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510(k) Data Aggregation
(192 days)
ORTHO PHARMACEUTICAL CORP.
The K-Y® Liquid Personal Lubricant is an over-the-counter personal lubricant. This device is indicated to enhance the comfort and ease of intimate activity with or without a latex condom. K-Y ® Liquid Personal Lubricant can be safely applied directly to a genital body orifice or a latex condom. The product can be used inside condoms to facilitate application or outside for lubrication during intercourse.
The K-Y® Liquid Personal Lubricant formula is non-sticky, nonstaining, non-greasy and is compatible with latex condoms in laboratory testing. It is a water soluble clear, high viscosity gel-like liquid. Because it is water-soluble, K-Y® Liquid Personal Lubricant is easily rinsed off with water. The product is packaged in a convenient to use squeeze bottle with a flip-top cap.
The provided text describes information for a 510(k) premarket notification for a medical device called "K-Y® Liquid Personal Lubricant". The primary "acceptance criteria" discussed relate to product performance characteristics and safety, particularly in comparison to predicate devices, rather than a quantifiable diagnostic outcome.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a personal lubricant and not a diagnostic device, the "acceptance criteria" are performance characteristics and safety profiles relative to predicate devices. The text doesn't explicitly state numerical acceptance thresholds but describes comparative performance.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| LATEX CONDOM COMPATIBILITY | No substantial differences in mechanical properties of condoms treated with the lubricant compared to untreated condoms. | "condoms treated with K-Y® Liquid Personal Lubricant and condoms that were not treated showed no substantial differences in mechanical properties." |
| LUBRICATING EFFECTIVENESS | Comparable to or better than predicate devices (K-Y® Jelly, ASTROGLIDE®). | "K-Y® Liquid Personal Lubricant was more lubricating than both K-Y® Jelly and ASTROGLIDE®." |
| NON-STAINING PROPERTY | Comparable to predicate devices, ideally with similar high percentages of no/very light staining observations. | "all of the devices had similar results," with K-Y® Liquid Personal Lubricant showing 98% observation of no stain or very light staining. This is compared to K-Y® Jelly at 99% and ASTROGLIDE® at 88%. Both predicate devices currently carry a non-staining claim. |
| DERMAL IRRITATION (HUMAN) | No significant evidence of primary irritation or allergic sensitization. | "Neither product [K-Y® Liquid Personal Lubricant and ASTROGLIDE®] showed significant evidence of primary irritation or allergic sensitization. There were no reactions during the induction series and only a single plus-minus reaction during the challenge phase." |
| VAGINAL IRRITATION (RABBIT) | No potential to produce significant irritation. | "This study...showed that the proposed device does not exhibit the potential to produce significant irritation in rabbits when administered intravaginally for ten consecutive days." |
| CONSUMER PREFERENCE | No significant negative preference against the new device compared to predicate. | "on virtually all individual characteristic, the majority of women did not have a preference between K-Y® Liquid Personal Lubricant and ASTROGLIDE®. Where preferences were indicated, they were split between K-Y® Liquid Personal Lubricant and ASTROGLIDE®, with each holding a few directional advantages over the other." |
2. Sample size used for the test set and the data provenance
- Latex Condom Compatibility: Not specified (laboratory testing).
- Lubricating & Non-staining Studies: "2 different studies" were conducted, but the sample size for tested samples (e.g., fabric swatches for staining, or specific lubricant volumes) is not explicitly mentioned. The data provenance is implied to be laboratory testing.
- Clinical Dermal Irritation Study (Human):
- Sample Size: 105 subjects completed the study.
- Data Provenance: Clinical study in humans (retrospective/prospective not specified, but typically prospective for such clinical trials). The location (country of origin) is not specified.
- 10-Day Rabbit Vaginal Irritation Study:
- Sample Size: Not explicitly stated, but implies a group of rabbits underwent the test.
- Data Provenance: Conducted at an "outside testing laboratory". Not specified if retrospective or prospective, or country of origin.
- Consumer Home Use Testing:
- Sample Size: Not specified ("majority of women").
- Data Provenance: Consumer home use testing. Not specified if retrospective or prospective, or country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not directly applicable in the context of this device. The studies described are primarily performance and safety assessments (e.g., mechanical properties, irritation potential, user perception), not diagnostic accuracy studies that require expert consensus for ground truth.
- For the dermal irritation study, clinical professionals would assess reactions, but these are direct observations and not "ground truth" established by consensus in the typical sense of a diagnostic study.
- For the animal study, veterinary professionals or toxicologists would make assessments.
4. Adjudication method for the test set
Not applicable. The studies described are not comparing diagnostic interpretations, so an adjudication method is not relevant. Results for irritation, staining, and lubrication are direct experimental observations or reader evaluations based on predefined criteria, not requiring consensus for "ground truth" of a disease state.
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. This is a personal lubricant, not an AI-powered diagnostic device. No "human readers" (in the medical diagnostic sense) making interpretations are involved, nor is there any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a personal lubricant, not a standalone algorithm.
7. The type of ground truth used
- Latex Condom Compatibility: Objective physical measurements (mechanical properties).
- Lubricating & Non-staining Studies: Objective measurements or trained assessor evaluations against criteria for staining and lubrication. The "98% observation of no stain or very light staining" implies human observation/evaluation.
- Clinical Dermal Irritation Study (Human): Direct clinical observation of dermal reactions (e.g., erythema, edema) by qualified clinical personnel.
- 10-Day Rabbit Vaginal Irritation Study: Histopathological examination and macroscopic observation of vaginal tissue for signs of irritation by veterinary pathologists/toxicologists.
- Consumer Home Use Testing: User self-reported preference and satisfaction.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no training set in the computational sense. The studies described are for direct product performance and safety evaluation.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI model.
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