(70 days)
H2O Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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 Cooling Personal Lubricant, H2O Anal Cooling Personal Lubricant, JO 2 To Tango for Me, JO 2 To Tango Couples Pleasure Kit, #LubeLife Sensations Cooling 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.
H2O Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 1 fl. oz./30 mL, 2 fl. oz./60 mL and 4 fl. oz./120 mL sizes. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 1 fl. oz./30 mL size bottles are capped with natural disc tops. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
H2O Anal Cooling Personal Lubricant is sold as an over-the-counter (OTC) product in 2 fl. oz/60 mL and 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL and 4 fl. oz./120 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango for Me is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
JO 2 To Tango Couples Pleasure Kit is sold as an over the counter (OTC) product in 2 fl. oz/60 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 2 fl. oz./60 mL size bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Cooling is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
#LubeLife Sensations Pleasure Kit for Two is sold as an over the counter (OTC) product in 4 fl. oz./120 mL. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The 4 fl. oz./120 mL size bottles are capped with natural disc tops. The individual bottles are hermetically sealed during the production process.
These devices are composed of Water (Aqua), Glycerin, Polysorbate 20, Propylene Glycol, Hydroxyethylcellulose, Chlorphenesin, Mentha Piperita (Peppermint) Leaf Extract and Sodium Hydroxide.
The document describes the acceptance criteria and supporting studies for several H2O and JO brand cooling personal lubricants.
1. Table of Acceptance Criteria and Reported Device Performance:
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Semi-viscous liquid | Met |
| Color | Colorless | Met |
| Odor | Peppermint | Met |
| Viscosity (cps) per USP | 2150 - 4000 | Met |
| pH per USP | 3.50 - 4.50 | Met |
| Specific Gravity per USP | 1.010 - 1.030 | Met |
| Osmolality per USP | 1000 – 1100 (1:1 dilution with purified water) | Met |
| Antimicrobial effectiveness per USP | Meets USP acceptance criteria for Category 2 products. | Met |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g | Met |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Met |
| Presence of Pathogens per USP : Pseudomonas aeruginosa | Absent | Met |
| Presence of Pathogens per USP : Staphylococcus aureus | Absent | Met |
| Presence of Pathogens per USP : Salmonella/Shigella | Absent | Met |
| Presence of Pathogens per USP : Escherichia coli | Absent | Met |
| Presence of Pathogens per USP : Candida albicans | Absent | Met |
| Biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity) | Demonstrates biocompatibility per ISO 10993 standards | Met |
| Shelf-Life | 3 years (maintaining all device specifications) | Met |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms | Met |
2. Sample size used for the test set and the data provenance:
- Biocompatibility: The document states that "Biocompatibility studies... were performed," implying specific samples were used for testing. However, the exact sample sizes (e.g., number of animals or in-vitro replicates) are not specified. The provenance is not explicitly stated beyond being performed "in accordance with the 2020 FDA Guidance document Use of International Standard ISO 10993-1" and "ISO 10993-1:2019." These are international standards. The study is prospective in nature as it involves testing the device.
- Shelf-Life: The document states "All the devices specifications listed in Table 1 were tested at 0, 1, 2 and 3 years." This indicates longitudinal testing of samples over time. The sample size at each time point is not specified. Data provenance is not detailed, but it's a real-time aging study, implying internal testing by the manufacturer. This is a prospective study.
- Condom Compatibility: The document states "The compatibility... was evaluated in accordance with ASTM D7661-10 (Reapproved 2017)." The number of lubricant and condom samples tested is not specified. This is a prospective study following an ASTM standard.
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 the device is a personal lubricant, and the testing involves laboratory and in-vivo biocompatibility, shelf-life, and material compatibility tests, not clinical performance requiring expert interpretation of diagnostic images or patient data. The criteria are based on established scientific standards and physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable for the type of testing performed (laboratory and material compatibility). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations (e.g., radiology reads).
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:
This information is not applicable. The device is a personal lubricant, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance comparisons are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a personal lubricant, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the performance criteria is established by:
- Established physical and chemical specifications: For properties like appearance, color, odor, viscosity, pH, specific gravity, and osmolality.
- Microbiological standards: For antimicrobial effectiveness (USP ) and microbial counts/absence of pathogens (USP , , ).
- International and national testing standards: Specifically ISO 10993 for biocompatibility and ASTM D7661-10 for condom compatibility. These standards define the methodologies and corresponding acceptance criteria.
- Real-time aging study: For shelf-life, the ground truth is the documented stability of the product properties over the specified time period.
8. The sample size for the training set:
This information is not applicable. As a physical product, there is no "training set" in the context of machine learning or AI development.
9. How the ground truth for the training set was established:
This information is not applicable. There is no training set for this type of 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.