(265 days)
Hyalo GYN® Vaginal Moisturizing Suppositories are personal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. Hyalo GYN® Vaginal Moisturizing Suppositories are not compatible with natural rubber latex, polyurethane, and polyisoprene condoms.
Hyalo GYN® Vaginal Moisturizing Suppositories are non-sterile, glyceride-based personal lubricants. The subject lubricant is intended to moisturize and lubricate the vaginal epithelium to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The Hyalo GYN® Vaginal Moisturizing Suppositories are provided in peel-to-open pre-cut strips, in an outer cardboard box with a package insert.
The provided text describes the regulatory clearance of a medical device, Hyalo GYN® Vaginal Moisturizing Suppositories, and presents a 510(k) summary. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific clinical performance criteria in the way an AI algorithm might. Therefore, the information requested about acceptance criteria and a study to prove meeting those criteria, in the context of an AI device, is not fully applicable or directly available in this document.
However, I can extract the closest analogous information regarding the device's specifications and supporting performance data provided in the 510(k) summary. It details technical requirements and testing conducted to ensure safety and effectiveness, which are regulatory "acceptance criteria" for this type of product.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For a medical device like Hyalo GYN® Vaginal Moisturizing Suppositories, the "acceptance criteria" are the defined specifications that the product must meet. The "reported device performance" indicates that the device did meet these specifications during testing.
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | White to ivory white suppositories in suitable plastic pre-formed shells, tightly sealed & easy to open | Met specification (implied by 510(k) clearance and conclusion stating device is safe and effective) |
| Odor | Wax-like smell | Met specification (implied by 510(k) clearance and conclusion stating device is safe and effective) |
| Antimicrobial Effectiveness | Meets requirements per the standard. (USP ) | Met specification |
| Uniformity of dosage unit | Meets requirements for Content Uniformity (Ph. Eur. , current ed.) | Met specification |
| Hyaff11p50 assay | 0.18-0.22 % w/w | Met specification |
| Disintegration time | No more than (NMT) 60 minutes (Ph. Eur. , current ed.) | Met specification |
| Osmolality | ≤ 1200 mOsm/kg (Ph. Eur. , current ed.) | Met specification |
| Consistency | 0.1-5.0 mm | Met specification |
| Peroxide value (Ip) | ≤ 10 mEqO2 / kg (Ph. Eur. , current ed., method A) | Met specification |
| Microbiological quality (TAMC) | ≤100 cfu/g (Ph. Eur. , current ed., Ph. Eur. , current ed.) | Met specification |
| Microbiological quality (TYMC) | ≤10 cfu/g (Ph. Eur. , current ed.) | Met specification |
| Microbiological quality (pathogens) | Pseudomonas aeruginosa: Absent; Staphylococcus aureus: Absent; Candida albicans: Absent | Met specification |
| Biocompatibility | Demonstrated to be biocompatible per ISO 10993-1, 10993-5, 10993-10, 10993-11. (Specific criteria for each test not detailed in summary but implied) | Demonstrated to be biocompatible (Results of testing "demonstrated that the subject lubricants are biocompatible.") |
| Condom Compatibility | Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (this is a stated characteristic, not a performance target to "meet" as much as a determination) | Demonstrated that the device is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms based on ASTM D7661-10. This is reflected in labeling |
| Shelf-life | Maintain all specifications for 24 months | Met all specifications at baseline and following aging for 24-month shelf life. |
2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes for each of the performance (stability, biocompatibility, microbiology, etc.) or material compatibility tests. The tests refer to established standards (USP , Ph. Eur., ASTM D7661-10, ISO 10993 standards). The data provenance is laboratory testing performed by the manufacturer, Fidia Farmaceutici S.p.A., to support device specifications and substantial equivalence. It is not patient or clinical data, thus concepts like country of origin for patient data or retrospective/prospective are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and submission. This is not an AI/diagnostic device that requires expert ground truth for image or data interpretation. The "ground truth" for this device's performance is established by standardized laboratory test methods and their defined pass/fail criteria.
4. Adjudication method for the test set
This question is not applicable. There's no "adjudication" in the sense of reconciling multiple expert opinions for data labeling for an AI algorithm. The tests are scientific and follow established protocols with objective outcomes.
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
This question is not applicable. The device is a personal lubricant, not a diagnostic imaging or AI-assisted device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical product, not an algorithm.
7. The type of ground truth used
For the laboratory performance tests and material compatibility, the "ground truth" is defined by the validated and established scientific methods and standards themselves (e.g., USP for antimicrobial effectiveness, Ph. Eur. for disintegration time and osmolality, ISO 10993 for biocompatibility, ASTM D7661-10 for condom compatibility). The criteria within these standards define what constitutes an acceptable result.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
§ 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.