(271 days)
The Durex Play™ Tingling aqueous based Lubricant is a personal lubricant, for penile and/or vaginal application, intended to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is only compatible with natural rubber latex condoms.
Durex Play™ Tingling aqueous based personal lubricant is a slightly hazy/clear, water soluble personal lubricant.
The provided text is for a 510(k) premarket notification for a personal lubricant, not a medical device that would require the typical performance studies described in your request. Therefore, most of the requested information regarding acceptance criteria, study findings, sample sizes, expert ground truth, adjudication methods, and comparative effectiveness studies is not applicable to this type of submission.
This submission focuses on demonstrating substantial equivalence to a predicate device, Durex Play™ Personal Lubricant (K032124), rather than proving specific performance metrics against defined acceptance criteria for a diagnostic or therapeutic device. The key elements for this type of submission are typically:
- Intended Use Compatibility: Ensuring the new device's intended use is substantially equivalent to the predicate.
- Material Compatibility: Proving the formulation and materials are safe and compatible with intended use (e.g., condom compatibility).
- Biocompatibility (if applicable): Testing for irritation or sensitization.
- Performance (functional): Ensuring the lubricant functions as expected (e.g., lubrication properties).
Given the nature of the device (a personal lubricant), the "acceptance criteria" and "study" are not presented in the format one would expect for a diagnostic AI device. The approval is based on "substantial equivalence" to a predicate device.
Here's an attempt to address your points based on the provided text, highlighting what is and isn't available:
1. A table of acceptance criteria and the reported device performance
-
Acceptance Criteria: Not explicitly stated as quantitative metrics in the provided text. The FDA's acceptance is based on the determination of "substantial equivalence" to the predicate device. This implies that the device must perform similarly and safely for its intended use as the predicate. The crucial "performance" for a lubricant typically involves:
- Lubrication effectiveness: Enhancing ease and comfort of intimate sexual activity.
- Moisturizing properties.
- Condom compatibility: "This product is compatible with natural rubber latex condoms."
- Safety: Not causing irritation or adverse reactions.
-
Reported Device Performance: The text states the device's intended use is "to moisturise and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication." It also explicitly states, "This product is compatible with natural rubber latex condoms." The implication (by FDA approval) is that the submission provided data demonstrating these claims were met, and no significant differences from the predicate device were found. Specific quantitative performance data is not included in this summary.
| Acceptance Criteria (Implied from Intended Use & Predicate Equivalence) | Reported Device Performance (Implied by 510(k) Clearance) |
|---|---|
| Enhances ease & comfort of intimate sexual activity. | Device is intended to achieve this. |
| Supplements body's natural lubrication. | Device is intended to achieve this. |
| Moisturizes. | Device is intended to achieve this. |
| Compatible with natural rubber latex condoms. | Product is compatible with natural rubber latex condoms. |
| Safe for penile and/or vaginal application. | Deemed safe through substantial equivalence. |
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 / Not provided: The provided 510(k) summary does not contain information about specific test sample sizes or data provenance for performance testing. For a device like a lubricant, testing often involves bench testing (e.g., viscosity, pH, osmolality, condom compatibility testing) and biocompatibility studies, which would have their own sample sizes but are not detailed here.
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: This type of medical device (personal lubricant) does not involve ground truth establishment by experts in the sense of diagnostic interpretation (e.g., radiologists reviewing images). The assessment is based on physical/chemical properties and biological safety.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are relevant for subjective interpretations, often in diagnostic imaging or clinical trials with ambiguous endpoints. This is not pertinent to a personal lubricant's evaluation for substantial equivalence.
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
- No: This is entirely irrelevant to a personal lubricant. MRMC studies and AI assistance are typically for diagnostic imaging or similar interpretation tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No: This is irrelevant as there is no algorithm associated with a personal lubricant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Ground Truth by Proxy: For a lubricant, "ground truth" would be established by laboratory standards for material properties (e.g., pH, viscosity, osmolality), standardized biocompatibility testing (e.g., cytotoxicity, irritation, sensitization assays), and validated methods for condom compatibility. This isn't "ground truth" in the diagnostic sense but rather objective compliance with established performance standards for such products.
8. The sample size for the training set
- Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.
9. How the ground truth for the training set was established
- Not Applicable / No Training Set: There is no "training set" for an AI algorithm in the context of a personal lubricant.
§ 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.