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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.

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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.

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