Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S)

The Microtek decanters and transfer devices are sterile, single-use hollow tubes with spiked ends designed for aseptic transfer of IV fluids and medications from bags or vials to IV administration devices. Four models are included: C-Flo Bag Decanter (2000S), Bag Decanter II (2002S), Vial Decanter with splash guard (2006S), and Transfer Device with dual spikes (2008S). The devices are intended for use in adult and pediatric patients at the discretion of the healthcare professional.

The proposed devices use spike-and-tube design similar to the predicate, made of polymer-based plastics (PMMA, HIPS825, or ABS) rather than the predicate's mix of ABS, PE, and K Resin. All are sterilized by ethylene oxide with equivalent sterility assurance levels and residual limits. Device lengths range from 3 to 8.25 inches, with minor variations versus the predicate's 3 to 9 inches that do not affect safety or effectiveness. Biocompatibility testing was performed to ISO 10993 series standards and performance testing to ISO 22413:2021 and ISO 8536-4:2019.

Biocompatibility per ISO 10993-1:2018, ISO 10993-4:2017, ISO 10993-5:2009, ISO 10993-10:2021, ISO 10993-11:2017, and ISO 10993-23:2021. Sterilization validation per ISO 11135:2014. Performance testing per ISO 22413:2021 (closure piercing) and ISO 8536-4:2019. Risk management per ISO 14971:2019. Ethylene oxide residuals per ISO 10993-7.

The devices achieve substantial equivalence through identical intended use (aseptic transfer of IV solutions), same regulatory classification (Class II, product code LHI), same sterilization method (ethylene oxide), and equivalent operating principle (spike-and-tube design for sterile fluid pathway). Although materials differ slightly from the predicate, biocompatibility testing confirms no safety concerns. Performance testing demonstrates the devices meet necessary safety and efficacy standards. Minor length variations do not raise questions regarding safety or effectiveness. All identified design and use risks were deemed broadly acceptable after risk control measures.