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510(k) Data Aggregation
(71 days)
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are personal lubricants 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. These products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.
H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming and #LubeLife Sensations Pleasure Kit for Two are clear, semi-viscous personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms. These devices are non-sterile personal lubricants 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. These devices are composed of water (aqua), Glycerin, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Capsicum Frutescens Fruit Extract and PEG-60 Hydrogenated Castor Oil.
This document describes the validation of several personal lubricants for over-the-counter use. The products are H2O Warming Personal Lubricant, H2O Anal Warming Personal Lubricant, JO 2 To Tango for You, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Warming, and #LubeLife Sensations Pleasure Kit for Two.
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-viscous liquid | Semi-viscous liquid (implied by meeting other specifications) |
| Color | Colorless | Colorless (implied by meeting other specifications) |
| Odor | Odorless | Odorless (implied by meeting other specifications) |
| Viscosity (cps) per USP <911> | 2150 - 4000 | Met (tested at 0, 1, 2, and 3 years) |
| pH per USP <971> | 3.50 - 4.50 | Met (tested at 0, 1, 2, and 3 years) |
| Specific Gravity per USP <841> | 1.010 - 1.030 | Met (tested at 0, 1, 2, and 3 years) |
| Osmolality per USP <785> | 950 – 1100 mOsm/kg (1:1 dilution with purified water) | Met (tested at 0, 1, 2, and 3 years) |
| Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2 products. | Met (tested at 0, 1, 2, and 3 years) |
| Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 100 cfu/g | Met (tested at 0, 1, 2, and 3 years) |
| Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g | Met (tested at 0, 1, 2, and 3 years) |
| Pseudomonas aeruginosa | Absent | Absent (tested at 0, 1, 2, and 3 years) |
| Staphylococcus aureus | Absent | Absent (tested at 0, 1, 2, and 3 years) |
| Salmonella/Shigella | Absent | Absent (tested at 0, 1, 2, and 3 years) |
| Escherichia coli | Absent | Absent (tested at 0, 1, 2, and 3 years) |
| Candida albicans | Absent | Absent (tested at 0, 1, 2, and 3 years) |
| Biocompatibility | Pass cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity | Passed (demonstrated biocompatible) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. |
| Shelf life | 3 years | Met (demonstrated through real-time aging study) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" in the context of a dataset for an AI/algorithm study. The performance data is derived from various laboratory tests and a real-time aging study of the physical lubricant products themselves. Therefore, information on sample size and data provenance in terms of country of origin or retrospective/prospective for a test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as there is no mention of a test set requiring expert ground truth in the context of an AI/algorithm study. The "ground truth" for the device specifications and biocompatibility is established through adherence to recognized scientific standards (USP, ISO, ASTM) and laboratory testing by presumably qualified personnel in those fields.
4. Adjudication Method for the Test Set
This information is not applicable as there is no test set requiring adjudication in the context of an AI/algorithm study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC comparative effectiveness study was not done. This document concerns the performance of personal lubricants, not an AI or imaging device that would involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not done. This document is about physical personal lubricant products.
7. The type of ground truth used
The ground truth for the device's performance is based on:
- Established scientific standards and pharmacopeial monographs: USP (United States Pharmacopeia) for viscosity, pH, specific gravity, osmolality, antimicrobial effectiveness, and microbial counts.
- International standards: ISO 10993 for biocompatibility (cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity), and ASTM D7661-10 for condom compatibility.
- Laboratory test results: Derived from direct measurements and analyses of the lubricant's physical and chemical properties, as well as its interaction with biological systems (biocompatibility) and condoms.
- Real-time aging study: For shelf-life determination.
8. The Sample Size for the Training Set
This information is not applicable as there is no mention of a "training set" in the context of an AI/algorithm study for these personal lubricants. The product formulation development and testing would constitute the "development" phase, but it's not described as a training set for an AI.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" in the context of an AI/algorithm study. The composition and characteristics of the lubricants were developed and confirmed through standard chemical formulation, analytical testing, and quality control processes.
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