(499 days)
- To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions.
- As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms.
This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms.
This document describes a 510(k) submission for a vaginal lubricant, not an AI-powered medical device. Therefore, many of the requested categories are not applicable. I will provide the information directly relevant to the submission and note when a category is not applicable for this type of device.
1. A table of acceptance criteria and the reported device performance
This product is a Class II medical device (vaginal lubricant) seeking substantial equivalence to a predicate device (K-Y Brand Ultra Gel, K020827). For such devices, acceptance criteria are typically met by demonstrating that the new device has "technological characteristics" and "preclinical/clinical performance data" that are substantially equivalent to the predicate device, especially regarding safety and effectiveness for its intended use.
| Acceptance Criteria (Demonstrated Substantial Equivalence to K-Y Brand Ultra Gel) | Reported Device Performance (Pre' Vaginal Lubricant) |
|---|---|
| Technological Characteristics: | |
| - Highly lubricious | Shares this characteristic |
| - Medium viscosity | Shares this characteristic |
| - Water-based | Shares this characteristic |
| - Clear | Shares this characteristic |
| - Non-irritating | Preclinical biocompatibility studies in rabbits revealed no penile or vaginal irritation. Slug Mucosal Irritation Test demonstrated no potential for vaginal mucosal irritation. Biocompatibility studies in humans found no evidence of skin irritation or sensitization. |
| - Non-sterile | Shares this characteristic |
| - Condom compatible | Formulation is compatible with latex and polyurethane condoms. |
| Specific Performance for Intended Use: | |
| - Does not harm sperm function (for fertility interventions) | No detrimental effects on human sperm motility parameters, sperm viability, or sperm chromatin. |
| - pH balanced to match fertile cervical mucus | Formulated to be pH balanced to match fertile cervical mucus. |
| - Non-toxic to embryos | Mouse Embryo Assay (MEA) studies demonstrated normal embryo development with no suggestion of toxicity. No detrimental effects on the ability to fertilize bovine embryos in vivo. |
| - Stable formulation | Stability confirmed in accordance with FDA and ICH guidelines. |
| - Effective as a personal lubricant | Focus groups and consumer-use testing demonstrated it is "very effective as a personal lubricant." |
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 Test Set:
- Preclinical Animal Studies: Not explicitly stated, but "studies in rabbits" and "Mouse Embryo Assay (MEA) studies" are mentioned, implying multiple animals were used. "No detrimental effects on the ability to fertilize bovine embryos in vivo" suggests a study involving bovine subjects.
- Human Biocompatibility: Not explicitly stated, but "Biocompatibility studies found no evidence of skin irritation or sensitization in humans" implies a cohort of human subjects.
- Focus Groups & Consumer-Use Testing: Not explicitly stated, but "Focus groups and consumer-use testing" implies a group of participants.
- In vitro studies: Tests on human sperm and material compatibility (latex/polyurethane condoms) were conducted, but specific sample sizes of sperm or condom units are not provided.
- Data Provenance: Not explicitly stated for specific studies. Given the applicant is in the USA (Washington), it's reasonable to infer studies were conducted in the USA or under internationally recognized standards (e.g., ICH guidelines). The studies appear to be prospective for the purpose of this submission.
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)
Not applicable. This is a medical device (lubricant) submission, not an AI model requiring "ground truth" established by experts in the context of image interpretation or diagnosis. The evaluation relies on standardized biological, chemical, and physical tests, and performance assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a medical device (lubricant) submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials involving expert interpretation of medical images or outcomes where discrepancies need resolution. For this device, standard laboratory and clinical study protocols would be followed, and results are typically analyzed statistically or qualitatively based on predefined endpoints.
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. MRMC studies are for evaluating diagnostic performance (e.g., radiologists reading images). This is a lubricant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a lubricant, not an algorithm or AI system. Its performance is evaluated through laboratory and preclinical/clinical studies.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI sense. The "ground truth" or reference standards for evaluating this device were based on:
- Established biological and chemical standards: For pH, osmolarity, sperm viability, embryo development, material compatibility.
- Preclinical irritation assessments: Observation of animal tissues, validated irritation tests (e.g., Slug Mucosal Irritation Test).
- Human irritation/sensitization clinical observations: Direct observation and potentially patient reporting.
- Consumer feedback: For effectiveness as a personal lubricant through focus groups and consumer-use testing.
8. The sample size for the training set
Not applicable. This is a lubricant, not an AI model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 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.