Rectal Applicator

The Elekta Rectal Applicator is a flexible, sterile, single-use brachytherapy device with eight integrated channels designed to guide radioactive sources to treat rectal and anal cancer. It is used in hospitals in combination with Elekta HDR and PDR remote-controlled afterloading systems and can be inserted free-hand or with an insertion tool.

The device features eight parallel, straight catheters (versus slightly converging in the predicate), an integrated marker for depth verification, MR-conditional labeling with MR-safe accessories, simplified fixation using a non-metallic fixation element and clip, and a single insertion tool design. Materials changed from mixed metals/PPSU to primarily PPSU and silicone. Applicator length increased from 280 mm to 320 mm silicone part.

IEC 60601-2-17, ISO 20417, ISO 15223-1, ISO 17664-1, ASTM F2503, ASTM D4169, ASTM F88, ASTM F1886, ASTM F1929, ASTM F1980, ASTM F2096, ISO 11607, ISO 10993 series (biocompatibility), ISO 11135 and ISO 17665 (sterilization), ISO 14971 (risk management), and IEC 62366-1 (usability).

The device maintains the same fundamental design (eight lateral channels, flexible cylinder, intracavitary placement in rectum via anal canal), intended use, anatomical site, and clinical workflow as the predicate K041715. Design improvements—straight catheters, integrated marker, MR compatibility, simplified fixation, material changes—do not introduce new safety risks and are supported by comprehensive verification, validation, biocompatibility, and usability testing demonstrating safety and effectiveness equivalent to the predicate.