Intended for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Device Description

KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness.

The subject device will be packaged as follows:

12 mL Polyethylene terephthalate (PET) bottle
Polypropylene (PP) pump
Polypropylene (PP) snap-on cap
Outer carton

The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

AI/ML Overview

The provided document describes the K-Y® Marilyn Pleasure Gel (K151884), a personal lubricant. It presents performance data to demonstrate its substantial equivalence to predicate devices, particularly concerning biocompatibility and condom compatibility.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria / Standard	Reported Device Performance (K-Y® Marilyn Pleasure Gel)	Conclusion
Biocompatibility:
ISO 10993-10:2009 (Irritation)	Non-irritant to vaginal tissue of the rabbit.	Device shown to be non-irritating
ISO 10993-10:2009 (Sensitization)	No evidence of causing delayed dermal contact sensitization in the guinea pig.	Device shown to be non-sensitizing in guinea pig maximization study.
ISO 10993-11:2009 (Systemic Toxicity)	Not considered a sensitizer in the guinea pig maximization test (and by implication, no mortality or systemic toxicity).	Device did not cause any mortality or systemic toxicity
USP <87>: 2015 (Cytotoxicity)	Evidence of slight cytotoxicity to the cells exposed to the test item.	Device shown to be non-cytotoxic (Note: The reported performance states "slight cytotoxicity," but the conclusion states "non-cytotoxic." This discrepancy suggests a threshold where "slight" is deemed acceptable for "non-cytotoxic.")
Condom Compatibility:
ASTM D7661-10:2010 (Natural Rubber Latex & Polyisoprene Condoms)	Passed the condom compatibility test for 3NRL and PI condoms- with no tests having % difference values > 20% and the majority of results < 10%.	The Device is shown to be compatible with NRL and PI condoms.
Condom Compatibility:
ASTM D7661-10:2010 (Polyurethane Condoms)	Not compatible with polyurethane condoms.	The Device is shown to be not compatible with PU condoms.
Stability:
(Not explicitly a standard, but a criterion)	9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions.	9 month shelf life demonstrated.

2. Sample sizes used for the test set and the data provenance

The document does not explicitly state the exact sample sizes (e.g., number of rabbits, guinea pigs, or specific condom batches) for each test. However, it indicates standard animal models were used:

Biocompatibility (Irritation): Rabbit vaginal tissue.
Biocompatibility (Sensitization/Systemic Toxicity): Guinea pig maximization test.
Cytotoxicity: In vitro cell culture.
Condom Compatibility: 3NRL (Natural Rubber Latex) and PI (Polyisoprene) condoms.

The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin of the data. However, given it's a 510(k) submission, the studies would generally be conducted by the manufacturer or contracted labs under Good Laboratory Practice (GLP) standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to the studies presented. These are performance tests against established scientific standards (ISO, USP, ASTM), not diagnostic accuracy studies requiring expert judgment for ground truth. The "ground truth" is defined by the technical criteria of the standards themselves (e.g., a certain percentage difference for condom compatibility, histological findings for irritation).

4. Adjudication method for the test set

Not applicable. The tests are objective measurements and interpretations against predefined criteria in the standards, not subjective assessments requiring adjudication.

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 medical device (personal lubricant), not an AI-powered diagnostic tool, so MRMC studies involving human readers and AI are irrelevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the test results is based on:

Standardized test methods and protocols: Defined by ISO, USP, and ASTM.
Objective measurements: Such as percentage difference in condom properties (ASTM D7661-10).
Biological observations: Such as absence/presence of irritation or sensitization in animal models, or cytotoxic effects in cell cultures.
Analytical chemistry: For stability and compositional analysis.

8. The sample size for the training set

Not applicable. This document describes the testing of a physical product and its formulation, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as there is no machine learning training set involved.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 11, 2016

Reckitt Benckiser LLC Elizabeth Torre Regulatory Operations Lead 399 Interpace Parkway Parsippany, NJ 07054

Re: K151884 Trade/Device Name: K-Y® Marilyn Pleasure Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: December 2, 2015 Received: December 3, 2015

Dear Elizabeth Torre,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151884

Device Name K-Y® Marilyn Pleasure Gel

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	【X】Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for RB, a company focused on health, hygiene, and home products. The logo features a pink triangle pointing upwards with the letters "rb" in white inside. Below the triangle, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with small triangles separating each word.

510(k) Summary

Submitted by:	Reckitt Benckiser, LLC
	399 Interpace ParkwayParsippany, NJ 07054-0224973-404-2715973-404-5702
Contact Person:	Elizabeth Torre, Regulatory Operations Lead, Reckitt Benckiser, LLC.
Date Prepared:	January 4, 2016
Proprietary Name:	K-Y ® Marilyn Pleasure Gel
Trade Name:	K-Y ® Marilyn Pleasure Gel
Common Name:	Personal Lubricant
Classification Name:	Lubricant (21 CFR §884.5300, Product Code NUC)
Predicate Device(s):	KY® Brand Liquid Reckitt Benckiser LLCProduct Code: NUC510(k) No.: K955648Durex® Embrace Warming Sensation GelReckitt Benckiser LLCProduct Code: NUC510(k) No.: K140193Durex® Embrace Tingling Experience GelReckitt Benckiser LLC

Product Code: NUC 510(k) No.: K140193

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Image /page/4/Picture/0 description: The image shows the logo for RB, which stands for Reckitt Benckiser. The logo features a pink abstract shape resembling a stylized letter 'r' and 'b' stacked on top of each other. Below the logo, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with heart symbols separating the words.

Description of the Device:

The subject device will be packaged as follows:

12 mL Polyethylene terephthalate (PET) bottle ●
Polypropylene (PP) pump ●
Polypropylene (PP) snap-on cap ●
. Outer carton

The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use.

Indications for Use Statement: KY Marilyn is indicated for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms.

Summary of Technological Characteristics of New Device in Comparison to Predicate:

Predicate comparison can be seen in Table 1 below.

510(k)	Device Name	Intended Use	Indications for Use	Physical	Manufacturer
				Features
K151884	KY Marilyn	The intended use of thisdevice is for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activity andsupplement the body'snatural lubrication.This device is compatiblewith natural rubber latexand syntheticPolyisoprene condoms.This device is notcompatible withpolyurethane condoms.	Intended for penile and/orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.This product is compatiblewith natural rubber latex andpolyisoprene condoms. Thisproduct is not compatiblewith polyurethane condoms.	HomogeneousClearGel/Odorless	ReckittBenckiserLLC

Table 1: Technological Characteristics of Subject Device Compared to Predicate

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Image /page/5/Picture/0 description: The image shows a logo with the letters 'rb' in lowercase, stylized in a modern, sans-serif font. The letters are a vibrant pink color and are positioned above a pink, triangular shape that resembles an arrowhead pointing downwards. The overall design is simple, clean, and eye-catching, suggesting a brand identity that is contemporary and dynamic.

K955648	KY Liquid	The intended use of thisdevice is a personallubricant (for vaginal andpenile application)compatible with latexcondoms ONLY.	Intended as a personallubricant for penile andvaginal application. It iscompatible with latexcondoms ONLY.	HomogeneousClearGel/Odorless	ReckittBenckiserLLC
K140193	DurexEmbraceWarmingSensation Gel	The intended use of thisdevice is for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activity andsupplement the body'snatural lubrication.This device is compatiblewith natural rubber latex,synthetic Polyisopreneand polyurethanecondoms.	Intended for penile and/orvaginal application, intendedto moisturize and lubricate,to enhance the ease andcomfort of intimate sexualactivity and supplement thebody's natural lubrication.Lubricant is compatible withnatural rubber latex.synthetic polyisoprene andpolyurethane condoms.	HomogeneousClearGel/Odorless	ReckittBenckiserLLC
K140193	DurexEmbraceTinglingExperienceGel	The intended use of thisdevice is for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activityand supplement thebody's natural lubrication.This device is compatiblewith natural rubber latex,synthetic polyisopreneand polyurethanecondoms.	Intended for penile and/orvaginal application,intended to moisturize andlubricate, to enhance theease and comfort ofintimate sexual activityand supplement the body'snatural lubrication.Lubricant is compatiblewith natural rubber latex,synthetic polyisoprene andpolyurethane condoms.	HomogeneousClear Gel/Odorless	ReckittBenckiserLLC

Stability: KY Marilyn is shown to have a 9 month shelf life based on 9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions.

Summary of Performance Data:

Standard Used	Name of Standard	Result	Conclusion
ISO 10993-10:2009	Biological Evaluation andBiocompatibility Testingof Medical Devices	The test article was considered a non-irritant to vaginal tissue of the rabbit.	Device shown tobe non-irritating
ISO 10993-10:2009	Biological Evaluation andBiocompatibility Testingof Medical Devices	The test article solution showed noevidence of causing delayed dermalcontact sensitization in the guinea	Device shown tobe non-sensitizingin guinea pigmaximizationstudy.

Table 2: Summary of Performance Data

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Image /page/6/Picture/0 description: The image shows the logo for RB, a health, hygiene, and home company. The logo features a pink triangle with the letters "rb" in white inside. Below the triangle are the words "HEALTH, HYGIENE, HOME" in black with pink triangle bullet points separating the words.

ISO 10993-11:2009	Biological Evaluation andBiocompatibility Testingof Medical Devices	The test article was not considered asensitizer in the guinea pigmaximization test.	Device did notcause anymortality orsystemic toxicity
USP <87> :2015	Biological ReactivityTests, in vitro	There was evidence of slightcytotoxicity to the cells exposed tothe test item of the subject device.	Device shown tobe non-cytotoxic
ASTM D7661-10:2010	Standard Test Method forDetermining Compatibilityof Personal Lubricantswith Natural Rubber latexCondoms	The test results indicate that KYMarilyn (TDS8125708), have passedthe condom compatibility test for510(k) condom for 3NRL and PIcondoms- with no tests having %difference values > 20%and themajority of results < 10%.	The Device isshown to becompatible withNRL and PIcondoms and notcompatible withPU condoms.

Conclusion: Substantial Equivalence of proposed devices can be achieved when the proposed device and the predicate device(s) share the same intended use and the same technological characteristics or when the proposed device and the predicate device(s) share the same intended use with different technological characteristics but when the information submitted to the FDA: 1) does not raise different questions of safety and efficacy of the proposed device and 2) demonstrates that the proposed device is at least as safe and effective as the legally marketed device.

In this case, the predicate devices K140193 and K955648 as well as the proposed device (K151884) share the same intended use for penile and vaginal application for personal lubrication. Based on this information the proposed device and the predicates fall under the FDA Classification NUC for personal lubricant. Both predicates (K140193 and K955648) as well as the proposed device (K151884) are compatible with NRL condoms as per ASTM D7661-10.

Both the proposed device (K151884) and predicate devices K140193 and K955648 are transparent, odorless liquids. They have similar formulation profiles and all contain a thickener, humectant, pH modifier and preservatives. The proposed and predicate devices also share similar technological characteristics including pH and microbial profiles (Specified Organisms Testing). In addition to the technological characteristics, the safety profiles of the proposed and predicate devices are similar. All are non-sensitizing, non-irritating and none are shown to result in mortality or systemic toxicity. All cleared devices have the same fundamental and scientific technology, and based on presented data are considered safe and effective for use. Based on this information, it can be stated that the proposed device is substantially equivalent to the predicate devices.

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.