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The Photon Radiosurgery System (PRS) is indicated for radiation therapy treatments. The PRS Spherical Applicators are indicated for use with the Photon Radiosurgery System (PRS) to deliver a prescribed dose of radiation to the treatment margin or turnor bed during intracavity or intraoperative radiotherapy treatments.

The Photoelectron Corporation Photon Radiosurgery System (PRS) is a miniature, high-dose rate, low energy X-ray source that emits X-ray radiation from the tip of a 3 mm diameter probe. The original PRS Model was cleared for marketing in the 510(k) K964947. The PRS was subsequently modified and cleared for marketing in 510(k) K980526 (PRS400). The PRS was cleared by these 510(k)s for the irradiation of intracranial tumors. Since the currently cleared PRS400 is restricted to treatment of intracranial tumors, Photoelectron Corporation is also proposing in this 510(k) to modify the PRS indications for use to permit use of the PRS to irradiate tumors other than at intracranial locations. This 510(k) is also being submitted to add the use of PRS Spherical Applicators to the PRS System. The Spherical Applicators will permit the PRS to be used for intracavitary or intraoperative radiation therapy. In addition, two accessories for use with the Spherical Applicators are also being added to the PRS: the Radiation Shields, which protect surrounding tissue and/or organs from radiation, and the PRS Interface Adapters, which provide a means for connecting the PRS X-ray Source (XRS), and the Spherical Applicators to various commercially available surgical support systems for non-stereotactic applications.

The Photon Radiosurgery System is intended to be used for the irradiation of intracranial tumors.

The Photon Radiosurgery System (PRS) is a complete system for highly focused treatment of intracranial tumors. The PRS includes an X-ray Source and Control Box, along with accessories for clinical treatment, quality assurance, laboratory calibration and dose verification. The miniature X-ray source incorporates a 3.175 mm diameter. 10 cm long interstitial probe and is designed to be mounted on a stereotactic frame so that the probe tip, covered with a sterile sheath, can be positioned precisely into the tumor. High dose rate, low energy X-rays are emitted from the probe tip in a spherical pattern and a prescribed therapeutic radiation dose delivered in a single fraction destroys the tumor from the inside out. Voltage, beam current, and treatment time or photon count are set on the Control Box which is powered by a rechargeable battery. Accessories are provided to assist in placement of the interstitial probe and to perform quality control of the X-ray source in the clinical setting. Additional laboratory-based components of the PRS include an automated dosimetry water tank for calibration and a CCD-camera based radiochromic film reader for dose verification.