(537 days)
"Erozone" personal lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.
"Erozone" is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. "Erozone" Personal Lubricants may be used with condoms.
Not Found
This document is a 510(k) premarket notification letter from the FDA regarding the "Erozone" Glide Fluid, which is classified as a condom (21 CFR 884.5300). The letter confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information about acceptance criteria or a study proving device performance in the context of an AI/algorithm-based medical device. Therefore, I cannot provide the requested information. The content is an FDA approval letter for a physical product, a lubricant, not a software device that would typically have acceptance criteria, test sets, ground truth, or MRMC studies as described in your prompt.
§ 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.