(167 days)
Actively Trying Personal Lubricant Unfragranced is a personal lubricant for penile, and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of sexual activity and supplement the body's natural lubrication. This product is compatible with sperm, oocytes and embryos and can be used by couples trying to conceive. This product is compatible with natural rubber latex and polvisoprene condoms. This product is not compatible with polyurethane condoms.
Actively Trying Personal Lubricant Unfragranced is a clear, semi-viscous personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is compatible with sperm, oocytes and can be used by couples trying to conceive. Actively Trying Personal Lubricant Unfragranced is sold as an over-the-counter (OTC) product in 4 fl. oz./120 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The individual bottles are hermetically sealed during the production process. This device is composed of Water (Aqua), Hydroxyethylcellulose, Sodium Chloride, Sodium Phosphate, Potassium Phosphate, Propylene Glycol, Chlorphenisen, Fructose and Arabinogalactan.
This document describes the regulatory submission for the Actively Trying Personal Lubricant Unfragranced (K212705). The information provided focuses on the device's characteristics and the non-clinical performance testing conducted to demonstrate its safety and effectiveness.
Here’s a breakdown as requested:
1. Table of Acceptance Criteria and the Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Appearance | Semi-viscous liquid | Semi-viscous liquid |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity (cps) per USP | 8,500 - 13,000 | Within range (actual value not reported, but stated to meet) |
| pH per USP | 7.25 - 7.80 | Within range (actual value not reported, but stated to meet) |
| Specific Gravity per USP | 0.900 - 1.100 | Within range (actual value not reported, but stated to meet) |
| Osmolality per USP | 300 – 410 mOsm/kg | Within range (actual value not reported, but stated to meet) |
| Human Sperm Survival Assay (HSSA) | ≥ 80% of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant | ≥ 80% of control motility at 24 hours after 30 minutes exposure to 10% of subject lubricant (reported as "compatible with sperm and does not inhibit sperm motility") |
| Limulus Amebocyte Lysate (LAL) Gel-Clot Method | Meets USP acceptance criteria for Category 2 products | |
| Total aerobic microbial count (TAMC) per USP and | Less than 100 cfu/g | Less than 100 cfu/g |
| Total yeast and mold count (TYMC) per USP and | Less than 10 cfu/g | Less than 10 cfu/g |
| Presence of Pathogens per USP | Absent for Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella/Shigella, Escherichia coli, Candida albicans | Absent for all listed pathogens |
| Biocompatibility (Acute Systemic Toxicity) | Non-toxic | Non-systemically toxic |
| Biocompatibility (Vaginal Irritation) | Non-irritating | Non-irritating |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | (Implied non-cytotoxic, stated "results of this testing demonstrated that the subject lubricant is... nonsensitizing") |
| Biocompatibility (Sensitization) | Non-sensitizing | Non-sensitizing |
| Condom Compatibility (Natural Rubber Latex) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible | Not compatible |
| Shelf Life (2 years) | Meets device specifications at all time points (0, 1, and 2 years) | Met device specifications at all time points |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the exact sample sizes for each non-clinical test (e.g., number of animals for toxicity, number of sperm samples for HSSA). The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective, but they are described as "non-clinical performance testing" and "real time aging study", implying prospective testing for the shelf life.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that does not involve human readers or interpretation of medical images. Ground truth is established through laboratory test results against predefined scientific and regulatory standards (e.g., USP, ISO, ASTM).
4. Adjudication method for the test set
Not applicable. As noted above, this device does not involve expert adjudication for ground truth.
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
Not applicable. This document is for a personal lubricant, not an AI-powered diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the performance criteria is established by:
- Physical and Chemical Property Standards: USP (United States Pharmacopeia) standards for viscosity, pH, specific gravity, osmolality.
- Biological Standards: ISO (International Organization for Standardization) standards for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity), USP standards for LAL (endotoxin) and antimicrobial effectiveness, and HSSA guidelines.
- Microbiological Standards: USP standards for total aerobic microbial count, total yeast and mold count, and presence of specific pathogens.
- Material Compatibility Standards: ASTM (American Society for Testing and Materials) standards for condom compatibility.
- Real-time aging study: to determine shelf life.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.