BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G

The BIOTEQ Drainage Catheter Set is a percutaneous drainage catheter used to drain abscess fluid, cysts, fluid from gall bladders, nephrostomy sites, urinary collections, and other bodily fluids. It is made from soft, biocompatible plastic with radiopaque material for X-ray visualization and features a pigtail or mini-pigtail loop at the distal end with drainage holes.

The subject device is made of TPU (thermoplastic polyurethane) with Hydromer AQUA 65JL hydrophilic coating. It comes in sizes 5–16 French, usable lengths 20–50 cm, and includes string-locking and non-string-locking pigtail configurations. The main difference from predicate is catheter color (green vs. blue in predicate) and expanded size/length ranges. Accessories include metal and flexible stiffening cannulas, trocar needles, wire caps, suture wire, and curve straighteners.

Sterilization: ISO 11135, ISO 10993-7, ISO 11737-1/2, USP, EN 556-1. Shelf-life: ISO 20697, ISO 80369-7/20, ASTM F1140/F1140M, ISO 11070, ISO 9626, ISO 2859-1. Biocompatibility: cytotoxicity, sensitization, irritation, acute toxicity, pyrogen, systemic toxicity, mutagenicity, and muscle implantation studies per ISO standards. Performance: ISO 20697, ISO 80369-7/20.

The subject device is substantially equivalent to two predicate devices (K210419 and K200103) because it shares identical intended use (percutaneous drainage), prescription-use classification, material composition (TPU and Hydromer coating), distal configuration (pigtail types), sterilization method (ethylene oxide), and biocompatibility profile. Differences in catheter color and expanded size/length ranges do not raise new safety or performance issues and are considered routine design variations.