Ancora-SB

The Ancora-SB is a single-use balloon overtube accessory that slides over a standard endoscope (9.0–9.4 mm diameter) to facilitate small intestine positioning and visualization. It features dual lumens: a major lumen with hydrophilic coating for endoscope insertion and a minor lumen for balloon inflation. When inflated, the textured distal balloon stabilizes endoscope position or facilitates advancement through a technique called plication, enabling diagnostic and therapeutic endoscopic procedures.

The modified device changes the hydrophilic coating formulation from PVP-based to PEG-based to improve friction performance in challenging use cases, and replaces the radiopaque marker material from platinum to barium sulfate-impregnated silicone. All other specifications remain identical: 38 mm balloon diameter, 43 mL injection volume, 132 cm working length, dual-lumen silicone construction, and identical proximal connections and balloon design.

Biocompatibility evaluated per ISO 10993-1:2018 and associated FDA guidance. Bench testing included friction evaluation under challenging use conditions, end cap bond strength verification, and radiopacity assessment. A revised proprietary test method was implemented to support the coating formulation change.

Substantial equivalence is supported by identical indications for use, operating principle, and design intent compared to the originally cleared Ancora-SB (K231323). The material changes are limited in scope and targeted to address performance (friction), not safety or effectiveness. Testing demonstrates the new PEG-based coating maintains acceptable friction, the modified end cap maintains structural integrity, and the new radiopaque material functions adequately—none of these changes raise new safety or effectiveness concerns relative to the predicate.