(188 days)
The Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
The device consists of a pre-shaped curved microwave antenna which is contained within a delivery cannula. The electrode is attached to a handle mechanism that deploys the antenna into the targeted tissue. The electrode comes with a connector that can be attached to a standard RF electrosurgical generator to assist in deployment of the curved microwave antenna into tissue. Once the curved antenna is fully deployed, the RF connector can be removed and the remaining microwave cable is connected to the Vivant VivaWave™ Microwave Generator. The microwave energy is then transmitted to the curved antenna which heats the tissue within and around the antenna.
The provided text describes a 510(k) summary for the Vivant Medical Loop™ Microwave Ablation Probe. It focuses on regulatory approval and substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics.
Therefore, I cannot populate the requested table and answer questions 1 through 9 with the provided text.
The document is a regulatory approval letter and a summary of the device for that approval. It states the intended use and compares it to predicate devices to establish substantial equivalence for market clearance. It does not include performance data or studies that would typically define and demonstrate meeting acceptance criteria in the way a clinical or technical study would.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.