(164 days)
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Replens Long-Lasting Vaginal Moisturizer is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. It is a smooth, white, homogenous vaginal gel packaged with a reusable applicator. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Mineral Oil, Polycarbophil, Carbomer Homopolymer Type B, Hydrogenated Palm Oil Glyceride, Sorbic Acid, Benzyl Alcohol, Ethylhexylglycerin, tocopherol, and Sodium Hydroxide. Replens Long-Lasting Vaginal Moisturizer is packaged in a 35g aluminum tube (14 applications), with a reusable two-piece, blue translucent, polyethylene applicator designed to dispense 2.5g of lubricant.
The reusable applicator is packaged with an over-wrap in clear, biaxially oriented polypropylene film. The subject device and applicator are packaged together in a carton with a consumer leaflet.
The provided document is a 510(k) Pre-market Notification from the FDA regarding a medical device, the Replens Long-Lasting Vaginal Moisturizer. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study with a test set, expert ground truth, or MRMC studies.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics (like sensitivity, specificity, or reader improvement) are not applicable to this type of regulatory submission. The goal here is to show that the new device is as safe and effective as the predicate device, primarily through non-clinical performance testing and comparison of technological characteristics.
However, I can extract information related to what is presented as "acceptance criteria" in the context of this submission, which are primarily product specifications and performance testing results.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents product specifications as the "acceptance criteria" for the device itself, rather than acceptance criteria for a diagnostic algorithm's performance. The "reported device performance" is essentially that the device meets these specifications.
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied by "demonstrated that the device can maintain its specifications") |
|---|---|---|
| Appearance | White to off-white smooth homogenous gel | Met |
| Odor | Odorless | Met |
| Viscosity | 30,000 - 130,000 cPs | Met |
| pH | 2.5 - 3.5 | Met |
| Osmolality | 1200 - 2000 mOsm/Kg | Met |
| Total Aerobic Microbial Count (TAMC) |
§ 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.