(272 days)
Good Clean Love BIO-pHRESH is a personal lubricant for penile and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms.
Good Clean Love BIO-pHRESH contains water-solvent materials. The primary ingredient (95%) is aloe vera and it includes aromatics of apple. The product is provided in tube container and has a gel consistency. It is supplied with a vaginal applicator. The lubricant is not a spermicide or contraceptive. It is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. The product is formulated to match the osmolality and pH found in the human vagina.
The provided document is a 510(k) premarket notification letter and supporting summary for a personal lubricant called "Good Clean Love - BIO-pHRESH." This document DOES NOT describe a study involving an AI-powered device or a medical imaging device.
Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, or MRMC studies, as these concepts are not applicable to the information contained within this document.
The document discusses the substantial equivalence of the lubricant to predicate devices based on:
- Non-clinical performance testing: Compatibility with condoms (latex and polyisoprene only), antimicrobial effectiveness, appearance, color, odor, texture, pH, specific gravity, viscosity, osmolality, biocompatibility (cytotoxicity, sensitization, irritation, acute systemic toxicity), and shelf-life.
- Formulation comparison: Similar primary ingredients (aloe vera), thickeners, and preservatives to predicate devices.
- Intended use: Moisturizing and lubricating for intimate sexual activity, supplementing natural lubrication, and compatibility with specific condom types.
The conclusion drawn is that the product is as safe and effective as its predicate devices, supporting a determination of substantial equivalence for marketing.
§ 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.