(190 days)
Durex Play™ is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
The provided text is a 510(k) Premarket Notification summary for Durex Play™ Personal Lubricant and the FDA's clearance letter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study with specific acceptance criteria and performance data for the device itself.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed ground truth establishment for a study proving the device meets acceptance criteria.
The information present in the document pertains to:
- Device Description: Durex Play™ is a clear colorless personal lubricant composed of purified water, Hydroxyethyl cellulose (Natrosol 250), propylene glycol, benzoic acid, sodium hydroxide.
- Intended Use: As a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.
- Predicate Devices: K-Y Jelly Personal Lubricant (K955648) and AstroGlide (K935299).
- Substantial Equivalence: Durex Play™ is substantially equivalent to the predicate devices in intended use and similar in composition. All products are marketed as personal lubricants, safe to use with condoms, water soluble, and sold Over-the-Counter.
In summary, this document describes a regulatory filing based on substantial equivalence, not a clinical or performance study with the detailed aspects requested in the prompt.
§ 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.