PROWESS

K032456 · Prowess, Inc. · MUJ · Oct 16, 2003 · Radiology

Device Facts

• Record ID: K032456
• Device Name: PROWESS
• Applicant: Prowess, Inc.
• Product Code: MUJ · Radiology
• Decision Date: Oct 16, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

Prowess 3D™ Radiation Therapy Treatment Planning System, including the IMRT option Panther™, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Pather™ provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.

Device Story

Prowess Panther is an inverse planning software module for the Prowess 3D Radiation Therapy Treatment Planning System. It processes patient CT-simulator images to generate IMRT treatment plans. The system utilizes Direct Aperture Optimization (DAO) to iteratively adjust deliverable parameters (field shapes and weights) in a single step, accounting for physical limitations of linear accelerators and multileaf collimators. It employs a convolution superposition algorithm for final dose calculation. Operated by trained medical physicists or dosimetrists in clinical settings, the software runs on Windows-based workstations. Output includes treatment plan parameters transferred via DICOM-RT to delivery control systems (Record and Verify or linear accelerator controllers). The device simplifies IMRT planning, improves delivery reliability, and assists clinicians in achieving target dose uniformity while limiting dose to critical organs.

Clinical Evidence

Clinical testing conducted at the University of Maryland Medical System using real patient cases. Testing involved commissioning machine data, dose calculation algorithm verification, CT-image transfer, treatment plan development, and delivery to a phantom. Results showed measured point doses agreed with calculated values within 3% (surpassing the 5% ASTRO guideline). High dose gradient regions showed distance-to-agreement less than 2mm.

Technological Characteristics

Software-based radiation therapy treatment planning system. Operates on Windows 2000 or later on Intel Pentium-based workstations. Uses convolution superposition algorithm for dose calculation and simulated annealing for optimization. Employs Direct Aperture Optimization (DAO). Connectivity via DICOM-RT for plan transfer. Standalone software module.

Indications for Use

Indicated for patients requiring external photon beam intensity-modulated radiation therapy (IMRT) treatment planning, as well as photon and electron radiation therapy planning using linear accelerators and Cobalt-60 beams.

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

• Varian Eclipse, Helios option (K021268)
• Nomos CORVUS Inverse Planning System (K940663)
• ADAC P3IMRT IMRT option (K002237)

Submission Summary (Full Text)

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OCT 1 6 2003

## Ko 32 456 510(K) SUMMARY

| 1. | Submitter: | Prowess, Inc.<br>1370 Ridgewood Drive, Suite 20<br>Chico, CA. 95973 |
|----|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | W. James Bishop<br>Regulatory /QA Manager<br>Prowess, Inc.<br>1370 Ridgewood Drive, Suite 20<br>Chico, CA. 95973<br>PHONE: [phone]<br>FAX: [phone] |
| 2. | Device Manufacturer: | Prowess, Inc.<br>1370 Ridgewood Drive, Suite 20<br>Chico, CA. 95973 |
| 3. | Device Trade Name: | Prowess Panther |
| 4. | Classification Name: | Accelerator, Linear, Medical<br>(21 CFR § 892.5050), Class II |
| 5. | Reg. No.: | 2939248 |
| 6. | Common Name: | Radiation Therapy Treatment Planning System |
| 7. | Predicate Devices: | Varian Eclipse, Helios option K021268 |

Nomos CORVUS Inverse Planning System K940663 ADAC P3IMRT IMRT option K002237

#### 8. Device Description

PROWESS PANTHER is an inverse planning option to the Prowess radiation therapy planning software for supporting intensity-modulated radiation therapy (IMRT) (K980379). The Prowess 3D system is composed of a Workstation with an Intel Pentium* processors (or later versions) running Windows 2000 operation system (or later versions) and proprietary software that allows the trained users to generate radiation therapy treatment plans.

The Prowess IMRT software contains 3 components:

- 1) Objective and constraint specification --- The first step of the inverse planning process is to allow the user to specify the treatment objectives,

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which include the dose and dose uniformity to the target or targets, the dose and volume limits to different critical organs, and the relative importance of achieving these objectives.

- 2) Optimization --- This is a process by which the system iteratively adjust the deliverable parameters including the field shapes and their weights to derive a treatment plan that best achieves the treatment objectives. A proven and most widely used optimization algorithm, simulated annealing, was used. As with P3IMRT™ system by ADAC (K002237), IMRT uses the convolution superposition algorithm as the final dose calculation engine.
- 3) DICOM Transfer --- This involves transfer the plan parameters via DICOM-RT to a delivery control system (a Record and Verify system or the linear accelerator controller itself) for delivery.

#### 9. Intended Use

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Prowess Panther is an optional software module to the Prowess 3D™ Radiation Therapy Treatment Planning System. It is intended to provide treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.

#### 10. Summary of Comparisons to Predicate Devices

There are many inverse planning systems for IMRT on the market. These predicate devices include the NOMOS CORVUS™ Inverse Treatment Planning System (K940663), Varian Eclipse, Helios Option (K021268) and the P1MRT ™ system by ADAC (K002237). Prowess IMRT adds inverse planning capabilities to the existing Prowess 3D planning system (K980379). The entire system with the IMRT option incorporates no technical characteristics not currently contained in the predicate devices. It has the same intended use and the same optimization algorithm as the NOMOS CORVUS™ Inverse Treatment Planning System (K940663). As with P31MRT™ system by ADAC (K002237), Prowess Panther uses the convolution superposition algorithm as the dose calculation enqine.

What distinquishes Prowess Panther from the predicate systems is described in detail under Section IV: Substantial Equivalence Comparisons. Our view, which is supported in the literature, is that aperture-based inverse planning such as the Direct Aperture Optimization (DAO) developed at the University of Maryland simplifies the planning and delivery process and makes IMRT less labor intensive and more reliable. Instead of a two-step process that first optimizes beam intensities and then convert the intensity distributions into deliverable parameters. DAO directly optimizes the deliverable parameters in one step. Since physical limitations of the linear accelerator and the multileaf collimator are

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considered in the optimization process, the actual delivered treatment more closelv reflects the treatment plan.

#### 11. Summary of Non-clinical Tests

A Hazard Analysis was completed for Prowess Panther. Methods for preventing such hazards were detailed (Section VII). Verification and validation of the software was conducted in house according to the Verification and Validation (V&V) Protocol. The V&V Protocol, and test results are included in Section VIII of this submission. Functional testing was conducted both in-house and by medical physicists/dosimetrists at the University of Maryland, School of Medicine. These tests have demonstrated that the Panther option to the Prowess 3D treatment planning system has met its specifications, demonstrated substantially equivalent performance to the predicate devices, and is safe and effective for its intended use.

#### Summary of Clinical Tests 12.

Although clinical testing is not required to demonstrate substantial equivalence in safety and effectiveness. we elect to conduct testing at the University of Maryland Medical System using real patient cases. We feel that, no matter how carefully a product is tested in the factory. such testing cannot replace testing in the field. Clinical testing included commissioning machine data in the Prowess system, testing the dose calculation algorithm, transferring the patient images from a CT-Simulator, developing a treatment plan as described in the user manual, transferring the treatment plan to a linear accelerator and finally. delivering the plan to a phantom. The measured point doses showed agreement with calculated values within 3% for all the cases tested. This value surpasses the 5% specified in the quideline published by the American Society of Therapeutic Radiology and Oncology (ASTRO). The dose distributions captured by films showed that for high dose gradient regions, the distance to agreement is less than 2mm.

#### 13. Labeling

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The CD media labeling is provided in Section X and User's Manual are provided in Section VI of this submission. The entire user's manual in digital format is also included in the software media and can be viewed as part of the on-line help.

Commercial and marketing materials are also included in Section III.

Product labels comply with 21 CFR 1040.10 and 1040.11 as applicable.

#### 14. Summary of Safety and Effectiveness Information

Summary of Safety and Effectiveness Information is included in Section VI as a free standing document. Only the contents of Section VI may be released by the

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FDA in satisfaction of Summary of Safety and Effectiveness Information requests as provided by SMDA 1990.

#### 15. Conclusions

Prowess 3D's inverse planning option, Prowess Panther, is substantially equivalent to the predicate devices. It has the same intended use and similar technical characteristics. It generates equivalent quality of treatment plans as compared with the predicate devices as demonstrated in our field tests, and its use does not raise any new, or different issues of safety or effectiveness when compared with the predicates. As demonstrated in the comparison with predicate devices, the use of direct aperture optimization simplifies the planning and delivery of IMRT without sacrificing plan quality.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three curved lines that suggest the wings and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 6 2003

Mr. W. James Bishop Regulatory/QA Manager Prowess Inc. 1370 Ridgewood Drive, Suite 20 CHICO CA 95973

Re: K032456

Trade/Device Name: Prowess Panther Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: 90 MUJ Dated: July 17, 2003

Received: August 16, 2003

Dear Mr. Bishop:

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. Drug. 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.

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This letter will allow you to begin marketing your device as described in your Section 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 the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications For Use

510(k) Number (if known): Pending K032456

Device Name: Prowess Panther

### Indications for Use:

Prowess 3D™ Radiation Therapy Treatment Planning System, including the IMRT option Panther™, is used to plan photon and electron radiation therapy treatments using linear accelerators and Cobalt-60 beams. The optional software module with the trade name Pather™ provides treatment planning for intensity-modulated radiation therapy (IMRT) treatments using external photon beams.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

*Prescription Use* ✓

Nancy C Broydon

(Division Sign-Off)

Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K032456