(32 days)
The Aragon Surgical LapCap is intended for use in the peri-umbilical region of the abdominal wall with a Veress needle for the establishment of a pneumoperitoneum during gynecologic (pelvic) and general surgical (intraabdominal) laparoscopic procedures.
The Aragon Surgical LapCap is a single-use device used during laparoscopic surgical procedures. The device consists of a bell-shaped polycarbonate dome housing containing a pass-through port for introduction of a standard Veress needle and a vacuum port for attachment to a standard hospital vacuum line.
The provided text does not contain any information about acceptance criteria or a study proving device performance.
The document is a 510(k) summary and the FDA's clearance letter for the Aragon Surgical LapCap. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies or pre-defined acceptance criteria for the new device's efficacy or accuracy.
Therefore, I cannot populate the requested table and information points as the source material does not contain the necessary details.
§ 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.