(11 days)
The AtriCure Transpolar™ System is intended to ablate soft tissues during i General, ENT, Thoracic, Gynecology, and Urology surgical procedures.
The AtriCure Transpolar System includes a hand held, single use, bipolar radiofrequency (RF) surgical instrument (AtriCure Transpolar Clamp) intended for the ablation of soft tissues (for use by trained surgeons only) innonou for the and the and guide (Glidepath™ Tape). The Transpolar and an accessory of an integral cable to the AtriCure re-useable Ablation and Sensing Unit (ASU).
The provided text is a 510(k) summary for the AtriCure Transpolar System. It describes the device, its intended use, predicate devices, and manufacturing materials. However, it does not contain any information regarding acceptance criteria, device performance studies (like accuracy, sensitivity, specificity), ground truth establishment, sample sizes for training or test sets, or expert involvement for assessing performance.
Therefore, I cannot provide the requested table and information as the source document does not contain this data. The document focuses on establishing substantial equivalence to a predicate device based on indications for use, basic overall function, and materials, rather than detailed performance metrics.
§ 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.