(296 days)
Lubrease is a personal lubricant for vaginal application, intended to moisturise and lubricate to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.
This product is NOT compatible with latex or synthetic condoms
Lubrease is a single use applicator containing 1.6ml water based lubricating gel. The applicator is designed to lock after the gel has been applied to prevent inadvertent re-use of the applicator.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for a personal lubricant, and it explicitly states:
"Curves Limited has not performed any clinical trials on Lubrease and there are consequently no financial implications to be considered in accordance with 21 CFR 54."
This indicates that no clinical trials or studies were conducted to assess the performance of the device against specific criteria for regulatory submission. The submission relies on demonstrating substantial equivalence to predicate devices (Aquagel K951431 and Rephresh K021737) based on technological characteristics and intended use, rather than presenting performance data from its own studies.
Therefore, I cannot provide the requested information in a table or answer the specific questions about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment, as this information is not present in the provided document.
§ 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.