(54 days)
EMBRYON® Intra-uterine Insemination Cathetors are purpose designed for the introduction of washed spermatazon into the uterus.
EMBRYON® Intra-uterine Insemination Catheters
The provided text is a 510(k) summary for the EMBRYON® Intra-uterine Insemination Catheters. It asserts substantial equivalence to predicate devices already on the market. However, it does not contain any information regarding specific acceptance criteria, device performance metrics from a study, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or details of comparative effectiveness studies.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document focuses on regulatory approval through substantial equivalence, not on a detailed performance study summary.
The "Summary of Safety and Effectiveness" section only states: "The devices we believe are safe and effective for the application for which they are intended, intrauterine insemination, having been subjected to full design evaluation. They have been on sale and in commercial distribution within the UK and many other countries for more than 6 years." This is a general statement, not a reporting of specific study results with acceptance criteria.
§ 884.5250 Cervical cap.
(a)
Identification. A cervical cap is a flexible cuplike receptacle that fits over the cervix to collect menstrual flow or to aid artificial insemination. This generic type of device is not for contraceptive use.(b)
Classification. Class II (performance standards).