(99 days)
The Adjustable Multi-Catheter Source Applicator is intended to provide brachytherapy when the physician chooses to deliver intracavitary radiation to the surgical margins following lumpectomy of breast cancer.
Not Found
I am sorry, but the provided text from the FDA letter regarding the Adjustable Multi-Catheter Source Applicator (K062241) does not contain any information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria.
The letter is a 510(k) substantial equivalence determination. It primarily:
- Confirms the device is substantially equivalent to a legally marketed predicate device.
- States the device's indications for use.
- Imposes a specific labeling limitation (a "black box warning") about the device's safety and effectiveness not being established for use as a replacement for whole breast irradiation in the treatment of breast cancer. This explicitly indicates a lack of such evidence for this specific use case.
- Outlines general regulatory requirements for the manufacturer.
Therefore, I cannot fulfill your request to describe acceptance criteria and the study proving device performance using the provided text. The document does not contain this type of information.
§ 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.