(63 days)
The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are intended for use by a physician familiar with electrosurgery in bipolar and monopolar coagulation for general surgery where coagulation of soft tissue is needed. The bipolar forceps are used with the bipolar and the monopolar forceps with the monopolar output of standard electrosurgical generators. The EGON FAULHABER Bipolar and Monopolar Forceps have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures. The types of surgery intended are: General surgery, Laryngeal coagulation, Orthopedic coagulation, Thoracic coagulation, Neurosurgical coagulation, Gynecological coagulation (except for use in female sterilization), Urological coagulation, Ear-, Nose- and Throat coagulation.
The EGON:FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are reusable devices and provided non sterile. They must be cleaned and sterilized before use. Bipolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Bipolar Forceps are of the same basic design with differences in tip sizes and handle styles. Two types of electrical plugs are available: flat plug, or 2 pin plug. The Bipolar Forceps are to be connected through a suitable bipolar cable with the bipolar output of an electrosurgical generator. Bipolar Forceps must only be used with bipolar coagulation current. Non-Stick Bipolar Forceps: The Non-Stick Bipolar Forceps have the same characteristics as the Bipolar Forceps except for the special material with excellent thermal properties, applied to the tips of the forceps. Thereby difficult and time consuming cleaning of the forceps during an operation can be avoided and enables non-stop working. The non-stick effect is permanently ensured and will not be reduced, even if subject to frequent sterilization. Monopolar Forceps: The branches are made of stainless steel insulated with Polyamide (PA) except for the tip of the instrument. The EGON FAULHABER Monopolar Forceps are of the same basic design with differences in tip sizes and handle styles. They are available with or with out plug socket. The Monopolar Forceps can be connected through a suitable monopolar cable with the monopolar output of an electrosurgical generator. Monopolar Forceps must only be used with monopolar coagulation current.
The provided document is a 510(k) summary for Egon Faulhaber Bipolar, Non-Stick Bipolar, and Monopolar Forceps. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting new performance studies against specific acceptance criteria. Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states:
- "The EGON FAULHABER Bipolar, Non-Stick Bipolar and Monopolar Forceps are substantial equivalent to the predicate devices, since the basic features, design and intended uses are the same. The minor differences between the EGON FAULHABER forceps and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no effect on the performance, function or intended use of the devices."
This indicates that the device's market clearance is based on its similarity to already legally marketed devices, not on a new study demonstrating performance against a set of predefined acceptance criteria.
The requested information regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details are typically found in clinical validation studies or performance testing reports, which are not included in this 510(k) summary.
§ 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.