(83 days)
VB10 K150843
No
The document describes standard image processing and visualization tools, including manual and semi-automatic contouring and registration. There is no mention of AI, ML, or related terms like deep learning or neural networks. The performance studies focus on functional and integration testing, not AI/ML specific metrics or validation.
No
Explanation: This device is an image visualization, manipulation, and contouring tool used for the preparation and response assessment of treatments, particularly in radiation therapy. It does not directly provide therapy or interact therapeutically with the patient; rather, it aids medical professionals in planning and assessing treatment.
No
Explanation: The device is described as a "visualization, multimodality manipulation and contouring tool" and "image analysis software" used for the preparation and response assessment of treatments and for "segmentation of tumors and organs-at-risk, prior to dosimetric planning and response assessment in radiation therapy." Its primary function is to process and present medical images for treatment planning and assessment, not to diagnose medical conditions or diseases.
Yes
The device description explicitly states "syngo.via RT Image Suite is an image analysis software" and "The synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support." While it operates within a hardware/software architecture, the device itself, as described, is the software application for image analysis and manipulation.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (like blood, urine, tissue). The intended use and device description clearly state that syngo.via RT Image Suite is a software tool for visualizing, manipulating, and analyzing medical images acquired from various imaging modalities (CT, PET, MRI, etc.). These images are representations of the body, not samples taken from it.
- The purpose is image processing and analysis for treatment planning and assessment. The software helps medical professionals prepare for and assess treatments like radiation therapy by providing tools for viewing, contouring, and comparing images and anatomical structures. This is distinct from the diagnostic purpose of an IVD, which is to provide information about a patient's health status based on the analysis of biological samples.
The device is a medical image processing and analysis software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools: · Multi-modality viewing and contounical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images · Multiplanar reconstruction (MPR) thingthick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique · Creation of contours on any type of mages without prior assignment of a planning CT · Manual and semi-automatic registration using rigid and deformable registration · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points Supports the user in comparing images and contours of different patients · Supports multi-modality image fusion · Visualization and contouring of moving tumors and organs
Product codes
MUJ, LLZ
Device Description
syngo.via RT Image Suite is an image analysis software used for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-atrisk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, 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 synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, PET, PET/CT, MRI, Linac Cone Beam CT (CBCT)
Anatomical Site
Regions of the body, skin outline, targets, organs-at-risk, moving tumors and organs.
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
Integration and functional tests were conducted for syngo.via RT Image Suite during product development. The test results show that all of the software specifications have met the acceptance criteria. 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance tests were conducted to test the functionality of the subject device, syngo.via RT Image Suite. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence. The non-clinical test data demonstrates that syngo.via RT Image Suite device performance is comparable to the predicate devices that are currently marketed for the same intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 13, 2015
Siemens Medical Solutions USA, Inc. % Ms. Eve Davis Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K151380
Trade/Device Name: syngo.via RT Image Suite Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ and LLZ Dated: May 21, 2015 Received: May 22, 2015
Dear Ms. Davis:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: January 31, 2017 See PRA Statement below. Indications for Use 510(k) Number (if known) 51380 levice Name syngo.via RT Image Suite Indications for Use (Describe) syngo via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy). It provides tools to efficiently view existing contours, create, edit, modify, copy contours of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools: · Multi-modality viewing and contounical, functional, and multi-parametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images · Multiplanar reconstruction (MPR) thingthick, minimum intensity projection (MIP), volume rendering technique (VRT) · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique · Creation of contours on any type of mages without prior assignment of a planning CT · Manual and semi-automatic registration using rigid and deformable registration · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points Supports the user in comparing images and contours of different patients · Supports multi-modality image fusion · Visualization and contouring of moving tumors and organs
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.'
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Poblishing Services (101) 443-5740 EP
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510(K) SUMMARY FOR syngo.via RT Image Suite
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: May 21, 2015
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Establishment Registration Number: 2240869
Manufacturing Site:
Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany
Establishment Registration Number: 3004977335
2. Contact Person:
Eve Davis Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, Mail Code D02 Malvern, PA 19355 Phone: (610) 219-7133 Fax: (610) 448-1787 Email: eve.davis@siemens.com
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| 3. | 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 | |||
| Additional Product Code: | LLZ | |||
| Legally Marketed Primary Predicate Device: | ||||
| Trade Name: | syngo® Dosimetrist Workspace v2.7 | |||
| 510(k)#: | K101119 | |||
| Clearance Date: | June 16, 2010 | |||
| Classification Name: | System, Planning, Radiation Therapy Treatment | |||
| Classification Panel: | Radiology | |||
| Classification Regulation: | 21 CFR §892.5050 | |||
| Device Class: | II | |||
| Product Code: | MUJ | |||
| Recall Information: | Recall 68395 | |||
| Legally Marketed Secondary Predicate Device: | ||||
| Trade Name: | syngo.PET&CT Oncology | |||
| 510(k)#: | K093621 | |||
| Clearance Date: | February 23, 2010 | |||
| Classification Name: | Picture Archiving and Communication Systems | |||
| Classification Panel: | Radiology | |||
| Classification Regulation: | 21 CFR § 892.2050 | |||
| Device Class: | II | |||
| Product Code: | LLZ | |||
| Recall Information: | There have been no recalls for this device |
4. Substantial Equivalence:
The subject device, syngo.via RT Image Suite, is substantially equivalent to following medical devices in commercial distribution:
| Predicate Devices | FDA Clearance
Number | FDA Clearance
Date |
|---------------------------------------------------------------------------|-------------------------|-----------------------|
| Primary Predicate Device:
Siemens
syngo® Dosimetrist Workspace v2.7 | K101119 | June 16, 2010 |
| Secondary Predicate Device:
Siemens
syngo.PET&CT Oncology | K093621 | February 23, 2010 |
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5. Device Description:
syngo.via RT Image Suite is an image analysis software used for viewing, manipulation, 3D and 4D visualization, comparison of medical images from multiple imaging modalities and for the segmentation of tumors and organs-atrisk, prior to dosimetric planning and response assessment in radiation therapy. syngo.via RT Image Suite combines routine and advanced digital image processing and visualization tools for easy manual and software assisted contouring of volumes of interest, identification of points of interest, 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 synqo.via RT Image Suite post-processing software application is embedded in the Siemens syngo.via framework (operating platform most recently cleared as VB10 K150843) of a multi-user HW/SW architecture with Client-Server support. Software information is located in Section 16.
The following modifications have been made to the previously cleared primary predicate device (syngo® Dosimetrist Workspace 2.7 K101119, clearance date June 16 2010) and the secondary predicate device (syngo.PET&CT Oncology K093621, clearance date February 23 2010).
-
- A new software version SOMARIS/8 VB10 which supports the following:
- New post-processing software application "syngo.via RT Image . Suite" which has been designed for the new syngo.via platform (SOMARIS/8 VB10) and contains the following application modifications compared to the predicate devices:
- o Advanced Contouring: offers freehand editing and 3D Nudge tools for editing in non-original image orientations. These two features are segmentation improvements to the already cleared feature "Advanced Segmentation" described in Premarket Notification K101119. clearance date 06/16/2010.
- o Deformable Alignment: for cases where rigid alignment does not provide sufficient anatomical correspondence between secondary images and the reference image, deformable registration is an option. The deformable registration allows the user to map the corresponding anatomy captured in the two images. Rigid Alignment has been cleared within the Premarket Notification K093621, cleared date 02/23/2010.
- Contouring on 4D CT: The subject device allows the user to o display a cine loop of images acquired through gated CT. This is a new feature supported by software testing.
-
- An extended, more descriptive Indication for Use statement to include details of device functionality
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6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
syngo.via RT Image Suite has the same intended use and operating principle as the predicate devices. The synqo.via RT Image Suite application is designed to be operated on the syngo.via platform in a single or multi server environment.
syngo.via RT Image Suite does not have significant changes in technological characteristics when compared to the predicate devices. The subject device is the same to either one or both of the predicate devices in regards to:
- Visualization ●
- Routine Contouring .
- Annotation
- Reference Point Management ●
- Structure Set Management ●
- User Interface ●
- Archiving/Storage ●
- Hardware ●
- Image Processing and Evaluation ●
- Communication ●
The following table shows the differences in technological characteristics between the subject device and the predicate devices.
| Feature | Subject Device
syngo.via RT
Image Suite | Primary
Predicate Device
Siemens
syngo®
Dosimetrist
Workspace v2.7
(K101119) | Secondary
Predicate Device
Siemens
syngo.PET&CT
Oncology
(K093621) | Comparison |
|------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Advanced
Contouring | Freehand
editing 3D | Random Walker
Tools | N/A | The subject device offers
freehand 3D editing and 3D
Nudge tools for editing in
non-original image
orientations. These two
features are segmentation
improvements to the 2D
tools cleared in K101119. |
| | Nudge 3D | Contour Nudge
Tool | N/A | Contour interpolation was
cleared as part of both the
primary and secondary
predicate devices. |
| | Contour
interpolation | Contour
interpolation | Contour
interpolation | |
| Alignment | Rigid
alignment tools | Rigid alignment
tools | Rigid alignment
tools | The subject device contains
the same rigid alignment
tools as cleared in both the
primary and secondary
predicate devices |
Table 1: Differences in technical characteristics
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| Feature | Subject Device
syngo.via RT
Image Suite | Primary
Predicate Device
Siemens
syngo®
Dosimetrist
Workspace v2.7
(K101119) | Secondary
Predicate Device
Siemens
syngo.PET&CT
Oncology
(K093621) | Comparison |
|------------------------|-----------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Deformable
alignment tools | N/A | N/A | The Deformable alignment
used to map the
corresponding anatomy
captured on two registered
images is an optional,
additional feature for cases
where rigid alignment does
not provide sufficient
anatomical correspondence
between secondary images
and the reference image. |
| Contouring
on 4D CT | Present | N/A | N/A | The subject device allows
the user to display a cine
loop of images acquired
through gated CT. This is a
new feature and was not
available on the predicate
devices. |
7. Nonclinical Testing:
syngo.via RT Image Suite is designed to fulfill the requirements of the following safety and performance standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 12-238 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.18 | 03/16/2012 | NEMA |
| 13-8 | Software | Medical device software -
Software life cycle processes | 62304 First
edition 2006-05 | 08/20/2012 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
Edition 2007-
03-01 | 08/20/2012 | ISO |
| 5-85 | General | Medical electrical equipment --
Part 1-6: General requirements
for basic safety and essential
performance -- Collateral
Standard: Usability | 60601-1-6
Edition 3.0
2010-01 | 1/30/2014 | IEC |
| 5-41 | General | Medical electrical equipment -
Part 1-4: General requirements
for safety -- Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-
4:2000, Consol.
Ed. 1.1 | 09/08/2009 | IEC |
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Verification and Validation
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Integration and functional tests were conducted for syngo.via RT Image Suite during product development.
Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The test results show that all of the software specifications have me the acceptance criteria.
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 conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. It is the hospital's responsibility to comply with IEC 8001-1-2010.
Summary
Performance tests were conducted to test the functionality of the subject device, syngo.via RT Image Suite. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
8. Indications for Use:
syngo.via RT Image Suite is a 3D and 4D image visualization, multimodality manipulation and contouring tool that helps the preparation and response assessment of treatments such as, but not limited to those performed with radiation (for example, Brachytherapy, Particle Therapy, External Beam Radiation Therapy).
It provides tools to efficiently view existing contours, create, edit, modify, copy contours of regions of the body, such as but not limited to, skin outline, targets and organs-at-risk. Contours and images can subsequently be exported to a Treatment Planning System. The software combines following digital image processing and visualization tools:
- · Multi-modality viewing and contouring of anatomical, functional, and multiparametric images such as but not limited to CT, PET, PET/CT, MRI, and Linac Cone Beam CT (CBCT) images
- · Multiplanar reconstruction (MPR) thin/thick, minimum intensity projection (MIP), volume rendering technique (VRT)
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- · Freehand and semi-automatic contouring of regions-of-interest on any orientation including oblique
- · Creation of contours on any type of images without prior assignment of a planning CT
- · Manual and semi-automatic registration using rigid and deformable registration
- · Supports the user in comparing, contouring, and adapting contours based on datasets acquired with different imaging modalities and at different time points. Supports the user in comparing images and contours of different patients
- · Supports multi-modality image fusion
- · Visualization and contouring of moving tumors and organs
9. General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
10. Conclusion as to Substantial Equivalence
The predicate devices were cleared based on non-clinical supportive information. The subject device was tested using the same non-clinical methods. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and Validation testing also demonstrates that syngo.via RT Image Suite performs as intended. The non-clinical test data demonstrates that syngo.via RT Image Suite device performance is comparable to the predicate devices that are currently marketed for the same intended use. In summary, Siemens is of the opinion that the syngo.via RT Image Suite does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.