(152 days)
HyaloGYN® is a personal lubricant for 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 polyisoprene condoms.
HyaloGYN is a line extension to add a formulation of HyaloGYN not made with parabens. It is a nonsterile, colorless, odorless, transparent, aqueous, hydrating gel that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid), propylene glycol, a carbomer, preservatives and sodium hydroxide (to balance the pH). The hyaluronic acid is manufactured using a bacterial fermentation process.
HyaloGYN is a non-hormonal vaginal moisturizer intended to hydrate the vaginal epithelium because of the strong hydrating properties of its hyaluronic acid derivative component. The carbomer and propylene glycol combine with the hyaluronic acid derivative to enable HyaloGYN to achieve its thick, viscous gel form, and the mucoadhesive properties to allow it to adhere to the vaginal mucosa, enhancing the residence time, thus hydrating this tissue. It is provided in an aluminum tube and packaged together with single-use applicators in a cardboard box. HyaloGYN has a shelf life of 3 years.
This document is a 510(k) summary for the HyaloGYN Vaginal Hydrating Gel, demonstrating its substantial equivalence to previously cleared devices. It describes the device, its intended use, and provides a summary of performance data including biocompatibility, bench testing, and a clinical study.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" for the device's main function (vaginal moisturizing and lubrication) in the typical sense of numerical thresholds for sensitivity, specificity, or similar metrics for a diagnostic or AI device. Instead, the "acceptance criteria" are implied by the successful completion of various tests and the positive outcomes of the clinical study, demonstrating safety and effectiveness for its intended use.
However, where an explicit criterion is mentioned (condom compatibility), it is included. For other assessments, the "acceptance criteria" are interpreted as successful completion of the test/study without adverse findings, and "reported device performance" summarizes the key findings.
| Acceptance Criteria (Implied/Explicit) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| - In vitro Cytotoxicity Assay per ISO 10993-5 | Confirmed safe. |
| - Sensitization (Guinea Pig Maximization Test) per ISO 10993-10 | Confirmed safe. |
| - Vaginal Irritation Test per ISO 10993-10 | Confirmed safe. |
| - Acute Systemic Toxicity Rat per ISO 10993-11 | Confirmed safe. |
| Bench Performance: | |
| - Condom compatibility per ASTM D7661-10 | The subject device product is compatible with polyisoprene condoms. |
| - Appearance | Met product specifications at release. |
| - Odor | Met product specifications at release. |
| - Color | Met product specifications at release. |
| - Weight | Met product specifications at release. |
| - pH | Met product specifications at release. |
| - Hyaluronic acid content | Met product specifications at release. |
| - Total Aerobic Microbial Count | Met product specifications at release. |
| - Total combined yeasts/molds count | Met product specifications at release. |
| - Absence of common pathogens (Pseudomonas aeruginosa, Staphylococcus | Met product specifications at release. |
| aureus, Candida albicans) | |
| - Viscosity | Met product specifications at release. |
| - Osmolality | Met product specifications at release. |
| Clinical Performance: | |
| - Safety (absence of adverse events) | Safety considered excellent, demonstrated by absence of adverse events and investigator's overall tolerability score (98.7%). No alterations of the vaginal ecosystem. |
| - Effectiveness (moisturizing effects on vaginal mucosa) | The test material demonstrated moisturizing effects on the vaginal mucosa. |
| Stability Testing: | |
| - Shelf life | HyaloGYN® has a 36-months shelf life based on the results of shelf life testing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set:
- Clinical Study: 80 women were enrolled.
- Biocompatibility and Bench Testing: Sample sizes are not explicitly stated for these tests, but they were conducted on the device material itself.
- Data provenance:
- Clinical Study: Conducted in Italy, and was a prospective, open, uncontrolled pilot clinical study.
- Other tests (Biocompatibility, Bench, Stability): The specific origin of data for these tests is not explicitly stated beyond being conducted by Fidia.
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)
- The document refers to "investigator's overall assessment of tolerability score (98.7%)" in the clinical study. It does not specify the number of investigators/experts or their specific qualifications (e.g., years of experience, specialty beyond being the study investigator) who established ground truth for the clinical performance points like tolerability and moisturizing effects.
- For biocompatibility and bench testing, "experts" involved are implied to be personnel conducting the tests according to ISO/ASTM standards, but their specific number and qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The document does not describe an explicit adjudication method (like 2+1 or 3+1) for the clinical study's outcomes. It was an "open, uncontrolled clinical study" where a single investigator's assessment contributed to the "tolerability score."
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
- This device is a vaginal hydrating gel, not an AI or diagnostic imaging device. Therefore, a study assessing human reader improvement with AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, this is not an algorithm or AI device. Therefore, "standalone" algorithm performance is not applicable. The device itself (the gel) is the "standalone" product being tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Clinical Study: The ground truth for effectiveness (moisturizing effects) and safety (tolerability, absence of adverse events, no alterations of vaginal ecosystem) was established through clinical observation and assessment by the study investigator based on pre-defined clinical endpoints and patient feedback.
- Biocompatibility Testing: Ground truth established by adherence to and results of standardized ISO test methods.
- Bench Testing: Ground truth established by adherence to product specifications at release (e.g., pH, viscosity, microbial counts) and standardized ASTM test methods (condom compatibility).
8. The sample size for the training set
- This device is a medical product (gel), not an AI algorithm. Therefore, the concept of a "training set" for an algorithm is not applicable. Its formulation and design would be based on scientific principles and previous research/development, not algorithmic training data.
9. How the ground truth for the training set was established
- As stated above, this is not an AI algorithm, so there is no "training set" in the context of machine learning. The "ground truth" for the device's formulation and design would be based on chemical, biological, and pharmaceutical principles, historical data from similar products, and laboratory studies of its components.
§ 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.