(200 days)
Intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and the responsiveness (ease and comfort) during intimate sexual activity.
SENSUA! is a clear, colorless personal lubricant composed of: purified water. Propylene glycol, L-arginine, Hydroxyethyl cellulose, Methylparaben and other ingredients.
This document is a 510(k) summary for a personal lubricant called "SENSUA! Personal Lubricant". It is not a study about a medical device that utilizes an algorithm or AI. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance.
The document discusses the device's general information, predicate devices, description, and intended use as a moisturizer for vaginal dryness and personal lubrication. It also confirms that the device has been tested for condom compatibility and preservative effectiveness to demonstrate substantial equivalence to predicate devices. However, no specific performance metrics or studies are detailed in relation to these tests.
§ 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.