Rio™ Drug Reconstitution Transfer Device

The Rio™ Drug Reconstitution Transfer Device is a single-use, sterile connector that attaches a drug vial (13mm or 20mm closure) to an ICU Medical LifeCare IV bag (up to 500mL) to enable aseptic reconstitution and transfer of liquid or lyophilized drugs into intravenous solution for patient infusion. It is used in pharmacy and patient care settings by trained clinicians.

The subject device differs from the predicate in three key areas: (1) expanded IV bag compatibility from 250mL to 500mL; (2) new 13mm vial spike model alongside the existing 20mm model; (3) material changes including polybutylene body (vs. polycarbonate), ABS bag-side cap (vs. polyethylene), LDPE vial-side cap (vs. PVC tubing); and (4) addition of a tamper clip/wedge and 13mm adapter. Sterilization method, shelf life, and SAL (10⁻⁶) remain identical.

ISO 10993-1 (biocompatibility), ISO 22413, ISO 8536-4, ISO 8871-5, ISO 11137 (sterilization validation), ISO 11607 (packaging), USP <788> (particulates), and FDA's September 2023 guidance on ISO 10993-1 implementation.

The subject device performs the same reconstitution and transfer function with identical indications for use as the predicate. Although material composition and design features differ (new tamper clip, 13mm vial compatibility, expanded bag size, material substitutions), biocompatibility and functional performance testing demonstrated these changes do not raise new safety or effectiveness concerns. All critical performance parameters including leak rates, flow rates, retention, fragmentation, sterilization, and particulate levels met acceptance criteria, establishing technological equivalence despite the design modifications.