(123 days)
The LcVcen SupersSlim Needle Electrode is intended to be used in conjunction with a radiofrequency (RF) generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.
The LeVeen SuperSlim Needle Electrode consists of a pre-shaped, multi-armed electrode array which is contained within a delivery cannula. The array is attached to a handle mechanism that deploys the array into targeted tissue. The device is connected to a generator so that RF energy passes from the array to a patient ground pad and heats the tissue surrounding the array.
The provided text is a 510(k) summary for the Boston Scientific LeVeen SuperSlim Needle Electrode. It is a submission to the FDA for market clearance, not a study report. As such, it does not contain the detailed information required for a full description of acceptance criteria and the study proving the device meets them.
Specifically, the document states: "Testing has been completed to demonstrate that the proposed changes do not result in any new issues of safety or effectiveness." and "Boston Scientific Corporation has demonstrated that the proposed changes do not raise any new issues of safety or effectiveness." However, it does not provide any specific performance data, acceptance criteria, study methodologies, or results.
Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a study that proves the device meets the acceptance criteria, as this information is not present in the provided text.
The device described is an electrosurgical electrode for thermal coagulation necrosis, primarily of nonresectable liver lesions. Its purpose is to ablate tissue using radiofrequency energy. Acceptance criteria for such a device would typically involve testing its ability to achieve desired lesion size, temperature profiles, safety against unintended tissue damage, and electrical performance, but no details are given here.
§ 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.