Disposable Trocars

Disposable Trocars are single-use surgical instruments that penetrate the abdominal wall during laparoscopic (minimally invasive) surgery. They create a passageway for inserting and removing surgical instruments while maintaining pneumoperitoneum (pressurized gas in the abdomen). Available in multiple sizes (5–15 mm diameter, 70–100 mm length), they consist of a puncture rod that withdraws after insertion, leaving a casing component as the working channel for endoscopes and surgical staplers.

The proposed device uses a puncture rod mechanism versus the predicate's puncture needle. It offers shaft diameters of 5, 10, 12, and 15 mm (predicate: 3, 5, 8, 10, 12, 15 mm) and lengths of 70 and 100 mm (predicate: 75 and 100 mm). Materials are ABS, PC, PE, colorant, and silica gel (predicate uses rubber instead of silica gel). Both are EO-sterilized to SAL 10⁻⁶, have identical endotoxin limits (20 EU/device), similar fin-shaped needle tips, and identical labeling requirements. The proposed device has a 3-year shelf life versus the predicate's 2 years.

ISO 10993 series (biocompatibility: parts 1, 5, 10, 11, 12, 18, 23); ISO 11135:2014 (EO sterilization validation); ISO 10993-7:2008 (EO residuals); ASTM F88/F88M-23 (seal strength); ASTM F1929-23 (seal leak detection); ASTM D4169:2022 (simulated transport); USP <85> (bacterial endotoxins); ASTM F1980-21 (accelerated aging of sterile barriers).

Both devices are Class II trocars (product code GCJ, regulation 876.1500) with identical intended use in minimally invasive abdominal surgery. Non-clinical testing—including dimension verification, bench performance (compatibility, flexibility, airtightness, connection strength, gas leak rate), ex vivo porcine tissue studies (penetration and fixation forces), biocompatibility, sterility, and shelf-life testing—demonstrated that the proposed device meets the same performance specifications as the predicate. The differences in size range, shaft configuration (puncture rod vs. needle), and material substitution (silica gel vs. rubber) do not raise new safety or effectiveness concerns because comparable dimensional and performance characteristics were validated and the device maintains identical sterilization assurance levels, endotoxin limits, and biocompatibility profiles.