Insufflator (OPTO-IFL1000)

The Insufflator (OPTO-IFL1000) is a CO₂ insufflation device that generates and maintains pneumoperitoneum by filling the abdominal cavity with gas during diagnostic or therapeutic laparoscopic procedures. It creates a surgical field of view and operating space by separating the abdominal wall from internal organs.

Subject device offers four operational modes (Pediatric, Adult, Obese, Veress) with pressure ranges 1–30 mmHg and flow rates 0.1–50 L/min, compared to predicate's three modes (1–30 mmHg, 1–50 L/min). Subject adds heating function support with OPTO-T1000H tubing; predicate has none. Both maintain ±2 mmHg pressure accuracy and include overpressure/gas supply alarms and contamination detection. Subject device dimensions are 370×410×166.5 mm, weighs 11 kg versus predicate's 267×395×134 mm, 8.2 kg.

IEC 60601-1-2:2020 Edition 4.1 (Medical electrical equipment—electromagnetic disturbances). Software verified per FDA's Content of Premarket Submissions for Device Software Functions guidance (June 2024) at 'Enhanced' documentation level. Performance testing covered gas supply indication, pressure accuracy, overpressure alarms, heating function, and flow accuracy.

The subject device is substantially equivalent because non-clinical and performance testing demonstrate it meets the same design specifications and performs identically to the predicate device. Hardware operation is unchanged from the reference device (K231342). Differences in modes, flow/pressure ranges, heating capability, and alarms do not raise different safety or effectiveness questions, as the device maintains the same intended use, regulatory classification (Class II), and core pneumoperitoneum-creation function.