(235 days)
Gynatrof 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.
Gynatrof is compatible with natural rubber latex, polyisoprene condoms and polyurethane condoms.
Gynatrof® is a personal lubricant intended to moisturize, lubricate, and enhance the ease and comfort of intimate sexual activity as well as supplement the body's natural lubrication. The product is supplied with a reusable, non-sterile, single-patient use applicator. Gynatrot® is compatible with natural rubber latex, polyisoprene, and polyurethane condoms. The product is intended for over-the-counter use.
The device formulation consists of Aqua/Water, Hydroxyethylcellulose, Lactic Acid, Polysorbate 20, Potassium Sorbate, Sodium Hyaluronate, Sodium Levulinate, Tocopherol. Gynatrof® is supplied in a 50 mL white tube; each tube contains sufficient product for 20 applications using the reusable applicator.
The provided text describes the 510(k) premarket notification for the medical device Gynatrof®. It focuses on demonstrating substantial equivalence to a predicate device, not on evaluating the device's performance against specific acceptance criteria in a clinical study involving human patients or complex AI algorithms.
Therefore, many of the requested elements are not applicable to this submission. The information provided is primarily related to the device specifications and non-clinical performance data which are used to show that the device is as safe and effective as a legally marketed predicate device.
Here's a breakdown of the applicable and non-applicable requested information:
1. A table of acceptance criteria and the reported device performance
The document provides "Device Specifications" which can be considered acceptance criteria for the physical and chemical properties of the lubricant. It then states that a shelf-life study evaluated these specifications, and the results demonstrated the device's stability over 12 months.
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (Implied from "The shelf-life study evaluated all device specifications listed in Table 1") |
|---|---|---|
| Appearance | Off white to pale yellow gel | Met specifications after real-time aging for 12 months. |
| Odor | Characteristic | Met specifications after real-time aging for 12 months. |
| pH (25°C) | 5.00 ± 0.50 | Met specifications after real-time aging for 12 months. |
| Viscosity | 67,500 - 100,000 cps (T4- 3rpm) | Met specifications after real-time aging for 12 months. |
| Osmolality | 120 - 250 mOsm/kg | Met specifications after real-time aging for 12 months. |
| Specific Gravity (25°C) | 0.9000 - 1.1000 | Met specifications after real-time aging for 12 months. |
| Antimicrobial Effectiveness | Bacteria - Not less than 2.0 log | |
| reduction from the initial count at | ||
| 14 days, and no increase from the | ||
| 14 days' count at 28 days. | ||
| Yeast and Molds - No increase | ||
| from the initial calculated count at | ||
| 14 and 28 days. No increase is | ||
| defined as not more than 0.5 log | ||
| unit higher than the previous | ||
| value measured. | Met specifications (implied, as this testing was conducted). | |
| Total Microbial Count | for pH) and the results derived from those methods. Biocompatibility and condom compatibility also rely on standardized methodologies and measurable outcomes, not expert consensus interpretation in a clinical context. |
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As this is not a clinical study involving human interpretation of medical data, there is no need for adjudication methods typical of multi-reader studies.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by reference to:
- Standardized Test Methods: e.g., USP for pH, USP for viscosity, USP for Antimicrobial Effectiveness, USP for Total Microbial Count, USP for Absence of Pathogenic Organisms.
- International Standards for Biocompatibility: ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization, Vaginal Irritation), ISO 10993-11 (Acute Systemic Toxicity).
- ASTM Standard for Condom Compatibility: ASTM D7661-18.
The "ground truth" for these tests is therefore the objective, measurable outcome of these standardized scientific and engineering tests, not subjective expert consensus or clinical outcomes.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device. The product formulation is developed through research and development, and then tested for specifications.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" in the context of an AI algorithm. The product formulation and manufacturing process are developed to meet the desired specifications and performance characteristics, which are then verified through the non-clinical testing described.
§ 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.