject device were similar to those for the predicate device. Newly added organs in the subject device were detected at a rate of 100%. The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the overlap measure DICE coefficient.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
Integration and functional tests were conducted for syngo.via RT Image Suite during product development to test the ability of the included features of the subject device. The results demonstrated that the subject device performs as intended and were acceptable to support the claim of substantial equivalence.
Summary of the Performance Evaluation of the Algorithm:
The performance of the automated organ segmentation algorithm in the subject device was evaluated and compared to the predicate device. The segmentation algorithm was evaluated on a test set of 112 subjects. The detection rates for the subject device were similar to those for the predicate device. Newly added organs in the subject device were detected at a rate of 100%. The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the overlap measure DICE coefficient. The quantitative evaluation demonstrated non-inferior or superior performance for all organ segmentations in the subject device compared to the predicate device. The evaluation thus supports the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DICE coefficient
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
Siemens Medical Solutions USA, Inc. % Ms. Cynthia Busch Regulatory Affairs Specialist 2501 N Barrington Road HOFFMAN ESTATE IL 60192
August 13, 2020
Re: K201444
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 29, 2020 Received: June 1, 2020
Dear Ms. Busch:
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/cfpmp/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
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020 |
|-------------------------------------------------------------------------|-----------------------------------------------------------------|
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | K201444 |
|---|---|
| Device Name | syngo.via RT Image Suite |
| Indications for Use (Describe) | 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, functional, 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
| 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
"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."
3
Image /page/3/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots.
Section 5
510(k) Summary
I. Identification of the 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
Submitter Contact Person:
Cynthia Busch Regulatory Affairs Specialist 2501 North Barrington Road Hoffman Estates, IL 60192-2061 Phone: (847) 643-6818 Email: cynthia.busch(@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 |
4
Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.
Predicate Device III.
| Trade Name: | syngo.via RT Image Suite |
|---|---|
| 510(k) Number: | K192065 |
| Clearance Date: | 09/18/2019 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892. 5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
IV. Device Description
The subject device with the current software version SOMARIS/8 VB50 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.
The following already cleared features in the previous version of syngo via RT Image Suite (SOMARIS/8 VB40) have been modified:
- Contouring
- Routine Contouring o
- Advanced Contouring O
- Structure Set Management ●
- Deformable Alignment ●
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 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:
- l 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
5
SIEME Healthineer
- 트 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
- 트 Automated Contouring on CT images
- 트 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
- 트 Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points
- 트 Supports multi-modality image fusion
- I Visualization and contouring of moving tumors and organs
- 트 Management of points of interest including but not limited to the isocenter
- 트 Creation of simple geometric treatment plans
- I Generation of a synthetic CT based on multiple pre-define MR acquisitions
The Indications for Use has minor changes as clarification of wording.
Comparison of Technological Characteristics with the Predicate Device VI.
As with the predicate device syngo.via RT Image Suite SOMARIS/8 VB40, 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.
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 VB50:
| Feature | Description and Comparison of the Subject Device to the Predicate Device |
|---|---|
| Routine | |
| Contouring | Routine Contouring tools (e. g. freehand drawing tools, creation of margins |
| etc.) |
Modification:improvements in the contour interpolation tool and a tool to
merge multiple structures. |
| Advanced
Contouring | Advanced Contouring tools (automatic contouring of different structures,
nudge 3D tool,contour interpolation.). Automatic contouring of pelvic and
head/neck regions, support of Rapid Results Technology.
Modification: This subject device provides the following extensions:
• Automatic Contouring can be applied on further structures (thoracic and
pelvic regions)
• Automatic Contouring in the head/neck region, which was previously atlas-
based, is now done with deep learning. The atlas method is entirely removed
from this version.
• Streamlined workflow to automatically adapt contours from a prior to a
current planning CT |
6
Image /page/6/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 orange dots.
| 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. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Modification:
• multiselection of structures and POIs to apply basic operations such as copy
or delete,
• auto-completion for structure names,
• manual and automatic save function for structure sets,
• and modifications in the user interface of structure database and template
creation. |
| Deformable
Alignment | Deformable registration of images of the same patient acquired with the same
or different modalities within different imaging sessions. The transformation
allows for local deformation to adapt to changing anatomy (many degrees of
freedom).
Modification: The deformation visualization tool was simplified and now
utilizes color-coded vectors to display the deformation vector field and its
magnitude at the same time. The visualization is restricted to the patient outline
for CT images. |
7
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 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 performance of the automated organ segmentation algorithm in the subject device syngo.via RT Image Suite (software version SOMARIS/8 VB50) was evaluated and compared to the predicate device syngo.via RT Image Suite (software version SOMARIS/8 VB40).
The organ segmentation consists of a region of interest detection based on anatomical landmarks, followed by a Deep Image Network performing the actual segmentation step. This technology was introduced in the predicate device. In the subject device, the same technology is extended to additional organs. The fundamental algorithm did not change. As described, we're using the same technology (or in other words the same algorithm) but the organ portfolio has been extended. The AI or deep learning-based algorithm has been initially cleared with the predicate device RT Image Suite SOMARIS/8 VB40 (K192065).
The segmentation algorithm of the subject device was evaluated on a test set of 112 subjects. The detection rates for the subject device were similar to those for the predicate device. Newly added organs in the subject device were detected at a rate of 100%. The segmentation quality was assessed by comparing a manually annotated ground truth with the algorithm result using the overlap measure DICE coefficient. The quantitative evaluation demonstrates non-inferior or superior performance for all organ segmentations in the subject device compared to the predicate device. The evaluation thus supports the claim of substantial equivalence.
8
Image /page/8/Picture/1 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 orange dots arranged in a circular pattern.
Risk Analvsis
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 will meet the following voluntary standards covering electrical and mechanical safety listed below, prior to introduction into interstate commerce:
| Recognition
Number | Product
Area | Title of Standard | Date of
Recognitio
n | Standards
Development
Organization |
|-----------------------|------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------------|------------------------------------------|
| 12-300 | Radiology | Digital Imaging and Communications
in Medicine (DICOM) Set; PS 3.1 -
3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -Software
Life Cycle Processes; 62304:2006 (1st
Edition) | 01/14/2019 | AAMI, ANSI,
IEC |
| 5-40 | Software/
Informati
cs | Medical devices – Application of risk
management to medical devices; 14971
Second Edition 2007-03-01 | 06/27/2016 | ISO |
| 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 VB50) has the same intended use and same indication for use as the predicate device, syngo.via RT Image Suite (software version SOMARIS/8 VB40). The fundamental technological characteristics are 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 (software version SOMARIS/8 VB50), 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 device.