VSS, VIRTUAL SIMULATION SYSTEM

K980629 · Nucletron Corp. · IYE · May 6, 1998 · Radiology

Device Facts

• Record ID: K980629
• Device Name: VSS, VIRTUAL SIMULATION SYSTEM
• Applicant: Nucletron Corp.
• Product Code: IYE · Radiology
• Decision Date: May 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

VSS is a software package for virtual simulation of radiation therapy plans; runs on PLATO treatment planning system workstation. Inputs: CT images (DICOM 3 or PLATO database); anatomical structures/beams from PLATO database; real-time position data from Nucletron Simulix simulator. Processing: 3D patient model generation; surface rendering; digitally reconstructed radiographs (DRRs); beam simulation. Outputs: Visualized 3D volumes/field geometries; automated set-up parameters for Simulix simulator; comparison of CT-based plan vs. actual simulator set-up. Used in clinical radiation therapy settings by oncology staff. Benefits: Enables pre-treatment verification of geometric beam parameters and set-up conditions; improves accuracy of radiation therapy delivery by aligning virtual plans with physical simulator configurations.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use comparisons to predicate devices.

Technological Characteristics

Software-based virtual simulation system; runs on PLATO workstation. Inputs: DICOM 3 CT images. Features: 3D patient modeling, surface rendering, digitally reconstructed radiographs (DRRs). Connectivity: DICOM RT compatible; direct interface with Nucletron Simulix simulator for automated set-up and real-time parameter transfer.

Indications for Use

Indicated for use in preparing geometric and anatomical data for radiation therapy treatment planning. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

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.

Predicate Devices

• Picker International ACQSIM (K923851)
• GE Medical Systems Advantage Sim (K951830)
• Nucletron PLATO (K964206)

Submission Summary (Full Text)

{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 [phone] [phone] Fax

K980629

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:. [phone] 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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