(47 days)
Electrosurgical coagulation, electrosurgical cutting, dissection of tissue, irrigation and aspiration during the performance of laparoscopic and general surgical procedures.
The device is a Class II medical device. The Bipolar L Hook is a modification to the predicate device cleared under K904993. The Bipolar L Hook is identical 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 refurn electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation, grasping and dissection of the tissue during surgical procedures is similar to the predicate devices cleared under K904993. The energy source, bipolar electrosurgical energy, is the same energy type as used for the predicate devices.
This document is a 510(k) summary for a medical device called the Everest Bipolar L Hook and Gyrus Bipolar L Hook. It is a premarket notification to the FDA to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing new acceptance criteria or performance metrics.
Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be extracted from this document.
Here's why and what can be understood from the provided text:
- No new acceptance criteria or device performance: The document explicitly states: "In conclusion, as the design, materials of construction, function and intended use of the modified Bipolar L Hook 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 device relies on the established safety and effectiveness of its predicate, not on new studies with specific acceptance criteria that need to be met.
- Substantial Equivalence: The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a device already legally marketed. This typically involves comparing device features, intended use, technology, and performance data (if applicable) to the predicate, rather than conducting new, large-scale clinical trials that define new acceptance criteria.
- Lack of Clinical Study Details: The document does not describe any clinical study or performance testing that would generate data for an "acceptance criteria" table. It mentions "electrosurgical coagulation, grasping and dissection of the tissue" as the intended use, which is similar to the predicate.
In essence, this document is a regulatory submission for a modification of an existing device, focusing on demonstrating similarity rather than presenting new performance data 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.