VSim provides features to define anatomical regions, reference points and geometric treatment plans prior to dosimetric planning with a treatment planning system.

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.

AI/ML Overview

I am sorry, but the provided text does not contain the specific details about acceptance criteria, device performance, and study information that you requested. The document is a 510(k) premarket notification for a software device, syngo VSim, and primarily focuses on establishing substantial equivalence to a predicate device.

The document discusses:

Intended Use and Indications for Use: The software prepares anatomical data (CT) for external beam radiation therapy treatment planning, defining anatomical regions, reference points, and geometric treatment plans.
Comparison to Predicate Device: It states that syngo VSim is substantially equivalent to syngo Dosimetrist Workspace v2.7 (K101119). The main difference noted is that syngo VSim is a standalone software, while the predicate was a component.
Nonclinical Testing: Mentions that nonclinical tests (integration and functional) were conducted and supported by verification/validation testing, and that a risk analysis was completed. It also lists several recognized safety and performance standards the device is designed to fulfill.
Software Verification and Validation: Indicates that documentation for a Moderate Level of Concern software was included and that performance tests were conducted to test its functionality.

However, it does not provide:

A table of acceptance criteria and reported device performance.
Sample size used for the test set or data provenance.
Number of experts and their qualifications used to establish ground truth for the test set.
Adjudication method for the test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
Explicit statement about a standalone algorithm-only performance study.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The document states that "The testing results support that all the software specifications have met the acceptance criteria" and "The result of all conducted testing was found acceptable to support the claim of substantial equivalence," but it does not specify what those acceptance criteria were or what the specific numerical performance results were against those criteria.

Summary

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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.

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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. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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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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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

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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:

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SIEMENS

1. 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.

Predicate and Subject Device Comparable Technological Table 2: Characteristics

Property	Subject Device	Primary Predicate DeviceK101119
Indications for Use	Modified to reflect syngo VSim as astandalone software device. There is nochange in the intended use from thepredicate device.	Indications for use reflects syngoVSim as a component of syngo®Dosimetrist Workspace 2.7
VSim software	Stand alone software device to bemarketed as syngo VSim.	Component of syngo® DosimetristWorkspace 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:

RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and Date	PublicationDate	StandardsDevelopmentOrganization
N/A	General	General Requirementsfor Collateral Standard:ProgrammableElectrical MedicalSystems	IEC 60601-1-4:2000, Consol.Ed. 1.1, MedicalElectricalEquipment - Part1-4:	09/08/2009	IEC
12-217	Radiology	Medical ElectricalEquipment -Requirements for the	62083 Edition 2.02009-09	03/18/2011	IEC

Table 3: Performance Standards

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RecognitionNumber	ProductArea	Title of Standard	ReferenceNumber and Date	PublicationDate	StandardsDevelopmentOrganization
N/A		Safety of RadiotherapyTreatment PlanningSystems
N/A	Software	Medical device software- Software life cycleprocesses	IEC 62304 FirstEdition 2006-05	09/09/2008	IEC
N/A	General	Medical devices -Application of usabilityengineering to medicaldevices (General)	EN/IEC 62366	09/08/2009	IEC
N/A	Radiology	Digital Imaging andCommunications inMedicine (DICOM) Set	PS 3.1 - 3.18	03/16/2012	NEMA
5-40	General	Medical devices -Application of riskmanagement to medicaldevices	14971 SecondEdition 2007-03-01	08/20/2012	ISO
N/A	General	Medical electricalequipment -- Part 1-6:General requirementsfor basic safety andessential performance --Collateral Standard:Usability	60601-1-6:2004	1/30/2014	IEC
12-267	Radiology	Radiotherapyequipment -Coordinates,movements, and scales	61217 Edition 2.02011-12	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

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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.

Regulation Number and Section

§ 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.