CT/ MR Tandem and Ovoid Set

The CT/MR Tandem and Ovoid Set is a gynecological brachytherapy applicator designed for cancer treatment of the uterus, cervix, paracervix, endometrium, and vagina using high-dose-rate (HDR) brachytherapy. The applicator guides a remote-controlled radioactive source to target locations during radiation therapy and is compatible with both CT and MR imaging.

The subject device differs from the predicate (K241853) in material composition—using PEEK and PAEK instead of stainless steel, PPSU, PEEK, and titanium—and achieves MR safe (rather than MR conditional) status due to its fully non-metallic, non-conductive design. It supports only HDR brachytherapy, not PDR, and is limited to 100 sterilization cycles versus the predicate's 250–500 cycles. Several new components were added to the design, including an assembly module, guide tube collector, clamping unit, and disassembly pin, all marked 'CT/MR'.

Testing included biocompatibility per ISO 10993 (parts 1, 2, 5, 6, 10, 11, 12, 17, 18, 23), MR safety per ASTM F2503-23, design verification/validation per 21 CFR §820, ISO 13485, and ISO 14971, human factors per IEC 62366, sterilization per EN ISO 17665-1, and cleaning/processing per EN ISO 17664-1 and EN 60601-2-17:2015.

The intended use and indications for use are substantially equivalent to the predicate. Although the subject device narrows the scope to HDR only (excluding PDR) and uses non-metallic materials, these differences do not raise new safety or effectiveness questions; the all-polymer construction actually improves MR safety. Verification, validation, and conformance to relevant consensus standards demonstrate equivalent safety and performance. The design differences—new components and fewer sterilization cycles—reflect material properties rather than altered function; the applicator still guides radioactive source placement identically to the predicate.