PROWESS PRO-SIM

K980379 · Ssgi Prowess Systems · IYE · May 18, 1998 · Radiology

Device Facts

• Record ID: K980379
• Device Name: PROWESS PRO-SIM
• Applicant: Ssgi Prowess Systems
• Product Code: IYE · Radiology
• Decision Date: May 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer's display prior to actual treatment. Prowess Pro-Sim acquires CT and MR image data from a variety of DICOM compliant sources via its server module called APEX. MRI and CT machine data is acquired in a standard format from a variety of sources and stored in a database. Prowess Pro-Sim is used to contour and simulate radiation treatment therapy. Depending on the type of therapy, contouring information is passed from the Prowess Pro-Sim module to the Prowess 500 module for Brachytherapy planning or the Prowess 3000 module for External Beam planning. Once planning is complete, plans can be saved on the computer and printed using a variety of printers.

Device Story

Prowess Pro-Sim is a PC-based radiation treatment planning system. It ingests CT and MR images via the APEX server module (DICOM compliant) and machine-specific data. Clinicians use the software to contour anatomical regions and simulate radiation delivery. For brachytherapy, it computes dose distributions for multiple sources using isotropic point or anisotropic line source models. For external beam, it calculates dose using primary fluence and scatter models (1D, 2D, or 3D depending on configuration). The system generates 3D dose distributions and digitally reconstructed radiographs (DRRs) for visualization. Output includes treatment plans, dose statistics, and hardcopy printouts for patient records. The system aids clinicians in optimizing radiation therapy delivery, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

Bench testing only. The device underwent a documented verification and validation process according to a signed test plan. Testing confirmed that functional requirements were met and the system performs according to published specifications.

Technological Characteristics

PC-based software (Windows NT, DOS, or Windows-95). Requires 160 MB RAM, high-resolution graphics, network card, digitizer, and backup drives. Supports DICOM 3.0 image import. Dose calculation models include isotropic point source (1D), anisotropic line source (2D), and primary fluence/scatter models (1D, 2D, 3D). Features include manual and automatic contouring, window/level image adjustment, and 3D visualization. Security programs enforce access control to patient data.

Indications for Use

Indicated for cancer patients undergoing therapeutic radiation treatment, including Brachytherapy and External Beam (photon or electron) therapy, for the purpose of preparing individual treatment plans.

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

• PLATO (K921991)
• Theraplan Plus (K970236)
• Picker Acqusim (K923851)
• TPS 1031 (K862643)

Submission Summary (Full Text)

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# MAY 1 8 199 510(k) Summary of Safety and Effectiveness

The following Summary of Safety and Effectiveness is being submitted in conformance with 21 CFR 807.92.

#### 1. Contact Person / Submitter

Thomas A. Boone
Director of Regulatory Affairs and Quality Assurance
SSGI
1370 Ridgewood Drive
Suite 20
Chico, CA 95973-7803
Phone: (916) 898 – 0660
Fax: (916) 342 – 8966

#### 2. Device Name

Classification Name: Radiation therapy treatment planning computer program Common/Usual Name: 3-D treatment planning system Proprietary Name: Prowess Pro-Sim

#### Substantial Equivalence 3.

Prowess Pro-Sim is substantially equivalent to other legally marketed radiation therapy treatment planning systems currently in commercial distribution and previously determined to be substantially equivalent under section 510(k) including:

| Manufacturer | 510(k) number | Device Name |
|---------------------------------|---------------|----------------|
| Nucletron | K921991 | PLATO |
| Theratronics International Ltd. | K970236 | Theraplan Plus |
| Picker International, Inc. | K923851 | Picker Acqusim |
| ROCS | K862643 | TPS 1031 |

A description of the operating principles and a detailed comparison of Prowess Pro-Sim to other legally marketed devices can be found in Appendix 2 of the 510(k) Submission.

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#### Device Description 4.

The Prowess treatment-planning product is a series of independent software programs that are used to plan a course of radiation therapy. The treatment plan is an estimated dose distribution for a patient. The dose is computed by applying known and tested algorithms. Measured treatment machine data combined with geometric and tissue information, for a particular patient, are processed by the algorithm into a dose distribution.

The TPS software is designed to run on a personal computer (PC). Depending on the configuration of the program, the PC requires one of the following operating system: Windows NT, DOS or DOS under Windows-95. Other system components and peripherals include: 160 Mb of RAM, high resolution graphics display video card, network card, printer, plotter, digitizer, 3.5 inch floppy disk and tape backup drives.

#### 5. Intended Use

Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer's display prior to actual treatment.

Prowess Pro-Sim acquires CT and MR image data from a variety of DICOM compliant sources via its server module called APEX. MRI and CT machine data is acquired in a standard format from a variety of sources and stored in a database. Prowess Pro-Sim is used to contour and simulate radiation treatment therapy. Depending on the type of therapy, contouring information is passed from the Prowess Pro-Sim module to the Prowess 500 module for Brachytherapy planning or the Prowess 3000 module for External Beam planning. Once planning is complete, plans can be saved on the computer and printed using a variety of printers.

### Summary of Technological Characteristics 6.

The Prowess Pro-Sim software can be run in several different configurations, depending on the users needs. Each major level of the configurations is listed below in order of increasing complexity. Each level of complexity will automatically include the previous levels and provide further capabilities and functions.

A utility program that is found in all configurations are a device testing program that is provided to perform hardware testing of any devices necessary to the film scanners, mouse, digitizing bit-pads, tape drives, printers and plotters to aid in diagnosing

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hardware connectivity. Also global menu and security programs are provided to allow the user to enter the programs from the operating system as well as to provide and enforce secure methods to prevent unauthorized access to restricted devices, machine table data and patient sensitive information.

The P-500 series encompasses the brachytherapy planning functions of the software. The purpose of the program is to compute the radiation dose delivered for simple and complex treatment plans consisting of a multiple brachytherapy sources. The patient and plan information may be entered via the keyboard or digitizer, or imported from other file formats. Methods for entering sources and patient anatomy contours via pre-set templates, sliced film series and from shifted or rotated film sets are provided. The plans calculate the dose using a isotropic point source (1-D) or anisotropic line source (2-D) superposition of dose model. The doses may be computed at any point in 3D space, and may be visualized as 3-D dose sets. Statistical computations for plan adequacy as compared to specific anatomy and dose characteristic are also provided. Methods are also provided for printing and plotting the completed plan and patient model on hardcopy devices for later inclusion in the permanent patient record.

The P-1000 series includes subprogram to plan and compute the external beam, irregular fields, and simple daily calculation treatments along with the functionality of the P-500. The additional programs all use machine data that is entered, manipulated and stored in the machine database program.

The P-1000 Simple (Daily) Calculation product computes the radiation dose delivered for simple treatment plans consisting of a single beam of external radiation. Patient and plan information may be entered via the keyboard. The plans calculate the dose using a 1-D primary fluence and 1-D scatter model and provide a method for sending the data to a standard hardcopy device for later inclusion in the permanent patient record.

The P-1000 Prowess Irregular Fields computes the radiation dose delivered for simple treatment plans consisting of a single beam or two opposing beams of external beam radiation. Patient and plan information may be entered via the keyboard, augmented by a digitization method to enter block and collimator contours. The plans calculate the dose using a 2-D primary fluence and 2-D scatter model using data from the machine tables database. The results may be observed on the computer monitor and may be printed or plotted.

The P-1000 Prowess External Beam program is designed to allow the user to enter patient images or contours necessary to create radiotherapy treatment plans using external radiation, to enter treatment parameters and to compute the expected doses of radiation in the patient. It has the ability to use contoured from mouse or digitizer input and then store the information for later use. One transverse slice with multiple contours may be entered. Treatment plans in the form of beam geometry may be

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applied and then calculated using a 3-D primary fluence and 1-D scatter model. The final results may be examined on the screen, and then may be printed or plotted.

The P-2000 Prowess External Beam program includes all of the functionality of the P-1000, and also allows the user to input more than one slice at a time of patient anatomy model data. Images may be imported directly onto the screen from film scanners using an image import utility program from several standard file formats. Contours must then be derived from the images using the mouse, digitizer or automatic contouring of well-defined anatomical regions. Window and level adjustments are available and provide enhanced visualization of an image when editing contours. Each slice may be calculated separately using the same algorithm as the P-1000 and the final results may be examined on the screen, and then may be printed or plotted.

The P-3000 Prowess External Beam program includes all of the functionality of the P-2000, and also allows the user to calculate, view and print all transverse slices in the patient model at the same time. The Apex version of this program expands the image import capability with the ability to transfer and convert DICOM 3.0 images into P-3000 format.

Pro-Sim VPS is a computed simulation program and may be used by itself or as a starting point for Prowess-3000. Pro-Sim VPS mimics the functionality of the standard x-ray treatment simulation in radiation therapy. In Pro-Sim VPS, images from the Apex transfer system may be imported and used to create a patient model. Contours and other identifying marks may be placed on the images from a 2D view, and a treatment plan may be generated using external beam machine data specified by the user and imported for use in Pro-Sim. The software generates a 3D view of the patient model using a digitally reconstructed radiograph that mimics the x-ray taken during the simulation step. The 2D and 3D information may be viewed from any direction, and may be printed or plotted to a hardcopy device. In addition, the images, contours, plans and beams may be exported to a Prowess-3000 compatible file for subsequent calculation of doses.

Lastly, FS2 is an additional film densitometry program that makes optical density measurements of film. It is not required for any of the other programs, and depending on the users needs, this option may be added to any of the above systems. The measurements may be exported to text files for later import into the machine database. Statistical summaries of film densities corresponding to common radiation therapy physics quality assurance techniques are also provided.

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# 7. Testing

· The Prowess Pro-Sim product was developed and tested according to a documented and signed plan. The plan provides details regarding the specific validation and verification protocols required to test the product. The Test plan, Verification and Validation protocols, example results, as well as a detailed summary of testing and results are provided as Appendix 5 of the 510(k) submission.

## 8. Conclusion

Documentation provided in the premarket notification shows in sufficient detail that the software development process was followed, that quality assurance procedures were adhered to, that testing demonstrates that the functional requirements were met, that the system meets its published specifications, and that the system performs as well as or better than the legally marketed devices specified in section 3 of this document.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the eagle's wings and head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 8 1899

Thomas A. Boone Director of Regulatory Affairs and Quality Assurance Prowess Systems 1370 Ridgewood Dr. Suite 20 Chico, CA 95973

Re:

K980379 Prowess Pro-Sim System Dated: April 21, 1998 Received: April 23,1 998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE

Dear Mr. Boone:

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 (Special Controls) or class III (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 (21 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 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 question 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/dsmaldsmam.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# PREMARKET NOTIFICATION

Indications for Use Statement

K980399

510(k) Number (if known)______________________________________________________________________________________________________________________________________________________

Device Name: Prowess Pro-Sim

Indications For Use;

Prowess Pro-Sim is a modularly designed Radiation Treatment Planning Computer Program used to prepare individual treatment plans for cancer patients undergoing therapeutic radiation treatment. The system is utilized to develop treatment plans for Brachytherapy and External Beam (photon or electron) therapy. Completed treatment plans can be simulated using Prowess Pro-Sim in 3D on the computer's display prior to actual treatment.

Prowess Pro-Sim acquires CT and MR image data from a variety of DICOM compliant sources via its server module called APEX. MRI and CT machine data is acquired in a standard format from a variety of sources and stored in a database. Pro-Sim is used to contour and simulate radiation treatment therapy. Depending on the type of therapy, contouring information is passed from the Prowess Pro-Sim module to the Prowess 500 module for Brachytherapy planning or the Prowess 3000 module for External Beam planning. Once planning is complete, plans can be saved on the computer and printed using a variety of printers.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Whind li. Syrm
(Division Sign-Off)

Division Sign-Off) Division of Reproductiv and Radiological De 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use _

(Optional Format 1-2-96)

OR