K-Y® Brand Vaginal Moisturizer is a personal lubricant, for 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 not compatible with natural rubber latex or synthetic condoms.

Device Description

K-Y® Brand Vaginal Moisturizer is a non-sterile personal moisturizer formulated to supplement the body's own natural lubricating fluids to provide personal moisturization when vaginal dryness causes discomfort. K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E. The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided text, focusing on the K-Y® Brand Vaginal Moisturizer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Lubricity	Comparable to the predicate device (K-Y® Brand Jelly Personal Lubricant).
Stability	2-year shelf life confirmed by real-time stability data.
Condom Compatibility	Not compatible with condoms. Labeling will include a warning statement.
Biocompatibility (Cytotoxicity)	Agar Overlay Cytotoxicity testing performed on the current device.
Biocompatibility (Vaginal Irritation)	Rabbit Vaginal Irritation testing performed on a prototype formula.
Human Safety (Exaggerated Use)	Exaggerated Human Use (Human Repeat Insult Patch Test) performed.
Human Safety (In-Home Use)	In-Home Consumer Use Study performed.

Study Details:

This document is a 510(k) summary for a medical device (K-Y® Brand Vaginal Moisturizer) seeking substantial equivalence to a predicate device. It describes the performed tests to demonstrate the device's safety and effectiveness. It's crucial to understand that this document primarily focuses on demonstrating substantial equivalence, not conducting a multi-reader, multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as these are not relevant for this type of product and regulatory filing.

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

The document does not explicitly state the specific sample sizes for each test listed (e.g., Agar Overlay Cytotoxicity, Rabbit Vaginal Irritation, Human Repeat Insult Patch Test, In-Home Consumer Use Study). It only mentions that these tests were "performed."

Data Provenance: The studies were conducted by the applicant, Johnson & Johnson Healthcare Products. The location of the studies (e.g., country of origin) is not specified, but the applicant's address is in Morris Plains, NJ, USA. The studies would be considered prospective as they were conducted specifically for this regulatory submission.

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

Not applicable. This device is a personal lubricant, not an diagnostic imaging or AI-driven decision support system that requires expert interpretation for ground truth establishment. The "ground truth" here is determined by direct laboratory tests and human safety assessments.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiologists reviewing images) to resolve discrepancies and establish a consensus "ground truth." This is not relevant for the types of tests described for a vaginal moisturizer.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic tools or imaging systems where human readers interpret data with and without AI assistance. K-Y® Brand Vaginal Moisturizer is a physical product (lubricant), not an AI system.

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

No, a standalone (algorithm only) performance study was not done. This concept applies to AI algorithms. K-Y® Brand Vaginal Moisturizer is a physical product.

7. The type of ground truth used

The "ground truth" for this product is established through:

Laboratory Testing: For factors like lubricity, stability, and condom compatibility.
Biocompatibility Testing:
- Agar Overlay Cytotoxicity (in vitro lab test).
- Rabbit Vaginal Irritation (in vivo animal model).
Human Safety Studies:
- Exaggerated Human Use (Human Repeat Insult Patch Test) – direct observation of human skin reactions.
- In-Home Consumer Use Study – direct user feedback on safety and performance.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm requiring a training set.

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

Not applicable, as there is no "training set" for this type of product.

Summary

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K 101585

SECTION 5 - 510(K) SUMMARY

ﺮ ﺍ

MAY 1 0 2011

Date Prepared:	May 4, 2011
Applicant:	Johnson & Johnson Healthcare Products,Division of MCNEIL - PPC, Inc.185 Tabor RoadMorris Plains, NJ 07950
Contact Person:	Brad LaMotte, PharmDManager, Global Regulatory AffairsJohnson & Johnson Consumer & Personal Products WorldwideDivision of Johnson & Johnson Consumer Companies, Inc.Phone 973-385-3667Fax 973-385-4300e-mail BLaMotte@its.jnj.com
Proposed Device:	K-Y® Brand Vaginal Moisturizer
	Classification Name:	Lubricant, Vaginal, Patient, LatexCompatible
	Classification:	Class II
	Product Code:	NUC
	Regulation:	21 CFR §884.5300
	Document Control No:	K101585
Predicate Device:	K-Y® Brand Jelly Personal Lubricant
	Regulation Description:	Lubricant, Vaginal, Patient
	Classification Name:	Lubricant, Patient
	Classification:	Class I
	Product Code:	KMJ
	Regulation:	21 CFR §880.6375
	Document Control No.:	K810310
Description:	K-Y® Brand Vaginal Moisturizer is a non-sterile personalmoisturizer formulated to supplement the body's own naturallubricating fluids to provide personal moisturization when vaginaldryness causes discomfort.
Indication for Use:	K-Y® Brand Vaginal Moisturizer is a personal lubricant, for vaginalapplication, intended to moisturize and lubricate, to enhance the easeand comfort of intimate sexual activity and supplement the body'snatural lubrication. This product is not compatible with natural rubberlatex or synthetic condoms.

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Comparison to the Predicate Device:

K-Y® Brand Vaginal Moisturizer and the predicate device are similar in all characteristics except:

. Technical Composition - As water based gels, the formulations of the proposed device and the predicate device are substantially equivalent. They each contain ingredients from the same or similar functional categories. Both products have excellent moisturization/lubrication characteristics and similar lubricity. The composition of the proposed device includes additional emollients, lubricants and polymers to enhance the feel and lubricity of the formula. This difference does not negatively affect the safety, effectiveness, or intended use of the device.
. Packaging - The proposed device is packaged in pre-filled applicators to facilitate insertion directly into the vagina while the predicate device is packaged in a tube. The formulation has been determined to be stable in this packaging. This difference does not affect the safety, effectiveness, or intended use of the device.
Intended Use The proposed device is not intended for use with . condoms as it contains mineral oil which is known to be deleterious to latex condoms. To address this difference, the proposed device will contain the following warning statement:

DO NOT USE WITH CONDOMS. This lubricant contains mineral oil which may damage the condom.

Directions for Use The directions for use of the proposed device . differ only in the method of application. The proposed device is inserted directly into the vagina via a pre-filled applicator, while the predicate device is applied directly to the vaginal area or directly to the device being inserted into the vagina. This difference does not affect the safety, effectiveness, or intended use of the device.
Based on the comparisons above, performance data, biocompatibility review and testing, and human use and safety data, we conclude that K-Y® Brand Vaginal Moisturizer and K-Y® Brand Jelly are substantially equivalent.

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Technological Characteristics:

Formulation: K-Y® Brand Vaginal Moisturizer, is a stable, non-sterile, translucent, aqueous based, preserved, formulated product composed of a combination of emollients, gelling agents, preservatives, vehicles, and an antioxidant. It is non-fragranced, pH balanced, and contains Vitamin E.

Stability: Real time stability date confirms a 2 year shelf life.

Performance Data:

Lubricity: Lubricity of K-Y® Brand Vaginal Moisturizer is comparable to the predicate device.

Condom Compatibility: This product has not been shown to be compatible with condoms. Labeling will contain a statement to this effect and a warning not to use with condoms.

Biocompatibility: The following biocompatibility testing has been performed on the current K-Y® Brand Vaginal Moisturizer.

Agar Overlay Cytotoxicity ●
The following biocompatibility testing has been performed on a prototype formula of K-Y® Brand Vaginal Moisturizer.
Rabbit Vaginal Irritation .
Human Safety and Use: The following Human Use and Safety testing has been performed on K-Y® Brand Vaginal Moisturizer.
Exaggerated Human Use (Human Repeat Insult Patch Test) .
. In-Home Consumer Use Study

Conclusion: K-Y® Brand Vaginal Moisturizer is safe and well tolerated when used as intended to provide long lasting relief from vaginal dryness.

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Image /page/3/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem is a stylized representation of an eagle or bird with three curved lines forming its body and wings. The text is arranged around the top and sides of the circle.

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

Johnson & Johnson Healthcare Products Division of McNEIL-PPC, Inc. % Brad LaMotte, PharmD, RPh Manager, Global Regulatory Affairs Johnson & Johnson Consumer & Personal Products Worldwide Division of Johnson & Johnson Consumer Companies, Inc. 185 Tabor Road MORRIS PLAINS NJ 07950

MAY 10 201

Re: K101585

Trade/Device Name: K-Y® Brand Vaginal Moisturizer Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 29, 2011 Received: May 2, 2011

Dear Dr. LaMotte:

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 of medical device-related

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adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) 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 STATEMENT 4.

510(k) Number:

K101585

. '

Device Name:

Indications for Use:

K-Y® Brand Vaginal Moisturizer

This product is not compatible with natural rubber latex or synthetic condoms.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

. . . . .

Prescription Use (Per 21 CFR §801.109) OR

Over-the-Counter Use

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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.