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510(k) Data Aggregation
(128 days)
HYALO GYN 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.
HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process. HYALO GYN is intended for use as a personal lubricant. HYALO GYN is compatible with latex condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and a shelf life of 3 years.
HYALO GYN acts as a moisturizer and lubricant because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol, combined with the hyaluronic acid derivative, enable HYALO GYN to achieve its thick, viscous gel form, and the mucoadhesive properties of the product allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating and protecting this tissue.
The provided document is a 510(k) summary for the device HYALO GYN®, a vaginal lubricant. It details the device's characteristics, intended use, and the studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, pre-defined manner for all performance aspects. Instead, it describes studies and their outcomes to support safety and effectiveness. Based on the information provided, the following table summarizes the performance data and the implied criteria met:
| Performance Aspect | Implied Acceptance Criteria (Based on Study Outcome) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Not cytotoxic | Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic. |
| Acute Intraperitoneal Toxicity | Lethal dose >10 ml/kg | An acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal dose is >10 ml/kg but <20 ml/kg. |
| Skin Sensitization | Lack of a sensitizing effect | A skin sensitization study provides evidence for the lack of a sensitizing effect. |
| Vaginal Tolerance | Minimal vaginal irritant | Vaginal tolerance testing demonstrated that HYALO GYN is a minimal vaginal irritant in the rabbit model. |
| Non-Clinical Performance | ||
| Condom Compatibility | No macroscopic signs, no statistically significant differences in tensile strength, elongation at break, and breaking force with various condom types. | Condom compatibility testing demonstrates that HYALO GYN is compatible with latex, polyurethane, and natural skin condoms. No macroscopic signs and no statistically significant differences were observed in tensile strength, elongation at break, and breaking force between treated and non-treated groups of condoms. |
| Shelf Life | 36 months | Stability studies conducted in accordance with the ICH Q1A guidelines confirm a shelf-life of 36 months. |
| Clinical Performance | ||
| Moisturizing Effects | Demonstrated moisturizing effects on the vaginal mucosa. | The results obtained in this study demonstrated that the test material had moisturizing effects on the vaginal mucosa. |
| Safety/Tolerability | Absence of adverse events, excellent tolerability score, no alterations of vaginal ecosystem. | Safety was considered to be excellent as demonstrated by the absence of adverse events and the investigator's overall assessment of tolerability score (98.7%). There were no alterations of the vaginal ecosystem. The conclusion also notes "the lack of adverse events reported over 8 years of postmarket experience with HYALO GYN outside of the U.S. demonstrate the safe and effective use of this device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Clinical Study:
- Sample Size: 80 women.
- Data Provenance: Conducted in Italy; "pilot, open, uncontrolled clinical study" which typically implies prospective data collection for the duration of the study.
- Biocompatibility Studies: Specific sample sizes are not provided for the individual in vitro and animal studies (cytotoxicity, acute intraperitoneal toxicity, skin sensitization, vaginal tolerance).
- Non-Clinical Performance (Condom Compatibility, Stability): Specific sample sizes are not provided for the individual tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- For the clinical study, the document mentions "the investigator's overall assessment of tolerability score (98.7%)". The number and qualifications of the investigators (experts) are not specified.
- For other performance assessments (biocompatibility, condom compatibility, stability), the "ground truth" or evaluators are implied by the nature of the tests (e.g., laboratory personnel for cytotoxicity, tensile strength measurements). Specific details on the number or qualifications of experts involved in establishing ground truth for these non-clinical tests are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- For the clinical study, the document states it was an "open, uncontrolled clinical study." There is no mention of an adjudication method for the clinical outcomes or adverse events. The tolerability assessment was by "the investigator."
- For non-clinical tests, adjudication methods are generally not applicable in the same way as for clinical studies involving subjective assessments.
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
- No, an MRMC comparative effectiveness study was not done. This study is for a medical device that is a personal lubricant, not an AI-assisted diagnostic or imaging device, so such a study design is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This device is a physical product (a lubricant), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study: The effectiveness (moisturizing effects, tolerability, absence of adverse events, no alterations of vaginal ecosystem) was assessed based on clinical observation and patient outcomes data, likely clinician assessment and patient-reported symptoms, though specific details of the assessment tools are not provided. The tolerability score was based on "the investigator's overall assessment."
- Biocompatibility Studies: Ground truth was established through laboratory testing standards and measurements (e.g., cell viability for cytotoxicity, animal responses for toxicity and irritation).
- Non-Clinical Performance (Condom Compatibility, Stability): Ground truth was established through standardized physical and chemical laboratory tests (e.g., tensile strength testing, stability protocols).
8. The sample size for the training set
- For a device like HYALO GYN® (a lubricant), the concept of a "training set" as understood in machine learning or AI is not applicable. The device's performance is not based on a trained algorithm. Its formulation is developed through pharmaceutical research and manufacturing processes, and then tested for safety and efficacy.
9. How the ground truth for the training set was established
- As noted above, a "training set" is not applicable for this type of medical device. The "ground truth" for its development would involve established scientific principles, pharmaceutical formulation expertise, and pre-clinical testing to ensure its properties met the intended design specifications, but not in the context of an algorithm's training data.
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