(26 days)
The VivaRing™ Microwave Ablation Probe is intended for coagulation of soft tissue. Not for use in cardiac procedures.
The VivaRing M Microwave Ablation Probe 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. Once deployed, the antenna can be powered by the Vivant Medical VivaWave™ Microwave Generator to coagulate a region of tissue within and around the antenna. VivaRing™ Microwave Ablation Probe also incorporates a saline-cooled shaft for percutaneous and laparoscopic use.
The provided document is a 510(k) summary for the VivaRing™ Microwave Ablation Probe and Accessories, a medical device submission to the FDA. It outlines the device's intended use, description, and claims of substantial equivalence to predicate devices.
However, a critical review of the provided text reveals that it does not contain any information regarding acceptance criteria or the study that proves the device meets specific performance criteria. The document focuses on regulatory approval based on "substantial equivalence" to previously cleared devices rather than providing detailed performance data, clinical study results, or specific acceptance metrics.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the input document. The input primarily serves as a regulatory approval letter and a summary of the device for submission purposes, not a performance study report.
To address the prompt as best as possible, I can state that the document does not provide the requested information.
§ 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.