(493 days)
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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 natural rubber latex, polyisoprene, and polyurethane condoms
Play & Joy InvisiLube Lubricant Capsule is a personal lubricant for over-the counter use, 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. Play & Joy InvisiLube Lubricant Capsule is a non-sterile, anhydrous silicone inner component encapsulated with a gelatin shell. It is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The inner component is composed of a blend of silicone with primary ingredients: Cyclopentasiloxane, Dimethiconol, and Dimethicone. The gelatin shell is composed of gelatin, glycerin, Phatic acid, and water.
The provided text is a 510(k) summary for a medical device called "Play & Joy InvisiLube Lubricant Capsule." This document is used to demonstrate substantial equivalence to a predicate device, not to showcase a study comparing human reader performance with and without AI assistance for tasks like image interpretation.
Therefore, the requested information regarding acceptance criteria and a study proving device performance in the context of AI assistance (e.g., sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth for training/test sets) is not applicable to this specific document.
The document describes the non-clinical performance testing conducted for the Play & Joy InvisiLube Lubricant Capsule to demonstrate its safety and effectiveness relative to a predicate device. This includes:
1. A table of acceptance criteria and the reported device performance (Non-clinical Specifications):
| Property | Acceptance Criteria (Specification) | Reported Device Performance (Implied to meet specification) |
|---|---|---|
| Appearance | Colorless | Colorless |
| Color | Clear | Clear |
| Odor | Odorless | Odorless |
| Viscosity | 75 - 201 cps | (Tested to be within this range) |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) | ) |
| - Pseudomonas aeruginosa | Absent | Absent |
| - Staphylococcus aureus | Absent | Absent |
| - Candida albicans | Absent | Absent |
| - Escherichia coli | Absent | Absent |
| - Salmonella | Absent | Absent |
| Biocompatibility | Non-sensitizing, Non-irritation, Not systemically toxic | Met (Results demonstrate non-sensitizing, non-irritation, and not systemically toxic) |
| Shelf-Life | 6 months (maintains specifications) | Met (Demonstrated stability over 6 months) |
| Condom Compatibility | Compatible with natural rubber latex, polyisoprene, and polyurethane condoms | Met (Showed compatibility with all three types) |
Regarding the other points, they are not relevant to this type of device and study:
- 2. Sample size used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance and biocompatibility studies, not clinical studies with patient data.
- 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for these tests is based on established testing standards (e.g., USP, ISO, ASTM).
- 4. Adjudication method: Not applicable.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is not an AI-assisted diagnostic device.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- 7. The type of ground truth used: For non-clinical tests, the "ground truth" is defined by the specific parameters and limits set by the referenced standards (e.g., sterility limits, pH ranges, cytotoxicity assays).
- 8. The sample size for the training set: Not applicable. This product does not involve machine learning or AI models with training sets.
- 9. How the ground truth for the training set was established: Not applicable.
§ 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.