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510(k) Data Aggregation
(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 ) |
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