(307 days)
pjur® AQUA Baseline for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA Guarana for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® BACK DOOR anal Provitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
pjur® AQUA ProVitamin B5 for penile, vaginal and/or anal application, intended to moisturize and lubricate, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
The piur® AQUA Baseline, pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 are water-based personal lubricants provided non-sterile. These personal lubricants are for over-the-counter use. They are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. The products are provided in 30 mL and 100 mL polyethylene bottles.
The pjur® AQUA Baseline consists of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyl guar hydroxypropyltrimonium chloride, hydroxyethylcellulose, and citric acid. The pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, and pjur® AQUA ProVitamin B5 have the same formulation and consist of water, glycerin, ethoxydiglycol, phenoxyethanol, hydroxypropyltrimonium chloride, propylene glycol, hydroxyethylcellulose, panthenol, polysorbate 20, citric acid, chamomilla recrutita (matricaria) flower extract, paullinia cupana seed extract, cananga odorata flower oil, alcohol, 1,2hexanediol, decylene glycol, lactic acid, sodium benzoate, and potassium sorbate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are presented as "Specifications" in "Table 1: Device Specifications" on page 4. The reported device performance is implicitly stated as meeting these specifications.
| Parameter | Acceptance Criteria (pjur® AQUA Baseline) | Reported Device Performance (pjur® AQUA Baseline) | Acceptance Criteria (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5) | Reported Device Performance (pjur® AQUA Guarana, pjur® BACK DOOR anal Provitamin B5, pjur® AQUA ProVitamin B5) |
|---|---|---|---|---|
| Appearance | Clear fluid | Clear fluid (Implied from meeting specifications) | Clear fluid | Clear fluid (Implied from meeting specifications) |
| Odor | Product typical | Product typical (Implied from meeting specifications) | Product typical | Product typical (Implied from meeting specifications) |
| pH | 4.1-4.7 | Meets 4.1-4.7 (Implied) | 4.1-4.7 | Meets 4.1-4.7 (Implied) |
| Viscosity (mPa*s) | 750 - 1250 | Meets 750 - 1250 (Implied) | 690 - 1100 | Meets 690 - 1100 (Implied) |
| Osmolality (mOsmol/kg) | 500-625 (diluted 1:3.9) | Meets 500-625 (diluted 1:3.9) (Implied) | 500-625 (diluted 1:4.1) | Meets 500-625 (diluted 1:4.1) (Implied) |
| Total Yeast and Mold Count (TYMC) | , USP, USP). |
- Microbiological standards: Total microbial counts and absence of specific pathogens, measured according to USP and USP.
- Antimicrobial effectiveness: Standardized challenge tests per USP.
- Safety standards: Biocompatibility testing conforms to ISO 10993 series for cytotoxicity, sensitization, irritation, and systemic toxicity.
- Functionality standards: Condom compatibility testing follows ASTM D7661-10.
- Stability standards: Real-time and accelerated aging studies for shelf-life determination.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of a personal lubricant's physical, chemical, and biological testing. These are direct measurements of manufactured product characteristics.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8.
§ 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.