(308 days)
Aqua Lube Personal Lubricant is a personal lubricant, for penile and/or vaginal 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, polyisoprene, and polyurethane condoms.
Aqua Lube® is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. This product is a clear, non-greasy, high-viscosity, liquid. This product may be used with or without a condom during intimate sexual activity.
This document describes the safety testing and substantial equivalence of the Aqua Lube® Personal Lubricant (K110325) to predicate devices. It is not a study proving the device meets specific performance criteria in a clinical setting as would typically be described for a diagnostic or AI-based device. Instead, it focuses on laboratory tests to demonstrate safety and compatibility.
Therefore, many of the requested elements for a study on "acceptance criteria" and "device performance" in the context of an AI or diagnostic device are not applicable to this 510(k) submission for a personal lubricant.
However, I can extract the relevant information regarding the acceptance criteria and how the device proved to meet them in the context of the provided document.
Here's the breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Safety Testing | Biocompatibility: | Met acceptance requirements for all tests | |
| Cytotoxicity | (Absence of cytotoxic effects) | ||
| Irritation | (Absence of irritant effects) | ||
| Sensitization | (Absence of sensitization) | ||
| Systemic Toxicity | (Absence of systemic toxic effects) | ||
| Product Compatibility | Latex Condom Compatibility | Does not affect mechanical or physical integrity of condoms | Does not affect the mechanical or physical integrity of natural rubber latex, polyisoprene, and polyurethane condoms |
| Technological Characteristics | Substantial Equivalence to predicate devices | Similar intended use, similar formulations | Substantially equivalent to K-Y Personal Lubricant and ForPlay Personal Lubricant |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for individual tests. The document broadly states "laboratory studies" and "studies on latex condom compatibility." For biocompatibility and toxicity studies, it refers to "the proposed devices" (plural, likely implying multiple samples of Aqua Lube were tested).
- Data Provenance: The studies were conducted by "outside laboratories." The country of origin is not specified, but the submission is to the U.S. FDA. The studies are by nature prospective, as they were conducted specifically for the purpose of demonstrating safety and equivalence for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This is a laboratory-based safety and compatibility assessment, not a clinical study involving expert interpretation of diagnostic output or ground truth establishment based on human review. The "ground truth" or "reference standard" for these tests would be the established scientific methods and pass/fail criteria for biocompatibility and condom compatibility.
4. Adjudication Method for the Test Set
Not applicable. This is not a study where human adjudication of results would be relevant. The outcome of the laboratory tests (e.g., cytotoxicity assay results, physical property measurements of condoms) are objectively measured.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not applicable. This type of study is used for diagnostic or AI-assisted interpretation, where human readers evaluate cases with and without AI assistance. This document describes laboratory safety and compatibility testing for a personal lubricant.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is a physical product (personal lubricant), not an algorithm or AI. The tests performed are inherent to the product itself.
7. The Type of Ground Truth Used
The "ground truth" or reference standard for these tests are the established scientific and regulatory methods for evaluating:
- Biocompatibility: Standardized assays (e.g., ISO standards for cytotoxicity, irritation, sensitization, systemic toxicity) with predefined pass/fail criteria.
- Condom Compatibility: Standardized methods to assess the mechanical and physical integrity of condoms after exposure to the lubricant (e.g., burst pressure, tensile strength tests) with established acceptance limits for material degradation.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an artificial intelligence or machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of product.
§ 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.