(560 days)
Durex® RealFeel™ Pleasure Gel Personal Lubricant is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. This lubricant is compatible with polyurethane condoms. It is not compatible with natural rubber latex and polyisoprene condoms.
Durex® RealFeel™ Pleasure Gel is a non-sterile, personal silicone base lubricant. The lubricant is comprised of cyclopentasiloxane and dimethiconol. Durex® RealFeel™ Pleasure Gel contains a blend of silicone fluid ingredients similar to ingredients found in the predicate device The specifications for Durex® RealFeel™ Gel include appearance, odor, viscosity, specific gravity, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans).
This document describes the review of Durex® RealFeel™ Pleasure Gel Personal Lubricant for 510(k) premarket notification. The review focuses on establishing substantial equivalence to a legally marketed predicate device, ONE® Silicone Lubricant (K110690).
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Test | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (moisturize and lubricate for intimate sexual activity, supplement natural lubrication). Condom compatibility is the key differentiating factor. | Durex® RealFeel™ Pleasure Gel is intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease of comfort of intimate sexual activity and supplement the body's natural lubrication. |
| Material Composition | Similar to predicate device (silicone-based). | Comprised of cyclopentasiloxane and dimethiconol; a blend of silicone fluid ingredients similar to ingredients found in the predicate device. |
| Physical Specifications | Not explicitly stated, but assumed to be acceptable (e.g., appearance, odor, viscosity, specific gravity). | "The specifications... include appearance, odor, viscosity, specific gravity..." (Specific values not provided in this document but implied to meet internal standards). |
| Microbiological Purity | Absence of pathogenic organisms; acceptable total aerobic microbial count, total yeast and mold count. | "total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeroginosa, Staphylococcus aureus, and Candida albicans)." (Specific limits not provided but implied to meet internal standards). |
| Biocompatibility | Pass relevant ISO 10993-1 standards for cytotoxicity, systemic toxicity, sensitization, and irritation. | "The results demonstrate that the subject device is biocompatible." (Based on four studies: cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits). |
| Condom Compatibility | Must be compatible with polyurethane condoms. | Compatible with polyurethane condoms. Not compatible with natural rubber latex and polyisoprene condoms (This is a differentiating factor from the predicate but is acceptable as it's clearly stated in the indications for use). |
| Stability/Shelf-Life | Maintains specifications over stated shelf life. | "The results of accelerated and real time studies demonstrate that the subject lubricant maintains its specifications over the duration of its shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
This document does not specify the exact sample sizes for each of the performance tests (biocompatibility, condom compatibility, stability). However, it states that:
- Biocompatibility Studies: Four studies were conducted. The specific number of animals/samples for each endpoint (cytotoxicity, systemic toxicity in mice, maximization in guinea pigs, and vaginal irritation in rabbits) is not detailed.
- Condom Compatibility Testing: The sample size for this testing is not provided.
- Stability Studies: The sample size for the accelerated and real-time studies is not provided.
The data provenance is not explicitly stated in terms of country of origin but is implied to be from studies conducted by or for Reckitt Benckiser, LLC. These studies are retrospective to the submission date of November 18, 2014.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation is for a personal lubricant, not a diagnostic device requiring expert interpretation of medical images or data for ground truth establishment. The ground truth (or reference standard) for this device's performance is based on standardized testing methods and laboratory measurements, not expert consensus on medical conditions.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where expert consensus is needed to establish a ground truth for diagnostic accuracy, which is not the case here.
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. This is a submission for a personal lubricant and does not involve AI, human readers, or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable. This is not an algorithmic or AI-based device.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Standardized Laboratory Testing and Measurement:
- Biocompatibility: Adherence to GLP requirements and applicable ISO 10993-1 standards for endpoints like cytotoxicity, systemic toxicity, sensitization, and irritation.
- Condom Compatibility: Testing conducted in accordance with ASTM D7661-2010.
- Physical and Microbiological Specifications: Internal quality control standards and established methods for appearance, odor, viscosity, specific gravity, microbial counts, and absence of specific pathogens.
- Stability: Laboratory assessment of product specifications over time under accelerated and real-time conditions.
8. The Sample Size for the Training Set
This information is not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for a training set.
§ 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.