(77 days)
K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.
The lubricous nature of this product helps to supplement the body's own natural lubricating fluids, thereby relieving friction to help enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissues for purpose of lubrication, and moisturization and is compatible with latex condoms. K-Y® Brand WARMING UltraGEL has the additional benefit of imparting a warming sensation when applied to the genital area.
Personal Lubricant For vaginal/penile and condom application during sexual intimacy
K-Y® Brand WARMING UltraGEL is a non-sterile, clear, non-staining, non-greasy, water soluble gel for use as a personal lubricant. This product imparts a gentle warming sensation when applied to the genitalia. This product was designed to meet a customer need for an intimate lubricant that does not feel cold when applied. K-Y® Brand Warming UltraGEL can reduce friction during sexual intercourse thereby enhancing sexual intimacy. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards as defined by ASTM D 3492. K-Y® Brand WARMING UltraGel is not a contraceptive nor spermicide.
This document describes the 510(k) clearance for K-Y® Brand WARMING UltraGEL Personal Lubricant, focusing on demonstrating its substantial equivalence to the predicate device, K-Y® Brand Warming LIQUID Personal Lubricant. Since this is a personal lubricant, the "device performance" in the context of this submission refers to its safety and effectiveness in providing lubrication and a warming sensation, especially its compatibility with condoms.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Study Objective/Focus) | Reported Device Performance (Results) |
|---|---|
| Biocompatibility: No contact sensitization or systemic toxicity | * Preclinical Testing (ISO 10993 & G95-1): Not considered a contact sensitizing agent and not associated with systemic toxicity. |
| Contact Sensitization (Human): No evidence of contact sensitization | * Human Repeated Insult Patch Test (Modified Draize Procedure): No evidence of contact sensitization elicited when compared to the predicate device. |
| Warming Sensation (Initial Application): Positive perception of warmth and not feeling cold. | * Consumer Perception Study (Single Application): 80.00% of participants rated the product as Excellent/Very Good for "Warms on Contact." 95.00% rated it as Excellent/Very Good for "Does not feel cold when applied." No adverse events observed/reported. |
| Warming Sensation (During Sexual Activity) & Enhanced Intimacy: Positive perception of warmth and enhanced intimacy. | * In-Home Consumer Use Study (245 responses): 91.67% positive for "Warms on Contact." 85.01% positive for "Enhances Intimacy." |
| Tolerability/Irritation (During Sexual Activity): No signs of irritation or discomfort. | * In-Home Consumer Use Study (245 responses): 8.6% responded positively to "experienced discomfort" (Note: This is an adverse finding, but the overall conclusion was that the product did not cause irritation based on final gynecological examination). After two weeks of home use (minimal two sexual encounters), no serious adverse events reported. Gynecological examinations detected only one instance of mottled irregular erythema of the inner thigh at baseline, which was not present at the return visit. Conclusion: Product did not cause irritation as determined by final gynecological examination. |
| Compatibility with Latex Condoms | * Condom Compatibility Testing (ASTM D 3492): Compatible with latex condoms. |
2. Sample Size Used for the Test Set and the Data Provenance
- Biocompatibility Testing: Not specified, but conducted by an "outside laboratory." Usually involves in-vitro and in-vivo animal models per ISO 10993, but specific numbers are not provided for the test set.
- Human Repeated Insult Patch Test: Not specified.
- Consumer Perception Study: Not specified for the number of subjects, only percentages reported.
- In-Home Consumer Use Study: 245 reported responses. Data provenance is implied to be from the US, as the study was conducted under FDA regulations (21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56). This was a prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Biocompatibility Testing: Conducted by an "outside laboratory in compliance with Good Laboratory Practices (GLPs)." No specific number or qualifications of experts are provided in the summary.
- Human Repeated Insult Patch Test: Not specified. Conducted by an "outside laboratory."
- Consumer Perception Study: The "ground truth" here is the subjects' subjective experience and self-reported perceptions of warmth. No external experts defining ground truth.
- In-Home Consumer Use Study:
- Tolerability/Irritation: "Consented female subjects received gynecological examinations at baseline and following the last coital episode." This implies gynecologists were the experts establishing the ground truth for physical irritation. The number of gynecologists is not specified, nor are their specific qualifications (e.g., years of experience), but it is generally assumed that certified medical professionals perform such examinations.
- Warming Sensation/Enhanced Intimacy: The "ground truth" is the subjects' subjective self-reported experiences and perceptions. No external experts defining ground truth.
4. Adjudication Method for the Test Set
- Biocompatibility Testing: No information on adjudication method. Results were likely evaluated against ISO 10993 and G95-1 criteria.
- Human Repeated Insult Patch Test: No information on adjudication method. Clinical assessment by trained personnel would be standard.
- Consumer Perception Study: No adjudication as it relies on subjective self-reporting.
- In-Home Consumer Use Study:
- Tolerability/Irritation (Gynecological Exam): Not explicitly stated, but typically a single gynecologist would perform the examinations for consistency. If multiple gynecologists were involved, a consensus or independent review process might be employed, but it is not detailed.
- Warming Sensation/Enhanced Intimacy: No adjudication as it relies on subjective self-reporting.
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 is not applicable. The device is a personal lubricant, not an imaging or diagnostic AI system. Therefore, an MRMC comparative effectiveness study involving human "readers" (e.g., radiologists) with or without AI assistance was not performed and is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. As mentioned above, the device is a personal lubricant, not an algorithm or AI system. Its performance is directly tied to human interaction and perception, and there is no "standalone" algorithmic performance to evaluate.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Biocompatibility: Scientific standards (ISO 10993, G95-1) and laboratory test results.
- Human Contact Sensitization: Clinical observation and assessment by medical professionals (implied).
- Warming Sensation/Enhanced Intimacy: Subjective self-reported perceptions and experiences of male and female subjects.
- Tolerability/Irritation: Objective clinical assessment by gynecologists (mottled irregular erythema observation) and subjective self-reported experiences.
8. The Sample Size for the Training Set
- Not applicable / No specific training set mentioned. For a personal lubricant, there is typically no "training set" in the sense of machine learning. The studies described are validation studies to demonstrate safety and effectiveness for substantial equivalence. The product formulation itself resulted from R&D, not an algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no "training set" for an AI or algorithmic device, the concept of establishing ground truth for it does not apply here. The product's development would have involved formulation chemists and product developers, guided by established chemical and physiological principles, and consumer research to meet desired characteristics.
§ 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.