(54 days)
The SAVI Preparation Device is temporarily implanted in the lumpectomy to access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytherapy applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator.
The SAVI Preparation Device is a specialized catheter with an inflatable balloon at the distal end. The SAVI Preparation Device is temporarily implanted in the lumpeon at the access the lumpectomy cavity, aid in the selection of the appropriate SAVI brachytheray applicator and serve as a placeholder until it is exchanged for the SAVI brachytherapy applicator. The SAVI Preparation Device is provided sterile for single use and is disposable.
The provided text describes a 510(k) summary for the SAVI Preparation Device. However, it does not contain explicit acceptance criteria or a detailed study description with performance metrics that would allow for the completion of the requested table and information points.
The document states:
- "All necessary verification and validation testing has been performed for the SAVI Preparation Device to assure substantial equivalence to the predicate devices." (Section 6, Page 20)
- It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against predefined acceptance criteria for a novel functionality.
Therefore, I cannot provide the requested information in the structured format because the necessary data is not present in the given text.
This document focuses on the regulatory submission process for substantial equivalence, not a detailed performance study against specific acceptance criteria for a new AI/software device. It's for a physical medical device (catheter) used in brachytherapy.
If this were a document about a software/AI device, it would typically include a dedicated "Performance Data" section with clinical or technical study outcomes, statistical analyses, and a comparison to acceptance criteria.
To answer your request, I would need a different type of document, specifically one detailing the clinical or technical performance study of the device against its acceptance criteria.
§ 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.