(186 days)
Astroglide® Brand WARMING LIQUID is recommended as a personal lubricant to enhance intimate activities. It is designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. Astroglide® Brand WARMING LIQUID may be used with condoms.
Astroglide® Brand WARMING LIQUID is a non-sterile clear non-greasy, high viscosity liquid used as a personal lubricant. The product is highly lubricous and may be used with or without a condom during sexual activity. Astroglide® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in condom compatibility testing conducted according to standards defined by ASTM D 3492.
This document describes the 510(k) premarket notification for the Astroglide® Brand WARMING LIQUID personal lubricant. It does NOT contain information about acceptance criteria or a study proving that the device meets those criteria in the context of an AI/medical device. Instead, it describes biocompatibility testing results for a personal lubricant.
Therefore, I cannot provide the requested information from the given input.
The input document outlines:
- Device Description and Intended Use: Astroglide® Brand WARMING LIQUID is a non-sterile, clear, non-greasy, high viscosity liquid personal lubricant. It is intended to enhance intimate activities by providing supplemental vaginal lubrication and can be used with or without condoms.
- Technological Characteristics: The formula is proprietary, mainly water-soluble ingredients, and produces a slight warming sensation. It is noted to be slightly more lubricious than its predicate due to an additional ingredient.
- Substantial Equivalence: It is deemed substantially equivalent to the K-Y Brand WARMING LIQUID personal lubricant (K021492) based on similar intended use and formulas.
- Product Testing (Biocompatibility): This section details various biocompatibility studies performed on the product. These are not "acceptance criteria" in the sense of performance metrics for an AI model, but rather safety and tolerability assessments for a topically applied medical device.
Biocompatibility Testing Results (Not Acceptance Criteria in the AI context):
| Test | Performance |
|---|---|
| Dermal Sensitization Study (Guinea Pigs) | Considered not to be a contact sensitizing agent. |
| 5-day Rabbit Vaginal Irritation Study | Did not cause any pharmacotoxic effects; irritation index score of 1 (minimal irritant). |
| Mouse Systemic Toxicity Evaluation | Did not cause mortality and was not associated with systemic toxicity at 50mL/kg IV or 50mL/kg IP. |
| USP Agar Diffusion Test | Did not produce any evidence of cytotoxicity. |
| Human Repeat Insult Patch Test (53 Adults) | Showed no evidence of increased likelihood of sensitization. |
| Condom Compatibility Testing | Compatible with latex condoms as demonstrated according to ASTM D 3492 standards. |
The document does NOT contain any information relevant to the following requested items because it is not about an AI/medical device:
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Standalone (algorithm only) performance
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
§ 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.