SperSort™ Sperm Sorting Chip (IPG02)

The SperSort™ Sperm Sorting Chip (IPG02) is a single-use, sterile device that separates motile sperm from semen samples for use in assisted reproductive procedures including ICSI, IVF, and IUI. The device uses a swim-up mechanism where liquefied semen is placed in a lower chamber and sperm washing medium in an upper chamber; motile sperm migrate through a porous filter over 30 minutes at 37°C for collection.

The device is made of polycarbonate (versus the predicate's polymethylmethacrylate, polycarbonate, and polyethylene fibers), has a 1.9 mL processing volume, a 2-year shelf-life (versus 12 months), and an endotoxin limit of ≤20 EU/device (versus ≤2.15 EU/device). Both devices use gamma irradiation sterilization to SAL 10⁻⁶ and are prescription-use, single-use products with identical indications and the same fundamental design of sample chamber, porous filter, and collection port.

ISO 11137-1:2018 and 11137-2:2015 for sterilization validation; ASTM F1980-21 for shelf-life/accelerated aging; ASTM D4169-22 for simulated transportation; ASTM F1886/F1886M-16 for package visual inspection; ASTM F1929-23 for dye penetration; ASTM F88/F88M-23 for seal strength; USP<85> for endotoxin testing.

The subject and predicate devices share the same indications for use and fundamental design principle (swim-up separation of motile sperm through a microporous membrane). Although they differ in materials, processing volume, shelf-life, and endotoxin specification, the submitter contends these differences do not raise different questions of safety and effectiveness because the core separation mechanism and clinical purpose are identical. Performance testing demonstrated the subject device achieves equivalent or superior sperm motility recovery (95.89% total motility, 92.97% progressive motility), and stability testing confirmed maintenance of performance over the stated shelf-life.