(488 days)
Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.
Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.
This document is a 510(k) premarket notification for a personal lubricant, Durex Play™ Massage gel. It focuses on establishing substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance evaluation in the typical sense of a medical diagnostic device.
Therefore, the requested information elements related to clinical study design, test sets, ground truth establishment, and expert involvement are not applicable in this context. The 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison of intended use, technological characteristics, and performance data if relevant to safety or effectiveness claims.
Here's a breakdown of the available information based on your request, highlighting what is not applicable (N/A) given the nature of a 510(k) for a personal lubricant:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (N/A for 510(k) for this device type) | Reported Device Performance (Focus on Substantial Equivalence) |
|---|---|
| N/A - No specific quantitative performance acceptance criteria are mentioned for this lubricant in the provided text, as this is a 510(k) submission for substantial equivalence. | 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. Compatibility with natural rubber latex and synthetic polyisoprene condoms. |
| N/A | Formulation: Very similar to existing Durex Play™ formulations (Durex Play™ and Durex Play Warmer™). |
| N/A | Safety & Effectiveness: Considered substantially equivalent to predicate devices (K-Y Jelly Personal lubricant, Astroglide, Durex Play™ Warmer lubricant, Durex Play™ Personal Lubricant) based on intended use and formulation similarity. |
| N/A | Biocompatibility: Implied through substantial equivalence to legally marketed predicates. |
| N/A | Condom Compatibility: Explicitly stated to be compatible with natural rubber latex and synthetic polyisoprene condoms. |
2. Sample size used for the test set and the data provenance:
- N/A. The provided document does not describe a "test set" in the context of a performance study for this device. The submission focuses on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. No expert ground truth establishment for a test set is described. The FDA's review process and the determination of substantial equivalence are made by regulatory experts based on the submitted documentation and comparison to predicate devices, rather than through expert review of a clinical test set for this product type.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. No test set or adjudication method is described.
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:
- N/A. This device is a personal lubricant, not an AI-assisted diagnostic or therapeutic device. Therefore, MRMC studies and AI-related effectiveness are irrelevant to this submission.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a personal lubricant, not an algorithm. Standalone performance as described is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. The concept of "ground truth" as typically applied in diagnostic device studies (e.g., pathology for cancer detection) is not applicable here. The "truth" in this 510(k) submission is the demonstration of substantial equivalence to already legally marketed devices based on intended use, technological characteristics, and safety profiles.
8. The sample size for the training set:
- N/A. As this is not an AI/algorithm-based device, there is no "training set."
9. How the ground truth for the training set was established:
- N/A. Not applicable, as there is no training set for this device.
In summary, for a 510(k) submission for a personal lubricant, the primary "study" is the comparison to predicate devices to demonstrate substantial equivalence. The provided document indicates that the device's formulation is "very similar" to existing Durex Play™ products and shares the same intended use as other legally marketed lubricants (K-Y Jelly, Astroglide, etc.). The FDA's issuance of the 510(k) clearance signifies their agreement that the Durex Play™ Massage gel lubricant is substantially equivalent to these predicate devices for its intended use.
§ 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.