(255 days)
The RayPilot® System is intended for use as an adjunct in treatment planning and radiation therapy, to align and monitor the patient's position relative to the isocenter of a linear accelerator. The RayPilot® System provides accurate, precise. and continuous localization of a treatment isocenter by using RayPilot@ HypoCath®, a transmitter located within one lumen of a urinary catheter, for prostate localization and tracking, and for automatic patient identification.
The device is limited for use to patients who both have prostate cancer and that would also be reasonably expected to require a urinary catheter for the radiation treatment, for example due to bladder outlet obstruction or patients who require a chronic indwelling Foley catheter.
The RayPilot system is designed to provide accurate, objective and continuous localization of a treatment target for patient setup before treatment and target position monitoring during radiation therapy. The RayPilot system is an electromagnetic positioning system, which detects the transmitter in the RayPilot HypoCath, placed in the prostate. The RayPilot HypoCath is removed after finalized treatment.
The RayPilot system provides objective information about the location of the treatment target in real-time in 3 dimensions. The system operator uses the information to setup the patient for treatment and to monitor the position during radiation delivery.
The provided text describes the RayPilot System, its indications for use, and a comparison to a predicate device. However, it does NOT contain the specific details about acceptance criteria, a study that proves the device meets those criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results.
The document mainly includes:
- A 510(k) clearance letter from the FDA.
- Indications for Use for the RayPilot System.
- A 510(k) Summary of Safety & Effectiveness.
- A predicate comparison table between the RayPilot System and the Calypso 4D Localization System.
- A brief mention of "Performance testing" which refers to design verification and validation, packaging, sterility, electromagnetic compatibility, biocompatibility, and software verification and validation, but no detailed results or methodology for these tests are provided.
Therefore, I cannot provide the requested information from the given text. The text explicitly states: "The RayPilot system have been the subject of performance testing, including design verification and validation, packaging, sterility, electromagnetic compatibility as well as other assessments to demonstrate that the system meets its intended use, is safe and effective and performs comparably to legally marketed devices. Other types of testing, such as biocompatibility and software verification and validation are performed as well." However, it does not provide the specifics of these tests or their results in relation to acceptance criteria.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.