(26 days)
Electrosurgical coagulation, mechanical cutting, dissection, and grasping of tissue during the performance of laparoscopic and general surgical procedures.
This device is a Class II medical device. The Bipolar Cutting Forceps is a modification to the predicate devices cleared under K904993. The Bipolar Cutting Forceps is similar in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The forceps jaws are electrically isolated from each other enabling one jaw to act as a return electrode, eliminating the need for a return pad. To transect tissue a cutting blade is actuated and moves between the electrode jaws. The modification has not altered the fundamental technology of the predicate devices. The intended use, electrosurgical coagulation, grasping, dissection and mechanical cutting of tissue during surgical procedures is identical to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.
The provided text describes a 510(k) premarket notification for a medical device, the Everest Bipolar Cutting Forceps and Gyrus Bipolar Cutting Forceps. This document asserts substantial equivalence to a predicate device rather than presenting a study regarding specific acceptance criteria and performance metrics for the modified device.
Therefore, the requested information in points 1, 2, 3, 4, 5, 6, 7, 8, and 9 cannot be extracted from the provided text because the document does not contain a study demonstrating specific performance against acceptance criteria for the new device.
The 510(k) summary (and the FDA clearance letter) states:
- "This device is a Class II medical device. The Bipolar Cutting Forceps is a modification to the predicate devices cleared under K904993."
- "The Bipolar Cutting Forceps is similar in construction (with the exception of shaft length) and in component materials when compared to the predicate device."
- "The modification has not altered the fundamental technology of the predicate devices."
- "The intended use, electrosurgical coagulation, grasping, dissection and mechanical cutting of tissue during surgical procedures is identical to the predicate devices cleared under K904993."
- "The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices."
- "In conclusion, as the design, materials of construction, function and intended use of the modified bipolar cutting forceps is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent."
This means the submission relies on the established safety and effectiveness of the predicate device and argues that the modifications do not introduce new questions of safety or effectiveness. It does not present a new clinical study with specific acceptance criteria, sample sizes, ground truth, or expert adjudication for the modified device.
§ 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.