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Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Flexiplan is a software package which runs on a Windows – based PC and is used by medical professionals to create a radiation therapy plan based on the input entered by the operator. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) Remote Afterloaders. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The main use of Flexiplan is to calculate the required dwell times at the pre – determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the pescribed dose while sparing the Organs At Risk (OAR). Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify the proposed treatment. The therapy planning is then transferred from Flexiplan to the Afterloader. The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device. The Flexiplan System comprises subjoined listed subsystems: - Personal Computer . It executes the Flexiplan software. - . Monitor To visualise the treatment planning process. - . Keyboard To enter treatment data. - . Mouse To select objects on the screen The PC is used to execute the Flexiplan software and runs under Windows XP Professional or Vista. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data.

Brachytherapy applicators are commonly used to facilitate the positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Cervix Ring Applicator: The Cervix Ring Applicator is for gynecological Brachytherapy of cervix, endometrium and vagina, to be used only by trained physicians. The Maximum implementation per treatment application is 28 days. Trocar Needle Sets: The intended use is interstitial HDR/PDR brachytherapy treatment, to be used only by trained physicians. The maximum implantation period of the needles is 28 days. Martinez Prostate Template Set: The Martinez Prostate Template Set is for assisting interstitial HDR/PDR brachytherapy of the prostate gland, to be used only by trained physicians. The Maximum application duration per treatment application is 28 days. Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esopheagel Applicator is intended for brachytherapy treatment of the esophagus, to be used only by trained physicians. The maximum implementation duration per treatment application is 24 hours.

The following described medical instruments are brachytherapy applicators for use with the Flexitron Brachytherapy Afterloader. Brachytherapy applicators are commonly used to facilitate the placement and positioning of a radioactive source inside or near the patient in order to administer radiation therapy to cancerous tissue. Prior to treatment radiation X-ray markers are positioned into the applicator channel(s) in order to determine source dwell positions with the help of radiographic images as part of the brachytherapy treatment planning process. Cervix Ring Applicator: The Cervix Ring Applicator is a tandem and ring brachytherapy instrument. The applicator consists of 2 separately placed ridged brachytherapy channels, i.e. 1 tandem (intrauterine tube) and a ring tube. The Cervix Ring Applicator is used as a gynaecological intracavitary instrument to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to cervix and uterus carcinoma. Trocar Needle Sets: The trocar Needles are straight ridged needles made out of stainless steel and have closed end sharp tip for skin and tissue perforation. The Trocar Needles are used as interstitial brachytherapy instruments to assist the positioning of a radioactive source under remote control (involving HDR or PDR Flexitron Remote Afterloader system), in order to administer radiation therapy to tissue and organ carcinoma. Martinez Prostate Template Set: The Martinez Prostate template is to be used for HDR/PDR brachytherapy of the prostate gland. In order to administer brachytherapy to the prostate, needles are inserted interstitially into the prostate with the guidance of a prostate template. The prostate template can be mounted on an Ultra Sound probe stepper device in such a manner that the US grid coordinates projected over the images of the prostate are corresponding to the grid indication of the prostate template and its holder. Bonvoisin Gerard Esophageal Applicator Set: The Bonvoisin Gerard Esophageal Applicator consists of a flexible tube with a tapered distal tip. This applicator tube is advanced through the mouth into the esophagus, the tapered distal tip gently dilitates the esophagus, in order to facilitate the placement of the applicator tube. When the applicator tube is in position the tube is to be immobilised in relation to the patient's mouth with the accompanied fixation mask. For connection and treatment with the brachytherapy remote afterloader a separate flexible treatment catheter is provided in the set. The distal end of the treatment catheter is to be inserted into the applicator tube and the proximal end is to be connected to the afterloader device. In order to fit different esophagus anatomy sizes and/or treatment requirements the applicator tube is provided in different diameter sizes, ranging in diameter from 5 mm to 20 mm. Both the fixation mask and the treatment catheter can be applicator tube sizes.

Flexiplan is a Brachytherapy Treatment Planning System used by medical professionals. Flexiplan is used for the creation of HDR or PDR treatment plans for remote afterloader based brachytherapy. It especially supports the Flexitron Remote Afterloader from Isodose Control. Flexiplan calculates a proposed treatment course based on imported clinical images and other user entered data. Flexiplan supports the evaluation of clinical images in calculating the local and global dose to organs at risk and target volume.

Flexiplan is a software package which runs on a Windows - based PC and is used by medical professionals to create a radiation therapy plan based on the input entered by the operator. The isotopes used in the calculations match those which are normally used in High Dose Rate (HDR) and Pulsed Dose Rate (PDR) Remote Afterloaders. The software offers tools to enhance imported images and offers contouring of the planned target volume and organs at risk. The main use of Flexiplan is to calculate the required dwell times at the pre - determined dwell positions in a uniform way so that the Planning Target Volume (PTV) is treated with the prescribed dose while sparing the Organs At Risk (OAR). Flexiplan can reconstruct one or more applicators. Based on the contoured target volume and the prescription dose, Flexiplan will calculate the optimal dose distribution for the tumor volume. Evaluation tools are available to qualify of the proposed treatment. The therapy planning is then transferred from the Flexiplan to the Afterloader. The Flexiplan software is intended to be used with the Flexitron Brachytherapy Remote Controlled Afterloading Device. The Flexiplan System comprises subjoined listed subsystems: - . Personal Computer It executes the Flexiplan software. - . Monitor To visualise the treatment planning process. - . Keyboard To enter treatment data. - . Mouse To select objects on the screen The PC is used to execute the Flexiplan software and runs under Windows XP Professional / Vista. The hard disk stores patient data and the built in DVD-RW is used for making backup of the Patient Data. The PC can be connected to the hospital network to import Patient Image Data. Accessory: Film Scanner The Film Scanner allows the user to scan in an X-Ray image to present it on the screen to visualise the implant. Accessory: Printer The Printer allows for hard copy of the patients treatment plan and other stored data. Accessory: Pen Tablet The Pen Tablet acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor. Accessory: Touch Panel The Touch Panel acts as an alternative replacement for the mouse enabling the user to outline more accurately and faster a contour on the monitor.

The Flexitron Remotely Controlled Brachytherapy Afterloading System is intended to enable an operator to apply by remote control a radionuclide source (Flexisource) into the body or to the surface of the body for radiation therapy. Flexitron is intended to be used in combination with applicators which makes it suitable for intracavitary, interstitial, intralumenary, bronchial, endovascular, intra-operative and surface brachytherapy treatment. Flexitron is intended to be used for medical procedures on patients to be prescribed and performed by a suitably trained and authorized medical professional.

Flexitron is a computer controlled medical device for brachytherapy treatment. The Flexitron Remotely Controlled Brachytherapy Afterloading System comprises subjoined listed subsystems: TDU - Treatment Delivery Unit, TCC - Treatment Communications Console, and TCP Treatment Control Panel. The TDU houses the radioactive source in its built-in shielding safe, the microcomputer controlled driving mechanism and channel selector mechanism. The TCC is for treatment program data entry, data storage and data displaying. The TCP comprises the basic operator elements for start and stop treatment and for displaying device status and used and remaining treatment time. The TDU is designed for positioning the source at 401 separate dwell positions in each of the 40 treatment channels and together with dwell time settings for each individual dwell position it enables the creation of isodose shapes targeted to the patients anatomy and geometry in order to irradiate the target patient body site and spare the healthy surrounding tissue. Dwell positions can be programmed at 1 mm intervals. The maximum source outdrive distance is 1400 mm from the channel selector front plate. Dwell times are programmable with increments of 0.1 second. Maximum dwell time is 999.9 seconds per position. Minimum dwell time is 0.1 second per position. A dwell position is skipped if its dwell time is 0 seconds. Before the radioactive source is moved into a treatment channel a check cable is first moved into it. A check cable is of a similar construction of a source cable but without radioactive isotope. It is a measure to check the treatment channel for free passage of the source immediately after the check. The TDU is connected to TCC via a serial data communications link to receive the patient treatment program and to return data of the performed patient treatment. TCC allows for manually entering a patient treatment program or for electronically transferring a patient treatment program from Brachytherapy Treatment Planning Software (Treatment planning software is not subject of this 510(k) PreMarket Notification). During patient treatment TCC displays treatment progress and logs patient treatment data and machine performance data in separate log files. TDU is connected via another serial communications port to TCP. TCP is a touchscreen device which is directly controlled from the TDU embedded microprocessor. TCP allows for starting the patient treatment when all conditions are fulfilled.