(68 days)
Not Found
No
The document describes standard image processing and segmentation tools without mentioning AI or ML. The testing described is functional and performance testing, not validation of an AI/ML model.
No
Explanation: The device is a software solution for planning external beam radiation therapy treatment, specifically for defining anatomical regions and planning geometric treatment. It does not directly provide therapy or interact with the patient for therapeutic purposes. Its function is to facilitate the planning process for radiation therapy, which is a therapeutic intervention, but the device itself is not therapeutic.
No
Explanation: The device is used for planning external beam radiation therapy and creating 3D models for treatment, not for diagnosing diseases or conditions.
Yes
The device is explicitly described as a "software solution" and a "software application" that runs on a "syngo® based workspace," processing CT images as input and producing DICOM-RT outputs. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to prepare anatomical data (CT) for the planning of external beam radiation therapy treatment." This is a planning tool for a medical procedure performed on a patient, not a test performed on a sample taken from the body.
- Device Description: The description reinforces its role in radiation therapy planning, using CT images to define anatomical regions and plan treatment. It doesn't mention analyzing biological samples or providing diagnostic information based on such analysis.
- Input: The input is "CT planning images," which are medical images of the patient's anatomy, not biological samples.
- Output: The output is "DICOM-RT Structures and DICOM RT Plans for treatment planning," which are data formats used in radiation therapy planning, not diagnostic test results.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is entirely focused on the planning phase of a medical treatment based on imaging data.
N/A
Intended Use / Indications for Use
V Sim is a software solution to prepare anatomical data (CT) for the planning of external beam radiation therapy treatment.
V Sim provides features to define anatomical regions, reference points and geometric treatment plans prior to dosimetric planning with a treatment planning system.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
Virtual simulation, the most basic form of planning, allows more accurate placement of radiation beams than is possible using conventional X-ray imaging, where soft-tissue structures are often difficult to assess and normal tissues difficult to protect. The virtual simulation application syngo VSim allows the use of contouring and segmentation tools to assist in the drawing of the borders of the treatment volume and organ at risk.
syngo VSim is a software application that runs on a syngo® based workspace. It is a 3D-post-processing software application that uses CT planning images as input and creates as output DICOM-RT Structures and DICOM RT Plans for treatment planning.
syngo VSim is used to create 3D-models of target volumes and organs at risk. The main functionalities of syngo VSim are segmentation of organs, management of reference points and placement of geometrical treatment beams.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests (integration and functional) were conducted for syngo VSim during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
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.
Performance tests were conducted to test the functionality of the syngo VSim. These tests have been performed to test the ability of the included features of the subiect 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 16, 2015
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K151887
Trade/Device Name: syngo VSim Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: June 15, 2015 Received: July 10, 2015
Dear Ms. Mangum:
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.
1
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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151887
Device Name
syngo VSim
Indications for Use (Describe)
V Sim is a software solution to prepare anatomical data (CT) for the planning of external beam radiation therapy treatment.
V Sim provides features to define anatomical regions, reference points and geometric treatment plans prior to dosimetric planning with a treatment planning system.
| 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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3
SIEMENS
510(k) Summary FOR syngo VSim Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: September 2, 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 Establishment: Registration No: 2240869 Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard
Malvern, PA 19355
Manufacturing Facility:
Siemens AG Medical Solutions Doris-Ruppenstein Straße 4 D-91052 Erlangen, Germany Establishment Registration Number: 3004977335
2. Contact Person:
Kimberly Mangum Requlatory Affairs Specialist Siemens Medical Solutions. Inc. USA 40 Liberty Boulevard Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
Product Name: svnao VSim Propriety Trade Name: syngo VSim System, Planning, Radiation Therapy Treatment Classification Name: Classification Panel: Radiology 21 CFR §892.5050 CFR Section: Class II Device Class: Product Code: MUJ
4
4. Legally Marketed Primary Predicate Device:
| Product Name: | syngo Dosimetrist Workspace v2.7 |
|---|---|
| Propriety Trade Name: | syngo Dosimetrist Workspace v2.7 |
| Classification Name: | System, Planning, Radiation Therapy Treatment |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR § 892.5050 |
| Device Class: | Class II |
| Product Code: | MUJ |
| 510(k) Number: | K101119 |
5. Indications for Use
VSim is a software solution to prepare anatomical data (CT) for the planning of external beam radiation therapy treatment.
VSim provides features to define anatomical regions, reference points and qeometric treatment plans prior to dosimetric planning with a treatment planning svstem.
6. Substantial Equivalence:
The subject device syngo VSim is substantially equivalent to following medical devices in commercial distribution as listed in Table 1:
Table 1: Predicate Devices
| Manufacturer | Predicate Device | 510(k) | Clearance Date |
|---|---|---|---|
| Siemens | syngo Dosimetrist Workspace v2.7 | K101119 | June 16, 2010 |
7. Device Description:
Virtual simulation, the most basic form of planning, allows more accurate placement of radiation beams than is possible using conventional X-ray imaging, where soft-tissue structures are often difficult to assess and normal tissues difficult to protect. The virtual simulation application syngo VSim allows the use of contouring and segmentation tools to assist in the drawing of the borders of the treatment volume and organ at risk.
syngo VSim is a software application that runs on a syngo® based workspace. It is a 3D-post-processing software application that uses CT planning images as input and creates as output DICOM-RT Structures and DICOM RT Plans for treatment planning.
syngo VSim is used to create 3D-models of target volumes and organs at risk. The main functionalities of syngo VSim are segmentation of organs, management of reference points and placement of geometrical treatment beams.
5
SIEMENS
-
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
The subject device syngo VSim application does not differ in intended use from the 510(k) cleared predicate device syngo® Dosimetrist Workspace 2.7 (K101119, clearance date 06/16/2010). A comparison of the technical characteristics for the subject device and the predicate device is provided in Table 2 below.
- Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
Predicate and Subject Device Comparable Technological Table 2: Characteristics
| Property | Subject Device | Primary Predicate Device
K101119 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Indications for Use | Modified to reflect syngo VSim as a
standalone software device. There is no
change in the intended use from the
predicate device. | Indications for use reflects syngo
VSim as a component of syngo®
Dosimetrist Workspace 2.7 |
| VSim software | Stand alone software device to be
marketed as syngo VSim. | Component of syngo® Dosimetrist
Workspace 2.7 |
The basic operating principle remains unchanged from the predicate device. Furthermore, there are no changes in regard to the features of VSim (Segmentation, Reference Point Management, Simulation) compared to the predicate device.
Testing and validation is completed. Test results show that the subject device, syngo VSim, is comparable to the VSim task card of the predicate device and therefore Siemens believes it substantially equivalent.
9. Nonclinical Testing:
syngo VSim is designed to fulfill the requirements of the following safety and performance standards listed in Table 3 below:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|---------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|---------------------|------------------------------------------|
| N/A | General | General Requirements
for Collateral Standard:
Programmable
Electrical Medical
Systems | IEC 60601-1-
4:2000, Consol.
Ed. 1.1, Medical
Electrical
Equipment - Part
1-4: | 09/08/2009 | IEC |
| 12-217 | Radiology | Medical Electrical
Equipment -
Requirements for the | 62083 Edition 2.0
2009-09 | 03/18/2011 | IEC |
| Table 3: Performance Standards | |
|---|---|
6
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and Date | Publication
Date | Standards
Development
Organization |
|-----------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| N/A | | Safety of Radiotherapy
Treatment Planning
Systems | | | |
| N/A | Software | Medical device software
- Software life cycle
processes | IEC 62304 First
Edition 2006-05 | 09/09/2008 | IEC |
| N/A | General | Medical devices -
Application of usability
engineering to medical
devices (General) | EN/IEC 62366 | 09/08/2009 | IEC |
| N/A | Radiology | Digital Imaging and
Communications in
Medicine (DICOM) Set | PS 3.1 - 3.18 | 03/16/2012 | NEMA |
| 5-40 | General | Medical devices -
Application of risk
management to medical
devices | 14971 Second
Edition 2007-03-
01 | 08/20/2012 | ISO |
| N/A | General | Medical electrical
equipment -- Part 1-6:
General requirements
for basic safety and
essential performance --
Collateral Standard:
Usability | 60601-1-6:2004 | 1/30/2014 | IEC |
| 12-267 | Radiology | Radiotherapy
equipment -
Coordinates,
movements, and scales | 61217 Edition 2.0
2011-12 | 01/30/2014 | IEC |
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) were conducted for syngo VSim during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
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.
Software Verification and Validation
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for
7
SIEMENS
Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
Non-Clinical Testing Summary
Performance tests were conducted to test the functionality of the syngo VSim. These tests have been performed to test the ability of the included features of the subiect 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.
10. 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, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
11. Conclusion as to Substantial Equivalence
syngo VSim has the same intended use and comparable indications for use as the predicate device. The technical characteristics of the VSim component remain unchanged from the predicate device. Any technological differences between the subject device and predicate device do not raise different questions of safety or effectiveness.
The predicate device was cleared based on non-clinical supportive information. The subject device non-clinical test data similarly supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that the subject device syngo VSim performs as intended. The non-clinical test data demonstrates that syngo VSim device performance is comparable to the predicate device that is currently marketed for the same intended use.
In summary, Siemens is of the opinion that the syngo VSim does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.