Titanium Flexible Geometry FSD Applicator Set (GM11013400)

The Titanium Flexible Geometry FSD Applicator Set is a brachytherapy applicator used for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina. It can be configured for intracavitary or combined intracavitary and interstitial high-dose-rate (HDR) brachytherapy treatment. The device consists of titanium tandems, ovoids, and optional interstitial ovoids with guide tubes, designed to be inserted into the patient and connected to an afterloader system for remote-controlled radioactive source delivery.

The subject device has flexible geometry with adjustable tandem angles (15°, 30°, 45°) and a movable cervical stop, compared to the predicate's fixed 30° angle. The subject uses larger-diameter tandems (3.5 mm vs. 3 mm) and has optional interstitial ovoids not present in the predicate. Both share the same general Fletcher-style design, titanium and PEEK materials, four ovoid sizes, CT and MR compatibility, and compatibility with GammaMedplus iX and BRAVOS afterloaders. The subject is not indicated for PDR (pulsed dose rate) brachytherapy, whereas the predicate is.

Biocompatibility testing per ISO 10993-1 and applicable parts; MR compatibility per ASTM F2503-23, F2182-19e2, F2052-21, F2213-17, and F2119-07; sterilization per ISO 11737-2, ISO 17665-1, and ISO 11607-1; human factors per IEC 62366-1; quality management per ISO 13485; and risk management per ISO 14971. Also electrical safety per EN 60601-1 and brachytherapy equipment standards per EN 60601-2-17.

Although the subject device provides greater flexibility and configurability (adjustable angles, interstitial capability) compared to the rigid predicate, both devices serve the same clinical purpose in the same anatomical sites using the same general Fletcher-style design with similar materials and afterloader compatibility. The differences in adjustability do not raise new safety or effectiveness questions because the predicate already incorporated configurable elements to accommodate varying anatomy. Design verification and validation testing demonstrates the subject device performs safely and effectively at a level equivalent to the predicate, and conformance to the same consensus standards and regulatory frameworks shows comparable risk management. Therefore, the technological differences are additive enhancements rather than fundamentally different safety concerns.