(171 days)
Aqua Lube® Natural 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 and polyisoprene condoms. This product is not compatible with polyurethane condoms.
Aqua Lube® Natural Personal Lubricant is a non-sterile, water-based, personal lubricant designed to supplement the body's own natural lubrication fluids. Aqua Lube® Natural Personal Lubricant consists of two models: "Regular" and "Warming." This product is a clear, non-greasy, high-viscosity, liquid. This product is composed primarily of organic aloe, hydroxyethycellulose, sorbitol, and tocopherols (vitamin E). The Warming model contains the same ingredients as the Regular model plus the additional ingredient organic peppermint oil. Aqua Lube® Natural Personal Lubricant causes a warming response. This product may be used with or without a condom during intimate sexual activity. This product is packaged in a tube made of low density polyethylene with a polypropylene cap. Tube sizes included 1 oz., 2.5 oz, and 4.0 oz. Each tube is packaged in a paperboard carton, which constitutes the device's individual carton.
Here's a breakdown of the acceptance criteria and study information for the Aqua Lube® Natural Personal Lubricant, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Rabbit Vaginal Irritation | Non-Irritating | Non-Irritating |
| Acute Systemic Toxicity | Non-systemically toxic | Non-systemically toxic |
| Sensitization Guinea Pig Maximization | Non-sensitizing | Non-sensitizing |
| Condom Compatibility (Natural Rubber Latex) | No effect on mechanical/physical integrity | Does not affect |
| Condom Compatibility (Polyisoprene) | No effect on mechanical/physical integrity | Does not affect |
| Condom Compatibility (Polyurethane) | (No specific "acceptance" criterion, but noted incompatibility) | Did affect |
| Shelf Life (Warming Model) | Minimum 24 months stability | Confirmed 24 months |
| Shelf Life (Regular Model) | Minimum 14 months stability | Confirmed 14 months |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes for the individual tests (Cytotoxicity, Irritation, Toxicity, Sensitization). However, it does state that "Biocompatibility testing was conducted on Aqua Lube® Natural Personal Lubricant per ISO 10993 series," which implies standard biological testing methods for medical devices.
- Provenance: The data provenance (country of origin, retrospective/prospective) is not explicitly stated. The studies were conducted in compliance with Good Laboratory Practices (GLPs), which are a set of principles for conducting non-clinical laboratory studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The studies listed (e.g., cytotoxicity, irritation, sensitization) are laboratory tests with objective endpoints, rather than subjective evaluations that typically require human expert consensus for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The tests described are primarily objective laboratory assessments, not requiring an adjudication method like those used for interpreting ambiguous results in image-based diagnostics.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for AI-powered diagnostic tools to assess the impact of AI assistance on human reader performance. The Aqua Lube device is a personal lubricant, not a diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone algorithm performance study was not done. This concept is relevant for AI algorithms, which are not applicable to a personal lubricant.
7. The Type of Ground Truth Used
The ground truth for the device's performance relies on objective laboratory measurements and standardized testing protocols:
- Biocompatibility: Results were based on measurable biological responses (e.g., cell viability for cytotoxicity, observable tissue reactions for irritation, systemic effects for toxicity, immune responses for sensitization) defined by the ISO 10993 series.
- Condom Compatibility: Results were based on mechanical and physical integrity testing of condoms as defined by ASTM D7661-10.
- Shelf Life: Results were based on real-time stability data, indicating the maintenance of product characteristics over time.
8. The Sample Size for the Training Set
This information is not applicable. The Aqua Lube device is a physical product, not an AI model requiring a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable. As stated above, this is not an AI model.
§ 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.