(138 days)
Sensual Massage/Ultra Pure 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.
Sensual Massage/Ultra Pure is a non-sterile, silicone-based personal lubricant comprised on dimethoconol, dimethicone, and cyclopentasiloxane. This over-thecounter product is formulated to be clear, non-greasy, and odorless. The Sensual Massage/Ultra Pure lubricant is neither a contraceptive nor a spermicide.
This document is a 510(k) premarket notification for a personal lubricant, not an AI/ML medical device. Therefore, the information requested about acceptance criteria, study details, and ground truth establishment for AI/ML performance evaluation is not applicable to this document.
The document discusses the following:
- Device Name: Sensual Massage/Ultra Pure (a personal lubricant)
- Regulatory Class: Class II
- Predicate Device: SILICONE Personal Lubricant (K191654)
- Indications for Use: Moisturize and lubricate for comfortable intimate sexual activity, supplement natural lubrication, and compatibility with natural rubber latex and polyisoprene condoms (not polyurethane).
- Performance Data: Biocompatibility testing (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), shelf-life testing, and condom compatibility testing.
The "acceptance criteria" in this context refer to the chemical and physical specifications of the lubricant and its biological and material compatibility, not performance metrics of an AI algorithm.
Therefore, I cannot provide the requested information regarding AI/ML device performance, sample sizes for AI/ML test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to AI/ML, as this is not an AI/ML device submission.
§ 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.