(89 days)
These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.
Not Found
The provided text is related to an FDA 510(k) premarket notification for an electrosurgical device (ABCSnare Electrosurgical Probe). It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot extract the requested information from the provided text. The document focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the device to be marketed, rather than detailed performance study results against specific acceptance criteria.
§ 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.