(191 days)
Nucletron Rotterdam Nasopharynx Mould Set is intended for use with the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
The Nucletron Rotterdam Nasopharynx Mould as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic and mPDR, for intracavitary nasopharynx brachytherapy procedures.
The Nucletron Rotterdam Nasopharynx Mould Set is inserted into the mouth and positioned within the nasopharynx cavity with the assistance of guidance tubes. Once in position, it is immobilized and treatment catheters are inserted. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic and mPDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete. the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient.
The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit: it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.
The provided text is a 510(k) premarket notification for the Nucletron Rotterdam Nasopharynx Mould Set, which is an accessory to remote afterloading brachytherapy equipment. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, or ground truth establishment in the manner typically seen for novel diagnostic AI devices.
Therefore, the requested information regarding acceptance criteria, device performance vs. acceptance criteria table, sample sizes, data provenance, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details cannot be extracted from this document, as it does not contain such information pertaining to a performance study.
Instead, the document primarily establishes:
- Device Name: Nucletron Rotterdam Nasopharynx Mould Set
- Intended Use: For intracavitary nasopharynx brachytherapy procedures with Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR) to deliver prescribed radiation dose and prevent contact of the radioactive source with body fluids.
- Predicate Device: Nucletron BV Standard Nasopharyngeal Applicator Set (K953946)
- Basis for Substantial Equivalence: The Rotterdam Nasopharynx Mould Set combines the functionality, components, and design of the predicate device while incorporating a new material. The device is a "closed system" to prevent the radioactive source from coming into contact with body fluids, and the afterloading system verifies proper attachment.
The FDA's letter (K983337) confirms that the device was found substantially equivalent to the predicate device, allowing it to be marketed. This regulatory pathway does not typically require the extensive clinical performance study data that would address the granular aspects of performance criteria outlined in your request.
§ 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.