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The MicroSelectron HDR Version 2 is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, Endovascular and Intra-operative) or to the surface of the body for radiation therapy.

The microSelectron-HDR is a remote afterloading system for high dose rate brachytherapy treatment using a single iridium-192 radioactive source. The MicroSelectron-HDR delivers a radiation dose distribution conforming to treatment data, r he Miorooolouren . Alle workstation or imported from a treatment planning system. The modifications to the cleared device k953946 are: - Increase of maximum source strength for treatment of patients from 10 Ci (aprox. 40.000 . μGy.m²/h) to 12Ci (aprox. 48.000 μGy.m²/h).

The Integrated Brachytherapy - Digital (IBU-D) is intended to be used for the visualization, localization and confirmation of the volume and the size of the brachytherapy irradiation field(s), using a fluoroscopic and/or radiographic system.

Integrated Brachytherap Unit - Digital (IBU-D) is a modification to the Integrated Brachytherapy Unit (IBU) in which the Image Intensifier of the IBU is replaced by a Flat Panel image detector. The Flat Panel image detector used in the IBU-D is the same Flat Panel image detector as used in Nucletron's Simulix Evolution product (K03347). The Integrated Brachytherpay Unit – Digital (IBU-D) is a localization and simulation device for a Brachy radiation therapy department. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-ray tube housing assembly with collimator on one side and a flat panel image detector. The movements of the IBU-D are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient table has mechanical motions which can be controlled from a hand pendant affixed to the table. Images are displayed and managed by a PC based workstation running specialized software. The system makes also use of the same third party X-ray tube and X-ray high tension generator as used in the Simulix Evolution system. The Flat Panel image detector which replaces the current Image intensifier is a Amorphous silicon, digital detector, with a square image area of 41 x 41 cm. The PC based workstation runs the same software as the workstation of the Simulix Evolution system. It supports the following functionality: - . Image acquisition - Image display . - Image annotation . - Database and DICOM Import / Export functionality - Position read out and display of the IBU-D gantry. . - Control of the IBU-D beam limiting device. .

The Intracavitary Mould Applicator Set is intended for use with Nucletron remote afterloading equipment for intracavitary rectal brachytherapy procedures. The applicator set provides a means of delivering the prescribed radiation dose to the treatment area.

The Nucletron Intracavitary Mould Applicator Set as described in this submission is designed for Intracavitary Brachytherapy procedures. The device consists of a disposable silicone cylinder, with eight radial placed catheters to the surface of the cylinder, which is inserted Intracavitary into the target volume, i.e. the rectum. The cylinder is fixated, by using an applicator introduction tool and the filling wires are removed, which protected the catheters from kinking during transport. In the center of the cylinder a central catheter can be placed. X-ray catheters or CT markers are inserted into the application. Radiographic images, planal images or transverse images of the target volume are taken to determine the precise position of the applicator. This information is then used for Brachytherapy treatment planning purposes. The Intracavitary Mould Applicator Set is a closed system to prevent the radioactive source from coming in contact with body fluids. The treatment catheter does not control the radioactive source. The afterloader is the treatment unit, it strictly provides a treatment path for the treatment source. The physicist and the clinical staff verify that the applicator is properly attached prior to treatment. For the first treatment the Intracavitary Mould Applicator Set is attached to the afterloader (treatment head), doing transfer tube. After the applicator is properly attached, a check cable run is performed to ensure that there are no obstructions, which will interest the transfer of the cable run. In a province of cable run, the radioactive source will be transferred into the applicator and the prescribed dose of radiation will be delivered. After the treatment is completed the Intracavitary Mould Applicator Set is removed from the patient. The device uses similar (implantable) materials as in the legally marketed predicate device cited the Freiburger Flap. The device uses similar implant techniques respect to the legally marketed predicate device cited the Miami Vaginal Applicator Set. The Intracavitary Mould Applicator Set is used as an accessory to the Nucletron microSelectron.

The MicroSelectron PDR is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, intra-operative) or to the surface of the body for radiation therapy.

The microSelectron Afterloading System concerns a microSelectron -HDR (V2) with treatment chambers. The operator console is a PC running dedicated software. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. Connection to a LAN is only for the purpose of Transfer of Treatment Plan Files. It is the same as in the predicate device. The radiotherapy treatment planning software is not part of this 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron PDR. The PC based Afterloader workstation is the current TCS workstation, but ported from a DOS based Afterloader workstation. The PC based Afterloader workstation comes with functionality to support PDR procedures (i.e. Scheduling of treatments). The modifications to the previously cleared device K953946 are: - Addition of RCU and NSD previously cleared device K902533 . - Addition of Radiation Status Indicator . - Changes to TCS to enable the PDR workflow . - Addition of Smoothbase, part of previously cleared device K031158 . The software runs on a PC with a Windows XP platform.

Oncentra-VISIR is designed to be a tool for supporting the process of scheduling, preparing, setting up, delivering and recording radiation therapy.

Oncentra-VISIR is a verification system designed to be a tool for supporting the process of preparing, setting up, delivering and recording radiation therapy. It will retrieve data from doseplan systems and simulators automatically or by manual input from the user. It will help administer patient sessions through the booking functionality. At each individual treatment Oncentra-VISIR will present setup data to the operator and also to the linac through a specific interface. Actual setup will be verified. During treatment Oncentra-VISIR can monitor the progress of both Monitor Unit values and optional in vivo dosimetry. All data relevant for the given treatment can be recorded. The main areas of modification to the previously cleared device k972617 are: - Image Based Verification (IBV) . - This module allows the user to schedule image acquisitions on the treatment machine. Once the images are acquired thev are compared to a reference image such as a DRR or digital simulator image. Automated edge detection will mark both the reference and control image and perform a comparison. A resultant displacement is translated into the treatment couch shifts required to reposition the patient correctly for the desired beam placement within the patient. - Improved user interface improved layout of data making it easier for the user to navigate . and display the data they require. Also improved workflow requiring less clicking and password entry than before. - Optional double signature for treatment lets 2 therapists sign for treatment delivery . - Dynamic MLC IMRT support . - Live MLC display in treatment screens . - More flexible port filming options such as film only and orthogonal film modes . - Image acquisition (port film) scheduling . - Detailed audit trail tracks all changes to patient data with time/date/signature stamps of anv . edit The software runs on a PC on a Windows NT, 2000, or XP platform.

Swift is a software application intended for use with Brachytherapy procedures, i.e. intercavitary, interstitial, intraluminal, involving afterloading radioactive sources. Swift is a software application for Brachytherapy Treatment Planning, for the treatment of cancer, i.e. intercavitary, interstitial, intraluminal, involving radioactive sources.

Swift is a "real time" treatment planning system for brachytherapy especially meant for treatment of cancer in the prostate. Direct 3D Ultrasound imaging of the treatment gives the physician the possibility to update the planning of the dwell positions of the source in the prostate of the patient. The program provides a variety of plan evaluation tools to assist in generating the most optimal dose distribution, i.e. dose volume histograms, dose verification points and dose profiles. The software program provides the physician with anatomical and dosimetric information, to determine the positioning and loading of the radioactive sources, prior to radiation treatment. The program also provides the treatment time and dose distribution for the specified loading. From this the information the patient can be treated with the dwell positions of the source. The modified device is an accessory to an afterloader. The program consists of two modules: Treatment Planning Software: Swift and Database: Smoothbase. The software runs on a Windows XP platform.

OTP is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer.

The Oncentra Treatment Planning (OTP 1.2) system is radiation treatment planning software designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel. OTP 1.2 is uses externally acquired medical images and user input. The OTP software is based on a modular client/server design, with the treatment planning functions divided into "Activities". OTP 1.2 contains the following Activities: Anatomy Module: Structure Definition, Target Definition, Image Registration. Beam Module. Connectivity Module. DICOM Import / Export. Dose Module. Evaluation Module: Plan Evaluation, Volume Rendering. In addition, various system utilities are available. The software runs on a Windows XP platform.

The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited. This device is intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy.

The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.

Nucletron Implant Guidance System Applicator Set is intended for interstitial brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.

The Nucletron Implant Guidance System as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR, and is intended for interstitial brachytherapy procedures. The Nucletron Implant Guidance System Applicator Set consists of an insertion needle with a plastic sheath, which is inserted through the skin surface into the target volume. The insertion needle is then removed and a closed end plastic catheter is placed into the sheath. A marker on the side of the insertion obturator insures the proper depth of catheter placement. Once the catheter is in place the sheath is removed and a button is placed over the plastic catheter and slid into contact with the skin surface. The catheter is then cut level with the button and attached. A closed end treatment needle is then inserted into the catheter, once in position a metal needle stopper is slid over the needle to the button surface and locked. Radiographic images, planar films or transverse slices, i.e. CT. MR is obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the treatment needle is then attached to the Nucletron remote afterloading equipment (treatment head), mHDR, by the Nucletron transfer tubes. The transfer tubes lock onto the open end of the treatment needles and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is attached, a check cable run is performed to ensure that the applicator is properly attached and that there are no obstructions, which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver the prescribed dose of radiation. When the treatment session is complete, the treatment needles are detached from the transfer tube and remote afterioading equipment. The treatment needles are then removed from the patient. When the course of treatment is completed the catheters and buttons are removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.