(65 days)
Not Found
No
The document describes a radiation therapy planning system with various functionalities, including image registration and dose calculation. While it mentions automated image registration, it does not explicitly state or imply the use of AI or ML algorithms for any of its functions. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a software package that assists in planning radiation therapy. It does not directly treat or diagnose patients.
No
The device is a radiation therapy planning system that assists clinicians in formulating treatment plans. It does not diagnose disease; rather, it uses existing diagnostic image data to plan treatments.
Yes
The device is explicitly described as a "software package" and its components are listed as software modules and features running on standard computing hardware (Oracle Server, Oracle UNIX workstation, clients). While it interacts with hardware (imaging devices, network), the device itself is the software for planning radiation therapy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as providing "planning support for the treatment of disease processes" using various radiation therapy techniques. This is a treatment planning system, not a diagnostic test performed on biological samples.
- Device Description: The description details a software package used by qualified medical personnel to generate, review, and approve radiation therapy plans based on medical images. It does not involve the analysis of in vitro samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological specimens (blood, urine, tissue, etc.)
- Detection or measurement of analytes in biological samples
- Providing information for diagnosis, monitoring, or prognosis based on in vitro testing.
The device is a medical device used in the planning phase of radiation therapy treatment, which is a therapeutic intervention, not a diagnostic process.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
MUJ, IYE
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 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.
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
CT, MR, PET, PET-CT, SPECT
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified medical personnel / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K/30992
Page 1 of 10
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
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
1
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.
2
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.
3
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.
4
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 Spot
Scanning | |
| 510(k) Number | Not assigned | K102216
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.
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. |
| Optimization
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
calculations, "Phys. Med. Biol. 41,
1305-1330 (1996). | algorithm for proton dose
calculations, "Phys. Med. Biol.
41, 1305-1330 (1996). | |
| Dose Engine:
uniform scanning | 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
algorithm for proton dose
calculations, "Phys. Med. Biol. 41,
1305-1330 (1996). | L. Hong et al., "A pencil beam
algorithm for proton dose
calculations,"Phys. Med. Biol.
41, 1305-1330 (1996). | |
| Dose model
parameter values
and related
functions | Measured data is imported and fitted
to models based on published works
for input into the dose engine:
-
A.Somov, D. Yeung, R.
Slopsema, et.al, "Modeling
and commissioning of a
proton pencil beam
algorithm at UFPTI" poster
Particle Therapy Cooperative
Group Annual Meeting 47,
Jacksonville, FL, USA, May
19-24. -
H. Szymanowski, A. Mazal, C.
Nauraye, S. Biensan, R.
Ferrand, M.C. Murillo, S.
Caneva, G. Gaboriaud, and
J.C. Rosenwald,
"Experimental determination
and verification of the
parameters used in a proton
pencil beam algorithm",
Med. Phys. 28, 975-987
(2001). -
T. Bortfeld, "An analytical
approximation of the Bragg
curve for therapeutic proton
beams", Med Phys. 24, 2024-
2033 (1997). -
Schaffner, B., Proton dose
calculation based on in-air
fluence measurements. Phys.
Med.Biol., 53, 1545-62
(2008). | An interpolation method to shift
and scale imported measured data
to determine modeling parameter
for input into the dose engine. | |
| Vendor Independent
Beam modifier | Yes
Uses standard ray tracing and | Yes
Uses 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
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Philips Medical Systems (Cleveland), Inc. Traditional 510(k) Premarket Submission
Pinnacle³● Radiation Therapy Planning System
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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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:
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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 Spot |
| Scanning | ||
| characteristics, | ||
| including aperture | ||
| and compensator | ||
| specification | projection techniques | |
| Materials, limitations of size and | ||
| thickness, physical milling techniques | ||
| and limitations are all modeled | 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 | Yes |
| DICOM RT-Dose | ||
| import and export | Yes | Yes |
| IMPT | No | 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 | No | |
| Quality Assurance | Yes. Plan and physics reports, | |
| compensator and aperture printing, | ||
| dose calculations in QA phantom, etc. | ||
| are supported | Yes. Plan 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. | unknown | |
| Compensator | ||
| Modification | ||
| (Manual and | ||
| Automatic) | Compensator thickness values are | |
| calculated from ray tracing | ||
| techniques by determining difference | ||
| in Water Equivalent Distance for each | ||
| ray that intersect target for | ||
| irradiation. The difference between | ||
| the most distant ray and the | ||
| individual ray represents the | ||
| thickness of that compensator pixel. | ||
| Physical milling techniques are | ||
| incorporated to make software's | ||
| representation of the compensator | ||
| match real-world compensator result. | ||
| User has manual and automated tools | ||
| to adjust compensator. Manual tools | ||
| based on user-desired thickness | ||
| adjustments to one or more pixels of | ||
| the compensator. | Compensator thickness values are | |
| calculated from ray tracing | ||
| techniques by determining | ||
| difference in Water Equivalent | ||
| Distance for each ray that | ||
| intersect target for irradiation. | ||
| The difference between the most | ||
| distant ray and the individual ray | ||
| represents the thickness of that | ||
| compensator pixel. Physical | ||
| milling techniques are | ||
| incorporated to make software's | ||
| representation of the | ||
| compensator match real-world | ||
| compensator result. | ||
| User has manual and automated | ||
| tools to adjust compensator. | ||
| Manual tools based on user- | ||
| desired thickness adjustments to | ||
| one or more pixels of the | ||
| compensator. | ||
| Manufacturer | Philips Medical Systems (Cleveland), | |
| Inc. | Computerized Medical Systems, | |
| Inc. | ||
| Trade Name | Pinnacle3 RTP System | Xio RTP System - Proton Spot |
| Scanning | ||
| published works: | compensator. | |
| 1) M. Urie, M. Goitein, and | ||
| M.Wagner. "Compensating | ||
| for heterogeneities in proton | ||
| radiation therapy." | ||
| Phys.Med.Biol , 29 , 553-66 | ||
| (1983) | Automated tools are based on | |
| published works: | ||
| M. Urie, M. Goitein, and | ||
| M.Wagner. "Compensating for | ||
| heterogeneities in proton | ||
| radiation 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 and | ||
| Performance | Same, see below | Same, see below |
Page 5 - 8
:
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Philips Medical Systems (Cleveland), Inc. Traditional 510(k) Premarket Submission Pinnacle3® Radiation Therapy Planning System
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
9
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.
10
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.
11
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-
12
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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