syngo.via RT Image Suite

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. Siemens Medical Solutions USA, Inc. % Monsuru Bello Official Correspondent 810 Innovation Drive KNOXVILLE, TN 37932 ### Re: K232799 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: March 27, 2024 Received: March 27, 2024 Dear Monsuru Bello: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). April 26, 2024 {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding 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 mediation-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. Locon Weidner Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) K232799 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, functional, and multiparametric 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. # K232799 - 510(k) Summary ### 1. Identification of the Submitter | Submitter / Primary Contact Person | Monsuru K Bello | |------------------------------------|-----------------------------------------------| | | Regulatory Affairs | | | monsuru.bello@siemens-healthineers.com | | | +1(202) 856-6099 | | Secondary Contact Person | Clayton Ginn | | | Regulatory Affairs | | | clayton.ginn@siemens-healthineers.com | | | +1 (865) 898-2692 | | Submitter Address | Siemens Medical Solutions, Inc. USA | | | Molecular Imaging | | | 810 Innovation Drive | | | Knoxville, TN 37932 | | | Establishment Registration Number: 1034973 | | Legal Manufacturer | Siemens Healthcare GmbH | | | Siemensstr 1 | | | D-91301 Forchheim, Germany | | | Establishment Registration Number: 3004977335 | | Importer/Distributor | Siemens Medical Solutions USA, Inc. | | | 40 Liberty Boulevard | | | Malvern, PA 19355 | | | Establishment Registration Number: 2240869 | # 2. Device Name and Classification | Product Name: | syngo.via RT Image Suite | |-----------------------|---------------------------------------------------| | Propriety Trade Name: | syngo.via RT Image Suite | | Classification Name: | Medical Charged-Particle Radiation Therapy System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.5050 | | Device Class: | Class II | | Product Code: | MUJ | # 3. Predicate Devices ### Predicate Device: | Trade Name: | syngo.via RT Image Suite | |-----------------------|---------------------------------------------------| | Classification Name: | Medical Charged-Particle Radiation Therapy System | | Classification Panel: | Radiology | | CFR Section: | 21 CFR §892.5050 | | Device Class: | Class II | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logos for Siemens and Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. Product Code: MUJ 510(k) Number: K220783 #### 4. Device Description The subject device with the current software version SOMARIS/8 VB80 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 current software version SOMARIS/8 VB80 are as follows: - Modifications in Advanced Contouring: Data for training and validation of Advanced Contouring was obtained through clinical collaborations from Asia, Australia, Europe, and America to provide variability in age, gender, geographic origin, etc. Both native and contrasted CT images are included. - . Revised User Interface #### 5. 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). lt 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: - 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 {6}------------------------------------------------ Image /page/6/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 word "Healthineers" is a graphic of orange dots in a circular pattern. - 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 | Subject Device | Predicate Device | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | syngo.via RT Image Suite | syngo.via RT Image Suite | | (software version: SOMARIS/8 VB80) | (software version SOMARIS/8 VB70) | | (510(k) number: K232799) | (510(k) number: K220783) | | syngo.via RT Image Suite is a 3D and 4D image visualization, | syngo.via RT Image Suite is a 3D and 4D image visualization, | | multi-modality manipulation and contouring tool that helps | multi-modality manipulation and contouring tool that helps | | the preparation of treatments such as, but not limited to | the preparation of treatments such as, but not limited to | | those performed with radiation (for example, | those performed with radiation (for example, | | Brachytherapy, Particle Therapy, External Beam Radiation | Brachytherapy, Particle Therapy, External Beam Radiation | | Therapy). | Therapy). | | It provides tools to view existing contours, create, edit, | It provides tools to view existing contours, create, edit, | | modify, copy contours of regions of the body, such as but | modify, copy contours of regions of the body, such as but | | not limited to, skin outline, targets and organs-at-risk. It also | not limited to, skin outline, targets and organs-at-risk. It also | | provides functionalities to create simple geometric | provides functionalities to create simple geometric | | treatment plans. Contours, images and treatment plans can | treatment plans. Contours, images and treatment plans can | | subsequently be exported to a Treatment Planning System. | subsequently be exported to a Treatment Planning System. | | The software combines the following digital image<br>processing and visualization tools:<br>• Multi-modality viewing and contouring of anatomical,<br>functional, and multi-parametric images such as but not<br>limited to CT, PET, PET/CT, MRI, Linac CBCT images<br>• Multiplanar reconstruction (MPR) thin/thick, minimum<br>intensity projection (MIP), volume rendering technique<br>(VRT)<br>• Freehand and semi-automatic contouring of regions-of-<br>interest on any orientation including oblique<br>• Automated Contouring on CT images<br>• Creation of contours on images supported by the<br>application without prior assignment of a planning CT<br>• Manual and semi-automatic registration using rigid and<br>deformable registration | The software combines the following digital image<br>processing and visualization tools:<br>• Multi-modality viewing and contouring of anatomical,<br>functional, and multi-parametric images such as but not<br>limited to CT, PET, PET/CT, MRI, Linac CBCT images<br>• Multiplanar reconstruction (MPR) thin/thick, minimum<br>intensity projection (MIP), volume rendering technique<br>(VRT)<br>• Freehand and semi-automatic contouring of regions-of-<br>interest on any orientation including oblique<br>• Automated Contouring on CT images<br>• Creation of contours on images supported by the<br>application without prior assignment of a planning CT<br>• Manual and semi-automatic registration using rigid and<br>deformable registration | | Supports the user in comparing, contouring, and<br>adapting contours based on datasets acquired with<br>different imaging modalities and at different time points | Supports the user in comparing, contouring, and<br>adapting contours based on datasets acquired with<br>different imaging modalities and at different time points | | Supports multi-modality image fusion | Supports multi-modality image fusion | | • Visualization and contouring of moving tumors and<br>organs | • Visualization and contouring of moving tumors and<br>organs | | Management of points of interest including but not<br>limited to the isocenter | Management of points of interest including but not<br>limited to the isocenter | | Creation of simple geometric treatment plans | Creation of simple geometric treatment plans | | Generation of a synthetic CT based on multiple pre-<br>define MR acquisitions | Generation of a synthetic CT based on multiple pre-<br>define MR acquisitions | # 6. Indications for Use Comparison to the Predicate Device {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows 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 word "Healthineers" is a cluster of orange dots. # 7. Comparison of Technological Characteristics with the Predicate Device The differences between the above referenced predicate device are listed at a high-level in the following table: | | Subject Device | Predicate Device | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Siemens | Siemens | | | syngo.via RT Image Suite<br>(software version SOMARIS/8 VB80) | syngo.via RT Image Suite<br>(software version SOMARIS/8 VB70)<br>(510(k) number: K220783) | | Advanced<br>Contouring | Advanced Contouring tools (automatic contouring of<br>structures, nudge 3D tool, etc.). Support of Rapid<br>Results Technology. Streamlined workflow to adapt<br>contours from a prior to a current planning CT<br>("adaptive contouring").<br>Modifications:<br>• The existing, cleared Advanced Contouring<br>feature has been extended by additional<br>anatomical structures. There are no changes<br>on the underlying DL-based autocontouring<br>algorithm. | Advanced Contouring tools (automatic contouring of<br>structures, nudge 3D tool, etc.). Support of Rapid<br>Results Technology. Streamlined workflow to adapt<br>contours from a prior to a current planning CT<br>("adaptive contouring"). | | User<br>Interface | syngo.via based GUI<br>Modifications:<br>• Minor modifications on the UI. Restructured<br>and revised UI elements. | syngo.via based GUI | The remaining functions in syngo.via RT Image Suite remain unchanged compared to the predicate version. - . Beam Placement - Reference Point Management - Patient Marking - . Routine Contouring - . Advanced Contouring - Routine Structure Operations - Duplication of Structures and POIs - Structure Set Management - Rigid Alignment - Deformable Alignment - Dose Evaluation - Synthetic CT - Contouring on 4D Image Data - Lobe-Based Lung Ventilation - Routine Reading Functionality {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. - Parallel Image Display - . Routine Annotation Functionality ### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. #### Non-Clinical Testing - Software Verification and Validation Software Documentation for Enhanced documentation Level per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Device Software Functions" issued on June 14, 2023, is also included as part of this submission. 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. #### Performance Evaluation of the Algorithm The Al-based autocontouring feature of syngo.via RT Image Suite was tested on 413 subjects. The test data was generated from an independent set that was not seen by the model during training stage to cover a wide range of CT scanners and typical CT acquisition parameters. The general guideline was to reserve 20% of the available data for validation. The test data covers: - . Regional distribution (Europe: IT, PT, CH, UK, NL, DE; North America: US, CA; South America: BR; Australia, Asia: JP, IN) - Demographic distribution: Male/female - Distribution by manufacturer of the scanner: GE, Siemens, Philips ● - Distribution in protocols of different slice thicknesses: between < 1 mm till > 3 mm - . Subgroup analysis regarding manufacturer, slice thickness and gender did not show any confounder. | Subgroup | # Validation data sets | |-------------------------|------------------------------------------------------------------------------------------| | Data Source | Europe: 58, US: 165, Canada: 39, South America: 78, Australia: 28, Asia: 33, unknown: 12 | | Body Region | Head&Neck: 113, Thorax&Abdomen: 216, Pelvis: 84 | | Gender | Male: 188, female: 174. Unknown: 51 | | Age | <=30: 1, [30-50]: 6, [50;70]: 46, >70: 20, unknown: 340 | | Slice thickness (in mm) | <=1: 19, (1,2]: 207, (2,3]: 168, >3: 19 | | Manufacturer | Siemens: 126, GE: 77, Philips: 140, unknown/others: 70 | Table 1: Distribution of validation data across subgroups Manual ground-truth segmentations were annotated by an expert team based on well accepted international contouring guidelines, followed by a rigorous independent quality assessment. The testing ensures the quantitative performance of the resulting segmentations by comparing them to the manually annotated ground truth based on the commonly used overlap metric Dice coefficient . All tests passed the defined acceptance criteria on the geometric overlap with the ground truth. The evaluation results confirm the clinical safety and performance of the autocontouring feature. {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots that are arranged in a circular pattern. #### 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 FDA Recognized Consensus standards listed below: | Standard | Version | Content | FDA<br>Recognition<br>Number<br>(if applicable) | |-----------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------| | ANSI AAMI IEC<br>62304 | :62304:2006/A<br>1:2016 | Medical device software - Software life cycle<br>processes [Including Amendment 1 (2016)] | 13-79 | | NEMA PS 3.1 -<br>3.20 2022d | :2022 | Digital Imaging and Communications in<br>Medicine (DICOM) Set | 12-349 | | ISO 14971 | :2019 | Application of Risk Management to Medical<br>Devices | 5-125 | | IEC 62366-1 | Edition 1.1<br>2020-06<br>CONSOLIDATED<br>VERSION | Medical devices - Part 1: Application of<br>usability engineering to medical devices | 5-129 | | ISO 15223-1 | Fourth edition<br>2021-07 | Medical devices - Symbols to be used with<br>information to be supplied by the<br>manufacturer - Part 1: General requirements | 5-134 | | ISO 20417 | First edition<br>2021-04<br>Corrected<br>version 2021-<br>12 | Medical devices - Information to be supplied<br>by the manufacturer | 5-135 | ### 9. Conclusion syngo.via RT Image Suite has the same intended use and indication for use 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, clinical and 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. 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.