(86 days)
Vessel Vapor™ is a gas conditioner accessory device intended to heat, humidify and filter an insufflating CO2 gas stream being used in minimally invasive cardiovascular, thoracoscopic, and vessel harvesting surgical procedures.
The Vessel Vapor™ device is a single use device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation into the surgical cavity. The Vessel Vapor™ device consists of a disposable tubing set with a filter and heater/humidifier cassette and a control module that houses the control and safety circuits for the system. Regulated CO2 gas flows into the Vessel Vapor™ device, through the in-line filter, continues along the tube to enter the Vessel Vapor™ device cassette that contains the heating element and humidification media, through a tube that connects via a Luer lock connector to a gas entrance port or an insufflation needle/trocar and finally flows into the patient's surgical cavity.
This document is a 510(k) summary for the Vessel Vapor™ device, a laparoscopic insufflator gas conditioner. It does not contain information about a clinical study with acceptance criteria and device performance. The document focuses on demonstrating substantial equivalence to predicate devices (Vessel Guardian® K102136 and Insuflow® K090456) based on technological characteristics and intended use.
Therefore, I cannot provide the requested information regarding acceptance criteria, reported device performance, study details (sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance), or training set information.
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.