i-Cut

The i-Cut is a single-use laparoscopic power morcellator indicated for morcellating and extracting tissue during gynecologic surgical procedures. It features a rotating cutting tube with a trocar that can be locked in a closed position for safety, is electrically operated by a 24V DC motor, and works with standard laparoscopic graspers or forceps of 10–14 mm diameter.

The i-Cut differs from the predicate LiNA eXcise in several specifications: mains-powered (24V DC) versus battery-powered (9V); two trocar positions versus three; higher rotational speed (1,100 rpm vs. 650 rpm); shorter shaft (100 mm vs. 155 mm); larger inner and outer diameters; and compatibility with 10–14 mm tools versus 10–12 mm tools. Motor lifetime is approximately 60 minutes continuous operation.

Testing included sterilization validation (ANSI/AAMI/ISO 11135:2014), shelf-life validation (ASTM F1980-21:2023), biocompatibility testing (ISO 10993 series including cytotoxicity, sensitization, irritation, and systemic toxicity), electrical safety (IEC 60601-1:2020), electromagnetic compatibility (IEC 60601-1-2:2020), and performance testing (load, gas tightness, functional, and usability tests).

Despite multiple technological differences (power source, speed, dimensions, tool compatibility), the submitter argues substantial equivalence because both devices perform the same intended function—morcellating and extracting tissue in laparoscopic gynecologic procedures—using the same fundamental design approach (rotating cutting tube with protected trocar). The performance testing demonstrates the i-Cut is as safe and effective as the predicate, and the differences in specifications do not raise different safety or effectiveness questions because the device maintains essential safety features (closed-position blade protection, gas tightness, biocompatibility) and achieves comparable functional performance.