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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/2 description: The image shows a handwritten number, "K955648", in black ink. The number is written in a bold, slightly irregular font, giving it a casual appearance. The digits are clearly legible, and the overall impression is that of a quickly jotted down note.

510 (k) SUMMARY of SAFETY AND EFFECTLIBNESS

Statement

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Information supporting claims of substantial equivalence, as defined under the Federal Food Drug and Cosmetic Act, with respect to safety and effectiveness is summanzed below. For the convenience of the reviewer, this summary is formatted in accordance with the Agency's final rule ... "510(k) Summaries and 510(k) Statements"(21CFR807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.

New Device's Name: K-Y® Liquid Personal Lubricant
Predicate Device(s)': . K-Y® Jelly Personal Lubricant, Johnson & Johnson ASTROGLIDE® Personal Lubricant, BioFilm Inc.

Intended Use - The K-Y® Liquid Personal Lubricant is an over-the-counter personal lubricant.

Indications - 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.

Device Description - 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.

Technological Characteristics - K-Y® Liquid Personal Lubricant is thoroughly tested and proven safe to use. It contains only United States Pharmacopeia (USP) or National Formulary (NF) ingredients all of which are listed as "generally recognized as safe" (GRAS), with the exception of Hydroxyethl Cellulose (Natrosol 250H).

[Hydroxycthl Cellulose is listed in the FDA's Inactive Ingredients Guide and has been safely used as an ingredient in the predicate device, K-Y Jelly for many years. It is also an ingrodiant in many drug products e.g.: oral syrups, oral tablets, ophthalmic, and otic solutions.]

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Advanced Care Products Premarket Notification [510{k)] K-Y® Liquid Personal Lubricant

Laboratory testing demonstrated K-Y® Liquid Personal Lubricant to be compatible with latex condoms. The testing concluded that condoms treated with K-Y® Liquid Personal Lubricant and condoms that were not treated showed no substantial differences in mechanical properties.

K-Y® Liquid Personal Lubricant has been shown to be both non-staining and lubricating when compared to the predicate devices, K-Y® Jelly and ASTROGLIDE®. In 2 different studies conducted to evaluate these attributes, the K-Y Liquid Personal Lubricant formulation was tested against the two predicate devices. The lubricating study showed that K-Y® Liquid Personal Lubricant was more lubricating than both K-Y® Jelly and ASTROGLIDE®. In the non-staining study, all of the devices had similar results with the predicate device, K.- Y® Jelly showing the least amount of any staining (99% observation of no stain or very light staining) compared to the proposed device, K-Y® Liquid Personal Lubricant with 98%. ASTROGLIDE® was rated at 88%. Both predicate devices currently carry a claim of non-staining.

Safety Testing

Clinical Laboratory and Safety testing in humans and in animals demonstrated that K-Y® Liquid Personal Lubricant is safe and effective for its intended use.

A) Clinical Dermal Irritation Study - Human Repeat Insult Patch Test

A total of 105 subjects completed the entire study which was conducted comparing K-Y® Liquid Personal Lubricant and the predicate device. ASTROGLIDE®. Neither product 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.

B) 10 -Day Rabbit Vaginal Irritation Study with K-Y® Liquid Personal Lubricant

This study, which was conducted at an outside testing laboratory, showed that the proposed device does not exhibit the potential to produce significant irritation in rabbits when administered intravaginally for ten consecutive days.

Substantial Equivalence

K-Y® Liquid Personal Lubricant is substantially equivalent to other marketed predicate devices, namely ASTROGLIDE® and K-Y® Jelly. All of these products are sold overthe-counter and are indicated as personal lubricants. Laboratory tests comparing K-Y® Liquid Personal Lubricant to K-Y® Jelly and ASTROGLIDE® demonstrated these products to perform in a similar manner under similar conditions.

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Advanced Care Products Premarket Notification [510(k)] K-Y® Liquid Personal Lubricant

Performance Data

Consumer home use testing of K-Y® Liquid Personal Lubricant compared to the predicate device, ASTROGLIDE®, demonstrated that 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.

Based upon testing data and FDA's Own Substantial Equivalence Decision Process. K-Y® Liquid Personal Lubricant has been demonstrated to be a device which is safe and effective for its intended use.

Regulation Number and Section

§ 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.