Single use stone retrieval balloons

The Single use stone retrieval balloons is a single-use, sterile medical device comprised of a natural latex balloon mounted on a Pebax catheter with two or three internal lumens. It is indicated for endoscopic use to remove stones from the biliary system or to facilitate contrast medium injection while occluding the bile duct. The balloon inflates to diameters of 8.5 mm, 12 mm, 15 mm, or 18 mm and is designed for adult use only.

Key differences from the predicate include the use of tantalum instead of platinum-iridium alloy for radiopaque markers, a smaller minimum balloon size (8.5 mm vs. 9 mm), and the availability of two-lumen (non-injection) models in addition to three-lumen models. Both devices use natural latex balloons, Pebax catheters, EO sterilization, single-use packaging, 2-year shelf life, 200 cm working length, and are compatible with endoscopy channels ≥3.2 mm.

ISO 13485 (Design controls, nonconforming product, corrective and preventative action), ISO 10993-1:2018 (Biocompatibility evaluation), ISO 11135 Second edition (EO sterilization requirements), ISO 10993-7 Second Edition (EO residual limits), ISO 11607-1 and ISO 11607-2 Second Edition (Sterile packaging). Bench testing included appearance, dimensions, flow rate, guidewire compatibility, endoscope compatibility, balloon strength, radio-detectability, and connection integrity.

The proposed device is substantially equivalent to the predicate device because it is intended for the same clinical use (biliary stone removal and contrast injection), uses the same regulatory classification, materials, sterilization method, and packaging approach. Minor design differences (tantalum vs. platinum-iridium markers, slightly different balloon sizes, and optional two-lumen configuration) do not raise new safety or effectiveness concerns and are supported by biocompatibility and performance testing.