MODIFICATION TO PROWESS PRO-SIM

K984196 · Ssgi Prowess Systems · MUJ · Dec 11, 1998 · Radiology

Device Facts

• Record ID: K984196
• Device Name: MODIFICATION TO PROWESS PRO-SIM
• Applicant: Ssgi Prowess Systems
• Product Code: MUJ · Radiology
• Decision Date: Dec 11, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Prowess Pro-Sim treatment planning system is used to plan patient treatment for radiation therapy.

Device Story

Prowess Pro-Sim is a radiation therapy treatment planning system (TPS) used by clinicians to design treatment plans for cancer patients. The system ingests patient CT images (DICOM 3.0) via network. It creates a patient model, defines tumor volumes via auto-contouring (Hounsfield thresholding) or manual editing, and simulates beam geometry (photon/electron). The system calculates dose distributions using established algorithms (Effective Path Length or Batho Power Law models). Outputs include 2D/3D dose distribution visualizations, DRRs, and machine settings for treatment delivery. It operates on Windows NT workstations in a clinical environment. By integrating dose calculation directly into the simulation software, it eliminates the need to export data to external systems, allowing immediate assessment of beam/plan changes on patient dosimetry. This facilitates optimized treatment planning and improved clinical decision-making for radiation therapy delivery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of software features and calculation algorithms against the predicate device.

Technological Characteristics

Software-based radiation therapy treatment planning system. Runs on Pentium Pro/II workstations with Windows NT. Supports DICOM 3.0, TCP/IP networking, and 24-bit True Color display. Features include auto-contouring (Hounsfield thresholding), 3D visualization, and dose calculation models (Effective Path Length, Batho Power Law).

Indications for Use

Indicated for cancer patients undergoing therapeutic radiation treatment, including Brachytherapy and External Beam (photon or electron) therapy, to prepare 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

• SSGI Prowess Pro-Sim (K980379)

Reference Devices

• Prowess 3000 RTP System

Submission Summary (Full Text)

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K984196

DEC 1 1 1998

Image /page/0/Picture/2 description: The image shows a logo with the letters "SSGI" below a triangular shape. The triangle has a stylized "S" shape cut out of it, and the upper left corner of the triangle is filled with a pixelated or fragmented pattern. A horizontal line is located under the letters "SSGI".

Prowess Systems 1370 Ridgewood Dr., Ste. 20 Chico, California 95973 Tel: [phone] Fax: [phone]

# 510(k) Summary of Safety and Effectiveness

- 1. Submitter:
SSGI 1370 Ridgewood Drive Suite 20 Chico, CA 95973

Contact: Robert J. Morton Director, Regulatory Affairs and Quality Assurance

Prepared: November 16, 1998

- Prowess Pro-Sim 2. Device Name: Radiation Therapy Treatment Planning System
- SSGI Prowess Pro-Sim, K980379 3. Predicate Device:
- 4. Description: The Prowess treatment-planning product is a series of independent software programs used to plan a course of radiation therapy. The treatment plan includes an estimated dose distribution for a patient. The dose is calculated 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 Prowess Treatment Planning System (TPS) is separated into three major components:

- 1. Incorporating patient data into a patient model.
- 2. Creating treatment plans for each set of patient data.
- Calculating the treatment plans. 3.

Pro-Sim TPS has all of the features of Pro-Sim VPS with the dose calculation capability of P3000. In this program the dose distribution can be shown in the 2D and 3D views.

- 5. Intended Use: The Prowess Pro-Sim treatment planning system is used to plan patient treatment for radiation therapy.
- Technological Characteristics: See attached Comparison Table. 6.

Image /page/0/Picture/19 description: The image shows the logo and contact information for Prowess Systems. The logo features a triangle with a stylized design inside, accompanied by the letters "SSGI" underneath. The contact information includes the address "1370 Ridgewood Dr., Ste. 20, Chico, California 95973", along with the phone number "[phone]" and fax number "[phone]".

"Serving our customers' needs"

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# Tab 15 Comparison to Unmodified Device

| Prowess Treatment Planning System | Prowess<br>Pro-Sim<br>Predicate<br>K0980379<br>Device | Prowess<br>Pro-Sim TP-<br>Modified<br>Device |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|----------------------------------------------|
| Basic Features<br>Pro-Sim VPS has the ability to receive information from any<br>manufacturer's CT scanner with DICOM 3.0 format on a network system.<br>The Pro-Sim VPS computerized simulation process involves creation of a<br>digitally reconstructed radiograph (DRR) in any plane desired. This appears<br>on the computer screen for modification. The tumor volume is defined by<br>adding multiple interior structure outlines to the transverse slices. In the<br>beam's eye view, custom blocks and multileaf collimator blocking are<br>accurately simulated by Pro-Sim VPS. These are superimposed on the<br>grayscale DRR presented on the screen. Advanced tools for 3D<br>visualization are transverse planes and wireframe contours surrounding 3D<br>renderings of internal tumors and structures. | X | X |
| As the computer simulation is performed, the actual dose generated from<br>the beams can be displayed in Pro-Sim TPS, change the beam or plan and<br>watch the effect on the patient dosimetry, immediately. | | X |
| Basic System Design<br>• DICOM 3 compliant.<br>• Multilingual product design.<br>• Screen layout organized for rapid and consistent image display. Screen<br>includes four display windows, a toolbar area, window and level graphic<br>display, menu area and common function areas. All windows are active<br>and have independent control. | X<br>X<br>X | X<br>X<br>X |
| Image Acquisition<br>• DICOM 3 compliant Pro-Sim will accept CT images from any DICOM 3<br>image source. | X | X |
| • Ability to recall patients stored on any network station.<br>• Supports local area networks, wide area networks, or a distributed<br>network through TCP/IP networking. | X<br>X | X<br>X |
| • At least 100 CT slices per study accepted. | X | X |
| Prowess Treatment Planning System | Prowess<br>Predicate<br>Device | Prowess<br>Modified<br>Device |
| <b>Image Processing and Anatomical Modeling</b> | | |
| • Rapid auto contouring includes multiple organ contouring using a<br>Hounsfield number threshold technique. | X | X |
| • Easy entry of field shapes and calculation points. | X | X |
| • External and internal autocontouring. Batch autocontouring for<br>multiplanar entry. | X | X |
| • Easy manual contouring and editing. | X | X |
| • Full mouse support. | X | X |
| • Easy to add margins on all volumes. | X | X |
| • Entry of calculation points for reference. | X | X |
| • Multiple calculation points available for a single field. | X | X |
| • Entry of fiducial points or isocenter marking to register patient anatomy. | X | X |
| <b>Full Three Dimensional Visualization of Treatment Setup</b> | | |
| • The treatment unit and patient anatomy can be visualized in three<br>dimensions from any point in the treatment room. | X | X |
| • Direction of view can be dynamically moved in real time for full<br>visualization of machine and patient. | X | X |
| • Anatomical features can be turned on and off easily. | X | X |
| • Full Zoom and Pan in each window. | X | X |
| • Turn on and off each contour display. | X | X |
| • Choose from a set of predefined beam configurations (e.g., Four Field,<br>AP/PA, etc...) | X | X |
| • Supports beam configured for any 'brand' accelerator gantry and/or table<br>orientation. | X | X |
| • Full 3-D patient and beam geometry. | X | X |
| • Independent jaws fully supported. | X | X |
| • Full couch, collimator and gantry rotation supported. | X | X |
| • MLC supported. | X | X |
| <b>External Beam Dose Calculations</b> | | |
| • Photon and electron beams can be combined in a single plane. | X | X |
| • Photon calculation makes extensive use of measured TMR/TPR data. Two<br>heterogeneity models available: | X | X |
| Effective Path Length | X | X |
| Batho Power Law | X | X |
| • Bolus, compensators, blocks, and/or wedges may be mixed freely. | X | X |
| • CT pixel/density correction available. | X | X |
| Prowess Treatment Planning System | Prowess<br>Predicate<br>Device | Prowess<br>Modified<br>Device |
| • At least 20 active beams per plan may be entered. They may be fixed or<br>rotational beams. | X | X |
| • Necessary to export for dose calculations | X | |
| • 2D scatter calculations available. | X | X |
| • Calculation matrix size up to 16,384 per slice. | X | X |
| • Calculation of machine setting for each field. | X | X |
| • Non-coplanar beam calculations. | | X |
| • 3D dose display. | | X |
| Hardcopy | | |
| • Scaleable color PostScript™ or HPGL hardcopy of CT images with color<br>isodose curves. | X | X |
| • Pro-Sim hardcopy produces full color or black and white output on paper<br>or film. | X | X |
| • Pro-Sim supports all printers supported by Windows NT. | X | X |
| • Full color hardcopy available. | X | X |
| • Dye sublimation printers (optional). | X | X |
| Recommended Minimum Hardware Configuration | | |
| • Pentium® Pro or Pentium II workstation. | X | X |
| • Windows NT server or workstation operating system. | X | X |
| • 17" monitor. | X | X |
| • Screen resolution 1280 x 1024 pixels. | X | X |
| • 24-bit True Color display. CT or MRI images displayed using full 256<br>gray levels. | X | X |
| • Windows NT networking allowing multiple workstations for simultaneous<br>simulation by physicians, physicists and dosimetrists. | X | X |
| Export / Import Features | | |
| • All anatomical data including CT images can be exported to the Prowess<br>3000 RTP System using APEXTM | X | X |
| • All anatomical contouring data can be exported to the Prowess 3000 RTP<br>system. | X | X |
| • Beam data generated by Pro-Sim can be exported to Prowess 3000 RTP. | X | X |

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#### Summary of Differences

Pro-Sim TPS is identical to Pro-Sim VPS, the predicate device with the exception that the dose calculations have been moved from Prowess 3000 into Pro-Sim VPS, creating Pro-Sim TPS. There is no longer a need to export the patient and beam geometry to Prowess 3000 to do the dose calculations. The calculation models are the same for both systems, Prowess 3000 and Pro-Sim TPS.

The comparison shows only two significant features that Pro-Sim TPS can do that the predicate system cannot do. First, Pro-Sim TPS can display the multi-slice dose calculation in 3D (there was no 3D view for dose calculations in the predicate device) and second, Pro-Sim TPS can do full non-coplanar beam calculations. The predicate device could perform dose calculations in all planes but could not combine them at one time due to machine interface limitations.

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 1 1998

Robert J. Morton Director. Regulatory Affairs and Quality Assurance Prowess Systems 1370 Ridgewood Dr. Suite 20 Chico, California 95973

Re: K984196

Prowess Pro-Sim (Radiation Therapy Treatment Planning System) Dated: November 19, 1998 Received: November 23, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 MUJ

Dear Mr. Morton:

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 III (Fremarket 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 OS 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 mobilish 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 Flectronic 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/dsmaldsmamain.html".

Sincerely yours,

Kilian 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

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## Tab 9

## Indications For Use

510(k) Number (if known):_

Device Name: Prowess Pro-Sim Treatment Planning System

Indications for Use:

Prowess Pro-Sim is a modularly designed radiation therapy 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 displayed in 3D prior to treatment.

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Vavid A. Seymann
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

Prescription Use V (per 21 CFR 801.109)

OR

Over-The-Counter Use_