DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

The DMRX Empty Container Solution is a sterile, single-use intravenous (IV) bag available in 100mL, 250mL, 500mL, and 1000mL volumes. It consists of a flexible polypropylene-based container with two ports: an injection port for filling the bag with medication using aseptic technique with a needle, and a spike port for connecting an IV administration set to deliver the solution to patients. After use, the bag is discarded.

The subject device uses a needle-based injection port with a self-sealing elastomeric plug, whereas the predicate device uses a luer lock connection. Both devices feature a spike port for IV administration and self-closing add ports requiring no clamp. The subject device's elastomeric plug is auto-sealable with a polycarbonate membrane and polyisoprene elastomer, while the predicate uses acrylic and polyurethane with a silicone plug. The subject device adds a 1000mL size option not available in the predicate.

Biocompatibility per ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11, 10993-18; performance testing per ISO 15747-4; sterilization per ANSI/AAMI/ISO 11137-1, 11137-2, 11137-3; particulate testing per USP <788>; packaging seal per EN868-5; and additional testing for bag integrity, shelf life, microbial ingress, drop resistance, and self-sealing capability.

The device is substantially equivalent because it is composed of the same base materials as the predicate (except for the add port design), maintains identical indications for use and intended patient populations, and performs the same fundamental functions of filling and administering IV solutions. Although the filling mechanism differs (needle-based vs. luer lock), both provide safe aseptic filling methods. The elastomeric plug design in the subject device prevents solution contact with the elastomeric portion, and comprehensive biocompatibility and performance testing demonstrates that the material differences raise no new safety or effectiveness questions.