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510(k) Data Aggregation
(128 days)
Glycerin and Paraben Free Astroglide® is a personal lubricant, for penile, anal, 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 latex condoms.
Glycerin & Paraben Free Astroglide® is a non-sterile, clear, non-greasy, high viscosity liquid used as a personal lubricant. Glycerin & Paraben Free Astroglide® is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.
This document is a 510(k) summary for a personal lubricant, Glycerin & Paraben Free Astroglide®. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to predicate devices and its safety. Since this is a submission for a personal lubricant and not an AI/ML powered medical device, the questions regarding AI/ML device performance metrics (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable in this context.
Here's an analysis of the provided text in relation to the acceptance criteria and study information, with an emphasis that many of the requested AI-specific points are not relevant for this type of device:
1. A table of acceptance criteria and the reported device performance
For a personal lubricant, acceptance criteria typically involve biocompatibility, compatibility with condoms, and performance related to its intended use (lubrication, moisturizing). The studies performed address these aspects.
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Condom Compatibility | Compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according to ASTM D 3492. |
| Dermal Sensitization (ISO 10993-10) | Considered to be a Grade I (weak) sensitizer in guinea pigs. (Note: While "Grade I" implies some sensitization, the submission likely aims to show it's within acceptable safety limits for its intended use, or that this level of sensitization is common/not clinically significant for topical products. Further interpretation of "acceptable" is not provided but inferred by FDA clearance.) |
| Rabbit Penile Irritation (ISO 10993-10) | Considered to be a minimal irritant as compared to control (0.9% NaCl). (Again, "minimal" implies within acceptable safety range.) |
| Rabbit Vaginal Irritation (ISO 10993-10) | Considered to be a nonirritant as compared to control (0.9% NaCl). |
| Mouse Systemic Injection (ISO 10993-11) | Did not cause mortality and was not associated with systemic toxicity. |
| Human Repeat Insult Patch Test (RIPPT) | May be considered as a Non-Primary Irritant and Non-Primary Sensitizer (in 50 human subjects). This is a strong indicator of low irritation and sensitization potential in humans. |
| Cytotoxicity (ISO 10993-5, MEM Elution Test) | Satisfied the requirements of an ISO MEM Elution Test and passed the test at a dilution of 1:4 or greater. |
| Substantial Equivalence to Predicate Devices | Shown to be substantially equivalent to Good Lubrications Personal Lubricant (K020586) and Astroglide Personal Lubricant (K935299) based on same intended use and similar formulation. (This is the primary regulatory pathway for 510(k) clearance, demonstrating that the new device is as safe and effective as a legally marketed device). |
Regarding AI-specific questions (2-9):
The device in question, Glycerin & Paraben Free Astroglide®, is a personal lubricant, which is a physical product and not an AI/ML powered medical device. Therefore, the following points are not applicable (N/A) to this 510(k) submission.
2. Sample size used for the test set and the data provenance: N/A (not an AI/ML device)
* For biocompatibility: Guinea pigs, rabbits, mice were used for animal studies. 50 human subjects were used for the Repeat Insult Patch Test. Data provenance is implied by the testing being conducted by "outside laboratories, in compliance with Good Laboratory Practices (GLP's)".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (not an AI/ML device)
* For the non-AI tests, "ground truth" is established by laboratory measurements and observations in controlled animal and human studies, interpreted by qualified laboratory personnel and clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (not an AI/ML device)
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: N/A (not an AI/ML device)
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (not an AI/ML device)
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): N/A (not an AI/ML device)
* The "ground truth" for this product is derived from direct biological response in controlled experiments (e.g., irritation, sensitization, toxicity, condom compatibility).
8. The sample size for the training set: N/A (not an AI/ML device)
9. How the ground truth for the training set was established: N/A (not an AI/ML device)
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