(90 days)
The Boston Scientific Tissue Coagulation System is intended for use only under direct visual control of the physician during open, general surgical procedures to coagulate soft tissues. The Tissue Coagulation System may also be used to coagulate blood and soft tissues to produce hemostasis.
The Boston Scientific Tissue Coagulation System is comprised of an Electrosurgical Unit (ESU), Electrosurgical Probe, and accessories for the application of radiofrequency energy to tissue. The ESU supplies up to 150 watts of radiofrequency energy in unipolar mode to the electrodes of the Electrosurgical Probe under temperature control while continuously monitoring and displaying actual power delivered, actual electrode temperature, and time of power duration. User controls are provided for setting desired temperature, maximum power output, and duration of power delivery. ESU safety features include overvoltage, overcurrent, and overpower shutdowns.
This 510(k) submission for the Boston Scientific Tissue Coagulation System does not contain a study section with acceptance criteria and a detailed report of device performance against those criteria.
The provided documents are primarily a 510(k) summary and the FDA's clearance letter. These documents attest to the device's substantial equivalence to predicate devices but do not detail the specific performance studies that a manufacturer typically conducts to demonstrate this equivalence.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details from the provided text.
To answer your request, I would need a different type of document, such as a "Special Controls Guidance Document" from the FDA for electrosurgical devices, or the original submission's testing and performance data.
§ 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.