Ruby Intravascular Catheter

The RUBY Intravascular Catheter is a single-use, sterile catheter designed for short-term insertion into a patient's vascular system to sample blood, monitor blood pressure, or administer fluids intravenously. It features a blood control valve mechanism that automatically stops blood flow when the needle is removed, and includes a safety container to prevent sharp injuries. The device is indicated for use in pediatric patients weighing ≥10 kg and adults, and is compatible with power injectors.

The subject device differs from the predicate AccuCath in three main ways: (1) the catheter guiding element is positioned outside the needle rather than inside the lumen; (2) the guiding element uses a combination of metallic and polymeric materials (nitinol and Pebax) instead of nitinol alone; and (3) the needle surface geometries differ. Additionally, the catheter shaft material is TPU instead of Pebax, the shelf life is 6 months instead of 1.4 years, and the device is offered only as a standalone rather than with a basic kit option.

Performance testing per ISO 10555-1, ISO 10555-5, ISO 7864, ISO 23908, ISO 80369-1, ISO 80369-7, ISO 80369-20, ISO 9626, and IEC 62366-1. Biocompatibility per ISO 10993-1, ISO 10993-12, and ISO 10993-18. Sterilization and packaging per ISO 10993-7, ISO 11607-1, ISO 11607-2, ASTM F2250-13, ASTM F1980, ASTM D4169-22, and ASTM D4332-22. Shelf-life testing supports 6-month shelf life.

Although the subject device differs from the predicate in guiding element design, catheter material, and shelf life, comprehensive simulated-use, performance, and biocompatibility testing demonstrated these differences do not raise new safety or effectiveness questions. The device maintains the same intended use (blood sampling, pressure monitoring, fluid administration), insertion method (percutaneous), insertion site (peripheral), patient population, and performance characteristics (6 mL/sec flow rate, luer connections, single lumen). The predicate's proven safety and effectiveness in these clinical applications supports substantial equivalence despite the design and material modifications.