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.

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.

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 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 DICOM-compliant 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.

AI/ML Overview

This 510(k) submission for the Philips Medical Systems (Cleveland), Inc. Pinnacle3 Radiation Therapy Planning System (Pinnacle3 RTP) primarily focuses on demonstrating substantial equivalence to a predicate device, the Computerized Medical Systems, Inc. Xio RTP System - Proton Spot Scanning (K102216), rather than detailing specific acceptance criteria and a study to prove they are met in a quantitative manner. Regulatory submissions for radiation therapy planning systems often rely on verification and validation activities to ensure the software performs as intended and is safe and effective when compared to a legally marketed predicate device.

However, based on the provided text, here's a breakdown of the information requested, with indications where details are not explicitly provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for features like dose calculation accuracy or planning capabilities, nor does it provide specific device performance metrics in a pass/fail format typical of quantitative studies. Instead, it relies on demonstrating similar functionalities and computational approaches to a predicate device.

The "Non-Clinical Tests" section mentions that "Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the Thunder Core Verification Test Report, which is included in section 16 of this submission. Pinnacle3 RTP successfully passed verification testing." This suggests that internal acceptance criteria and performance thresholds existed and were met, but these specific details are not included in the provided excerpt.

The comparison table (Table 5A) highlights technological characteristics and principles of operation, implying that similarity to the predicate device in these aspects serves as a primary "acceptance criterion" for substantial equivalence.

Characteristic / "Acceptance Criterion"	Reported Device Performance (Pinnacle3 RTP)
Intended Use	Software package intended to provide planning support for the treatment of disease processes, utilizing photon, proton, electron, and brachytherapy techniques. Assists clinicians in formulating treatment plans to maximize dose to treatment volume and minimize dose to normal tissues.
Dose Engine: passive double scattering	Pencil beam algorithm based on published work by L. Hong et al. (1996).
Dose Engine: uniform scanning	Pencil beam algorithm based on published work by L. Hong et al. (1996).
Dose model parameter values and related functions	Measured data is imported and fitted to models based on published works by A. Somov et al. (poster), H. Szymanowski et al. (2001), T. Bortfeld (1997), and Schaffner, B. (2008) for input into the dose engine.
Vendor Independent Beam modifier	Yes, uses standard ray tracing and projection techniques. Materials, limitations of size and thickness, physical milling techniques and limitations are all modeled.
Export plan parameters required by DICOM-RT Ion standard	Yes
DICOM RT-Dose import and export	Yes
Mixed Modality Planning	Yes. Dose is combined by summing up dose values from each modality in units of Co-60 equivalent Radiobiological Effective dose.
Quality Assurance	Yes. Plan and physics reports, compensator and aperture printing, dose calculations in QA phantom, etc., are supported.
Beam Weight Optimization of Proton Beams	Simple point based method. No full 3D dose optimization performed - Monitor Units of pre-calculated, static beams adjusted only to meet point dose criteria.
Compensator Modification (Manual and Automatic)	Compensator thickness values are calculated from ray tracing techniques by determining the difference in Water Equivalent Distance for each ray that intersects the target for irradiation. Physical milling techniques are incorporated. User has manual and automated tools, with automated tools based on published work by M. Urie et al. (1983).
Verification Testing (General Functionality & Design Specifications)	Successfully passed verification testing as documented in the internal "Thunder Core Verification Test Report" (not provided in this excerpt). Hazard analysis completed and mitigated. Verification and Validation test plans followed Philips procedures.
Dose Calculation Accuracy	Algorithm testing was performed in a QA "Phantom" to compare calculated against measured doses. (No specific numerical acceptance criteria or performance results are provided in this excerpt).
Clinical Validation (User Experience/Workflow)	Clinical-oriented validation test cases were written and executed by PMS customers at External evaluation sites with oversight by PMS customer support personnel. (No specific acceptance criteria or quantitative results provided in this excerpt).

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "algorithm testing was performed in a QA 'Phantom'" and "clinical orientated validation test cases were written and executed by PMS customers at External evaluation sites." However, the number of phantom configurations, patient cases (if simulated), or specific test sets used in these validations is not provided.
Data Provenance:
- Phantom Data: For "Algorithm testing... in a QA 'Phantom'", the data is synthetically generated or acquired in a controlled lab environment. This is typically internal, not from a specific country of origin in the clinical sense.
- Clinical-Oriented Validation: For "clinical orientated validation test cases... executed by PMS customers at External evaluation sites," the data would likely be based on simulated or mock patient cases, or potentially anonymized clinical data provided by these "PMS customers." The countries of origin for these "External evaluation sites" are not specified, nor is whether the data was retrospective or prospective. It is implied to be retrospective or simulated to prevent patient exposure to risk.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not explicitly stated.
Qualifications of Experts: For the "clinical orientated validation test cases," it mentions "oversight by PMS customer support personnel." It also states that treatment plans "are to be evaluated, modified, and implemented by qualified medical personnel." While this implies that qualified personnel are involved in the validation, their specific roles (e.g., medical physicists, radiation oncologists, dosimetrists) and years of experience are not detailed as "experts establishing ground truth." For the QA phantom testing, the "ground truth" (measured doses) would be established by the physical measurements themselves, typically verified by medical physicists via dosimetry.

4. Adjudication Method for the Test Set

Not explicitly stated. The document refers to "oversight by PMS customer support personnel" for clinical validation, but it doesn't describe any formal adjudication process for disagreements or discrepancies. For phantom testing, the "ground truth" is measured data, and the comparison is usually direct.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical trials were not performed as part of the development of this product." Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with AI vs. without AI assistance was not conducted or reported. The device is a planning system, not an AI-assisted diagnostic or interpretation tool in the typical sense of MRMC studies.

6. Standalone (Algorithm Only) Performance Study

Yes, in part. "Algorithm testing was performed in a QA 'Phantom' to compare calculated against measured doses to ensure dose calculation accuracy." This constitutes a standalone performance evaluation of the dose calculation algorithm.

7. Type of Ground Truth Used

Algorithm Testing: "Measured doses" in a QA "Phantom." This refers to physical measurements in a controlled environment as the ground truth.
Clinical-Oriented Validation: This implicitly relies on the consensus of "qualified medical personnel" and "PMS customer support personnel" validating that the plans generated by the system are clinically appropriate and meet intended goals. However, a formal "ground truth" establishment process for these cases is not described beyond this general validation.

8. Sample Size for the Training Set

Not applicable. This device is a radiation therapy planning system that uses established physics models and algorithms (e.g., pencil beam algorithm, dose model parameter fitting to published works and measured data) rather than a machine learning model that requires a distinct "training set" in the context of deep learning or AI. The algorithms are based on fundamental physics principles and validated against measured data and published literature.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there isn't a "training set" in the machine learning sense. The models used (e.g., pencil beam algorithm) are derived from fundamental physics and validated against "measured data... fitted to models based on published works." This fitting process uses measured physical data (e.g., Bragg Peak, Spread Out Bragg Peak, Effective SAD, Virtual SAD, Effective Source Size, CT-Number to Stopping Power Tables) as its "ground truth" for parameter derivation.

Summary

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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: +1 608.288.6941 Fax: +1 608.298.2101 Contact: Jill Kaeder, Manager, Regulatory Affairs (PROS)

2. Submission Correspondent

Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Diane Sudduth, Senior Consultant, QA Email: project.management@emergogroup.com

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

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

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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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),Inc.	Computerized Medical Systems,Inc.
Trade Name	Pinnacle3 RTP System	Xio RTP System - Proton SpotScanning
510(k) Number	Not assigned	K102216October 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.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.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.
OptimizationAlgorithm	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 dosecalculations, "Phys. Med. Biol. 41,1305-1330 (1996).	algorithm for proton dosecalculations, "Phys. Med. Biol.41, 1305-1330 (1996).
Dose Engine:uniform scanning	Pencil beam algorithm based on thepublished work by:	Pencil beam algorithm based onthe published work by:
	L. Hong et al., "A pencil beamalgorithm for proton dosecalculations, "Phys. Med. Biol. 41,1305-1330 (1996).	L. Hong et al., "A pencil beamalgorithm for proton dosecalculations,"Phys. Med. Biol.41, 1305-1330 (1996).
Dose modelparameter valuesand relatedfunctions	Measured data is imported and fittedto models based on published worksfor input into the dose engine:1) A.Somov, D. Yeung, R.Slopsema, et.al, "Modelingand commissioning of aproton pencil beamalgorithm at UFPTI" posterParticle Therapy CooperativeGroup Annual Meeting 47,Jacksonville, FL, USA, May19-24.2) H. Szymanowski, A. Mazal, C.Nauraye, S. Biensan, R.Ferrand, M.C. Murillo, S.Caneva, G. Gaboriaud, andJ.C. Rosenwald,"Experimental determinationand verification of theparameters used in a protonpencil beam algorithm",Med. Phys. 28, 975-987(2001).3) T. Bortfeld, "An analyticalapproximation of the Braggcurve for therapeutic protonbeams", Med Phys. 24, 2024-2033 (1997).4) Schaffner, B., Proton dosecalculation based on in-airfluence measurements. Phys.Med.Biol., 53, 1545-62(2008).	An interpolation method to shiftand scale imported measured datato determine modeling parameterfor input into the dose engine.
Vendor IndependentBeam modifier	YesUses standard ray tracing and	YesUses standard ray tracing and

Table 5A – Comparison of Characteristics

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

Image /page/6/Picture/1 description: The image shows the logo for Emergo Group. The logo consists of the word "EMERGO" in all caps, followed by a stylized symbol that resembles a globe with curved lines. To the right of the symbol is the word "GROUP" in all caps.

・

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

E MERGO G GROUP

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 SpotScanning
characteristics,including apertureand compensatorspecification	projection techniquesMaterials, limitations of size andthickness, physical milling techniquesand limitations are all modeled	projection techniquesMaterials, limitations of size andthickness,physical millingtechniques and limitations are allmodeled
Export planparameters requiredby DICOM-RT Ionstandard	Yes	Yes
DICOM RT-Doseimport and export	Yes	Yes
IMPT	No	Yes
Mixed ModalityPlanning	Yes. Dose is combined by summingup dose values from each modality inunits of Co-60 equivalentRadiobiological Effective dose	No
Quality Assurance	Yes. Plan and physics reports,compensator and aperture printing,dose calculations in QA phantom, etc.are supported	Yes. Plan reports, compensatorand aperture printing, dosecalculations in QA phantom, etc.are supported
Beam WeightOptimization ofProton Beams	Simple point based method. No full3D dose optimization performed-Monitor Units of pre-calculated, staticbeams adjusted only to meet pointdose criteria.	unknown
CompensatorModification(Manual andAutomatic)	Compensator thickness values arecalculated from ray tracingtechniques by determining differencein Water Equivalent Distance for eachray that intersect target forirradiation. The difference betweenthe most distant ray and theindividual ray represents thethickness of that compensator pixel.Physical milling techniques areincorporated to make software'srepresentation of the compensatormatch real-world compensator result.User has manual and automated toolsto adjust compensator. Manual toolsbased on user-desired thicknessadjustments to one or more pixels ofthe compensator.	Compensator thickness values arecalculated from ray tracingtechniques by determiningdifference in Water EquivalentDistance for each ray thatintersect target for irradiation.The difference between the mostdistant ray and the individual rayrepresents the thickness of thatcompensator pixel. Physicalmilling techniques areincorporated to make software'srepresentation of thecompensator match real-worldcompensator result.User has manual and automatedtools to adjust compensator.Manual tools based on user-desired thickness adjustments toone or more pixels of thecompensator.
Manufacturer	Philips Medical Systems (Cleveland),Inc.	Computerized Medical Systems,Inc.
Trade Name	Pinnacle3 RTP System	Xio RTP System - Proton SpotScanning
	published works:	compensator.
	1) M. Urie, M. Goitein, andM.Wagner. "Compensatingfor heterogeneities in protonradiation therapy."Phys.Med.Biol , 29 , 553-66(1983)	Automated tools are based onpublished works:
		M. Urie, M. Goitein, andM.Wagner. "Compensating forheterogeneities in protonradiation therapy." Phys.Med.Biol ,29 , 553-66 (1983)
Anatomical Sites	Same, see below	Same, see below
Target Population	Same, see below	Same, see below
Standards Met andPerformance	Same, see below	Same, see below

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EMERGO GEROUP

10. Non-Clinical Tests:

Verification tests were written and executed to ensure that the system is working as designed. Pass/fail requirements and results of this testing can be found in the Thunder Core Verification Test Report, which is included in section 16 of this submission. Pinnacle3 RTP successfully passed verification testing.

A Hazard Analysis was completed for Pinnacle RTP and hazards were mitigated as appropriate. Verification and Validation test plans were completed in compliance with Philips procedures and will be utilized to demonstrate that Pinnacle® RTP has met its specifications, demonstrates substantially equivalent performance to the predicate device and that it does not raise different questions of safety and effectiveness as compared to the predicate device.

11. Clinical Tests:

Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are e3xposed to risk. Algorithm testing was performed in a QA "Phantom" to compare calculated against measured doses to ensure dose calculation accuracy. In addition, clinical orientated validation test cases were written and executed by PMS customers at External evaluation sites with oversight by PMS customer support personnel.

12. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the difference between the Pinnacle2 RTP system and the predicate device do not raise any questions regarding its safety and effectiveness. The Pinnacle® RTP, as designed and manufactured, is determined to be

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EMERGO E GRO

substantially equivalent to the referenced predicate device.

13. Conclusions:

The Pinnacle® RTP is substantially equivalent to the predicate device. It has the same intended use as the predicate device and its use does not raise any new or different issues of safety or effectiveness when compared to the predicate device.

Image /page/9/Figure/5 description: This image is a flowchart that describes the radiation therapy planning system. The process starts with an imaging device such as CT, MR, PET, or SPECT. The data is then imported via DICOM image and processed by the Pinnacle3 Radiation Therapy Planning System. The flowchart continues with steps such as clinician review, QA data export, dosimetrist review, and finally patient treatment.

Image /page/9/Figure/6 description: The image shows the title of a figure. The title is "Figure 1 – General Workflow Diagram". The title is written in a clear, sans-serif font and is centered on the image.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. The logo is black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2013

Philips Medical Systems (Cleveland), Inc. % Ms. Diane Sudduth Senior Consultant. QA Emergo Group 816 Congress Avenue, Suite 1400 AUSTIN TX 78701

Re: K130992

Trade/Device Name: Pinnacle Radiation Therapy Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 9, 2013 Received: April 10, 2013

Dear Ms. Sudduth:

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-ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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Page 2 - Ms. Sudduth

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Michael D. O'Hara

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure-

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Indications for Use

510(k) Number (if known): K130992

Device Name: Pinnacle30 Radiation Therapy Planning System

Indications for Use:

Pinnacle" Radiation Therapy Planning System is a software package intended to provide planning support for the treatment of disease processes. Pinnacle' 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.

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.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Ireland D. O'Hara

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

510(k) K130992

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Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
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.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.