K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT

K040340 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · NUC · Apr 28, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040340
• Device Name: K-Y BRAND WARMING ULTRAGEL PERSONAL LUBRICANT
• Applicant: Personal Products Company, Div. of Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

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

Device Story

K-Y® Brand WARMING UltraGEL is a non-sterile, water-soluble, clear, non-staining, non-greasy gel. Applied topically to vaginal, anal, or penile tissues by the user to reduce friction and enhance comfort during sexual activity. Imparts a gentle warming sensation upon contact with genital skin. Compatible with latex condoms. Designed for over-the-counter use by consumers. Safety established via biocompatibility testing (ISO 10993) and clinical studies evaluating sensitization and consumer perception of warmth and intimacy enhancement. No complex electronics or software involved.

Clinical Evidence

Clinical evidence includes a Human Repeated Insult Patch Test (Modified Draize Procedure) showing no contact sensitization. A consumer perception study (n=not specified) reported 80% excellent/very good rating for 'Warms on Contact' and 95% for 'Does not feel cold'. An in-home consumer use study (245 responses) reported 91.67% positive for 'Warms on Contact' and 85.01% for 'Enhances Intimacy'. Safety was monitored via gynecological examinations pre- and post-use; no serious adverse events were reported, and the product was determined not to cause irritation.

Technological Characteristics

Water-soluble gel formulation; proprietary ingredients; non-sterile. Imparts warming sensation via chemical interaction upon application. Compatible with latex condoms per ASTM D 3492. No electronic components, software, or energy sources.

Indications for Use

Indicated for use as a personal lubricant for vaginal, penile, and condom application during sexual intimacy to supplement natural lubrication and relieve friction. Suitable for over-the-counter use.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• K-Y® Brand Warming LIQUID Personal Lubricant

Submission Summary (Full Text)

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APR 2 8 2004

### 510(k) SUMMARY

KO4034D

| Submitter | Personal Products Company Division of McNeil-PPC Inc.<br>199 Grandview Road<br>Skillman, New Jersey 08558-9418 |
|---------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Marylou P. Carlson<br>Mgr. Regulatory Affairs<br>[phone] phone [phone] fax |
| Date Prepared | February 02, 2004 |
| Proprietary Name | K-Y® Brand<br>WARMING UltraGEL Personal Lubricant |
| Common Name | Personal Lubricant |
| Classification Name | Condom: 21CFR § 884.5300 Product Code 85HIS<br>Patient Lubricant: 21CFR 880.6375 Product Code MMS |
| Predicate Device | K-Y® Brand Warming LIQUID Personal Lubricant |

# Description of Device

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.

# Intended Use

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

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.

# 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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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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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 [phone] or [phone] 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 [phone] or [phone] 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

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