(70 days)
The "Quick Switch" and "Re-New" are intended for use in endoscopic, including laparoscopic surgical procedures where instruments are introduced into the body through a cannula .
The Re-New" Laparoscopic Scissors are surgical instruments used to cut and dissect various abdominal tissue for use in endoscopic, including laparoscopic, surgical procedures. The product line includes reusable common handles that can be easily attached and detached from a series of surgical tips available, which include : disposable tips, and reusable tips. The tip assembly is designed with a proprietary double thread, which permits simple and reliable attachment and detachment of the desired tip to the shaft of the handle/shaft component. Tip configurations include: Metzenbaum, Mini, Hook, Endocut, and, Micro.
The provided text is a "510(k) Summary" for a medical device called "Re-New" Laparoscopic Instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, "Quick Switch." The document does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth, or MRMC studies as requested in the prompt.
Therefore, I cannot extract the requested information from the provided text. The document is an FDA submission for market clearance, not a detailed technical study report.
§ 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.