(143 days)
Desnuda Reflect 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. This product is not compatible with polyurethane condoms.
Desnuda Reflect is a water-based personal lubricant that is non-sterile and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of water, hydroxyethyl cellulose, xanthan gum, hyaluronic acid, Zemea propanediol, sodium benzoate, potassium sorbate, and DL lactic acid. Desnuda Reflect is packaged in 2 fl. oz high-density polyethylene pump bottles. Desnuda Reflect is a personal lubricant for over-the-counter (OTC) use.
The provided text describes the 510(k) premarket notification for a medical device called "Desnuda Reflect," a personal lubricant. It does not contain information about an AI-powered device or a study involving human readers and AI assistance for medical imaging, which is what your query is geared towards.
Therefore, I cannot provide the detailed information requested in points 1-9 of your prompt, as the document concerns a physical product (personal lubricant) and its testing for safety and effectiveness as a lubricant, not a digital AI medical device.
The document discusses various performance tests relevant to a personal lubricant, such as:
- Biocompatibility testing: Cytotoxicity, sensitization, irritation, and acute systemic toxicity.
- Condom Compatibility testing: Adherence to ASTM D7661-18 for natural rubber latex and polyisoprene condoms.
- Shelf-life testing: Accelerated aging study to confirm maintenance of specifications over one year.
- Device Specifications (Table 1): Appearance, color, odor, viscosity, osmolality, pH, microbial counts (TAMC, TYMC), absence of specific pathogens, and antimicrobial effectiveness.
These tests establish the safety and effectiveness of the lubricant but are not related to the acceptance criteria or study design for an AI medical imaging 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.