(231 days)
Durex Silicone is indicated for perile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Durex Silicone is a Personal Lubricant Device that is a non-sterile, odorless, anhydrous, silicone formulation that provides personal lubrication during intimate sexual activity. It is made up of 100% Dimethicone. The ingredient is clear (same as water) in appearance. The Viscosity at 25°C is 80-110 cps. The device will be made available in a 1.69 FL oz. (50mL) HDPE pump sealed bottle with an outer carton. The final dimensions of the carton are 138mmx74mmx28mm.
This document is a 510(k) Premarket Notification for Durex Silicone, a personal lubricant. It does not describe a study involving an AI medical device or other complex diagnostic or therapeutic device. Therefore, many of the requested categories for acceptance criteria and study details are not applicable.
However, I can extract the relevant information regarding the performance data and the comparison to the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from referenced standards) | Reported Device Performance (Durex Silicone) |
|---|---|
| Biocompatibility: | |
| Non-cytotoxic (ISO 10993-5:2009) | Non-cytotoxic |
| Non-irritating to the vaginal area (ISO 10993-10:2010) | Non-irritating to the vaginal area |
| Not systemically toxic (ISO 10993-11:2010) | Not systemically toxic |
| Non-sensitizing (ISO 10993-10:2010) | Non-sensitizing |
| Condom Compatibility: | |
| Compatible with natural rubber latex condoms (ASTM D7661-10) | Compatible with natural rubber latex condoms |
| Compatible with polyisoprene condoms (ASTM D7661-10) | Compatible with polyisoprene condoms |
| Compatible with polyurethane condoms (ASTM D7661-10) | Compatible with polyurethane condoms |
| Shelf Life: | |
| 24-month shelf life | Maintained specifications for 12 months in accelerated testing, supporting a 24-month shelf life. |
| Physical Appearance: | |
| Clear, odorless, anhydrous, silicone formulation | Clear, odorless, silicone formulation (100% Dimethicone) |
| Viscosity at 25°C: 80-110 cps | Viscosity at 25°C: 80-110 cps |
2. Sample size used for the test set and the data provenance
- Biocompatibility (Cytotoxicity, Irritation, Systemic Toxicity, Sensitization): The document does not specify the sample sizes (e.g., number of cell cultures, animals) used for these tests. The provenance of the data is implicit as part of a regulatory submission to the FDA by the manufacturer, Reckitt Benckiser LLC. These are likely prospective laboratory and in-vivo animal studies conducted according to the cited ISO standards.
- Condom Compatibility: The testing was done using ASTM method D7661-10 with "three marketed brands of Natural Rubber Latex condoms, one brand of polyisoprene condom, and one brand of polyurethane condoms." The specific number of condoms and lubricants tested per brand is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is a personal lubricant, and the 'ground truth' is established through standardized laboratory and animal testing for biocompatibility and material compatibility, not through expert clinical interpretation of medical images or patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. The tests performed are laboratory-based and follow standardized protocols, not human-read expert 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-enabled 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 software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" used for this device's performance evaluation is based on standardized testing protocols and methodologies defined by international (ISO) and national (ASTM) standards.
- For biocompatibility: Cellular response to extract, physiological reactions in animal models.
- For condom compatibility: Physical and chemical interaction with condom materials as measured by ASTM D7661-10.
- For shelf life: Stability of physical/chemical properties over time.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML model for this type of device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" for this 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.