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The Surgical Face Mask is intended for single use by operating room personnel, patients, and other general healthcare workers to protect against the transfer of microorganisms, blood, bodily fluids, and particulates. This is a non-sterile, single use, disposable device.

The proposed Surgical Face Mask is a non-sterile, single-use, 3-layer mask with outer and inner facing layers comprised of white spun-bond polypropylene and a middle layer comprised of white melt blown polypropylene. The mask is secured to the user via nylon/spandex ear loops that are ultrasonically welded to the mask. This mask does not contain any natural rubber latex. The device also contains a nose wire made of a pliable steel strip, coated in polypropylene, that helps to form the mask around the user’s nose.

SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data.

SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department's QA efforts.

Sun Nuclear's DoseCHECK is a software product intended to independently calculate radiotherapy dose to provide a quality check of the planned dose.

DoseCHECK provides the clinician with the opportunity to compute dose using a different algorithm from that used by their treatment planning system (TPS). DoseCHECK utilizes the DICOM RT Plan, RT Structure Set, and CT Image Set from the TPS as inputs for the calculation, along with a linear accelerator characterization and CT-to-ED curve. The resulting dose distribution can be compared to the TPS dose distribution as a means of independent check. This comparison allows for detection of errors or inaccuracies that may occur within the TPS such as with beam modeling, calculation algorithm, and inhomogeneities.

Model 1220-MR ArcCHECK-MR is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

Model 1220-MR ArcCHECK-MR is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220-MR ArcCHECK-MR by an 8 pin DIN cable and is unchanged from the K142617 predicate device. This submission introduces Model 1220-MR ArcCHECK-MR. This model is equivalent in form and function to the cleared Model 1220, but has been verified as an MR-conditional product.

ArcCHECK, Model 1220 is a three-dimensional (3D) ionizing radiation measurement device intended for radiotherapy quality assurance.

ArcCHECK, Model 1220 is a three dimensional diode sensor used for ionizing radiation measurement for radiotherapy quality assurance. The cylindrical diode array is embedded in a cylindrical plastic phantom that allows for dosimetry measurements to be made from all gantry angles as the therapy beam rotates about the diode array. The provided GUI 'SNC Patient' software application installed on the user's computer and connected to the Model 1220 ArcCHECK by an 8 pin DIN cable, includes the following functions: - . Array and dose calibration. - Measurement and display of the spatial distribution of the dose resulting from delivery of a radiation treatment plan. - . Save measurements. - Import treatment plan dose map in the phantom and compares with the measurement dose points. - . Compare the measured and planned dose distribution using the analysis methods of gamma or dose difference and distance to agreement (DTA) with user specified analysis criteria. - Report of the analysis including a percent pass rate. ● - Perform quality assurance (QA) on the planned versus delivered multi leaf ● collimator (MLC) pattern as a function of time. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This submission introduces a 'primary' software modification to the cleared Model 1220 ArcCHECK device (K131466). Sun Nuclear intends to introduce a software feature which allows for the user to perform quality assurance (QA) on the planned versus delivered Multi Leaf Collimator (MLC) pattern. The MLC QA is capable of detecting an error of 5mm or greater in the planned position of an MLC leaf. This 'primary' modification which is believed to affect the indications for use, but not the intended use, is the subject of this premarket notification.

The Sun Nuclear Dose Calculator is a software product intended to compute a radiotherapy dose volume.

Model 1218028 Dose Calculator computes a dose volume for a user-specified treatment delivery device based on user-provided three dimensional volumetric imaging information (e.g., computed tomography) and beam intensity values. Both the imaging data and beam intensity values are specified in DICOM-RT format. The beam model for the specified treatment delivery device is provided with the software. The output of the SDC is a DICOM RT dose volume. The Dose Calculator is for use with external beam photon radiation therapy calculations. Charged particle radiotherapy calculations (including electron, proton, and heavy ion therapy) are not indicated for use with this product. The Dose Calculator software application is considered to be a software module that may be used by several Sun Nuclear Corporation products and/or 300 party applications.

Model 1216 Quality Reports is intended for quality assessment of radiotherapy treatment plans and the radiotherapy treatment planning process.

Model 1216 Quality Reports is a multi-functional information and data management software application intended to be used by trained clinicians who are familiar with radiation therapy, such as medical physicists, medical dosimetrists, and radiation oncologists. Model 1216 Quality Reports receives DICOM data from Treatment Planning Systems (TPS) which are capable of providing such data. The data may include images, radiation therapy (RT) objects such as RT Plan, RT Structure Set and RT Dose. The user may also capture data through manual input. The application allows the user to: - Create reports and charts which may be sent to the institution's Electronic . Medical Record (EMR) system. - Measure quality with standardized metrics that are based on the institution's ● chosen standards. - Capture information from the clinical team during pre-treatment planning. ● - Establish benchmark and progress data to demonstrate continuous improvement. - Audit the Dose Volume Histogram (DVH) from the TPS. - . Facilitate quantitative review of the estimated dose via a single DVH metric. - Customize and save a library of non-dosimetric plan parameters and compare ● them against user defined constraints. - . Track plan quality scores over time to assess performance and provide the basis for measuring continual improvement.

The Model 1203 WaterProof PROFILER is intended for radiotherapy dosimetry measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

The WaterProof PROFILER, model 1203, is a linear array of radiation detectors that are housed in a water proof enclosure that mounts to the 3D SCANNER's movement mechanisms. The electronics in the array measures charge produced in the detectors due to ionizing radiation. The WaterProof PROFILER provides measurement updates to the 3D SCANNER. The 3D SCANNER correlates the dose information with motor position information and transfers the data to a computer running SNC Dosimetry. SNC Dosimetry then provides a graphical user interface for viewing the measured dose distributions and its parameter analysis; it also provides a tool for exporting the data to treatment planning systems. The WaterProof PROFILER includes five components: 1. a linear array of radiation detectors; 2. a water proof enclosure; 3. a means for connecting to the 3D SCANNER's movement mechanisms; 4. control electronics and embedded code to manage and transmit the data recorded from the radiation detectors; 5. a cable that connects the water proof enclosure to the 3D SCANNER

PerFRACTION is intended to allow for the detection of errors that can occur in the delivery of a patient's radiation therapy treatment. PerFRACTION allows for the comparison of the cumulative exit image(s) for one treatment fraction to the cumulative exit image(s) for another treatment fraction, thus providing a consistency check on the delivery of the treatment fraction.

PerFRACTION™ is a device that includes software installed on standard, modern computing hardware (provided with the software) that allows clinicians to perform quality assurance for each fraction of a radiotherapy treatment plan. PerFRACTION compares the beam-exit measurement data from a treatment fraction to data from a prior baseline fraction. This comparison allows for the detection of errors that may occur with the delivery system such as the multi-leaf collimator, accelerator, and collimating jaws.

Model 1212 3DVH is a radiotherapy dose delivery quality assurance (QA) software application intended to estimate the dosimetric impacts of the deviations and imperfections of a treatment delivery device. and its accessories, on the 3D patient dose volume as defined by a treatment planning system (TPS). These dosimetric impacts are based upon QA measurement of the radiation dose distributions that are delivered to a phantom.

The Sun Nuclear 3DVH product, model 1212, is a software application that creates an estimated patient dose distribution using data measured during delivery of the treatment plan to certain 2D or 3D detector arrays and the planning patient dose volume computed by the treatment planning system (TPS) as inputs. The patented 3DVH dose algorithm (US patent #7,945,022) uses the measured data to make perturbations to the TPS patient dose volume to produce the estimated patient dose volume. From a comparison of the 3DVH result to the TPS planned dose, a qualified clinician makes the decision whether the TDD along with its accessories (including the treatment planning system, or TPS) is capable of delivering the treatment as prescribed.