(381 days)
Walgreen's Personal Lubricating Jelly is a personal lubricant, for penile 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. It can ease insertion of rectal thermometers, enemas and tampons. This product is compatible with latex condoms.
Walgreen's Personal Lubricating Jelly is a non-sterile, aqueous based personal lubricant designed to supplement the body's own natural lubrication fluids. It is specifically formulated to be a clear, nonirritating, non-greasy, gel-like liquid and is compatible for use with or without a condom during intimate sexual activity as evidenced by condom compatibility test results. Walgreen's Personal Lubricating Jelly is a water-based personal lubricant containing chlorhexidine digluconate and methylparaben as preservatives in a vehicle for glucono delta lactone, glycerin, hydroxyethylcellulose, sodium hydroxide, and purified water. This product is designed in LDPE tube w/ plastic flip-top cap.
The Walgreen's Personal Lubricating Jelly is a personal lubricant. The provided information does not describe an AI/ML device, therefore, the requested information on studies, test sets, ground truth, and training sets is not applicable.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Condom Compatibility | Device meets established acceptance criteria |
| Biocompatibility | Device meets established acceptance criteria |
| Preservative Effectiveness | Device meets established acceptance criteria |
| Substantially Equivalent Ingredients to Predicate Device | Confirmed: Contains purified water, glycerin, gluconolactone, cellulose thickeners, chlorhexidine gluconate, methylparaben, sodium hydroxide. Does not contain alcohol and fragrance. Compatible with latex condoms. |
| Over-the-Counter Use | Yes |
| Labeled Water Soluble | Yes |
| Labeled Condom Compatible | Yes |
| Container Material | Plastic |
| Sterile | No |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device that would typically involve test sets or data provenance in this context. The product was tested by independent laboratories, but specific sample sizes and data provenance for these tests are not provided in the summary.
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)
Not applicable. The submission is for a medical device (personal lubricant) and not an AI/ML device. Ground truth as typically understood for AI/ML validation is not relevant here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device.
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/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The assessment relied on laboratory testing for condom compatibility, biocompatibility, and preservative effectiveness, and comparison of chemical ingredients and intended use to a predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML 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.