(110 days)
The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.
The ALATUS Vaginal Balloon Packing System is designed as an immobilizer to assist in positioning and displacing the vaginal wall in a more predictable and reproducible location during computed tomography (CT) exams and radiation treatment (RT) therapy. The proposed device is a latex free balloon made from Polyurethane consisting of the following components:
- Balloon
- Catheter tubing
- Connector
- Flex tubing
- 1-way stopcock, 90° turn handle
The provided text is a 510(k) summary for the ALATUS Vaginal Balloon Packing System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific performance studies with sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.
Therefore, I cannot fulfill your request for the tables and sections regarding acceptance criteria and performance study details. The document primarily addresses regulatory clearance based on substantial equivalence, rather than a detailed performance study as would be expected for an AI/ML 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.