(134 days)
No
The description focuses on traditional image processing, 3D modeling, and treatment planning tools, with no mention of AI or ML algorithms for image analysis, segmentation, or treatment optimization.
No.
The device is a software application for viewing, processing, and archiving medical images, specifically for CT simulation and treatment planning, which are preparatory steps for therapy rather than providing therapy itself.
No
Explanation: The device description states that the VSim software is intended for "viewing, processing, filming, and archiving of medical images" and "delineating and representing targets and critical Structures" for radiation treatment planning. It is a 3D post-processing software that uses medical images as input to create data objects for treatment planning, not for diagnosing new conditions. While it uses "diagnostic images," its function is not to perform diagnosis.
No
The device is described as a software application that runs on a medical workstation (Syngo, K010938), which is a hardware component. While VSim itself is software, its operation is dependent on and integrated with the Syngo workstation hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the SYNGO workstation and the VSim software are used for viewing, processing, filming, and archiving medical images (CT, PET, MR). VSim specifically focuses on using these images for radiation treatment planning.
- No Biological Samples: There is no mention of the device analyzing or interacting with any biological samples from the patient. Its input is medical imaging data.
- Purpose: The intended use is for radiation treatment planning, which is a clinical procedure based on imaging data, not a diagnostic test performed on biological specimens.
Therefore, the device falls under the category of medical imaging software and is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SYNGO workstation encompasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation, K010938.
VSim permits CT Simulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and MLCs). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
Siemens Virtual Simulation (VSim) is a software application that runs on Siemens Medical Workstation, Syngo (K010938). It is intended to give the user general Viewing & Examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSim. It will be possible to load other modality images, Positron Emission Tomography (PET) and Magnetic Resonance (MR), in conjunction with the CT images for treatment planning.
VSim is intended to provide tools for delineating and representing targets and critical Structures. It takes specifications and dimension for the dose delivery system (Siemens and other vendors). It will then enable the user to design complex beam profiles and place them for optimum treatment of the discase. 3D Graphical representation and visualization of all the relevant objects allow for a virtual setup and treatment of the patient without involving the patient.
The VSim software will be used in a typical scenario summarized below:
- Patient is registered, and the relevant data is entered into the system, ı
- Schedule is created for radiation therapy, I
- Patient is called in for a CT scan,
- CT scan is performed, 트
- VSim is used for initial viewing and definition of isocenter reference (for patient I marking)
- 트 Patient is marked prior to leaving the CT room,
- 트 VSim is used to delineate the Structures targeted for radiation and other critical Structures.
- . VSim is used to establish a reference point, known as the isocenter reference, which will be marked on the patient, and any other coordinates will be based on this reference coordinate,
- 트 VSim is used to design the beam geometry,
- . VSim is used to place the jaws and to define the blocks and/or MLC,
- 트 VSim is used to print charts used for flow of information,
- 트 VSim is used to print images on film,
- t The plans are transferred to radiation therapy planning station for dose calculation.
- l The isocenters may be changed by the dosimetrist,
- . The plans may be transferred back to the VSim workstation for verification.
VSim is a 3D post-processing software application that uses CT planning images as input and creates the following data objects as output:
-
- Structure sets stored in the form of DICOM-RT Structure-Set,
-
- Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
-
- Plans, including beams stored in the form of DICOM-RT-Plan, and
-
- Reference Images in the form of Digitally Reconstructed Radiographs (DRRs), (one DRR for each beam in the plan) stored in the form of DICOM-RT-Image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT) scans, Positron Emission Tomography (PET) and Magnetic Resonance (MR)
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)
Not Found
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.
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
5 2002 NOV
Image /page/0/Picture/1 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, filling most of the frame. The font appears to be sans-serif, and the overall impression is one of clarity and prominence.
510(k) Summary
| Submitter: | Siemens Medical Solutions USA, Inc.
Oncology Care Systems Group
4040 Nelson Avenue
Concord, CA 94520 |
|----------------------|---------------------------------------------------------------------------------------------------------------|
| Contact person: | Sean M. Curry
16787 Bernardo Center Drive, Suite A
San Diego, CA 92128 |
| Phone: | (858) 675-8200 |
| FAX: | (858) 675-8201 |
| Proprietary name: | Siemens Virtual Simulation (VSIM) |
| Common name: | Treatment Planning System |
| Classification: | 892.5050 |
| Product Code: | MUJ |
| Classification name: | System Planning Radiation Therapy Treatmen |
Substantial equivalence claimed to:
K013112, FocalSim, Computerized Medical Systems, Inc. K923851 , ACQSIM, Philips Medical Systems(Cleveland), Inc.
Description:
Siemens Virtual Simulation (VSim) is a software application that runs on Siemens Medical Workstation, Syngo (K010938). It is intended to give the user general Viewing & Examination tools for viewing medical diagnostic images. Computed Tomography (CT) scans are the centerpiece of the diagnostic images used by the VSim. It will be possible to load other modality images, Positron Emission Tomography (PET) and Magnetic Resonance (MR), in conjunction with the CT images for treatment planning.
VSim is intended to provide tools for delineating and representing targets and critical Structures. It takes specifications and dimension for the dose delivery system (Siemens and other vendors). It will then enable the user to design complex beam profiles and place them for optimum treatment of the discase. 3D Graphical representation and visualization of all the relevant objects allow for a virtual setup and treatment of the patient without involving the patient.
Siemens Medical Solutions USA, Inc.
1
SIEMENS
The VSim software will be used in a typical scenario summarized below:
- Patient is registered, and the relevant data is entered into the system, ı
- Schedule is created for radiation therapy, I
- Patient is called in for a CT scan,
- CT scan is performed, 트
- VSim is used for initial viewing and definition of isocenter reference (for patient I marking)
- 트 Patient is marked prior to leaving the CT room,
- 트 VSim is used to delineate the Structures targeted for radiation and other critical Structures.
- . VSim is used to establish a reference point, known as the isocenter reference, which will be marked on the patient, and any other coordinates will be based on this reference coordinate,
- 트 VSim is used to design the beam geometry,
- . VSim is used to place the jaws and to define the blocks and/or MLC,
- 트 VSim is used to print charts used for flow of information,
- 트 VSim is used to print images on film,
- t The plans are transferred to radiation therapy planning station for dose calculation.
- l The isocenters may be changed by the dosimetrist,
- . The plans may be transferred back to the VSim workstation for verification.
VSim is a 3D post-processing software application that uses CT planning images as input and creates the following data objects as output:
-
- Structure sets stored in the form of DICOM-RT Structure-Set,
-
- Reference Points (including isocenters) stored in the form of DICOM-RT Structure-Set.
-
- Plans, including beams stored in the form of DICOM-RT-Plan, and
-
- Reference Images in the form of Digitally Reconstructed Radiographs (DRRs), (one DRR for each beam in the plan) stored in the form of DICOM-RT-Image.
Intended use:
The SYNGO workstation, K010938, encompasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation.
VSim permits CT Simulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and Multi-Leaf Collimators (MLCs)). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.
Siemens Medical Solutions USA, Inc.
2
SIEMENS
Summary of technological characteristics Compared to Predicate Devices:
The VSim software described in this 510(k) will be an add-on to the SYNGO workstation, K010938. The VSim system incorporates no technological characteristics not currently in the predicate simulation devices. VSim supports the most popular CT Scanners as well as the three most common linear accelerators (Siemens, Varian, and Philips/Elekta)
Siemens Medical Solutions USA, Inc.
3
Image /page/3/Picture/1 description: The image shows a logo with a stylized eagle or bird symbol on the right. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH &" is arranged in a circular fashion. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight.
5 2002 NOV
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Siemens Medical Solutions USA. Inc. % Mr. Sean M. Curry Chief Operating Officer Certified Software Solutions, Inc. 16787 Bernardo Center Drive Suite A SAN DIEGO CA 92128
Re: K022036
Trade/Device Name: Siemens Virtual Simulation (VSIM) Release 1.0 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: October 18, 2002 Received: October 21. 2002
Dear Mr. Curry:
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, Drue, 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.
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); 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.
4
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Henry C. Snodgin
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):_
Device Name: Siemens Virtual Simulation (VSIM)
Indications for Use:
The SYNGO workstation encompasses a number of software applications for viewing, processing, filming, and archiving of medical images. VSim is one of the software applications that are offered on the SYNGO workstation, K010938.
VSim permits CT Simulation to be performed on the SYNGO workstation. The CT scans are first loaded into the VSim software. On VSim the user is able to create 3D models of targets and organs. On VSim the user is able to identify the patient isocenter, place treatment beams and identify beam modifiers (blocks, apertures, and MLCs). This information is then sent to a radiation treatment planning system for dose calculation. The plans are then reviewed and approved by the clinician prior to transfer to the delivery system for the actual treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-the-Counter Use (Per 21 CER 801.109)