SwimCount® Harvester (1 mL); SwimCount® Harvester (3 mL)

The SwimCount® Harvester (1 mL and 3 mL variants) is a sperm separation device used to prepare motile sperm cells from semen for assisted reproductive procedures including ICSI, IVF, and IUI. It works by allowing motile sperm to swim through a microporous filter membrane from a lower sample compartment into an upper collection compartment containing separation medium, enabling selective harvesting of mobile sperm cells for fertility treatment.

Both the subject and predicate devices use the same fundamental micropore technology with a polycarbonate filter membrane to separate motile sperm. Key differences include: subject device housing uses TOPAS (cycloolefin copolymer) versus predicate's flash-spun polyethylene fibers and polymethylmethacrylate; subject device processes 1 mL and 3 mL volumes versus predicate's 0.85 mL and 3 mL; subject device specifies ≥80% control motility at 24h and <20 EU/device endotoxin, versus predicate's ≥80% at 24 hours after 30-minute exposure and <2.15 EU/device endotoxin.

ISO 11137-2:2015 (sterilization validation); ASTM D4169-22 DC13 (transportation simulation); ASTM F1886/F1886M-16 (visual inspection); ASTM F1929-15 (dye penetration); ASTM F88/F88M-21 (seal strength); USP<85> (endotoxin testing).

Both devices share identical intended use (sperm preparation for ICSI, IVF, IUI), same regulatory classification (Class II), same product code (MQK), and identical fundamental design incorporating a sample chamber, polycarbonate filter membrane, and collection port. Material and specification differences (housing material, device volumes, endotoxin/motility specifications) do not raise different safety or effectiveness questions because both devices achieve comparable clinical performance: the subject device achieved 95.1% motility enrichment (1 mL) and 94.9% (3 mL) in performance testing, demonstrating equivalent sperm separation effectiveness to the predicate device.