(441 days)
Me Again® Long Lasting Vaginal Moisturizer 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
vH Essentials® Long Lasting Vaginal Moisturizer 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 not compatible with natural rubber latex, polyisoprene, and polyurethane condoms.
Long Lasting Vaginal Moisturizer is a non-sterile, non-greasy, water-based personal lubricant delivered in single-use, pre-filled vaginal applicators. Long Lasting Vaginal Moisturizer can be used daily to supplement the body's natural lubrication. Long Lasting Vaginal Moisturizer contains ingredients commonly found in cleared personal lubricants.
This document is a 510(k) Summary for a medical device called "Long Lasting Vaginal Moisturizer" (marketed as Me Again® and vH Essentials®). It describes the device, its intended use, and provides evidence of its substantial equivalence to predicate devices.
However, the provided text does not contain any information about acceptance criteria or a study designed to demonstrate that the device meets specific performance acceptance criteria, as one would typically find for a complex diagnostic or therapeutic device.
Instead, the summary focuses on demonstrating substantial equivalence to previously cleared predicate devices for personal lubricants/vaginal moisturizers. This is a common pathway for Class II devices. The "performance data" presented is primarily related to safety (biocompatibility) and product integrity (stability) rather than a comparative effectiveness or diagnostic accuracy study.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to the information provided.
I will address the questions to the extent possible given the content:
Acceptance Criteria and Device Performance for Polichem SA Long Lasting Vaginal Moisturizer
The primary objective of the studies described in the 510(k) summary is to demonstrate substantial equivalence to predicate devices by ensuring the new device meets safety and basic functional requirements consistent with its classification as a personal lubricant/vaginal moisturizer. There are no explicit "acceptance criteria" for accuracy, sensitivity, specificity, or similar metrics that would be present for a diagnostic or therapeutic device.
The performance data listed addresses biocompatibility, stability, and compatibility.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the device and the 510(k) submission, "acceptance criteria" are implied by compliance with recognized standards and successful completion of tests. There are no quantitative "performance metrics" in the traditional sense for this type of device submission's "performance data."
| Category | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Biocompatibility | Device materials are non-cytotoxic, non-irritating, and non-sensitizing for vaginal application. | - Cytotoxic evaluation following EN ISO 10993-5 rule: Performed (implies acceptable results). |
- Delayed hypersensitivity test (GPMT) according to ISO 10993-10:2010: Performed (implies acceptable results).
- Acute Vaginal Irritation hybrid test: Performed (implies acceptable results).
- Acute Systemic Toxicity hybrid test: Performed (implies acceptable results). |
| Stability | Device maintains its properties for the claimed shelf life. | - Stability data confirms: A shelf life of 24 months. |
| Compatibility | Condom compatibility is tested and clearly labeled. | - Recent condom compatibility testing per ASTM D7661-10 demonstrates: Not compatible with natural rubber latex, polyisoprene, and polyurethane condoms (This results in a clear labeling instruction rather than a "failure" of the device itself). |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the biocompatibility, stability, or compatibility tests. These types of tests typically follow recognized standards (e.g., ISO, ASTM), which specify sample sizes. The data provenance is not explicitly stated beyond indicating the performing entity ("Polichem SA") and the submission to the FDA. It is prospective testing for the specific device.
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. The studies performed are laboratory-based tests (biocompatibility, stability, ASTM compatibility), not clinical studies involving expert interpretation of patient data or images to establish a "ground truth." The "ground truth" for these tests is the objective outcome of the test itself (e.g., cytotoxicity present/absent, irritation present/absent, shelf life determined, material compatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable, as these were laboratory tests, not studies requiring expert adjudication of clinical or imaging data.
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. This device is a personal lubricant/vaginal moisturizer, not an AI-powered diagnostic or decision-support tool. Therefore, no MRMC study or AI-related effectiveness study was performed or is relevant to this submission.
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 or software. No standalone algorithm performance study was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned in #3, the "ground truth" for the tests described is the objective result of standardized laboratory testing according to established protocols (e.g., ISO, ASTM standards for biocompatibility and material testing). There is no "expert consensus," "pathology," or "outcomes data" in the context of device performance demonstration here, beyond the demonstration of safety and stability.
8. The sample size for the training set
This question is not applicable. This is a physical medical device, not an AI/machine learning algorithm 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.