(130 days)
Sperm Preparation Media is a culture media used to prepare sperm prior to Intrauterine Insemination (IUI) procedures. The preparation of sperm includes washing of the sperm and its separation from the semen.
Sperm Preparation Media is a mineral essential media with glucose and penicillin. This product is provided in sterile bottles. This products as indicated in the label is For In Vitro Use Only.
This document is a Premarket Notification (510(k)) for a medical device. It describes the device, its intended use, and claims substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert evaluations that would typically be found in a clinical study report or a more detailed device performance section.
Therefore, I cannot extract the requested information from the provided text. The document focuses on the equivalence of the "GenX Sperm Preparation Media" to an existing product based on its ingredients and intended use, rather than presenting a detailed performance study with acceptance criteria.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.