(63 days)
The instruments are for use on the laryngeal anatomy, e.g., the vocal cords, false cords, surpraglottis, glottis, epiglottis, tongue base, oral pharynx, and uvula. The instruments are used to grasp and hold tissue for dissection or vaporization. The forceps may be used to coagulate blood vessels within the tissue when it is connected to a unipolar high frequency generator. Depending on where the bleeding vessel is located, coagulate by applying a low dose of HF current. The intensity depends on the severity of the bleeding and on the vessel. Always start with a low dosage and increase the power if necessary.
The forceps are made of medical grade stainless steel, teflon coated medical grade stainless steel, black chrome plating, and plastic. The grasping forceps have been insulated and now allow the application of high frequency current.
The provided text is a 510(k) summary for the RICHARD WOLF Unipolar HF Grasping Forceps. It details the device, its intended use, and the basis for its substantial equivalence to previously marketed devices. However, it does not contain any information regarding acceptance criteria, study performance, sample sizes, expert qualifications, or ground truth establishment.
Specifically, the document states:
- "5.0 Performance Data None"
- "6.0 Clinical Tests No clinical tests performed."
Therefore, I cannot provide the requested table or answer the questions related to acceptance criteria, study details, and performance data, as this information is explicitly stated as not being included in the submission. The device's clearance was based on substantial equivalence to existing predicate devices, rather than through a performance study 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.