(107 days)
The SAVI Scout Reflector is intended to be placed percutaneously in soft tissue to mark (>30 days) a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SAVI Scout System) the SAVI Scout Reflector is located and surgically removed with the target tissue. The SAVI Scout System is intended only for the non-imaging detection and localization of the SAVI Scout Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the Cianna Medical SAVI Scout Reflector and SAVI Scout System. It confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market entry.
However, the letter does not contain any information about acceptance criteria for device performance or a study proving that the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness data.
Therefore, I cannot provide the requested information from the given text. The document is solely a regulatory approval letter and does not include details on performance metrics, study design, or results.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.