Denudation Pipettes

Denudation Pipettes are sterile, single-use polycarbonate capillary tubes with tapered tips used to remove cumulus cells from oocytes before intracytoplasmic sperm injection (ICSI) and in vitro fertilization (IVF). They are also used for handling gametes, embryos, and biopsied cells during assisted reproductive techniques. The devices are not intended for biopsy of cells from oocytes or embryos.

The subject device has an outer diameter of 0.9mm at the proximal end, tip length of 90mm, and distal inner diameter sizes ranging from 80μm to 290μm. It is made of polycarbonate, gamma-irradiated to sterility (10⁻⁶), with volumetric capacity of 18.6-21.9µl, and is supplied in pouches of 5 or 10 units. The predicate device has a similar configuration but with distal sizes ranging from 75μm to 600μm; the subject device specifications are more stringent for endotoxin (<0.5 EU/device versus <20 EU/device) and uses a different MEA assessment timepoint (96 hours versus 120 hours).

ISO 11137-1:2006 and ISO 11137-2:2013 (sterilization validation); ASTM D4169-23 (simulated transportation); ASTM F1980-21 (accelerated aging); ASTM F1886/F1886M-16 (package integrity visual test); ASTM F1929-23 (dye penetration); ASTM F88/F88M-23 (seal strength); USP<85> (endotoxin LAL); and 2021 FDA guidance on Mouse Embryo Assay for Assisted Reproduction Technology Devices.

The subject device has identical indications for use and intended purposes as the predicate (denudation of oocytes and handling of oocytes and embryos during ART). Both devices share the same material (polycarbonate), sterilization method (gamma irradiation), proximal outer dimension (900µm), and length (90mm). Although the subject device has a narrower distal tip size range (80–290µm versus 75–600µm), this falls entirely within the predicate's cleared range. The stricter endotoxin specification and shorter MEA assessment timepoint represent improvements rather than safety concerns. Non-clinical testing demonstrates the subject device meets or exceeds performance standards equivalent to the predicate.