(128 days)
The Medline Pneumoperitoneum Needle has applications in gynecologic and abdominal endoscopic procedures for establishment of a pneumoperitoneum.
Not Found
The provided text is a 510(k) substantial equivalence letter from the FDA for a medical device called the "Medline Pneumoperitoneum Needle." This document establishes the device's regulatory classification and outlines general controls and regulations. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot provide the requested information. The letter is a regulatory approval document and not a scientific study report.
§ 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.