(259 days)
The SperSort™ Sperm Sorting Chip is intended for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection (ICSI), in vitro fertilization (IVF) and intrauterine insemination (IUI) procedures.
The SperSort™ Sperm Sorting Chip is used to prepare motile sperm for assisted reproductive technology (ART) procedures. The device separates motile sperm from the semen based on the mobility (i.e., swim-up nature) of motile sperm. The SperSort™ Sperm Sorting Chip consists of an upper collection chamber and a lower semen sample chamber. The chambers are separated by porous filter which allow motile sperm to pass from the lower chamber to the upper chamber. Both the semen sample injection port and sperm collection port are located on the upper cover. The semen sample injection port directly connects to the lower chamber, while the sperm collection port is connected to the upper chamber. The SperSort™ Sperm Sorting Chip accommodates a 1.9 mL semen sample. Liquefied semen is added to the lower chamber and cleared sperm washing medium (1.5 mL) is added to the upper chamber. Following incubation for 30 minutes at 37°C, the isolated sperm are gathered from the collection port. The SperSort™ Sperm Sorting Chip is a radiation-sterilized device with a sterility assurance level (SAL) of 10-9. They are individually packaged and for single use only.
The FDA 510(k) summary for the SperSort™ Sperm Sorting Chip (IPG02) provides information on its acceptance criteria and non-clinical performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a single table, but can be inferred from the performance testing section and comparison with the predicate device.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (SperSort™ Sperm Sorting Chip) |
|---|---|---|
| Sterility Assurance Level (SAL) | 10⁻⁶ (as per predicate device and FDA guidance) | 10⁻⁶ |
| Package Integrity | Maintain sterile barrier after simulated transport and aging | Passed (Can withstand shipping, sterile barrier maintained) |
| Shelf-Life Performance (HSSA) | ≥ 80% of the control motility at 24 hours after exposure for 30 minutes | Maintained performance after two years accelerated aging and passed HSSA (≥ 80% control motility) |
| Endotoxin | ≤ 20 EU/device (device specific) |
§ 884.6160 Assisted reproduction labware.
(a)
Identification. Assisted reproduction labware consists of laboratory equipment or supplies intended to prepare, store, manipulate, or transfer human gametes or embryos for in vitro fertilization (IVF), gamete intrafallopian transfer (GIFT), or other assisted reproduction procedures. These include syringes, IVF tissue culture dishes, IVF tissue culture plates, pipette tips, dishes, plates, and other vessels that come into physical contact with gametes, embryos or tissue culture media.(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, and clinical testing). The device, when it is a dish or plate intended for general assisted reproduction technology procedures, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.