(150 days)
This product is intended for penile, vaginal and/or anal application 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
KY Banksy Moisture will be marketed as a non-sterile, non-prescription medical device for over-thecounter (OTC) use. This device is a water-based personal lubricant that contains: Water, Glycerin, Propanediol, Xanthan Gum, Benzoic Acid, Sodium Hyaluronate, Potassium Lactate and Lactic Acid. The tube material is composed of High-Density Polyethylene (HDPE) and Low-Density Polyethylene (LDPE), covered with a 50-micron aluminum/inear low-density polyethylene seal and fitted with the Polypropylene (PP) cap. The tube will be packaged in an outer cardboard carton.
The provided document is a 510(k) premarket notification for a medical device called "KY Banksy Moisture," a personal lubricant. It doesn't contain information about AI/ML models, human-in-the-loop performance, or a comparative effectiveness study. Therefore, I cannot provide details on those aspects.
However, I can extract the acceptance criteria and the studies performed to demonstrate substantial equivalence to a predicate device.
Here's the information based on the provided text:
1. Table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear colorless and homogeneous gel, free from extraneous matter | Clear colorless and homogeneous gel, free from extraneous matter |
| Odor | Odorless | Odorless |
| Viscosity | Release: 3,000 – 6,500 cps; Stability: 3,000 - 8,000 cps | Maintained within specified ranges for release and stability. |
| pH at 25°C | 3.5 – 4.5 | Maintained within the specified range. |
| Benzoic Acid | Release: 0.207 – 0.253 %w/w; Stability: 0.150 - 0.253 %w/w | Maintained within specified ranges for release and stability. |
| Osmolality | 1050 to 1250 mOsm/kg | Maintained within the specified range. |
| Total Yeast and Mold Count (TYMC) | ≤10 cfu/g (per EP 8.0 Section: 2.6.12) |
§ 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.