(110 days)
The Nortech Flo-Assistant™ Product is indicated to provide a squeezing mechanism to a tubing set, providing increased capacity fluid irrigation for arthroscopic procedures.
The Flo-Assistant™ is designed to be used with the Nortech® 7-510-33 Flo-Assistant™ tubing set for increased fluid capacity. The device is comprised of a main unit, cable and foot pedal assembly.
I am sorry, but the provided text does not contain any information regarding acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a 510(k) summary for the Flo-Assistant™ device, primarily focusing on its description, intended use, and assertion of substantial equivalence to predicate devices. It does not include details about clinical trials, performance specifications, or study methodologies.
§ 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.