(87 days)
The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.
The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.
The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.
I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Summary of Safety & Effectiveness for a medical device (Multi-Port Cannula), primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It does not detail specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.