(84 days)
VOMED trocars are intended to provide access to the thoracic cavity through ports in the intercostal spaces, with minimal to no rib retraction. VOMED trocars and trocar sleeves then allow endoscopic instruments, thoracoscopes, laparoscopes, a tube or a channel, and accessory devices to be inserted and used during cardiac surgery procedures.
VOMED adapters, tube connectors, caps and plugs, stopcocks and valves are noninvasive, reusable devices for use in cardiovascular applications to interconnect tubing and other devices during extracorporeal bypass procedures, effectively establishing a conduit between the devices for the flow of blood and other extracorporeal fluids.
VOMED Trocars and Adapters, Connectors, Stopcocks and Manifolds
I am sorry, but the provided text is a letter from the FDA to VOMED Volzer Medizintechnik GmbH & Co. regarding the clearance of their Trocars and Adapters, Connectors, Stopcocks and Manifolds. This document does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment. It is a regulatory clearance letter, not a study report.
Therefore, I cannot extract the requested information from the given text.
§ 870.1390 Trocar.
(a)
Identification. A trocar is a sharp-pointed instrument used with a cannula for piercing a vessel or chamber to facilitate insertion of the cannula.(b)
Classification. Class II (special controls). Except for trocars that are reprocessed for multiple use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.