(135 days)
The AngioDynamics Uniblate System is intended for coagulation and ablation of tissue during percutaneous, laparoscopic, and intraoperative surgical procedures, such ar martial or complete ablation of non-resectable liver lesions, osteoid osteoma, and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard therapy.
The UniBlate Electrosurgical Device is a monopolar radiofrequency (RF) device that consists of a variably insulated electrode that provides an adjustable ablation zone of 1 cm-3 cm. The device has an attached electrical cable and infusion tubing set which connects the it directly to the RTA Medical 1500X RF generator and the IntelliFlow peristaltic pump. The electrical cable provides RF energy and temperature feedback to the generator and the pump infuses normal salive through the infusion tubing set. The UniBlate Electrosurgical Device is a single use device.
The provided text is a 510(k) summary for the AngioDynamics Uniblate Electrosurgical Device (K080451). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain specific acceptance criteria, study data, or performance metrics that would typically be found in a detailed device validation study report.
The 510(k) summary primarily focuses on regulatory approval based on demonstrating substantial equivalence to existing devices, not on a detailed performance study with acceptance criteria.
Therefore, I cannot provide the requested information from this document. The sections you asked for, such as sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets, are not present in this type of regulatory submission summary.
The document lacks the information to answer all your specific points. This 510(k) submission is a declaration of intent to market and a comparison to predicate devices, not a detailed performance study report.
§ 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.