(383 days)
The BICAP COAG Bipolar Laparoscopy Probe is indicated for use in laparoscopic procedures to provide bipolar coagulation, blunt dissection, irrigation, and aspiration. The BICAP COAG Probe may be used in a variety of gastrointestinal, urological and gynecological procedures.
The 5 mm ACMI BICAP COAG Bipolar Laparoscopy Probe (32 cm working leneth) is designed for laparoscopic coagulation, irrigation, and aspiration. The RF current path within the patient is identical to standard bipolar; consequently, the need for a patient dispersive electrode is eliminated. The current flow through the tissue is localized to help prevent a thermal effect distant from the surgical site. The BICAP COAG Bipolar Laparoscopy Probe connects to ACMI Surgiflex WAVE suction-irrigation tubing sets. Use of the BICAP COAG Probe can help reduce operating room time by reducing the number of instrument exchanges. With a bipolar tip at the end of the suction-irrigation shaft, hemostasis, blunt dissection, irrigation, and aspiration may be readily performed withdrawing the instrument. The oval tip design of the probe provides easy, less traumatic access to ovarian and tubal cysts and other difficult to reach areas. BICAP COAG instruments are compatible with most bipolar generators. allowing them to be used with existing equipment.
I am sorry, but the provided text does not contain any information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, or specific performance metrics for the described medical device. The document is a 510(k) summary for premarket notification of the ACMI BICAP COAG Bipolar Laparoscopy Probe, which focuses on device description, intended use, and comparison to predicate devices for substantial equivalence. It does not include a performance study with 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.