(120 days)
The ART Breast Brachytherapy Applicator is a rigid applicator intended for use with Nucletron remote afterloading equipment for non-invasive brachytherapy. The applicator provides a means of positioning the HDR source near the breast to deliver radiation dose to the underlying tissue in areas of intact skin.
The Advanced Radiation Therapy (ART) Breast Brachytherapy Applicator is a rigid applicator used for non-invasive HDR treatment of the breast. The applicator is designed to be positioned external to the breast to receive the HDR afterloader source via catheter lumens. The position and placement of the applicator is verified by means of radiographic images and the travel distance of the HDR source in the lumens is determined radiographically by using the check cable of the afterloader equipment. With the applicator properly immobilized on the breast surface, the HDR treatment process can begin according to established protocols.
The ART Breast Brachytherapy Applicator is a passive device, and therefore, no performance testing was required or conducted. The 510(k) summary states, "The Advanced Radiation Therapy Breast Brachytherapy Applicator is a passive device. Performance testing was not required."
Given this, the following information cannot be provided as it pertains to performance studies:
- Table of acceptance criteria and reported device performance: Not applicable as no performance testing was done.
- Sample size used for the test set and data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.