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

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Study Objective/Focus)	Reported Device Performance (Results)
Biocompatibility: No contact sensitization or systemic toxicity	* Preclinical Testing (ISO 10993 & G95-1): Not considered a contact sensitizing agent and not associated with systemic toxicity.
Contact Sensitization (Human): No evidence of contact sensitization	* Human Repeated Insult Patch Test (Modified Draize Procedure): No evidence of contact sensitization elicited when compared to the predicate device.
Warming Sensation (Initial Application): Positive perception of warmth and not feeling cold.	* Consumer Perception Study (Single Application): 80.00% of participants rated the product as Excellent/Very Good for "Warms on Contact." 95.00% rated it as Excellent/Very Good for "Does not feel cold when applied." No adverse events observed/reported.
Warming Sensation (During Sexual Activity) & Enhanced Intimacy: Positive perception of warmth and enhanced intimacy.	* In-Home Consumer Use Study (245 responses): 91.67% positive for "Warms on Contact." 85.01% positive for "Enhances Intimacy."
Tolerability/Irritation (During Sexual Activity): No signs of irritation or discomfort.	* In-Home Consumer Use Study (245 responses): 8.6% responded positively to "experienced discomfort" (Note: This is an adverse finding, but the overall conclusion was that the product did not cause irritation based on final gynecological examination). After two weeks of home use (minimal two sexual encounters), no serious adverse events reported. Gynecological examinations detected only one instance of mottled irregular erythema of the inner thigh at baseline, which was not present at the return visit. Conclusion: Product did not cause irritation as determined by final gynecological examination.
Compatibility with Latex Condoms	* Condom Compatibility Testing (ASTM D 3492): Compatible with latex condoms.

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.

Summary

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APR 2 8 2004

510(k) SUMMARY

KO4034D

Submitter	Personal Products Company Division of McNeil-PPC Inc.199 Grandview RoadSkillman, New Jersey 08558-9418
Contact Person	Marylou P. CarlsonMgr. Regulatory Affairs(908) 904-3709 phone (908) 904-3748 fax
Date Prepared	February 02, 2004
Proprietary Name	K-Y® BrandWARMING UltraGEL Personal Lubricant
Common Name	Personal Lubricant
Classification Name	Condom: 21CFR § 884.5300 Product Code 85HISPatient Lubricant: 21CFR 880.6375 Product Code MMS
Predicate Device	K-Y® Brand Warming LIQUID Personal Lubricant

Description of Device

Intended Use

K-Y® Brand WARMING UltraGEL is intended as personal lubricant to be used with or without a condom.

Regulatory Status

Per 21CFR, 880.6375, Patient lubricant is defined as a Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. Patient lubricants are not exempt from 510(k) clearance. Additionally when used as an accessory to a condom, (a Class II medical device) the lubricant is considered, by FDA, as a Class II Medical Device requiring 510(k) clearance.

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510(k) SUMMARY (continued)

Technological Characteristics

The K-Y® Brand WARMING UltraGEL Personal Lubricant formula is proprietary. The product, has no exceptional technological characteristics and consists mainly of safe watersoluble GRAS status ingredients somewhat similar to other K-Y® Brand personal lubricants currently on the market.

Substantial Equivalence

K-Y® Brand WARMING UltraGEL Personal Lubricant has been shown, in laboratory tests, to be substantially equivalent to the currently marketed K-Y® Brand Warming LIQUID Personal Lubricant. Both devices have the same intended use with a variation in formula ingredients. The gentle warming technology is the special feature of the K-Y® Brand WARMING lubricant products.

Preclinical Testing of Formulation

Biocompatibility safety studies according to International Standard ISO 10993 and General Program Memorandum G95-1 on K-Y® Brand WARMING UltraGEL were conducted by an outside laboratory, in compliance with Good Laboratory Practices (GLPs). Results form these studies, demonstrated that K-Y® Brand WARMING UltraGEL was not considered to be a contact sensitizing agent, nor was it associated with systemic toxicity.

Human Clinical Testing

In a Human Repeated Insult Patch Test (Modified Draize Procedure), this product was compared to the currently marketed K-Y® Warming LIQUID for its potential for contact sensitization. Under the conditions of this test no evidence of contact sensitization was elicited.

A Consumer Perception Study evaluated both male and female subjects' experience of warmth with a single application of the product to their genitals during an on-site visit. Overall 80.00% of the participants rated the product as Excellent, Very Good for "Warms on Contact" and 95.00% for "Does not feel cold when applied" There were no adverse events observed or reported during the course of this study.

An In-Home Consumer Use Study was conducted to evaluate both consumer perception of warmth during sexual activity as well as the tolerability of the product through vulvo/vaginal speculum examination prior and post product use. Consented female subjects received gynecological examinations at baseline and following the last coital episode. The study was conducted in compliance with 21CFR Part 812 for Investigational Device Exemption and 21CFR Parts 50 and 56. Efficacy results for this study concluded that in 245 reported responses, 91.67% were positive for "Warms on Contact" and 85.01% were positive for "Enhances Intimacy" and 8.6% responded positively to "experienced discomfort". Additionally, after two weeks of home use, (with a minimal of two sexual intercourse encounters) there were no serious adverse events reported. Gynecological examinations detected only one instance of mottled irregular erythema of the inner thigh area at baseline, which was not present at the return visit. It was concluded that the product did not cause irritation as determined by final gynecological examination.

Preclinical and Clinical testing have provided scientific evidence that this product is safe for its intended use.

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Image /page/2/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" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another, possibly representing care and support.

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

FEB 2 4 2014

Ms. Marylou (Panico) Carlson Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558

Re: K040340

Trade/Device Name: K-Y® Brand Warming UltraGel Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): February 6, 2004 Received (Date on orig SE ltr): February 11, 2004

Dear Ms. Carlson:

This letter corrects our substantially equivalent letter of April 28, 2004.

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

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Page 2 -

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 device-related 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 contact 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. 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,

Benjamin R.Fisher -S

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): K040340

Device Name: K-Y® Brand Warming Ultra Gel

Indications For Use:

Personal Lubricant For vaginal/penile and condom application during sexual intimacy

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David H. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

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.