(101 days)
JO Coconut Hybrid Cooling Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. This product is not compatible with polyurethane condoms.
JO Coconut Hybrid Cooling Personal Lubricant is a clear, viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity supplement the body's natural lubrication.
JO Coconut Hybrid Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in a 1 fl. oz./ 30 mL and 4 fl. oz./ 120 mL bottle. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz/ 30 mL size bottle is capped with natural disc tops. The 4 fl. oz/ 120 mL is capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
This device is composed of Water (Aqua), Propylene Glycol, Caprylic/Capric Triglyceride, Cocos Nucifera (Coconut) Oil, Flavor (Aroma), Phenoxyethanol, Polyacrylate 13, Cellulose Gum, Raphanus Sativus (Radish) Seed Extract, Polyisobutene, Polysorbate 20, Butyrospermum Parkii (Shea) Butter Extract, Ethyl Menthane Carboxamide, Methyl Diisopropyl Propionamide, Beeswax Glyceryl Stearate, Menthyl Lactate, PEG-100 Stearate, Stearamidopropyl Dimethylamine Lactate, PEG45M, Caprylyl Glycol, Phenethyl Alcohol, Ethylhexylglycerin and Polyquaternium-67.
This document is a 510(k) Premarket Notification from the FDA, and it describes the JO Coconut Hybrid Cooling Personal Lubricant. It does not contain information about an AI/ML medical device. Therefore, I cannot provide the requested information regarding acceptance criteria, study details, and ground truth for an AI/ML device, as those details are not present in the provided text.
The document instead focuses on demonstrating the substantial equivalence of a personal lubricant to a legally marketed predicate device, based on:
- Device Specifications: Physical, chemical, and microbiological properties of the lubricant.
- Biocompatibility Testing: To ensure it's safe for human use (non-cytotoxic, non-irritating, non-sensitizing, not acutely systemically toxic).
- Shelf-Life Testing: To confirm the device maintains its specifications over a 3-year period.
- Condom Compatibility Testing: To determine which types of condoms it can be safely used with.
The provided text describes a traditional medical device (a personal lubricant) and its testing for safety and effectiveness, not an AI/ML 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.