(112 days)
K-Y® Brand Intrigue™ Intense Warming Sensation 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 document is a 510(k) Summary for a medical device called "K-Y® Brand Intrigue™ Intense Warming Sensation," which is a personal lubricant. It does not include information about a study involving an AI/algorithmic device with acceptance criteria, ground truth, or expert review in the manner typically described for such technologies.
The performance data mentioned in the document relates to laboratory testing, pre-clinical evaluations, and human use to demonstrate equivalence to a predicate device. This is a very different type of evaluation than what is requested in the prompt for an AI-powered device.
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence of a personal lubricant to a legally marketed predicate device based on its physical and performance characteristics, and its safety for human use and compatibility with latex condoms. It does not involve AI or algorithms that would require the specified acceptance criteria and ground truth methodologies.
§ 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.