(154 days)
Actively Trying Personal Lubricant Rose Scented is a personal lubricant for penile, and/or vaginal application, intended to lubricate and moisturize, 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 Rose Scented 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 Rose Scented 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, Arabinogalactan, and Rose water (Damascena).
This document describes the acceptance criteria and the study results for the "Actively Trying Personal Lubricant Rose Scented" to demonstrate its substantial equivalence to a predicate device.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | ||
| Appearance | Semi-viscous liquid | Semi-viscous liquid |
| Color | Clear | Clear |
| Odor | Rose Scented | Rose Scented |
| Viscosity (cps) per USP | 8,500 - 13,000 | Met (within 8,500 - 13,000) |
| pH per USP | 7.25 - 7.80 | Met (within 7.25 - 7.80) |
| Specific Gravity per USP | 0.900 - 1.100 | Met (within 0.900 - 1.100) |
| Osmolality per USP | 300 — 410 mOsm/kg | Met (within 300 - 410 mOsm/kg) |
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Non-cytotoxic |
| Sensitization (ISO 10993-10:2010) | Non-sensitizing | Non-sensitizing |
| Vaginal Irritation (ISO 10993-10:2010) | Non-irritating | Non-irritating |
| Acute Systemic Toxicity (ISO 10993-11:2006) | Not systemically toxic | Not systemically toxic |
| Sperm Compatibility | ||
| 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 (results indicate compatible and does not inhibit sperm motility) |
| Endotoxin Content | ||
| Limulus Amebocyte Lysate (LAL) Gel-Clot Method USP and/or AAMI/ANSI ST72:2011/(R) 2016 | 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 | Absent |
| Pseudomonas aeruginosa | Absent | Absent |
| Staphylococcus aureus | Absent | Absent |
| Salmonella/Shigella | Absent | Absent |
| Escherichia coli | Absent | Absent |
| Candida albicans | Absent | Absent |
| Condom Compatibility | ||
| Lubricant Barrier Assay (ASTM D7661-10) with natural rubber latex and polyisoprene condoms | Pass | Pass (compatible) |
| Lubricant Barrier Assay (ASTM D7661-10) with polyurethane condoms | Fail (not compatible) | Not compatible |
| Shelf Life | Maintains all device specifications in Table 1 at 0, 1, and 2 years | Met all device specifications at 0, 1 and 2 years |
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 clinical trials with human subjects. The testing described is primarily non-clinical, involving laboratory assays and material compatibility tests. Therefore, typical "sample size" for a clinical test set and "data provenance" (country of origin, retrospective/prospective) are not applicable in the way they would be for a diagnostic device or a drug.
For the biocompatibility studies and non-clinical performance testing (Human Sperm Survival Assay, Endotoxin Testing, Lubricant Barrier Assay), these are laboratory-based tests conducted under specific standards (e.g., ISO 10993, USP, ASTM D7661-10). The sample size would refer to the number of lubricant batches or test replicates used in each assay, which is not detailed in the document beyond stating that the tests were performed.
For shelf-life, tests were conducted at 0, 1, and 2 years. This is a prospective aging study performed on the device product itself.
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 to the non-clinical performance and biocompatibility testing described. These studies rely on standardized laboratory protocols and measurement techniques rather than expert consensus on a "ground truth" derived from human data. The "ground truth" for these tests comes from the established scientific and regulatory standards themselves (e.g., ISO, USP, ASTM).
4. Adjudication method for the test set
Not applicable, as the tests are objective laboratory measurements against defined acceptance criteria, not subjective interpretations requiring adjudication.
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 is not an AI-powered diagnostic device, but a personal lubricant undergoing non-clinical performance testing for substantial equivalence to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance and safety of this device is established by adherence to internationally recognized standards and pharmacopoeial methods. These include:
- ISO 10993 series: for biocompatibility (Cytotoxicity, Sensitization, Vaginal Irritation, Acute Systemic Toxicity).
- USP (United States Pharmacopeia) methods: for physical/chemical properties (Viscosity , pH , Specific Gravity , Osmolality ), endotoxin , antimicrobial effectiveness , and microbial counts , , .
- ASTM D7661-10 Standard Test Method: for condom compatibility (Lubricant Barrier Assay).
- Human Sperm Survival Assay: an established method for evaluating sperm compatibility.
Meeting the predefined specifications and passing these standardized tests constitutes the "ground truth" for demonstrating the device's acceptable performance and safety.
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI algorithms requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as 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.