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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

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.

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For vaginal/penile and condom application during sexual intimacy

Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

The provided text describes the 510(k) summary for the K-Y® Brand WARMING Jelly Personal Lubricant. It outlines preclinical and clinical testing to demonstrate safety and substantial equivalence to a predicate device. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes the tests and then reports the positive (or negative, where appropriate) outcomes as evidence of safety and performance. I've inferred the acceptance criteria based on the reported results.

2. Sample Sizes Used for the Test Set and Data Provenance

• Human Repeated Insult Patch Test: The sample size is not explicitly stated, but the test compared the product to the currently marketed K-Y® Brand Warming LIQUID.
• Consumer Perception Study (Warming): The total number of participants is not explicitly stated. It mentions "75.50% of the participants felt the product warmed well."
• In Home Consumer Use Study:
  • Female subjects: Consented female subjects received speculum examinations at baseline and following the last coital episode. The exact number of subjects is not explicitly stated but is implied to be at least 245 based on the reported responses.
  • Reported Responses: 245 reported responses for various criteria.
  • Data Provenance: The studies are described as "Human Clinical Testing" and "Preclinical Testing of Formulation," implying prospective human studies conducted by an "outside laboratory." The country of origin is not explicitly stated, but the submission is to the FDA in the US.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• In Home Consumer Use Study (Gynecological Examinations): The study involved "gynecological examinations at baseline and following the last coital episode." It then states, "It was concluded that the product did not cause irritation as determined by final gynecological examination." This implies a medical professional (likely a gynecologist) performed these examinations. The number of such experts and their specific qualifications (e.g., years of experience) are not specified in this document.
• Other studies (Human Repeated Insult Patch Test, Biocompatibility): The "ground truth" here would be laboratory analysis and expert interpretation of those results. The number and qualifications of experts involved in these analyses are not specified.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for any of its human studies. The results appear to be reported based on the observations and findings of the individuals conducting the tests and assessments. For the In Home Consumer Use Study, the "conclusion" about irritation was "determined by final gynecological examination," suggesting a single expert's assessment or the consensus of a study team.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or interpretative tasks where multiple human readers assess cases with and without AI assistance. The K-Y® Brand Warming Jelly is a personal lubricant, and the studies focused on safety, biocompatibility, and consumer perception, not diagnostic effectiveness.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

N/A (Not Applicable). This device is a personal lubricant, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm without human-in-the-loop is not relevant to this product. The testing performed evaluates the product's direct interaction with the human body and user perception.

7. The Type of Ground Truth Used

• Biocompatibility: Laboratory test results (e.g., contact sensitization, systemic toxicity measurements) interpreted against established scientific standards (ISO 10993 and G93-1).
• Human Repeated Insult Patch Test: Clinical observation by trained professionals for skin reactions, comparing the test product to a predicate.
• Consumer Perception Studies: Self-reported subjective experience of participants (e.g., rating warming, feedback on intimacy enhancement, discomfort).
• In Home Consumer Use Study (Irritation): Objective medical assessment via "gynecological examinations" by a qualified professional.
• Condom Compatibility: Laboratory testing results based on ASTM D 3492.

8. The Sample Size for the Training Set

N/A (Not Applicable). This device is a personal lubricant, not an AI or machine learning model. Therefore, there is no "training set" in the context of data science. The "formulation" of the product is proprietary and developed through chemical and material science processes, not through a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

N/A (Not Applicable). As explained above, there is no "training set" for this product. The ground truth for its development and testing is established through standard preclinical and clinical methodologies for medical devices, focusing on safety, biocompatibility, and intended use performance.

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