(212 days)
GM501 SpermAir is intended for the handling and preparation of sperm for use in assisted reproduction procedures. GM501 SpermAir is not intended for use in intrauterine insemination procedures.
GM501 SpermActive is intended for the handling and preparation of sperm for use in assisted reprocedures. GM501 SpermActive is not intended for use in intrauterine insemination procedures.
GM501 SpermAir and GM501 SpermActive are ready-to-use solutions for handling and preparation of sperm cells during assisted reproduction procedures. Both devices are aseptically filled into sterilized bottles and sealed. GM501 SpermAir comes in three volumes: 2 ml, 20 ml, and 50 ml. GM501 SpermActive comes in two volumes: 20 ml and 50 ml. Both media have a six-month shelf-life when stored as recommended and can be used for up to seven days after opening.
Here's a breakdown of the acceptance criteria and study information for the GM501 SpermAir and GM501 SpermActive devices, based on the provided FDA 510(k) summary:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| pH | 7.2-7.5 (GM501 SpermAir/SpermActive) |
| Osmolality (mOsm/kg) | 270-290 (GM501 SpermAir/SpermActive) |
| Sterility (per USP ) | No growth (demonstrated through testing) |
| Bacterial Endotoxins (per USP ) |
§ 884.6180 Reproductive media and supplements.
(a)
Identification. Reproductive media and supplement are products that are used for assisted reproduction procedures. Media include liquid and powder versions of various substances that come in direct physical contact with human gametes or embryos (including water, acid solutions used to treat gametes or embryos, rinsing solutions, sperm separation media, supplements, or oil used to cover the media) for the purposes of preparation, maintenance, transfer or storage. Supplements are specific reagents added to media to enhance specific properties of the media (e.g., proteins, sera, antibiotics, etc.).(b)
Classification. Class II (special controls) (mouse embryo assay information, endotoxin testing, sterilization validation, design specifications, labeling requirements, biocompatibility testing, and clinical testing). The device, when it is phosphate-buffered saline used for washing, and short-term handling and manipulation of gametes and embryos; culture oil used as an overlay for culture media containing gametes and embryos; and water for assisted reproduction applications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.