(73 days)
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 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.
Here's an analysis of the acceptance criteria and study proving the device meets those criteria, based on the provided text.
Note: The provided text is a 510(k) summary for an existing device's software update, not a full clinical study report. Therefore, some details typically found in a full study report (like the exact geographic origin of all data, detailed expert qualifications and adjudication methods for ground truth, or full power analysis for sample sizes) are not explicitly stated. The information below is extracted and inferred from the available document.
Acceptance Criteria and Device Performance Study for syngo.via RT Image Suite (SOMARIS/8 VB50) automated organ segmentation algorithm
The focus of the performance evaluation in this 510(k) application is on the updated automated organ segmentation algorithm in the syngo.via RT Image Suite (SOMARIS/8 VB50), specifically its extension to additional organs compared to the predicate device (SOMARIS/8 VB40). The core algorithm is stated to be the same.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied) | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|---|
| Segmentation Detection Rate | Similar detection rates for organs present in the predicate device. | "The detection rates for the subject device were similar to those for the predicate device." |
| 100% detection rate for newly added organs (new functionality). | "Newly added organs in the subject device were detected at a rate of 100%." | |
| Segmentation Quality (Overlap) | Non-inferior or superior performance (measured by DICE coefficient) for all organ segmentations compared to the predicate device. | "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." |
| Software Verification & Validation | Conformance with special controls for medical devices containing software; all software specifications meet acceptance criteria; 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." and "The risk analysis was completed, and risk control implemented to mitigate identified hazards." |
| Functional Performance | Performs as intended. | "The results of these tests demonstrate that the subject device performs as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 112 subjects.
- Data Provenance: Not explicitly stated regarding country of origin. The study is described as a "performance evaluation" of the algorithm, comparing it to a predicate device. It does not explicitly state if it was retrospective or prospective, but performance evaluations of algorithms on a test set often utilize retrospectively collected data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified. The document mentions "manually annotated ground truth" but does not detail the number of annotators.
- Qualifications of Experts: Not specified. It's common in this domain for medical professionals (e.g., radiation oncologists, radiologists, medical physicists) to perform such annotations, but their specific qualifications or years of experience are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Since the ground truth is referred to as "manually annotated," it's possible a single expert annotated or multiple experts annotated with or without an arbitration/adjudication process. The document does not provide these details.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or reported in this 510(k) summary. The evaluation focuses on the standalone performance of the automated segmentation algorithm compared to a "manually annotated ground truth" and compared to the predicate device's algorithm.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, a standalone (algorithm-only) performance evaluation of the automated organ segmentation algorithm was performed. The evaluation involved comparing the algorithm's output directly against a manually annotated ground truth using the DICE coefficient and assessing detection rates.
7. The Type of Ground Truth Used
- Type of Ground Truth: "Manually annotated ground truth." This typically implies expert consensus or single expert annotation, but the precise method and number of experts are not detailed. It is explicitly contrasted with the "algorithm result," confirming it's an expert-derived truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not specified. The document states that "The AI or deep learning-based algorithm has been initially cleared with the predicate device RT Image Suite SOMARIS/8 VB40 (K192065)," and "The fundamental algorithm did not change." This suggests the training was done for the predicate device's initial clearance, and this submission focuses on the extension of its application to more organs using the same fundamental algorithm. The size of the original training set is not provided in this document.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth Establishment: Not explicitly detailed in this document. Given that the fundamental algorithm was used in the predicate device, it can be inferred that the training data and corresponding ground truth were established historically for the original algorithm development. It is common for ground truth for deep learning training in medical imaging to be established through expert annotations, potentially with internal review or consensus processes, but specific details are not provided here.
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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
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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
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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120Expiration 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) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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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 |
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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
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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 |
|---|---|
| RoutineContouring | Routine Contouring tools (e. g. freehand drawing tools, creation of marginsetc.)Modification:improvements in the contour interpolation tool and a tool tomerge multiple structures. |
| AdvancedContouring | Advanced Contouring tools (automatic contouring of different structures,nudge 3D tool,contour interpolation.). Automatic contouring of pelvic andhead/neck regions, support of Rapid Results Technology.Modification: This subject device provides the following extensions:• Automatic Contouring can be applied on further structures (thoracic andpelvic regions)• Automatic Contouring in the head/neck region, which was previously atlas-based, is now done with deep learning. The atlas method is entirely removedfrom this version.• Streamlined workflow to automatically adapt contours from a prior to acurrent planning CT |
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| Structure SetManagement | • Loading and storing of DICOM RT structure sets, creating, editing anddeletion of structures and POIs.• Creating, editing and deletion of structure templates.• Customize predefined structure database with mapping to internationalnomenclature schemes. |
|---|---|
| Modification:• multiselection of structures and POIs to apply basic operations such as copyor delete,• auto-completion for structure names,• manual and automatic save function for structure sets,• and modifications in the user interface of structure database and templatecreation. | |
| DeformableAlignment | Deformable registration of images of the same patient acquired with the sameor different modalities within different imaging sessions. The transformationallows for local deformation to adapt to changing anatomy (many degrees offreedom).Modification: The deformation visualization tool was simplified and nowutilizes color-coded vectors to display the deformation vector field and itsmagnitude at the same time. The visualization is restricted to the patient outlinefor CT images. |
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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 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.
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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:
| RecognitionNumber | ProductArea | Title of Standard | Date ofRecognition | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 12-300 | Radiology | Digital Imaging and Communicationsin Medicine (DICOM) Set; PS 3.1 -3.20 | 06/27/2016 | NEMA |
| 13-32 | Software | Medical Device Software -SoftwareLife Cycle Processes; 62304:2006 (1stEdition) | 01/14/2019 | AAMI, ANSI,IEC |
| 5-40 | Software/Informatics | Medical devices – Application of riskmanagement to medical devices; 14971Second Edition 2007-03-01 | 06/27/2016 | ISO |
| 5-114 | General I(QS/RM) | Medical devices - Part 1: Applicationof usability engineering to medicaldevicesIEC 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.
§ 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.