FROG (Filter Removal of Glass)

The FROG (Filter Removal of Glass) is a hypodermic needle with an integrated removable filter designed for healthcare practitioners. It allows filtered aspiration of medications from glass ampules to remove glass fragments, then the filter is removed before injection. The device is intended for general-purpose fluid injection/aspiration in patients where drugs are housed in glass primary containers.

The FROG incorporates a removable 5-micron filter surrounding an 18G 1.5-inch hypodermic needle (the predicate device). Key differences include new materials (polypropylene body, chlorobutyl seal, porous polyethylene filter) and e-beam sterilization versus gamma sterilization of the predicate. The filtering capability distinguishes it, though the underlying needle design, gauge, and length remain identical to the predicate BD Precision Glide Needle.

ISO 7864 (sterile hypodermic needles), ISO 9626 (stainless steel needle tubing), ISO 10993-1 (biocompatibility evaluation), ISO 11137-2 (radiation sterilization dose), ASTM D4169, ASTM F88/F88M, ASTM F1886/F1886M, ASTM F2096, ASTM F1980, ISO 80369-7, and IEC 62366-1 (usability engineering).

The FROG is substantially equivalent because it incorporates the predicate needle as a core component with identical gauge and length, maintaining the same fundamental intended use for general-purpose fluid injection/aspiration. Although the filter adds new technology and materials, performance testing demonstrates the filter achieves 5-micron filtration equivalent to the reference device, and biocompatibility testing shows no new safety concerns. The filter feature does not alter the needle's indications for use; it merely adds a temporary aspiration step that is removed before injection, mirroring the reference device's workflow without raising new safety or effectiveness questions.