(314 days)
Patient Lubricants are devices intended to lubricate a body orifice to facilitate entry of a device. When used as an accessory to a condom, patient lubricants are deemed Class II Medical Devices. O'My Lubricant and O'My Flavored Lubricants are principally intended as personal lubricants to supplement the body's own natural lubrication fluids. O'My Lubricants also reduce friction enhancing the comfort and ease of intimate sensual activity with or without a latex condom. O'My Lubricant and O'My Flavored Lubricants are also recommended for personal lubrication when dryness causes discomfort.
O'My Lubricant and O'My Flavored Lubricants are non-sterile, water-based personal lubricants designed to supplement the body's natural lubrication fluids. The formula is a clear, non-greasy natural liquid gel.
The provided text is for a 510(k) summary for a personal lubricant. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.
The document states that "Tests have been performed to establish that the product does not compromise safety" and "No new safety or effectiveness issues have been raised through testing." However, it does not detail these tests, their methodology, acceptance criteria, or specific performance results. This type of information is typically required for medical devices that perform a diagnostic or analytical function.
Given that the device is a personal lubricant, the "acceptance criteria" and "study" would likely focus on aspects like biocompatibility, sterility (if applicable), consistency, pH, and compatibility with condoms, rather than diagnostic performance metrics. The 510(k) process for this type of device primarily aims to establish substantial equivalence to predicate devices, demonstrating that it's as safe and effective as a legally marketed product.
Therefore, I cannot provide the requested table and study details as they are not present in the provided text. The document focuses on regulatory approval based on substantial equivalence for a Class I/II medical device (personal lubricant), not on a performance study against specific, quantified acceptance criteria for an AI or diagnostic device.
§ 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.