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The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon treatment plans and displays, on-screen and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups. The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for: - contouring - image manipulation - simulation - image fusion - plan optimization - QA and plan review

Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179). The Monaco system accepts patient diagnostic imaging data and "source" dosimetry data from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a multileaf collimator (MLC) between the source of radiation and the patient to shape the beam. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.

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.

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 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. This Premarket Notification addresses the addition of the Proton Spot Scanning. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario.

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.

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 structure to be treated, and critical structures, or organs-atrisk, 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. This Premarket Notification addresses the addition of the Electron Monte Carlo dose calculation algorithm. XiO provides the user with the ability to choose between multiple dose calculation algorithms, selecting the algorithm most appropriate for the given clinical scenario. More accurate dose computation increases the probability that disease will be effectively treated and decreases the probability of undesirable side effects. No algorithm produces a perfectly accurate description of dose distribution; all algorithms have limitations, which are generally well understood and documented in scientific literature. The addition of the Monte Carlo dose calculation algorithm gives users a new option for electron treatment plans. The algorithm represents the state of the art in radiation treatment planning and is widely recognized as the most accurate method currently available for computing the dose delivered by a beam of high-energy electrons.

The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup. The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

Monaco uses local biological measures for optimization to create intensity modulated radiation therapy (IMRT) plans using Multileaf Collimators. With the addition of VMAT planning capability, Monaco also allows users to creatment plans in which the devices that aim and shape the beam are in motion while the beam is on.

Atlas-Based Autosegmentation is a standalone software application that produces estimates of anatomy boundary contours needed for the creation of a radiotherapy treatment plan.

Contouring of radiation therapy targets and surrounding anatomical structures (also known as image segmentation) is a critical part of radiation treatment planning that can be extremely time consuming. Atlas-Based Autosegmentation (ABAS) is a software application that automates the contouring process using atlas-based autosegmentation. This method uses an already-segmented image set (atlas) to segment a set of new, user-input images using deformable registration algorithms. The contours ABAS generates are not usable for treatment as-is; they must be exported to a treatment planning system for editing. However, Atlas-based Autosegmentation provides a good starting point from which minimal editing is required, enabling the clinician to create a high quality treatment plan more efficiently.

The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) 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. The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.

Monaco uses local biological measures for optimization to create intensity modulated radiation therapy (IMRT) plans using Multileaf Collimators.

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. Optionally, the user may elect to generate plans using Dynamic Conformal Arc Therapy capability. Dynamic Conformal Arc Therapy is a treatment modality in which the gantry rotates in an arc (or multiple arcs) over user-specified angles while the leaves of a multileaf collimator (MLC) continually reshape the beam to conform to the targer.

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) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, 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 then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file. This Premarket Notification addresses the addition of support for Dynamic Conformal Therapy. Dynamic Conformal is a treatment modality in which radiation beams are continuously shaped to conform to a target while the gantry rotates and the beam is on. In XiO, the user chooses the target, defines structures to avoid, optional margin(s), and treatment angles. XiO then plans a treatment over a specified arc and with specified beam increments, with the leaves of the multi-leaf collimator (MLC) continually reshaping the beam to conform to the target. The target receives a homogenous dose while the structures designated as "avoidance structures" are avoided absolutely. Dose calculation is performed using existing, validated algorithms within XiO. Determination of dose at the specified angles is calculated in the same way as conventional and asymmetric arc beams; the calculated dynamic beam dose distribution is determined as the sum of multiple fixed beam dose distributions across the specified arc.

I-Beam is a self-contained mobile patient positioning system that uses real time ultrasound images of patient target organs or tumors while the patient is positioned on the couch of the linear accelerator to confirm the location of these patient target organs or tumors prior to delivery of external beam radiation therapy.

The I-Beam Patient Positioning System provides a method for a hospital/clinic to accurately position a patient prior to delivery of external beam radiation therapy each day such that the patient tumor volume on the day of therapy coincides with the tumor volume from the treatment plan. Patient positioning may be necessary because of day-to-day movement of the soft tissue target within the patient. Closer alignment assures proper tumor coverage and a minimum of dose to healthy tissue and structures surrounding the target. I-Beam achieves this alignment by having a camera provide a signal to I-Beam. The camera is attached to an ultrasound transducer body by use of a custom "clamshell" in an orientation that points the camera in a direction 180 degrees from the plane of the transducer output. As the transducer ultrasound system (not part of I-Beam) images the patient target, the camera is looking up at a targeting grid located on the shadow tray of the linear accelerator. Using pattern recognition techniques, the I-Beam system is able to determine the position of the isocenter of the target volume relative to the isocenter of the linear accelerator. The user then superimposes the ultrasound tumor volume data obtained from this scan on that from the original treatment plan data input to I-Beam earlier. This treatment plan is based on a CT study set, and the user aligns the two tumor volumes by "moving" one relative to the other. I-Beam senses this relative movement of the ultrasound tumor volume to that from the treatment plan and converts that into a three axis "translation" figure which gives the operator the amount and direction the patient must be moved in each axis to achieve alignment with the treatment plan and thus the linear accelerator. Correct re-positioning of the patient is verified by performing a second ultrasound scan of the patient and overlaying that with the original CT-based treatment plan tumor volume information. The translation figures will advise the user of any remaining misalignment should there have been a misinterpretation of the translation date and/or patient positioning.

The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons)..

The FOCUS 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) a) the target volume to be treated and b) critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, 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 FOCUS system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The "best" plan satisfying the prescription is then selected, one which maximizes dose to the target volume while minimizing dose to surrounding healthy volume. The parameters of the plan are output in hard-copy format for later reference and for placement in the patient file. Previously, for situations where external beam therapy was to be used, either Electron and/or Photon radiation beams could be selected.. These were delivered by a linear accelerator whose output characteristics are input to the treatment planning system prior to beginning planning. This Premarket Notification addresses the addition of a third type of radiation beam -Proton. The algorithm for calculating dose was provided by the Massachusetts General Hospital (MGH), based on their years of experience at the Harvard Cyclotron Lab. In addition to providing the algorithm, MGH also worked with CMS in its implementation. Software developers at MGH were trained on the CMS software development process to permit them to create code directly for use in FOCUS. As the final step, MGH provided the verification testing to assure the algorithm had been implemented correctly, measuring calculated dose against measures. A FOCUS RTP System with proton planning capability is now in clinical use at the Northeast Proton Therapy Center.

The FOCAL workstation software is a computer software package intended to be used as an accessory to a radiation treatment planning system. FOCAL Sim is intended to permit CT simulation to be performed on the FOCAL workstation. The CT scan is read into the radiation treatment planning system and then sent to the FOCAL workstation. On FOCAL, the user is able to identify patient isocenters, place treatment beams and identify beam modifiers (blocks, wedges, etc.). This information is then passed back to the radiation treatment planning system for storage and documentation of the resultant treatment plan and calculation of patient dose based on this information. The resultant plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel.

The FOCAL Workstation was initially cleared for marketing under K981535. The initial release of the product had, as its intended use, the remote contouring of patient outlines, structures and tumors as part of radiation therapy planning. The FOCAL Workstation was designed to work with our FOCUS Radiation Treatment Planning (RTP) System. The task of contouring, typically performed by the Radiation Oncologist, is the most time consuming task in radiation therapy planning and requires a minimum of the most recently cleared FOCUS RTP Computer Capacity. It was our goal to free up the higher powered UNIX-based RTP Workstation for performing the calculation-intensive activities of treatment planning by moving the contouring to a remote device. This remote device was a Personal Computer loaded with the FOCAL contouring software running on that PC. While contouring was complete, the information was returned to the RTP System to continue the treatment planning process. The first release of FOCAL contained only manual contouring capability and was given the trade name of "FOCAL Ease". The second release enhanced the users ability to view CT and MR images as well as providing an autosegmentation capability. This added functionality was given the trade name "FOCAL Fusion". A later release of FOCAL software provided the capability to view the results of treatment planning performed earlier on the FOCUS RTP System. This included the ability to view isodose contours as well as Dose Volume Histograms (DVH's) and Digitally Reconstructed Radiations (DRR's). This was given the name "FOCAL Vue". This provided the Radiation Oncologist with a remote capability to view and compare alternate treatment plans and select the one which best satisfied her/his prescription. The subject of this Premarket Notification is the addition of the ability to perform CTV simulation, a feature we call "FOCAL Sim". This addition moves the FOCAL Workstation from merely contouring of patient targets or viewing of treatment planning results into a more active role in the treatment planning process.