(293 days)
- To lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. Pre~Va may be applied directly to the device or may be deposited intravaginally using the applicator, prior to the insertion of diagnostic or therapeutic devices used in fertility interventions.
- As a personal lubricant Pre-Va supplements the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. Pre~Va is safe for use by couples who are trying to conceive and may be applied to vaginal or penile tissues for lubrication and moisturization purposes. It is compatible with latex and polyurethane condoms.
This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. Pre~Va is used to lubricate vaginal tissues to facilitate entry of diagnostic or therapeutic devices including those used in fertility interventions. It is also used as a personal lubricant to supplement the body's own natural lubricating fluids and to enhance the comfort of intimate sexual activity. The formulation does not harm sperm function and has a pH and osmolarity that are physiologic ("balanced") to that of fertile cervical mucus and semen. The product is compatible with latex and polyurethane condoms.
This document is a 510(k) summary for the Pre~Va Vaginal Lubricant. It states that the device is substantially equivalent to a predicate device, and as such, it does not present acceptance criteria or a study proving that the device meets those criteria.
The 510(k) summary explicitly states:
"All of the technological characteristics of PreVa are identical to the predicate device."Va are identical to the predicate."
"The performance data of Pre
"Pre~Va Vaginal Lubricant is safe for its intended use and substantially equivalent to the predicate device Pre' Vaginal Lubricant."
Therefore, the requested information regarding acceptance criteria and performance studies is not available in this document because the device's approval is based on its substantial equivalence to a previously approved predicate device, not on a new performance study against specific acceptance criteria.
§ 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.