PINNACLE3 RADIATION THERAPY PLANNING SYSTEM

K130992 · Philips Medical Systems (Cleveland), Inc. · IYE · Jun 14, 2013 · Radiology

Device Facts

• Record ID: K130992
• Device Name: PINNACLE3 RADIATION THERAPY PLANNING SYSTEM
• Applicant: Philips Medical Systems (Cleveland), Inc.
• Product Code: IYE · Radiology
• Decision Date: Jun 14, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Pinnacle3 Radiation Therapy Planning (RTP) System is a software package intended to provide planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.

Device Story

Pinnacle3 RTP is a software-based radiation treatment planning system. It imports patient image data (CT, MR, PET, SPECT) via DICOM. Clinicians use the system to contour anatomy, define target volumes, and configure beam parameters (energy, geometry, modifiers). The system computes dose distributions using physics models (e.g., pencil beam algorithms for protons). It supports forward and inverse planning modes to maximize dose to tumors while sparing normal tissue. Outputs include treatment plans, DRRs, and reports for transfer to OIS or linear accelerators. Used in clinical settings by dosimetrists, medical physicists, and physicians. It facilitates clinical decision-making by providing dosimetric visualization and verification prior to patient treatment, potentially improving treatment accuracy and patient outcomes.

Clinical Evidence

No clinical trials were performed. Evidence consists of bench testing and algorithm validation using QA phantoms to compare calculated versus measured doses. Clinical-oriented validation test cases were executed by customers at external evaluation sites.

Technological Characteristics

Software-based planning system running on Oracle Server/UNIX workstations. Interfaces via DICOM 3.0. Features include pencil beam dose algorithms for proton delivery (passive double scattering and uniform scanning), ray tracing for beam modifiers, and CT-number to stopping power calibration. Connectivity via LAN/WAN. No hardware components; software-only.

Indications for Use

Indicated for planning support for treatment of benign or malignant disease processes in patients requiring radiation therapy (photon, proton, electron, or brachytherapy). Intended for use by qualified medical personnel to formulate, review, and verify treatment plans. No specific age or gender contraindications stated.

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

• Xio RTP System - Proton Spot Scanning (K102216)

Submission Summary (Full Text)

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K/30992
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EMERGO GROUP

## 510(k) Summary

## JUN 1 4 2013

## 1. Submission Sponsor

Philips Medical Systems (Cleveland), Inc. 5520 Nobel Drive, Suite 125 Fitchburg, WI 53711 USA Phone: [phone] Fax: [phone] Contact: Jill Kaeder, Manager, Regulatory Affairs (PROS)

## 2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: [phone] Fax: [phone] Contact: Diane Sudduth, Senior Consultant, QA Email: [e-mail]

## 3. Date Prepared

April 9th, 2013

#### Device Identification 4.

| Trade/Proprietary Name: | Philips Medical Systems (Cleveland), Inc. |
|----------------------------|----------------------------------------------------------|
| Common/Usual Name: | Pinnacle ^3® Radiation Therapy Planning System |
| Classification Name: | Accelerator, Linear, Medical |
| Classification Regulation: | 892.5050 |
| Product Code: | MUJ |
| Device Class: | Class II |
| Classification Panel: | Radiology, RA90 |

## 5. Predicate Devices

K102216, Computerized Medical Systems, Inc., Xio RTP System - Proton Spot Scanning

## 6. Device Description

Pinnacle3® Radiation Therapy Planning System (hereafter Pinnacle3 RTP) provides radiation treatment planning for the treatment of benign or malignant diseases. When using Pinnacle " RTP, qualified medical personnel may generate, review, verify, approve, print and export the radiation therapy plan prior to patient treatment. Pinnacle RTP can provide

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Philips Medical Systems (Cleveland), Inc. Traditional 510(k) Premarket Submission Pinnacle3 Radiation Therapy Planning System

# EMERGO GROUP

plans for various radiation therapy modalities including, utilizing photon, proton, electron and brachytherapy techniques Stereotactic Radiosurgery, and Brachytherapy.

The Proton module builds on the Pinnacle Photon Treatment Planning Solution. A substantial part of the software architecture, display, connectivity and planning tools are transferable or extensible to the Proton Treatment Planning module. Using Pinnacle® RTP as the base-line architecture will address the needs of operating and future treatment centers to seamlessly integrate photon with proton treatment planning.

Pinnacle® RTP is a software package that runs on a Oracle Server and accessed through one or more clients, or an Oracle UNIX workstation and consists of a core software module (Pinnacle') and optional software features (the Proton module requires the Oracle server and cannot be run on a workstation). These optional software features, commonly referred to as "plug-ins", are typically distributed separate from the core software product (separate CD or DVD). The device has network capability to other Pinnacle® RTP workstations, thin client, and to both input and output devices via local area network (LAN) or wide area network (WAN).

Image data is imported from CT, MR, PET, PET-CT and SPECT devices using a DICOMcompliant interface. A qualified medical professional uses the Pinnacle® RTP for functions such as viewing and analyzing the patient's anatomy, and generating a radiation therapy plan. The following are examples of tasks that may be performed by clinicians when using the base features of the Pinnacle3 RTP system:

- Evaluate the treatment plan based on radiation-sensitive structures and the tumor. .
- Combine both geometric and dosimetric planning on the same platform, including CT . simulation data and plans. Configure beam variables such as energy, geometry, and beam modifiers such as blocks, wedges, multi-leaf collimators, bolus and compensators.
- Visualize the beam on a display, initiate the dose computation, and set the weight of . each beam.
- . Obtain dose values at any Points of Interest (POI).
- Perform photon and electron physics modeling, dose algorithm and machine . commissioning. This functionality is supported by the Physics Utility Module.
- . Evaluate images away from the workstation via a laptop or physician group workstation. Create data for use in conjunction with treatment QA systems.
- . Configure, backup, archive, restore, and scripting.
- Evaluate Digitally Reconstructed Radiographs (DRRs) on Pinnacle® RTP or remote . system using DICOM Secondary Capture (SC) Export.

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Philips Medical Systems (Cleveland), Inc. Traditional 510(k) Premarket Submission Pinnacle 3 Radiation Therapy Planning System

## EMERGO GROUP

In addition to the base Pinnacle RTP functionalities, Pinnacle Proton will provide the following:

## Physics

- . Define properties and parameter values for devices specific for passive double scattering and uniform scanning proton delivery techniques.
- · Determine dose model parameter values and related functions, including Bragg Peak, Spread Out Bragg Peak, Effective SAD, Virtual SAD and Effective Source Size based on beam measurement data.
- . Compute proton dose in a phantom and validate model implementation by comparing the computed profiles with the measured profiles for the same beam specifications, including Range, Modulation, Snout position, beam geometry, etc.
- . Define parameters for beam modifier characteristics, including aperture and compensator specification. The parameters are material, stopping power, maximum and minimum physical thickness, milling specifications.
- . Calibrate CT image data through the support of CT-Number to Stopping Power Tables for each CT scanner providing image data to be used for dose computation.
- . Print a physics report containing machine and dose model information.

## Planning

- Create a beam with a proton modality and determine clinical parameter values, . including range, modulation and field size, based on a user-specified target.
- . Generate beam dose computation parameters based on beam clinical parameters and a commissioned dose model.
- Provide a proton-specific compensator modifications user-specified edge . processing (border smoothing).
- . Automatically generate beam apertures based on an assigned target, with the ability to specify a uniform margin and make manual edits to the aperture shape as desired.
- . Provide the ability of overriding determined Stopping Power values in an image dataset, aiming to overcome artifacts in the planning CT image.
- . Automatically determine target range and modulation, with the ability to determine set range and modulation through distal/proximal margin specification or manual entry.
- . Generate setup DRRs at various commissioned imaging device positions.
- . Detect a potential collision between the machine and the patient surface and support a variable snout position.
- . Print a plan report containing proton beam specific information.

Once complete, Pinnacle " RTP has the ability to transfer the finished plan to other devices used in the therapy process such as an OIS, Linear Accelerator (Linac) Workstations (as appropriate for photon) and/or 310 Party QA systems.

The following Pinnacled RTP features are also available to assist the clinician with the radiation therapy planning process. These features are distributed on standalone CD/DVD media, and installed onto the Pinnacle3 RTP workstation. Corresponding instructions for use such as User Guides or Release Notes are also provided to the clinician for each optional feature.

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Philips Medical Systems (Cleveland), Inc. Traditional 510(k) Premarket Submission Pinnacle ** Radiation Therapy Planning System

## PSIMRT (Intensity Modulated Radiation Therapy):

P3MRT combines both forward and inverse planning functionality. The system determines a plan that satisfies the user's treatment goals through an optimization process. The user's treatment goals are specified as objectives and constraints based on dose distribution characteristics.

## Syntegra (also referred to as AutoFusion):

Syntegra automates multi-modality image registration and fusion by overlaying images from CT, MR, PET, PET-CT and SPECT devices using a DICOM-compliant interface. This feature provides clinicians with the ability to relate interpret and contour an image's anatomic and functional information.

In addition to the above, the following software options are available to facilitate image and/or data import and export between radiation therapy devices such as the imaging camera, Pinnacle RTP, and Record &Verify system. DICOM is the acronym for Digital Imaging and Communications in Medicine and is an internationally recognized standard for transferring biomedical information such as images and data between devices or over a network.

## DICOM RT:

DICOM RT software is used to support both Structure Set and Radiation Therapy Plan import and export functions. Structure Sets describe regions and points of interest to other systems. Plan information includes beam geometry and delivery information.

## DICOM Image:

DICOM Image software is used to support image import and export to and from the Pinnacle 3 RTP workstation according to the NEMA DICOM standard, version 3.0. This functionality allows diagnostic imaging devices supporting the DICOM 3.0 standard to interface with the Pinnacle system.

### Mitsubishi DME:

A proprietary interface has been created within the Pinnacle " RTP to support plan export to Mitsubishi Record and Verify systems. This interface is called the "Mitsubishi DME" system. This is implemented as a simple file based interface according to a format specified by Mitsubishi.

### P3 MD:

P3MD allows for treatment plan review and minor alternations by a physician from a PC-based workstation that is connected to the same network as the primary Pinnacle® Treatment Planning workstation.

VCC: VCC allows for treatment plan review and minor alternations by a physician from a PCbased workstation that is connected to the same network as the primary Pinnacle Treatment Planning workstation based on Oracle Virtual Desktop Client (OVDC) software.

P3PDF: P3PDF allows users to print to a .PDF file.

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## 7. Indications for Use:

Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3 Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle3 Proton, which supports proton therapy planning. The full Pinnacle" Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.

Pinnacle " Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. Plans generated using this system is used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel.

## 8. Intended Use:

Pinnacle3 Radiation Therapy Planning (RTP) System is a software package intended to provide planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.

## 9. Substantial Equivalence Discussion

The following table compares the Pinnacle® RTP system to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

| Manufacturer | Philips Medical Systems (Cleveland),<br>Inc. | Computerized Medical Systems,<br>Inc. | |
|------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Pinnacle3 RTP System | Xio RTP System - Proton Spot<br>Scanning | |
| 510(k) Number | Not assigned | K102216<br>October 01, 2010 | |
| Product Code | MUJ | MUJ | |
| Regulation Number | 892.5050 | 892.5050 | |
| Regulation Name | Accelerator, Linear, Medical | Accelerator, Linear, Medical | |
| Indications for Use | Pinnacle3 Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle3 Radiation Therapy Planning System incorporates a number of fully integrated subsystems, including Pinnacle3 Proton, which supports | The XiO Radiation Treatment Planning system accepts a) patient diagnostic imaging data from CT and MR scans, or from films, and b) "source"~ dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume, which is the | |
| Pinnacle 3® Radiation Therapy Planning System | Manufacturer | Philips Medical Systems (Cleveland), Inc. | Computerized Medical Systems, Inc. |
| Trade Name | Pinnacle3® RTP System | | Xio RTP System - Proton Spot Scanning |
| | proton therapy planning. The full Pinnacle3® Radiation Therapy Planning System software package provides planning support for the treatment of disease processes, utilizing photon, proton, electron and brachytherapy techniques.<br>Pinnacle3® Radiation Therapy Planning System assists the clinician in formulating a treatment plan that maximizes the dose to the treatment volume while minimizing the dose to the surrounding normal tissues. The system is capable of operating in both the forward planning and inverse planning modes. Plans generated using this system is used in the determination of the course of a patient's radiation treatment. They are to be evaluated, modified and implemented by qualified medical personnel. | | structure to be treated, and critical structures, or organs-at risk, to which radiation dose must be limited.<br><br>Based on the dose prescribed, the user, typically a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the type, number, position(s) and energy of radiation beams and the use of treatment aids between the source of radiation and the patient (wedges, blocks, ports, etc.). The XiO system produces a display of radiation dose distribution within the patient, indicating doses to the target volume and critical structures. Appropriate clinical personnel select the plan that they believe most effectively maximizes dose to the target volume while minimizing dose to critical structures. The parameters of the plan are output in hard-copy format for later reference placed in the patient file. |
| Intended Use | Pinnacle3 Radiation Treatment Planning System is a software package intended to provide planning support for the treatment of disease processes, utilizing photon, proton, electron, and brachytherapy techniques. | | The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. |
| Optimization<br>Algorithm | No control point based optimization for the proton modality is supported (IMPT). Static, "3D conformal" delivery is supported only. | | Full 3D optimization for Intensity Modulated Proton Therapy (IMPT) is supported as well as "3D conformal" therapy |
| Dose Engine: passive double scattering | Pencil beam algorithm based on the published work by: | | Pencil beam algorithm based on the published work by: |
| | L. Hong et al., "A pencil beam | | L. Hong et al., "A pencil beam |
| | Pinnacle ® Radiation Therapy Planning System | | |
| Manufacturer | Philips Medical Systems (Cleveland), Inc. | Computerized Medical Systems, Inc. | |
| Trade Name | Pinnacle® RTP System | Xio RTP System - Proton Spot Scanning | |
| | algorithm for proton dose<br>calculations, "Phys. Med. Biol. 41,<br>1305-1330 (1996). | algorithm for proton dose<br>calculations, "Phys. Med. Biol.<br>41, 1305-1330 (1996). | |
| Dose Engine:<br>uniform scanning | Pencil beam algorithm based on the<br>published work by: | Pencil beam algorithm based on<br>the published work by: | |
| | L. Hong et al., "A pencil beam<br>algorithm for proton dose<br>calculations, "Phys. Med. Biol. 41,<br>1305-1330 (1996). | L. Hong et al., "A pencil beam<br>algorithm for proton dose<br>calculations,"Phys. Med. Biol.<br>41, 1305-1330 (1996). | |
| Dose model<br>parameter values<br>and related<br>functions | Measured data is imported and fitted<br>to models based on published works<br>for input into the dose engine:<br><br>1) A.Somov, D. Yeung, R.<br>Slopsema, et.al, "Modeling<br>and commissioning of a<br>proton pencil beam<br>algorithm at UFPTI" poster<br>Particle Therapy Cooperative<br>Group Annual Meeting 47,<br>Jacksonville, FL, USA, May<br>19-24.<br><br>2) H. Szymanowski, A. Mazal, C.<br>Nauraye, S. Biensan, R.<br>Ferrand, M.C. Murillo, S.<br>Caneva, G. Gaboriaud, and<br>J.C. Rosenwald,<br>"Experimental determination<br>and verification of the<br>parameters used in a proton<br>pencil beam algorithm",<br>Med. Phys. 28, 975-987<br>(2001).<br><br>3) T. Bortfeld, "An analytical<br>approximation of the Bragg<br>curve for therapeutic proton<br>beams", Med Phys. 24, 2024-<br>2033 (1997).<br><br>4) Schaffner, B., Proton dose<br>calculation based on in-air<br>fluence measurements. Phys.<br>Med.Biol., 53, 1545-62<br>(2008). | An interpolation method to shift<br>and scale imported measured data<br>to determine modeling parameter<br>for input into the dose engine. | |
| Vendor Independent<br>Beam modifier | Yes<br>Uses standard ray tracing and | Yes<br>Uses standard ray tracing and | |

## Table 5A – Comparison of Characteristics

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Philips Medical Systems (Clèveland), Inc. Finilips Medical Systems (Groveland); Mor
Traditional 510(k) Premarket Submission
Pinnacle³® Radiation Therapy Planning System

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| Pinnacle 3 Radiation Therapy Planning System | | |
|----------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Philips Medical Systems (Cleveland),<br>Inc. | Computerized Medical Systems,<br>Inc. |
| Trade Name | Pinnacle3 RTP System | Xio RTP System - Proton Spot<br>Scanning |
| characteristics,<br>including aperture<br>and compensator<br>specification | projection techniques<br>Materials, limitations of size and<br>thickness, physical milling techniques<br>and limitations are all modeled | projection techniques<br>Materials, limitations of size and<br>thickness,<br>physical milling<br>techniques and limitations are all<br>modeled |
| Export plan<br>parameters required<br>by DICOM-RT Ion<br>standard | Yes | Yes |
| DICOM RT-Dose<br>import and export | Yes | Yes |
| IMPT | No | Yes |
| Mixed Modality<br>Planning | Yes. Dose is combined by summing<br>up dose values from each modality in<br>units of Co-60 equivalent<br>Radiobiological Effective dose | No |
| Quality Assurance | Yes. Plan and physics reports,<br>compensator and aperture printing,<br>dose calculations in QA phantom, etc.<br>are supported | Yes. Plan reports, compensator<br>and aperture printing, dose<br>calculations in QA phantom, etc.<br>are supported |
| Beam Weight<br>Optimization of<br>Proton Beams | Simple point based method. No full<br>3D dose optimization performed-<br>Monitor Units of pre-calculated, static<br>beams adjusted only to meet point<br>dose criteria. | unknown |
| Compensator<br>Modification<br>(Manual and<br>Automatic) | Compensator thickness values are<br>calculated from ray tracing<br>techniques by determining difference<br>in Water Equivalent Distance for each<br>ray that intersect target for<br>irradiation. The difference between<br>the most distant ray and the<br>individual ray represents the<br>thickness of that compensator pixel.<br>Physical milling techniques are<br>incorporated to make software's<br>representation of the compensator<br>match real-world compensator result.<br>User has manual and automated tools<br>to adjust compensator. Manual tools<br>based on user-desired thickness<br>adjustments to one or more pixels of<br>the compensator. | Compensator thickness values are<br>calculated from ray tracing<br>techniques by determining<br>difference in Water Equivalent<br>Distance for each ray that<br>intersect target for irradiation.<br>The difference between the most<br>distant ray and the individual ray<br>represents the thickness of that<br>compensator pixel. Physical<br>milling techniques are<br>incorporated to make software's<br>representation of the<br>compensator match real-world<br>compensator result.<br>User has manual and automated<br>tools to adjust compensator.<br>Manual tools based on user-<br>desired thickness adjustments to<br>one or more pixels of the<br>compensator. |
| Manufacturer | Philips Medical Systems (Cleveland),<br>Inc. | Computerized Medical Systems,<br>Inc.…