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510(k) Data Aggregation
(185 days)
Personal Lubricant is a water based 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. This product is not compatible with polyurethane condoms.
Personal Lubricant is a non-sterile, water-based personal lubricant for penile 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, glycerol, hydroxyethyl cellulose, potassium sorbate, methylparaben, carbomer and triethanolamine. Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 300 mL polyethylene terephthalate bottles.
This document is a 510(k) Premarket Notification for a Personal Lubricant, not an AI/ML medical device. Therefore, the information requested in your prompt (acceptance criteria, study details for AI/ML performance, sample sizes, expert ground truth, MRMC studies, etc.) is not present in this document.
The document discusses the substantial equivalence of the Personal Lubricant to a predicate device based on:
- Indications for Use: Same as predicate.
- Technological Characteristics: Similarities and differences in formulation, appearance, odor, viscosity, pH, and osmolality are compared.
- Non-Clinical Performance Testing:
- Biocompatibility: Tested according to ISO 10993 standards.
- Shelf-Life: Demonstrated to maintain specifications for 3 years.
- Condom Compatibility: Tested according to ASTM D7661-10(R) 2017 for compatibility with natural rubber latex and polyisoprene condoms, and incompatibility with polyurethane condoms.
The document does not describe an AI/ML device or its performance criteria.
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(246 days)
Personal Lubricant Jelly 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 condoms. This product is not compatible with polyurethane condoms and polyisoprene condoms.
Personal Lubricant Jelly is a clear, slightly yellow, water-based personal lubricant that is compatible with natural rubber latex condoms. This product is not compatible with polyisoprene and polyurethane condoms. The subject lubricant contains water, hydroxyethylcellulose, glycerin, phenoxyethanol, sodium benzoate, and lactic acid. The subject lubricant is provided in two types of packages: a 2 oz. and 4 oz. polyethylene tube with a screw on top, with sealing film placed over the tube, and a 2.5 oz high density polyethylene bottle with a screw on top. The subject lubricant is a personal lubricant for over the counter (OTC) use.
This document is a 510(k) Premarket Notification from the FDA regarding a Personal Lubricant Jelly. It does not describe an AI/ML medical device. Therefore, I cannot provide information on acceptance criteria or studies related to AI/ML device performance.
The document focuses on the substantial equivalence of the Personal Lubricant Jelly to a predicate device, based on:
- Physical and chemical properties (e.g., pH, viscosity, osmolality, microbial limits).
- Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity).
- Condom compatibility testing.
- Shelf-life stability studies.
There is no mention of AI/ML, human readers, or image analysis in this document.
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