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Clarity® is indicated for use in external beam radiation therapy. It provides 3D ultrasound and hybrid imaging of soft tissue anatomy to aid in radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment (Image Guided Radiation Therapy). When configured with an autoscan probe kit for transperineal ultrasound (TPUS) imaging, Clarity® may be used to continuously track and monitor the prostate and to accurately and precisely guide patient positioning during the delivery of treatment (Intrafractional Position Tracking and Monitoring). When configured with a gating option, Clarity® may also interface with radiation delivery systems equipped with a compatible external gating control device. With this option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked anatomy has exceeded pre-defined monitoring (tracking) limits, and signal again to release the tracked anatomy returns to a position within those limits (Exception gating has been shown to be compatible with radiation delivery systems equipped with Elekta's Response™ Gating Control System.

The Clarity® system integrates medical diagnostic ultrasound, real-time optical position tracking and proprietary software to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. Clarity® offers a non-invasive, non-ionizing means for accurate and precise localization of anatomical structures and patient positioning relative to the treatment isocenter. The Clarity® system (Model 310C00) is configured around a mobile image acquisition station with an integrated ultrasound scanner, high-resolution touch screen, and high-performance computer system running the Clarity® software. It may be used at the patient's side in the CT-Sim room (Clarity® Sim) and the treatment room (Clarity® Guide) when equipped with a ceiling-mounted optical tracking system, patient/couch position tracking tools and, optionally, remote control and treatment monitoring equipment. With the gating option, the Clarity® Guide acquisition station may interface with radiation delivery systems equipped with a compatible external gating control device. Each acquisition station is configured with up to three optically-tracked ultrasound probes: one or two hand-held probes for manual scanning and a motorized (autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the target anatomy and the patient's clinical presentation. The autoscan probe remains in contact with the patient for continuous imaging of the prostate and surrounding anatomy using specifically designed positioning apparatus for transperineal ultrasound (TPUS); it is operated from the acquisition station's remote control and monitoring equipment interface (touch-screen identical to that on the mobile acquisition station). A multimodality imaging phantom is used to calibrate Clarity® to the room coordinate system and to verify system integrity for sub-millimeter target localization accuracy and precision within each room (daily and monthly QC). A dedicated high-performance server and workstation computer system running the Clarity® software is connected to Clarity® acquisition stations through the hospital's local area network. The server houses the central database and web server, and provides for interoperability with other imaging and treatment planning/simulation systems via the DICOM 3/RT protocol. The workstation is used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, setup of monitoring parameters, and review of treatment and QC data. Optionally, additional Clarity® workstations may be connected to the central Clarity® server. The Clarity® software is designed to step the user through a radiation therapy workflow or "course" and QC procedures. Different courses are defined to help classify patients in the database and to present the user with reminders, default choices and configuration settings tailored to the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck). Such configurations include probe type, imaging (scan) presets, contouring and assisted segmentation tools, alert values for target misalignment, and prostate monitoring (tracking) parameters. The typical use of the system for a radiation therapy course begins with the acquisition of a baseline 3D ultrasound (3DUS) scan with the patient in the planning position. The planning CT is imported, registered and fused with the 3DUS on the Clarity® workstation to verify the alignment of the target anatomy. The structures of interest are then defined and a baseline positioning reference including, if applicable, monitoring (prostate tracking) parameters are approved. Optionally, the 3DUS and related contours may be exported via DICOM to a third-party virtual simulator or treatment planning system. To assist with patient positioning prior to each treatment session, a new 3DUS scan is acquired and used to determine target displacement relative to the baseline planning-day position. Optical tracking of couch position allows for accurate and precise patient repositioning relative to the treatment isocenter (Image Guided Radiation Therapy). Automatic image analysis identifies a soft-tissue structure such as the prostate in successive transperineal 3DUS images, which are acquired continuously during treatment, and allows Clarity® to track its motion and assist with patient repositioning (Intrafractional Position Tracking and Monitoring). When configured with the gating option, while in tracking and monitoring mode, Clarity® can signal the radiation delivery system to automatically impose a beam-hold when the tracked structure position has exceeded pre-defined monitoring (tracking) limits, and signal again to release the beam-hold when the structure returns to a position within those limits (Exception Gating). Clarity® may optionally be configured to send calculated couch shifts for patient repositioning to the operator at the couch control user interface using the MOSAIQ® Workflow Manager. A web-based interface is available for remote review and approval of positioning references and other treatment parameters, and review of completed treatment session and QC procedure data.

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The associated Integrity R3.1 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. Both High Dose Rate mode and flattened beams are intended to be used for single or multiple fractions, delivered as static and/or dynamic, in gated or un-gated deliveries, in all areas of the body where such treatment is indicated. The use of the Agility multileaf collimator in conjunction with an Elekta digital linear accelerator may be helpful in the delivery of radiation for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.

This Traditional 510(k) describes changes to the Elekta range of medical linear accelerators when fitted with the Agility multileaf collimator and associated Integrity linac control system. Items added are; High Dose Rate mode x-rays, specific clinical indications for use, and the Response™ gating interface that enables the linac treatment beam to be automatically turned on and off by signals from an external gating device. High Dose Rate mode x-rays are provided by changes to the filtering arrangement to reduce wasteful attenuation of the beam.

Clarity® is indicated for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment. Clarity® may also be used with an Autoscan Probe for transperineal ultrasound (TPUS) imaging, to continuously monitor the motion of the prostate and to accurately guide patient positioning during the delivery of treatment (i.e., intra-fractionally).

Clarity® integrates medical diagnostic ultrasound and a real-time optical measurement system, which determines the 3D position of the ultrasound probes, to acquire and reconstruct 3D images of soft-tissue anatomy for use in external beam radiation therapy. During the course of treatment, non-ionizing 3D ultrasound imaging and optical tracking of couch position with Clarity® offers a noninvasive means for accurate localization of anatomical structures and patient positioning. Clarity® comprises the following functional components: - The Clarity® Acquisition Station is configured around an ultrasound console, which may be suspended from an articulated arm or mounted on a cart, with an integrated computer system and high-resolution touch screen. Acquisition stations are placed in the CT-Sim room (Clority® Sim) and the treatment room (Clority® Guide), with a celling-mounted optical measurement system and patient/couch position tracking tools. - Each acquisition station is equipped with optically-tracked ultrasound probes; one or two hand-held probes for manual scanning and a motorized (Autoscan) probe for automated scanning. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The Autoscan probe includes a positioning apparatus that is specifically designed for transperineal imaging. The Autoscan probe remains in place during a CT-Sim scan and during radiation treatment; scanning is controlled from a remote console interface. - A multimodality phantom is used for image calibration to the room's coordinate system that is defined by the corresponding room lasers, and for daily verification of system integrity for sub-millimeter target localization accuracy within each room. - One or more dedicated workstation computer systems, connected to the hospital's local area network, are used for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and review of treatment sessions. - A dedicated central server computer system (typically combined with a workstation) houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol. The Clarity® software is designed to step the user through a radiation therapy workflow or "course." Different courses are defined (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g., prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for target misalignments. At the time of CT-Simulation, a 3D ultrasound (3DUS) scan is acquired with the patient in the planning position. At the Workstation, the planning CT is imported and fused with the 3DUS, the structure of interest is defined, and a baseline positioning reference is approved. The 3DUS may be exported via DICOM to a third-party virtual simulator or treatment planning system (TPS), In the treatment room, a 3DUS scan is used to determine target displacement relative to the baseline planning-day position, and to guide patient positioning prior to treatment. When used with the Autoscan probe, Clarity® allows for continuous imaging of the prostate and surrounding anatomy to enable precise motion management during the delivery of treatment (i.e., intra-fractionally). To assist with the clinical workflow, Clarity® can be configured to send calculated couch shifts to the operator at the couch control user interface. A web-based software interface is available with Clarity® for remote review of treatment session data and positioning references.

The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. The associated Integrity R3.0 software is the interface and control software for the Elekta medical digital linear accelerator and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes the addition of the new Agility multileaf collimator beam limiting device and its associated control software to the Elekta medical linear accelerator. The new device has 160 leaves of 5mm width at isocenter, a fast leaf speed of up to 65 mm/s, low leakage (<0.5%) and is capable of interdigitation within a maximum field size of 40 x 40 cm. Control is by extension to the existing Elekta linear accelerator control system software. Synchronization of the movement of the dynamic leaf guides with individual leaf movements achieves enhanced leaf speed and removes the need for a split field. The Agility includes dynamic leaf guides, fluorescing ruby leaf markers ('Rubicon') for improved leaf tracking by the optics system, the elimination of backup diaphragms by providing low interleaf leakage, sculpted field defining diaphragms, separate lighting systems for patient plane illumination and movement control using LEDs, and a new control cabinet on which the Integrity user interface and machine control software is executed including a hardware firewall to provide safe network connection.

The Clarity™ OBP System is intended for use in external beam radiation therapy, to provide 3D ultrasound and hybrid imaging of soft-tissue anatomy to support radiation therapy simulation and planning, and to guide patient positioning prior to the delivery of treatment.

The Clarity™ OBP System integrates medical diagnostic ultrasound and optical position tracking to acquire and reconstruct three-dimensional ultrasound (3DUS) images of soft-tissue anatomy for use in external beam radiation therapy. During the course of radiation therapy, the Clority™ OBP System offers a non-ionizing means for daily localization of target anatomical structures. The Clarity™ OBP System comprises the following functional components: - The 3DUS imaging station (typically one in the CT-simulation room and one in the treatment . room}, including the 3DUS console with an integrated computer system and opticallytracked ultrasound probes, patient/couch position tracking tools, and a ceiling-mounted optical tracking system. - . A multimodality phantom, for 3DUS image calibration to the room's coordinate system defined by the corresponding room lasers, and for daily verification of system integrity. - . One or more dedicated workstation computer systems for multimodality image fusion and review, soft-tissue structure definition, approval of patient positioning references, and monitoring of treatment progress. - . A dedicated central server computer system (typically combined with a workstation), which houses the patient database and provides for interoperability with other imaging and treatment planning/simulation systems using the DICOM 3/RT protocol. All networked Clarity™ OBP System stations are configured to run the same software version. The software interface is designed to 'walk' the user through a sequence of steps (or "course") to acquire 3DUS scans in the planning position, import planning CT data and fuse with 3DUS, define the structure of interest and approve a baseline positioning reference, acquire another 3DUS in the treatment position to determine target displacement relative planning-day position, and adjust patient positioning prior to treatment. The 3DUS data may be exported through DICOM to a third-party virtual simulator or treatment planning system (TPS). Different courses are defined in the software (e.g., "Prostate", "General", "QC") to help classify patients in the database and to present the user with default choices and settings, tailored for the target anatomy (e.g. prostate, bladder, liver, uterus & cervix, breast, head & neck) and daily QC tasks. Such configurations include probe type, scan settings, contouring and assisted segmentation tools, and alert values for large target misalignments. The Clarity™ OBP System provides the option for hand-held ultrasound scanning or automated scanning with a motorized probe. The user can select the probe and scanning method that is most appropriate for the given target anatomy and the patient's clinical presentation. The autoscan probe comes with a probe holder apparatus and a remote control console, specifically designed to facilitate transperineal imaging of the prostate and surrounding soft tissues. The Clarity™ OBP System also includes an optional web-based interface for remote review of treatment session data and positioning reference images.

Integrity™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the Elekta range of medical digital linear accelerators. Integrity R1.0 employs a new LynxOS operating system that has a proven track record in safety and security to replace RMX. The software introduces Continuously Variable Dose Rate (CVDR), which is an enhancement to standard dose rate for dynamic delivery techniques. This function increases the number of available dose rates which can make treatment delivery more efficient and provide smoother delivery of VMAT prescriptions. The software supports the ability for the MLCi2 leaves to interdigitate, supporting the creation of island fields for X-Ray treatment delivery techniques.

The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner. XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.

This Traditional 510(k) describes modifications made to the XVI kilo-voltage imaging accessory of the Elekta range of digital linear accelerators. The primary reason for these enhancements is to improve the acquisition and utilization of kV images in facilitating the correction of patient position for anatomical changes or movement. The additional features are; Symmetry™ (4D VolumeView™) to evaluate respiration induced motion, 3D shaped region of interest for registration, dual registration for quantitative information regarding both the critical structures and target position, and 3D seed registration of implanted markers. Improvements have also been made to the operator interface, connectivity with other systems through DICOM and in the provision of licensable options to tailor individual features. The XVI system consists of a kV radiation source mounted onto the linac gantry drum and a kV radiation image detector.

The MLCi2 Multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed.

This Special 510(k) describes modifications to the MLCi multileaf collimator for use as an accessory for the Elekta range of medical digital linear accelerators. These modifications provide the following improvements; - . Improved x-ray performance (peak and average leakage). - Improved repeatability of leaf edge position. - . The ability for leaves to interdigitate.

Desktop Pro™ is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated.

This Traditional 510(k) describes enhancements to the integral software performing the graphical interface and machine control functions for the range of medical digital linear accelerators. These enhancements enable existing control functions to be continuously varied during the delivery of radiation therapy. Thus gantry rotation and speed of rotation, multi-leaf collimator - leaf position and head rotation, back-up diaphragms and dose rate can be continuously and simultaneously varied during treatment delivery. The suffix (VMAT) is used commercially to differentiate this version of the software. Desktop Pro™ (VMAT) is an integrated digital control system, providing interface and machine control functions for the Elekta range of digital accelerators. It comprises a dedicated control cabinet on which the interface and machine control software is executed.

The Elekta Beam Modulator is an X-ray collimator, designed to be used in a linear accelerators and intended to assist a licensed practitioner in the delivery of radiation to defined treatment volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumours), whilst sparing surrounding normal tissue and critical organs from excess radiation. It is intended to be used for single or multiple fraction delivery of radiation in all areas of the body where such treatment is indicated.

The Beam Modulator™ is an enhancement to the previously reported MLC, D.C. Number K904124, and the MLCi, multileaf collimator, D.C. Number K980024. The primary intention of this product is to provide more precise conformance to desired treatment volume by providing a leaf pitch of 4 millimetres.