Intracavitary/Interstitial System

The Intracavitary/Interstitial System is a brachytherapy applicator consisting of two hollow, open-ended catheters that connect to applicator sets with ovoids, ring caps, or templates. It is used to guide interstitial needles through fixation mechanisms for cancer treatment of the uterus, cervix, and vagina using high-dose-rate (HDR) or pulsed-dose-rate (PDR) brachytherapy.

The subject device is a guide tube accessory (193 mm length, 3.6 mm inner diameter, 4.5 mm outer diameter) made of biocompatible FEP/PEEK materials that connect to compatible applicator sets. Like the predicate Geneva device, it includes a fixation mechanism to secure needle insertion depth and is MR Safe, but differs in that it is a standalone guide tube component rather than an integrated tandem-and-ovoid applicator.

ISO 10993 series (biocompatibility, toxicity, irritation), ISO 14971 (risk management), ISO 13485 (quality management), IEC 62366 (usability engineering), ISO 17665 (sterilization validation), ASTM F2052/F2213/F2182/F2503/F2119 (MR safety and artifact testing), IEC 60601-1 and IEC 60601-2-17 (electromagnetic compatibility).

Both the subject device and predicate (Geneva) are guide tubes designed for interstitial brachytherapy with fixation mechanisms and similar geometric specifications. Although the subject device is a separate guide tube component while the predicate is an integrated applicator, both share the same fundamental function, material composition (biocompatible, non-metallic), MR Safety status, and clinical environment (hospital use by qualified physicians). The performance testing demonstrates equivalent safety and efficacy, and the differences in form factor do not raise new safety or effectiveness questions compared to the predicate's optional guiding tube.