(265 days)
The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures.
The subject device is composed of Gas Insufflator Unit (Model GVS100) and accessories Highpressure Gas Pipe, Insufflation Tubing Set (Model GI-S001), and power adapter). The Insufflation Tubing Set is provided sterile and disposable. The Gas Insufflator Unit is nonsterile, reusable, and AC-powered (100 - 240 VAC, 50/60 Hz, 200 W).
The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity to generate and maintain pneumoperitoneum during laparoscopic diagnosis and/or surgical treatment. The Gas Insufflator controls gas pressure and flow rate by the solenoid valve. The touchscreen displays the gas pressure and flow output. The Gas Insufflator is insufflate CO2 to a body cavity up to 30 mmHg/40 LPM for Adult mode and 15 mmHg/15 LPM for Child mode.
The Gas Insufflator is for professional healthcare environment use.
The provided text describes the acceptance criteria and the study conducted for the Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Gas Insufflator (K221995).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes performance testing rather than specific "acceptance criteria" in a tabular format with corresponding reported performance. However, the "Comparison of the technological characteristics" table (Table 1) acts as a de-facto acceptance criteria by demonstrating similarity or equivalence to the predicate device. The "Bench Performance testing" section lists tests conducted to demonstrate performance and safety features.
| Acceptance Criteria (Implied from comparison and performance testing) | Reported Device Performance (from "Bench Performance testing" and "Comparison" section) |
|---|---|
| General Intended Use | The Gas Insufflator is designed to use carbon dioxide gas to insufflate the abdominal cavity, so as to generate and maintain pneumoperitoneum, expand the surgical field and keep sufficient space during diagnostic and therapeutic laparoscopic procedures. (Same as predicate) |
| Distension Medium | CO2 (Same as predicate) |
| Indicated Population | Adult and Pediatric (Same as predicate) |
| Modes | Adult mode, Child mode (Similar to predicate's High Flow, Pediatrics) |
| Maximum Flow Rate | Adult: 40 L/min, Pediatric: 15 L/min (Same as predicate: High flow: 40 LPM, Pediatric: 15 LPM) |
| Maximum Pressure | Adult: 30 mmHg, Pediatric: 15 mmHg (Same as predicate: High flow: 30 mmHg, Pediatric: 15 mmHg) |
| Overpressure Action | Intr-abdominal pressure exceeds the set value 5mmHg and continuously exceeds 5s: visual and audible alarm followed by pressure relief after 5 seconds (Similar to predicate's overpressure action for Pediatric and High flow modes) |
| Gas Supply Shortage Action | At |
§ 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.