(159 days)
The SurgiQuest AirSeal ® Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the "DPIS 2000 System") is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas, to establish and maintain a path of entry for endoscopic instruments and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization.
The SurgiQuest AirSeal® Optical Trocar & Cannula Device Description: System with integrated Insufflator DPIS 2000 (the "DPIS System") consists of of the following 2000 major components: (1) a trocar, (2) a cannula, (3) tube sets, and (4) a micro-processor controlled insufflation, recirculation and filtration unit (the "DPIS 2000 Unit"). The cannula, trocar and tube sets are sterile, single-use products. The DPIS 2000 Unit is non-sterile and reusable.
The DPIS 2000 Unit is designed to function in one of three (3) separate modes of operation: (a) Insufflation Mode; (b) AirSeal Mode; or (c) Smoke Evacuation Mode.
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and noting what is absent for a comprehensive understanding:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes various tests and standards met by the device, rather than explicit "acceptance criteria" presented as quantitative thresholds. However, we can infer the performance statements from what was tested and validated.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Pneumoperitoneum Maintenance: Ability to create and maintain pneumoperitoneum in all operating modes (Insufflation, AirSeal, Smoke Evacuation). | "Bench test results demonstrate that the DPIS 2000 System is safe and effective in creating and maintaining pneumoperitoneum in all three modes." |
| Sterility Assurance Level (SAL): SAL of ≤ 10-6. | "A sterility assurance level (SAL) is ≤ 10-6 achieved." |
| Ethylene Oxide and Ethylene Chlorohydrin Residuals: EO |
§ 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.