(80 days)
K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.
This device is a personal lubricant compatible with latex condom.
The provided text is a 510(k) summary for a medical device called "K-Y Brand Intrigue™," which is a personal lubricant. This document states that the device is "substantially equivalent to currently marketed predicate device, K-Y® Brand ULTRA GEL™."
However, this document does not contain any information about acceptance criteria or a study that proves the device meets specific acceptance criteria. It is a regulatory filing focused on establishing substantial equivalence to a predicate device, not on presenting performance data against predefined criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The requested sections (1-9) detailing performance metrics, sample sizes, expert qualifications, etc., are not present in this regulatory submission.
§ 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.