(264 days)
The Stryker Bipolar Forceps are intended to be used during bipolar electrosurgery to grasp, manipulate and coagulate selected soft tissue. They are connected through a suitable bipolar cable to the bipolar output of an electrosurgical generator. Bipolar forceps must only be used with bipolar coagulation current. The Stryker Bipolar Forceps have not been shown to be effective for tubal ligation or tubal cauterization for sterilization procedures and should not be used for these procedures.
The Stryker Leibinger range of Bipolar Forceps contains instruments of various lengths, shapes and sizes. By means of a suitable bipolar cable, the forceps are connected with the bipolar output of an electrosurgery electrosurgical generator. Coagulation is achieved using electrosurgical energy generated by the electrosurgical generator activated by a footswitch. In the course of a surgical intervention, bipolar forceps may also be used to grasp and manipulate soft tissue without the activation of the high frequency current. The Stryker Bipolar Forceps are reusable and provided non-sterile. All forceps must be cleaned and sterilized prior to every use.
This document is a 510(k) premarket notification for a medical device, the Stryker Bipolar Forceps. It's a regulatory submission to the FDA demonstrating substantial equivalence to legally marketed predicate devices, not a study reporting on the device's performance against specific acceptance criteria.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance results, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The document serves to:
- Describe the device: Stryker Bipolar Forceps, their function (grasping, manipulating, coagulating soft tissue using electrosurgical energy).
- State the intended use/indications for use: Bipolar electrosurgery, connected to an electrosurgical generator, for bipolar coagulation current. Explicitly states contraindications for tubal ligation/cauterization.
- Establish substantial equivalence: Compares the device to existing predicate devices (Stingray Surgical Products Inc., Karl Storz, Silverglide Surgical Technologies) based on intended use, design, materials, and operational principles.
- Obtain FDA clearance: The letter from the FDA (JUN 22 2010) confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
In summary, this is a regulatory filing, not a scientific study with detailed performance metrics. There are no acceptance criteria or detailed study results presented in this document.
§ 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.