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The Rectal Applicator is intended for brachytherapy for treatment of rectal and anal cancer in combination with Elekta HDR and PDR remote controlled afterloaders.

In brachytherapy the first treatment step is to position a brachytherapy applicator in or on the patient in order to reach the target volume. The second step is to determine the desired positions and dwell times of the source within the applicator to encompass the target volumes as good and optimal as possible, creating a treatment plan.

The Rectal Applicator is an applicator for brachytherapy procedures indicated for treatment of rectal and anal cancer. The device is used in hospitals.

The Rectal Applicator has eight channels to guide a radioactive source or another accessory (e.g. check cable or marker) through the channel to a certain position. Transfer Tubes can be connected to the proximal end of the channels. The Transfer Tubes can be connected to Elekta HDR and PDR remote controlled afterloaders (Flexitron HDR/MicoSelectron digital / V2).

The applicator can be inserted free-hand or using the Insertion Tool. The Insertion Tool can be removed after the insertion or can stay in place during the treatment.

After the insertion of the applicator, the Fixation Element can be used for immobilization (using the Applicator clamp). The Fixation Element can be fixated to the applicator using the Fixation Clip.

Parts included in this 510(k):

• Rectal Applicator
• Fixation Element
• Fixation Clip
• Insertion Tool

Rectal Applicator
The Rectal Applicator is a flexible, cylindrical applicator containing eight flexible channels which can be used to optimize the target dose. In case of asymmetric tumors (which is mostly the case), only the needed channels can be loaded. When inserting the applicator under fluoroscopy (e.g., C-arm) in the sagittal or frontal plane, the integrated marker can be used to verify if the applicator has been inserted deep enough to cover the full target volume. The centimeter length markings on the applicator can be used as indications for the insertion depth. The markings can not be used for determining the most distal dwell position.

The Rectal Applicator is a sterile (EO), single use device mainly made of silicone material including an adhesive and silicone ink (centimeter scale). The applicator will come in direct contact with comprised mucosa (max. 24 h). The Rectal Applicator is classified as MR conditional.

Fixation Element and Fixation Clip
The Fixation Element can be placed on the applicator before or after insertion of the applicator. The Fixation Clip fixates the Fixation Element on the applicator and the design of the Fixation Element facilitate the possibility to immobilize the applicator to the CT/MR Applicator Clamp.

The Fixation Element and Clip are made of PPSU white and will come in indirect contact with intact skin (max. 24 h) and are MR Safe.

The Fixation Element and Fixation Clip are reusable and can be reprocessed using cleaning (manual or automated) and moist heat sterilization.

Insertion Tool
The Insertion Tool fits into the center cavity of the applicator and will make the applicator rigid to insert the rectal applicator into the rectum.

The Insertion Tool, made of PPSU white and glass fiber reinforced composite, is considered to be non-body contacting and can be reprocessed using cleaning (manual or automated) and moist heat sterilization.

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