(207 days)
This device is restricted to use by authorized expert personnel/physicians.
The WISAP Disposable Heating Tube 7642HSE is a laparoscopic accessory to be used in connection with the WISAP (02 insufflator. This system serves for building up a pneumoperitoneum during diagnostic-operative Pelviscopy/Laparoscopy. The insufflation gas is preheated to body temperature by the disposable tubing.
Laparoscopic Insufflator: Disposable Heating Tubing Set #7642 HSES
The provided text is a 510(k) clearance letter from the FDA for a medical device: a Disposable Heating Tubing Set #7642 HSES, used with a laparoscopic insufflator. This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
The 510(k) clearance process primarily establishes substantial equivalence to a legally marketed predicate device, rather than requiring detailed performance studies with acceptance criteria in the same way a Premarket Approval (PMA) would.
Therefore, I cannot fulfill your request for the specific details you outlined based on the given input text.
§ 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.