(292 days)
Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended 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 condoms only.
Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.
This document describes a 510(k) premarket notification for a personal lubricant, not a medical device that requires clinical performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies in the way requested.
The submission for Durex Play Soft & Sensual Lubricant (K071626) primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, not on proving clinical effectiveness through detailed performance metrics against pre-defined acceptance criteria.
Therefore, the information requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is not applicable or not provided in this type of regulatory submission for this product.
Here's why and what information is relevant from the document:
Key Takeaways from the Document:
- Device Type: Personal lubricant, classified as a Class II medical device (Regulation Number: 21 CFR §884.5300, Product Code: NUC).
- Regulatory Pathway: 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device.
- Predicate Devices: Durex Play™ personal lubricant (K032124), Durex Play™ Assorted Temptations lubricants (K060098), Durex Play™ Warmer lubricant (K042563), KY liquid (K955648), and Lifestyles (K033076).
- Basis for Substantial Equivalence: The document states the proposed and predicate devices are: "non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms." The intended use and labeling are also considered substantially equivalent.
- "Acceptance Criteria" in a 510(k) Context: For this type of device and regulatory pathway, the "acceptance criteria" isn't a specific set of clinical performance metrics, but rather the demonstration that the new device is as safe and effective as a legally marketed predicate device. This is often achieved through comparison of technical characteristics, intended use, and performance data if relevant (e.g., biocompatibility testing, lubricant compatibility with condoms), rather than complex clinical outcomes studies.
Regarding your specific questions:
- Table of acceptance criteria and reported device performance: Not applicable. There are no clinical performance metrics or acceptance criteria presented in this type of 510(k) submission for a personal lubricant. The "performance" is demonstrated by its similarity to already approved lubricants.
- Sample sizes used for the test set and data provenance: Not applicable for clinical performance. Any testing (e.g., for biocompatibility or condom compatibility) would have its own sample size, but that is not detailed here in the context of human clinical data for establishing performance.
- Number of experts used to establish ground truth and qualifications: Not applicable. This type of submission does not involve expert review for clinical ground truth.
- Adjudication method: Not applicable.
- Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic device where human readers are interpreting results.
- Standalone performance (algorithm only without human-in-the loop performance): Not applicable, as this is not an algorithm-driven device.
- Type of ground truth used: Not applicable. For material performance (e.g., condom compatibility), the "ground truth" would be established by standardized laboratory testing methods, not clinical outcomes.
- Sample size for the training set: Not applicable. This is not an AI/ML-driven device requiring training data.
- How the ground truth for the training set was established: Not applicable.
§ 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.