The Conception Kit® at-home system is built around the proven methodology of cervical cap insemination. Since the 1950s cervical cap insemination has been used by doctors as an effective in-office treatment for infertility.
The Conception Kit at-home system is 510k cleared with the FDA. To obtain this clearance the following had to be demonstrated:
- That the Conception Cap® (cervical cap) is substantially equivalent to the predicate devices in terms of safety and effectiveness.
- That patients could use the Conception Kit® and Conception Cap® in the privacy of their home correctly (keep in mind that up to this time period all cervical caps for insemination were used in a physician setting only). 84% of the women found the Conception Kit® at-home system easy to use.
- That the materials did not change the cervical mucus, or sperm in any way.
- Andrologia 2001 Jul; 33(4):207-13 Evaluation of the effects of a cervical cap device on sperm functional characteristics in vitro. Mahony MC.
Performance data was needed to support the new indication and demonstrate that new labeling provides adequate instruction for patient use and that women can successfully follow without direct supervision. 92% of the patients were able to understand and follow the instructions correctly.
With the 510k clearance Conceivex, Inc. is claiming the class of cervical caps using historical cervical cap pregnancy rates which are between 18% and 44%.