Patient lubricants are devices intended to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. When used as an accessory to a medical device such as a condom, they are considered Class II Medical Devices.

K-Y® Brand WARMING LIQUID is principally intended as personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal, anal or penile tissue for purpose of lubrication, and moisturization. It is also compatible with latex condoms.
Personal Lubricant (compatible with latex condoms)

Device Description

K-Y® Brand WARMING LIQUID is a non-sterile clear non-staining, non-greasy, high viscosity liquid gel used as a personal lubricant. This product is highly lubricous and may be used with or without a latex condom during intimate sexual activity. K-Y® Brand WARMING LIQUID is not a contraceptive or spermicide. It is compatible with latex condoms as demonstrated in Condom Compatibility Testing conducted according the standards defined by ASTM D 3492.

AI/ML Overview

The provided document describes the safety and performance testing of K-Y® Brand WARMING LIQUID™ Personal Lubricant, not an AI device. As such, many of the requested categories related to AI device evaluation (e.g., sample size for the test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.

However, I can extract the acceptance criteria and reported device performance from the provided text, focusing on the aspects that were evaluated.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Dermal Sensitization	Not to be a contact sensitizing agent.	The product was considered not to be a contact sensitizing agent.	Dermal Sensitization Study (in albino guinea pigs)
Penile Irritation	Not to cause any significant adverse effects or significant irritation.	The product did not cause any significant adverse effects and did not produce any significant irritation.	Rabbit Penile Irritation Study
Vaginal Irritation (Chronic)	Not to cause any pharmacotoxic effects; acceptable for use in humans.	The product did not cause any pharmacotoxic effects and was minimally irritating to the rabbit vaginal epithelium but considered acceptable for use in humans.	10-Day Rabbit Vaginal Irritation Study
Systemic Toxicity	Not to cause mortality and not to be associated with systemic toxicity.	The product did not cause mortality and was not associated with systemic toxicity.	Mouse Systemic Injection Study (25% w/v at 50mg/kg i.p.)
Human Cumulative Irritation	To be mildly irritating and elicit no evidence of sensitization.	The product was considered to be only mildly irritating and elicited no evidence of sensitization on the skin of healthy humans.	Human 21-Day Cumulative Irritation Assay (occluded conditions)
Human Contact Sensitization	To be essentially non-irritating and not elicit evidence of sensitization.	The product was considered essentially non-irritating and did not elicit evidence of sensitization on healthy human skin.	Human Repeat Insult Patch Test (Modified Draize Procedure), compared to K-Y® Liquid
Consumer Perception of Warmth	Desired warming sensation perceived by consumers.	Greater than 85% of the participants perceived a warming sensation while using the product.	Two-Phase Consumer Use Study
Human Irritation (Post-Use)	No observed irritation upon gynecological examination after use.	After one week of home use, there was no observed irritation upon gynecological examination.	Two-Phase Consumer Use Study
Condom Compatibility	Compatible with latex condoms.	Compatible with latex condoms as demonstrated.	Condom Compatibility Testing (according to ASTM D 3492)
Lubricity	Comparable to predicate device (K-Y® Brand LIQUID Personal Lubricant).	Comparable lubricity was demonstrated.	Laboratory coefficient of friction testing

Study Details (Non-AI Specific)

Sample size used for the test set and the data provenance:
- Dermal Sensitization Study: Albino guinea pigs (specific number not provided).
- Rabbit Penile Irritation Study: Rabbits (specific number not provided).
- 10-Day Rabbit Vaginal Irritation Study: Rabbits (specific number not provided).
- Mouse Systemic Injection Study: Mice (specific number not provided).
- Human 21-Day Cumulative Irritation Assay: Healthy humans (specific number not provided).
- Human Repeat Insult Patch Test: Healthy human skin (specific number not provided).
- Two-Phase Consumer Use Study: Males and Females (initial perception and home use). Number of participants not explicitly stated, but implies a cohort.
- Data Provenance: Studies conducted by "outside laboratories" (preclinical) and within the US (implied by FDA submission context and "healthy humans" / "consumers" for clinical tests). These are prospective studies designed to evaluate the product.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for these types of preclinical and clinical safety/performance studies. Ground truth is established by direct observation, laboratory measurements, and clinical assessments (e.g., macroscopic and microscopic findings for irritation, gynecological examinations).
Adjudication method for the test set: Not applicable for these types of studies. Results are based on direct measurements and observations, not a consensus among reviewers of a complex output.
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 not an AI device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
The type of ground truth used:
- Preclinical: Histopathological examination (macroscopic and microscopic findings), physiological responses (mortality), and direct observation of skin reactions.
- Clinical: Direct observation of skin reactions, gynecological examinations, and subject self-reporting (perception of warmth).
- Compatability/Lubricity: ASTM standard testing and laboratory coefficient of friction measurements.
The sample size for the training set: Not applicable. This is not an AI device.
How the ground truth for the training set was established: Not applicable. This is not an AI device.

Summary

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AUG 0 7 2002

K0.2149.2

TAB H XIII. 510(k) Summary

Pursuant to the Food and Drug and Cosmetic Act § 513(1)(B)(3)(A) as amended by the Safe Medical Device Act of 1990, this sponsor is providing a 510(k) Summary for the proposed device.

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510(k) SUMMARY

Submitter	Personal Products Company Division of McNeil-PPC Inc.
	199 Grandview Road
	Skillman, New Jersey 08558-9418
Contact Person	Marylou Panico
	Mgr. Regulatory Affairs
	(908) 904-3709 phone
	(908) 904-3748 fax
Date Prepared	May 3, 2002
Proprietary Name	K-Y® Brand
	WARMING LIQUID Personal Lubricant
Common Name	Personal Lubricant
Classification Name	Condom 21CFR § 884.5300 Product Code 85HIS
Predicate Device	K-Y® Brand LIQUID Personal Lubricant

Description of Device

Intended Use

Technological Characteristics

K-Y® Brand WARMING LIQUID formula is proprietary. The product is however has no exceptional technological characteristics consisting mainly of water soluble ingredients similar to other lubricants currently on the market.

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510(k) SUMMARY (continued)

Substantial Equivalence

This product has been shown in laboratory testing to be substantially equivalent to the currently marketed K-Y® Brand LIQUID Personal Lubricant. Both devices have the same intended use and similar formulas slightly varied ingredients. The unique feature of the K-Y® Brand WARMING LIQUID product is that this formula provides a warming sensation upon application. Comparable lubricity of the proposed K-Y® Brand WARMING LIQUID and the marketed K-Y® Liquid products was demonstrated in laboratory coefficient of friction testing.

Preclinical Testing of Formulation

Preclinical biocompatibility studies on K-Y® Brand WARMING LIQUID was conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs) demonstrated:

in a Dermal Sensitization Study that the product was considered not to be a contact . sensitizing agent in albino guinea pigs.
in a Rabbit Penile Irritation Study that the product did not cause any significant adverse . effects when directly administered to the rabbit penis and based on macroscopic and microscopic findings did not produce any significant irritation.
in a 10-Day Rabbit Vaginal Irritation Study, that the product did not cause any . pharmacotoxic effects when administered vaginally to rabbits for 10 consecutive days. K-Y® Brand WARMING LIQUID was minimally irritating to the rabbit vaginal epithelium but considered acceptable for use in humans.
in a Mouse Systemic Injection Study that a 25% w/v the product did not cause mortality . and was not associated with systemic toxicity when administered at 50mg/kg using the i.p. route of administration.

Clinical Testing

In a Human 21-Day Cumulative Irritation Assay, this product under occluded conditions was considered to be only mildly irritating and elicited no evidence of sensitization on the skin of healthy humans.

In a Human Repeat Insult Patch Test (Modified Draize Procedure), this product was compared to the currently marketed K-Y® Liquid for its potential for contact sensitization. This study concluded that K-Y® Brand WARMING LIQUID was considered essentially non-irritating and did not elicit evidence of sensitization on healthy human skin.

A Two-Phase Consumer Use Study provided data on consumer (Males and Females) perception of warmth with a single application of the K-Y® Brand WARMING LIQUID product at the test facility, as well as actual use at home during sexual activity. Female subjects received gynecological examinations at baseline and following the last intercourse episode. The study was conducted in compliance with 21CFR 812 for Investigational Device Exemption. This study concluded that, greater than 85% of the participants perceived a warming sensation while using the product. Additionally, after one week of home use, (with a minimal of two sexual intercourse encounters) there was no observed irritation upon gynecological examination.

Preclinical and Clinical testing conducted on this formulation has demonstrated scientific evidence that this product is safe for its intended use.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.

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

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

FEB 2 4 2014

Re: K021492

Trade/Device Name: K-Y® Brand WARMING LIQUID™ Personal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): May 8, 2002 Received (Date on orig SE ltr): May 9, 2002

Dear Ms. Panico:

This letter corrects our substantially equivalent letter of August 7, 2002.

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. Iisting 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 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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510(k) INDICATIONS FOR USE FORM (Replica of FDA Form)

510(k) Number (if known): _ |< 02 | 49 2

Device Name: K-Y® Brand WARMING LIQUID™ Personal Lubricant Indications For Use:

Personal Lubricant (compatible with latex condoms)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-the-Counter-Use -Prescription Use (per 21 CFR 801.109)

David A. Semm

00-000002

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.