Search Results

The Tri-Loop™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.

The device consists of 3 pre-shaped curved microwave antennas which is contained within 3 delivery cannulas. The cannulas are attached to a handle mechanism that deploys the antennas into the targeted tissue. RF energy can be used to facilitate deployment of the antennas into tissue. The Vivant VivaWave™ Microwave Generator (K011676) is used to deliver the microwave energy to the curved antennas which heats the tissue within and around the antennas.

The provided text is a 510(k) summary for the Tri-Loop™ Microwave Ablation Probe. It states the device's intended use and claims substantial equivalence to a predicate device. However, it does not contain any studies, acceptance criteria, or performance data to directly answer your specific questions about device performance and study methodology.

The supplied document is a regulatory submission for premarket clearance, which focuses on demonstrating equivalence to an already legally marketed device (predicate device). Such submissions typically do not include detailed performance studies with acceptance criteria in the way you've described for AI/diagnostic devices.

Therefore, I cannot populate the table or answer the subsequent questions based on the provided input. The document explicitly states:

• "Summary of Substantial Equivalence: The Tri-Loop™ Microwave Ablation Probe is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent."

This indicates that the clearance was based on equivalence, not on independent performance studies against defined acceptance criteria for a novel functionality.

Ask a specific question about this device

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.

Ask a specific question about this device