(169 days)
Varian's Nasopharynx Applicator is a device used to facilitate the delivery of a therapeutic dose of radiation therapy to treat cancer in the upper throat, nasal cavity and nasopharengeal regions.
The Nasopharynx Applicator Set has been designed for the treatment in the upper throat space. The design of the ENT mould probe permits an application in the nasopharyngeal to oropharyngeal area (ENT = Ear Nose Throat). The set contains two different ENT mould probes, one with and one without balloon.
The provided text is a 510(k) Premarket Notification summary for the Nasopharynx Applicator. This document is a regulatory submission to the FDA demonstrating that a device is substantially equivalent to a legally marketed predicate device.
It does not contain any information about acceptance criteria, device performance, a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The 510(k) summary focuses on:
- Predicate Device: Nucletron's Rotterdam Nasopharynx Mould Set (K983337).
- Product Description: A set of two ENT mould probes (one with and one without a balloon) for treatment in the upper throat space.
- Intended Use: For use with Varian high-dose rate afterloaders for intracavitary nasopharynx brachytherapy to deliver a prescribed radiation dose.
- Technological Characteristics: Stated to be "substantially equivalent" to the predicate device.
Therefore, I cannot fulfill your request for information regarding acceptance criteria and a study that proves the device meets those criteria, as such details are not present in the provided text. The 510(k) process primarily relies on demonstrating substantial equivalence to an already approved device rather than presenting detailed performance studies against specific acceptance criteria for a new device.
§ 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.