(444 days)
Elegant™ 2 in 1 Vaginal Moisturizer/ Elegant™ Advanced 5 is a personal lubricant for 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 polyurethane condoms. This product is not compatible with natural rubber latex and polyisoprene condoms.
The subject device is a non-sterile, water-based, personal lubricant that provides lubrication during intimate sexual activity. The formulation contains purified water, polycarbophil, carbomer homopolymer type B, labrafac, emulfree P, sorbic acid and sodium hydroxide. Elegant™ 2 in 1 Vaginal Moisturizer is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 2ml of product. Elegant™ Advanced 5, is packaged in an aluminium tube and applied using a reusable plastic applicator marked to deliver 3ml of product. Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are personal lubricants for over-the-counter (OTC) use.
The provided document is a 510(k) summary for the Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5. This document assesses the substantial equivalence of a new medical device to a legally marketed predicate device. The information required primarily applies to AI/ML medical devices, which this product (a personal lubricant) is not. Therefore, specific details like sample sizes for training/test sets, number of experts for ground truth, adjudication methods, or MRMC studies are not applicable or provided for this type of device.
However, I can extract the acceptance criteria and a summary of the studies conducted to demonstrate the device meets those criteria, as much as possible from the provided text.
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" in Table 1, which serve as the acceptance criteria for the physical and biological properties of the lubricant. It also summarizes the performance studies conducted to demonstrate compliance with these specifications and other safety/effectiveness aspects.
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Summary from studies) |
|---|---|---|
| Physical/Chemical Specifications (from Table 1) | ||
| Appearance | White to off-white | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Density USP | 0.9970 - 0.9995 g/cm² | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| pH USP | 2.5-3.5 | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Consistency Ph.Eur 2.9.9 | 145 – 200 mm | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Viscosity USP | 120 - 220 Pa-s | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Osmolality USP | 15 – 35 mOsm/kg | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Microbiological Specifications (from Table 1) | ||
| Total Aerobic Microbial Count (TAMC) USP | ≤ 10² CFU/g | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Total combined yeasts/molds count (TYMC) USP | ≤ 10¹ CFU/g | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Absence of pathogenic organisms: Staphylococcus Aureus, Pseudomonas Aeruginosa and Candida Albicans USP | Absent | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Antimicrobial Effectiveness USP | Bacteria: No less than 2.0 log reduction at 14 days and no increase from 14-day count at the 28-day count. Yeast/Mold: No increase from the initial calculated count at 14 and 28 count. | Implied to meet this, as the shelf-life testing demonstrated the device can maintain its specifications. |
| Biological Safety | Non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic. | Results of biocompatibility testing (Cytotoxicity, Intra-vaginal tolerance, Penile irritation, Sensitisation, Acute Systemic Toxicity) demonstrated that Elegant™ 2 in 1 Vaginal Moisturizer and Elegant™ Advanced 5 are non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic. |
| Shelf-Life | Maintain all Table 1 specifications over the stated shelf-life. | Long term data at 25°C/60% RH and accelerated data at 35°C/65% RH for the specifications in Table 1 have been generated up to 6 months, supporting an equivalent of a 12-month shelf life. |
| Condom Compatibility | Compatible with polyurethane condoms. Not compatible with natural rubber latex and polyisoprene condoms. | Testing conducted in accordance with ASTM D7661-10 confirmed the subject device is compatible with polyurethane condoms. It was also found to be not compatible with natural rubber latex and polyisoprene condoms, which is explicitly stated and accepted as a difference from the predicate device that does not raise different questions of safety and effectiveness. |
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 sample sizes for the biological or chemical tests, which is typical for this type of submission focusing on standard test methodology and results. The studies appear to be laboratory-based and likely prospective, following recognized international and national standards (e.g., ISO, USP, ICH, ASTM). No country of origin for the data is explicitly mentioned, but the submitter is Viramal Limited, located in the United Kingdom.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to a personal lubricant. The "ground truth" for this device type is established by standardized laboratory testing methods (e.g., pH meters for pH, specific assays for microbial counts, etc.), not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to a personal lubricant. Standard laboratory tests do not use adjudication methods in the way clinical studies for diagnostic algorithms do.
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 is not applicable to a personal lubricant. MRMC studies are relevant for medical imaging or similar diagnostic AI/ML devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to a personal lubricant, as it is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance criteria (specifications) of this device is based on objective measurements obtained through standardized laboratory testing methods (e.g., USP monographs for pH, density, viscosity, osmolality, microbial counts; ISO standards for biocompatibility; ASTM standards for condom compatibility).
8. The sample size for the training set
This is not applicable to a personal lubricant, as it is not an AI/ML device and does not involve training data.
9. How the ground truth for the training set was established
This is not applicable to a personal lubricant.
§ 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.