FemVue® Controlled Saline-Air Device (FSA-300)

The FemVue® Controlled Saline-Air Device is a sterile, single-use dual-barrel contrast media syringe that delivers an alternating pattern of saline and air into the uterus and fallopian tubes through a connected intrauterine catheter. It is used during sono-hysterosalpingogram (Sono-HSG) ultrasound procedures to visualize the fallopian tubes, with or without assessment of the uterine cavity.

Both the subject device and predicate device are dual-barrel contrast media syringes with identical core design features: ratcheted plunger design, spin Luer catheter connection, single-use construction, and ethylene oxide sterilization. The key difference is that the subject device views contrast bubbles through the Luer neck rather than through a viewing window, but this does not raise different safety or effectiveness questions.

ISO 11135:2014 and AAMI TIR 28:2016 for ethylene oxide sterilization; ISO 10993-5, 10993-10, and 10993-23 for biocompatibility (cytotoxicity, sensitization, irritation); ASTM F2096-11 for bubble leak testing; ASTM F88/F88M-23 for seal strength; ASTM D4169-22 for transportation simulation; ASTM F1980-21 for accelerated aging.

The subject device is substantially equivalent to the predicate device (FemChec® K241693) because both are dual-barrel contrast media syringes with identical intended use, same regulatory classification (Class II), same materials, fundamental design, and sterilization method. Testing demonstrates the subject device is as safe and effective as the predicate, with the viewing window difference not raising different safety or effectiveness concerns.