Universal Segmented Cylinder Applicator Set and Universal Stump Applicator Set

These applicators are specifically designed for intracavitary brachytherapy, a precise radiation therapy technique used to treat cancers of the vagina, vaginal stump, and rectum. They deliver high-dose-rate (HDR) or pulsed-dose-rate (PDR) radiation directly to the target area, ensuring concentrated treatment while minimizing exposure to surrounding healthy tissue. The segmented cylinder and stump designs allow for customizable placement to match anatomical variations, improving accuracy and patient comfort during therapy.

Yes, these applicators are reusable medical devices. Since they are intended for repeated use, proper cleaning and maintenance are critical to ensure sterility and functionality. While the data does not specify cleaning protocols, reusable devices of this nature typically require thorough disinfection between uses, adherence to manufacturer guidelines, and periodic inspection for wear or damage. The CT compatibility and conditional MRI safety also imply they must be handled carefully to avoid contamination or structural compromise.

The device includes multiple cylinder diameters and lengths, allowing clinicians to select the appropriate size based on the patient’s anatomy. This modular design ensures flexibility for treating varying anatomical requirements, particularly for vaginal, vaginal stump, and rectal applications. The segmented construction further enables precise positioning, enhancing treatment accuracy and patient-specific customization.

Yes, these applicators are conditionally MRI-safe, meaning they can be used in MRI environments under specific conditions. However, the exact limitations (e.g., MRI strength, imaging sequences, or distance from the magnet) are not detailed in the provided data. Clinicians should follow the manufacturer’s instructions and institutional protocols to ensure safe use, as improper handling could compromise imaging quality or patient safety.

These applicators were authorized through FDA 510(k) clearance and MDD (Medical Device Directive) compliance, indicating they were deemed substantially equivalent to a predicate device already on the market. The Traditional 510(k) pathway was used, involving a review by the Radiology (RA) Advisory Committee. The device falls under Class II classification, requiring performance standards and quality system regulations to ensure safety and effectiveness.