(176 days)
The Joylux Intimacy Gel is a water-based personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Joylux Intimacy Gel is a non-sterile, water-based, clear gel personal lubricant. It contains Water, Hydroxyethylcellulose, Polyquaterium-5, Propylene Glycol, PEG-45, Aloe Vera 200x Powder, Sodium Hyaluronate, Geogard Ultra (gluconolactone & sodium benzoate). The lubricant is compatible with natural rubber latex and polyisoprene condoms. The lubricant is not compatible with polyurethane condoms.
The lubricant is packaged in a 4oz / 120mL flip-top 5-layer polyethylene tube made up of 70% LDPE and 30% HDPE.
The provided document is a 510(k) summary for the Joylux Intimacy Gel (PG3100), a water-based personal lubricant. It describes the device, its intended use, comparison to a predicate device, and the non-clinical performance testing conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance/Color | Clear, colorless | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Odor | Odorless | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| pH | 4.0-5.0 | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Viscosity | 900-7800 cps | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Osmolality | 250-420 mOsm/kg (1:10 dilution factor) | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Antimicrobial Effectiveness | Meets USP acceptance criteria for Category 2 products. Bacteria: not less than 2.0 log reduction from the initial count at 14 days, and no increase from 14-days count at 28 days. Yeasts and Molds: no increase from the initial calculated count at 14 and 28 days. | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Total Aerobic Microbial Count (TAMC) | Less than 10 cfu/mL | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Total Yeast and Mold Count (TYMC) | Less than 10 cfu/mL | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Absence of Pathogenic Organisms (Candida albicans, Pseudomonas aeruginosa, Staphylococcus aureus) | Absent | Met (implied by "device met the specifications at all time points" in Shelf Life section) |
| Biocompatibility | Tested per ISO 10993-5, -10, -23, -11 | Supported (Results "support the biocompatibility") |
| Shelf Life | 24-month shelf-life (maintaining all specifications) | Achieved (per real-time and accelerated aging study) |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Not compatible with polyurethane condoms. | Met (Results show compatibility with NR latex and polyisoprene, not with polyurethane) |
2. Sample size used for the test set and the data provenance
The document does not specify typical "test set" sample sizes in the way one might for an AI/ML device. Instead, the testing described is analytical and performance testing for a personal lubricant.
- Biocompatibility: The sample size for animals or cell cultures used in these tests (Cytotoxicity, Guinea Pig Maximization, Vaginal Irritation, Acute Systemic Toxicity) is not explicitly stated.
- Shelf Life: Not specified, but standard aging study protocols typically involve multiple units tested at various time points.
- Condom Compatibility: The specific number of condoms or lubricant samples tested is not provided, but it would adhere to the ASTM D7661-18 standard method.
The data provenance is from non-clinical performance testing conducted on the Joylux Intimacy Gel device itself, likely performed in laboratories according to recognized international standards (ISO, USP, ASTM). It is prospective in the sense that the testing was conducted specifically for this submission. The country of origin of the data is not specified but is implicitly from testing labs adhering to these international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable in the context of this device. The ground truth for the performance of a personal lubricant is established through objective laboratory testing against defined physical, chemical, and biological specifications, not through expert consensus on interpretation of data like in medical imaging.
4. Adjudication method for the test set
Not applicable. As described above, the determination of meeting specifications is based on objective laboratory measurements and adherence to test standards, not on subjective expert interpretation 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/Machine Learning device or an imaging device requiring human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/Machine Learning device. The performance testing is for the physical and chemical properties of the lubricant itself.
7. The type of ground truth used
The ground truth for this device is based on:
- Established industry standards and methods: USP (United States Pharmacopeia) for pH, viscosity, osmolality, and microbial limits; ISO 10993 series for biocompatibility; ASTM D7661-18 for condom compatibility, and ASTM F1980-21 for accelerated aging.
- Pre-defined specifications: The specific quantitative and qualitative acceptance criteria listed in Table 1 for parameters like pH, viscosity, microbial counts, appearance, and odor.
8. The sample size for the training set
Not applicable. This is not an AI/Machine Learning device, so there is no "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.