(228 days)
Climax Personal Lubricant 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, polyurethane, and polyisoprene condoms.
Climax Personal Lubricant is a non-sterile, water soluble, viscous liquid which is intended to be used as a personal lubricant. The ingredients are Purified Water (Aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Diazolidinyl Urea, Methylparaben, Propylparaben. The product specifications include appearance, color, odor, pH, viscosity, specific gravity, osmolality, total aerobic microbial count per USP , total yeast and mold count per USP , absence of pathogenic organisms per USP , and antimicrobial effectiveness per USP . Climax Personal Lubricant is packaged in 5 fl. oz, and 6.5 fl. oz. bottles.
This document describes the premarket notification (510(k)) and summary for a personal lubricant, "Climax Personal Lubricant." It is not for a medical device that uses AI or complex algorithms requiring extensive performance testing with clinical data, ground truth establishment, or multi-reader studies.
Therefore, the requested information about acceptance criteria, study details (sample size, data provenance, expert adjudication, MRMC studies, standalone performance), and ground truth establishment cannot be provided from this document as it is not relevant to the type of device (personal lubricant) being discussed.
The document focuses on demonstrating substantial equivalence to a predicate device based on:
- Indications for Use: Same as predicate.
- Technological Characteristics: Largely similar to predicate, with differences not raising new safety/effectiveness questions.
- Performance Testing:
- Biocompatibility: Tested per ISO 10993 standards (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
- Condom Compatibility: Tested per ASTM D7661-10 with natural rubber latex, polyurethane, and polyisoprene condoms.
- Shelf Life: Demonstrated maintenance of specifications over proposed shelf life.
The acceptance criteria here are based on meeting these standardized tests rather than clinical performance metrics typical for diagnostic or AI-powered devices. No "ground truth" in the clinical sense (e.g., disease presence/absence determined by pathology) is applicable here.
§ 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.