Koala Intrauterine Pressure Catheter (IPC-5000E)

The Koala Intrauterine Pressure Catheter (IPC-5000E) is a disposable, sterile catheter designed to measure intrauterine contraction pressures during labor. It features a 360° pressure-sensing membrane at the tip, an amnioinfusion port, and connects to a reusable external transducer via an air-coupling cable. The device is indicated for intrapartum intrauterine pressure monitoring in patients requiring such monitoring.

The subject device differs from its predicate in the air-coupling channel design (lumen with integrated element versus single lumen with microfilament), catheter body material composition (Isothane 5055D as alternative to Pellethane), monofilament material (polyurethane removed versus nylon), introducer material (Ferro RxLOY polyolefin alloy versus polyethylene), storage temperature range (-25°C to +50°C versus -25°C to +65°C), shelf-life (6 months versus 2 years), and ink formulation. All other specifications, dimensions, and performance parameters remain the same.

ISO 10993-1 (biocompatibility), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization), ISO 10993-23 (irritation), ISO 10993-11 (acute toxicity and pyrogenicity), ISO 11737-1 and 11737-2 (sterilization validation), ANSI AAMI ST67:2019 (sterilization), ASTM D4169-22 (transportation), ASTM F1980:21 (shelf-life/accelerated aging), ASTM F1929-15 (dye penetration), ASTM F88/F88M-21 (seal strength), ASTM F1886/F1886M-16 (visual assessment), and USP <151> (pyrogenicity).

The subject device is substantially equivalent because it shares the same intended use, product code, indications, principle of operation (air-coupling technology), performance specifications, and catheter dimensions as the predicate. Although material and design modifications were made to the air-coupling channel, catheter body, and other components, these are minor changes that do not raise new safety or effectiveness questions. Comprehensive biocompatibility, sterility, functional, and shelf-life testing demonstrate the device performs as safely and effectively as the predicate throughout its shelf-life.