(77 days)
Not Found
No
The description focuses on virtual simulation, 3D visualization, data transfer, and comparison of planned vs. actual setup, without mentioning any AI/ML techniques for image processing, analysis, or decision support.
No.
This device is for preparing and simulating radiation therapy treatments, not for administering therapy or directly treating patients. It is a planning and verification tool.
No
The device is described as a virtual simulation system for radiation therapy planning, used to prepare geometric and anatomical data for treatment prior to dosimetry planning and to verify geometric beam parameters and set-up conditions. It does not provide a medical diagnosis of a disease or condition.
Yes
The device is explicitly described as a "software package" that is "installed and runs on a PLATO radiation therapy treatment planning system workstation." While it interacts with hardware (CT scanners, Simulix simulator, PLATO workstation), the device itself is the software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system." It focuses on visualizing and simulating radiation therapy plans based on imaging data.
- Device Description: The description reinforces this by explaining that it's a software package for "virtual simulation of radiation therapy plans" using CT images. It facilitates the definition of anatomical volumes and geometric treatment beams.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze biological specimens. Its function is centered around processing and visualizing medical imaging data for treatment planning and simulation.
The device falls under the category of medical imaging software used in radiation therapy planning, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.
When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
Product codes (comma separated list FDA assigned to the subject device)
90 IYE
Device Description
VSS virtual simulation described in this submission is a software package for the virtual simulation of radiation therapy plans. VSS is installed and runs on a PLATO radiation therapy treatment planning system workstation.
Nucletron's VSS provides the virtual simulation capabilities required to define anatomical volumes and geometric treatment beams for radiation therapy treatment simulation. The 3D patient model is based on CT images and is displayed in single or multiple image windows. Treatment beams are simulated using surface rendering and digitally reconstructed radiographs.
The system uses CT images either from a DICOM 3 compatible scanner or from the PLATO treatment planning system patient database. Previously defined anatomical structures and beams can be read from the PLATO patient database. All anatomical structures and beams can be stored in the PLATO patient database or sent to a DICOM RT compatible system.
When connected to a Nucletron Simulix radiation therapy simulator, VSS allows the planned beam parameters to be downloaded directly to the Simulator for automatic set-up. The user can initiate the real-time transfer of actual simulator position to update the field parameters on VSS. VSS can be used to display the live image intensifier image, viewed on the same screen as the beam's eye view and planar image(s). A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT images
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.
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
Nucletron VSS Date : 11, February 1998
Image /page/0/Picture/1 description: The image shows the word "Nucletron" in bold, black letters. To the left of the word is a logo of a circle with two smaller circles inside of it, all enclosed in a square. Below the logo and word is the text "MAY 6 1998".
Department of Health and Human Services Center of Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section
NUCLETRON B.V.
Waardgelder 1 3905 TH Veenendaal 3900 AX Veenendaal P.O.Box 930 The Netherlands Phone +31 318 557133 +31 318 550485 Fax
TBN MKT VSS 510k
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
as required by section 807.92(c)
Submitter of 510(k) a.
Company name: Registration # Address:
Nucletron Corporation 1121753 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Contact Person:
Ralph E. Shuping Regulatory Affairs Manager 410-312-4100 Phone:. 410-312-4197 Fax:
Device Name: b.
VSS, Virtual Simulation System Trade/Proprietary Name: Common/Usual Name: Radiation therapy virtual simulation system Radiation Therapy Simulation System, Classification Name: 21 CFR 892.5840 Class II.
Legally Marketed Predicate Device(s) C.
Our Device is substantially equivalent to the legally marketed predicate devices cited in the table below.
| Manufacturer | Device | 510(k) # |
|---|---|---|
| Picker International | ACQSIM | K923851 |
| GE Medical Systems | Advantage Sim | K951830 |
| Nucletron | PLATO | K964206 |
Appendix 5, page 2
1
Description d.
VSS virtual simulation described in this submission is a software package for the virtual simulation of radiation therapy plans. VSS is installed and runs on a PLATO radiation therapy treatment planning system workstation.
Nucletron's VSS provides the virtual simulation capabilities required to define anatomical volumes and geometric treatment beams for radiation therapy treatment simulation. The 3D patient model is based on CT images and is displayed in single or multiple image windows. Treatment beams are simulated using surface rendering and digitally reconstructed radiographs.
The system uses CT images either from a DICOM 3 compatible scanner or from the PLATO treatment planning system patient database. Previously defined anatomical structures and beams can be read from the PLATO patient database. All anatomical structures and beams can be stored in the PLATO patient database or sent to a DICOM RT compatible system.
When connected to a Nucletron Simulix radiation therapy simulator, VSS allows the planned beam parameters to be downloaded directly to the Simulator for automatic set-up. The user can initiate the real-time transfer of actual simulator position to update the field parameters on VSS. VSS can be used to display the live image intensifier image, viewed on the same screen as the beam's eye view and planar image(s). A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
Intended use e.
Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.
When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
Summary of technological considerations し
The VSS is substantially equivalent to the predicate devices. It allows the use of CT images for the definition of anatomical volumes and the simulation treatment beams.
7 J. St
11 Feb. 1998
Date
Name: T.J. Bateman Product Manager Title Nucletron bv Veenendaal Netherlands
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name encircling a symbol. The symbol consists of a stylized caduceus, a staff with two snakes entwined around it, representing medicine and healing. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 6 1998
Ralph E. Shuping. Sc.D. Regulatory Affairs Manager Nucletron Corporation 7080 Columbia Gateway Drive Columbia, MD 21046-2133
Re:
K980629 VSS Virtual Simulation System Dated: February 17, 1998 Received: February 18, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Mr. Shuping:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmadsmam.html".
Sincerely yours,
Kiliai Yi
Lillian Yin, Ph.D Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of indications for use
510(k) Number (if known):
Device Name: VSS Virtual Simulation System
Indications for Use: Virtual simulation with VSS is intended to be used to prepare geometric and anatomical data relating to a proposed radiation therapy treatment prior to dosimetry planning on a treatment planning system. Complex 3D volumes and field geometries can be visualised for plan preparation.
x980629
When connected to a Nucletron Simulix radiation therapy simulator, the simulation of the planned treatment fields can be aided by automated set-up on the Simulix simulator. Adjustments made on the Simulix can be reviewed on the virtual simulation system screen. A direct comparison of the CT-based treatment plan with the actual set-up on the Simulix, prior to patient treatment, can be made to verify the geometric beam parameters and set-up conditions.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over the Counter Use
David C. Beynon
(Division Sign-Off)
(Optional Format 1-2-96)
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological Devi 510(k) Number