(20 days)
MammoSource is indicated for high-dose-rate remotely controlled afterloading brachytherapy for the treatment of breast cancer and other cancers that can be treated with a single channel HDR system.
The GammaMed Plus device has been modified to reduce the number of channels from 24 channels to one channel that will simplify the device and make the MammoSource ideal for treating breast tumors with the MammoSite RTS applicators, K011690 and K030558, as well as other cancers where a single channel HDR system would be useful. The system is designed to provide a predetermined dose of radiation to tissue and organs by means of manipulating a radioactive source from a shielded position within in the device into a catheter, applicator, or needle, which has been placed within or on a patient.
This document is a 510(k) summary for a medical device (MammoSource HDR Remote Afterloader), which focuses on demonstrating substantial equivalence to a predicate device rather than presenting clinical study data with acceptance criteria for device performance.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text. The submission is primarily a regulatory filing for a modified device, explaining its design and intended use in comparison to an existing, cleared 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.