K-Y BRAND WARMING JELLY PERSONAL LUBRICANT

K040164 · Personal Products Company, Div. of Mcneil-Ppc, Inc. · NUC · Apr 5, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040164
• Device Name: K-Y BRAND WARMING JELLY PERSONAL LUBRICANT
• Applicant: Personal Products Company, Div. of Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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 sexual activity. This product is compatible with latex condoms. K-Y® Brand WARMING Jelly is intended for the purpose of lubrication, and moisturizing. It is capable of imparting a warming sensation when applied to the genital area.

Device Story

K-Y® Brand WARMING Jelly is a non-sterile, water-soluble, clear, non-staining, non-greasy personal lubricant. Designed for over-the-counter use by consumers during sexual intimacy, it functions by reducing friction and providing a warming sensation upon application to genital tissues. The device is compatible with latex condoms. It is applied topically by the user; no specialized operator or clinical setting is required. The warming effect is intended to enhance user comfort and intimacy. Safety is supported by biocompatibility testing and consumer perception/use studies confirming lack of irritation or sensitization.

Clinical Evidence

Evidence includes a Human Repeated Insult Patch Test (Modified Draize Procedure) comparing the subject device to the predicate, showing no contact sensitization. An In-Home Consumer Use Study (n=245 responses) evaluated perception and safety; 91.67% of responses were positive for 'Warms on Contact' and 85.01% positive for 'Enhances Intimate Activity'. Gynecological examinations at baseline and post-use confirmed no irritation or systemic toxicity. Bench testing confirmed compatibility with latex condoms per ASTM D 3492.

Technological Characteristics

Water-soluble, non-sterile, clear, non-staining, non-greasy jelly formulation. Compatible with latex condoms per ASTM D 3492. Biocompatibility verified per ISO 10993. No complex electronics, energy sources, or software components.

Indications for Use

Indicated for use as a personal lubricant for vaginal, penile, and condom application during sexual intimacy to supplement natural lubricating fluids and relieve friction.

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 (K040164)

Submission Summary (Full Text)

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APR ~ 5 2004

K040164
Page 1 of 2

# 510(k) SUMMARY

| 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<br>[phone] fax |
| Date Prepared | January 23, 2004 |
| Proprietary Name | K-Y® Brand<br>WARMING Jelly 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 |

K-Y® Brand JELLY Personal Lubricant

# Description of Device

Description of Delly is a non-sterile, clear, non-staining, non-greasy, water soluble ielly for use as a personal lubricant. This product imparts a gentle warming sensation when Jen' for use as a personal nas designed to meet a customer need for a lubricant that does not feel cold when applied. K-Y® Brand Warming Jelly reduce can reduce friction that does not feel cold which upplives and intimacy. It is compatible with latex during sexual mercounse theres your Compatibility Testing conducted according the condonis as defined by ASTM D 3492. K-Y® Brand WARMING Jelly is not a contraceptive nor spermicide.

## Intended Use

Intended OSE 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 SEXUAL activity. This noticall may be carey appatible with latex condoms. K-Y® Brand purpose of fubrication, and monearizante. In of imparting a warming sensation when applied to the genital area.

## Regulatory Status

Per 21CFR, 880.6375, Patient lubricant is defined as Class I medical device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or themed purposes that is about to the recessory to a condom, (a Class II medical device) the therapedia device. When accuse Class II Medical Device requiring 510(k) clearance.

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K040164
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# 510(k) SUMMARY (continued)

# Technological Characteristics

The K-Y® Brand WARMING Jelly Personal Lubricant formula is proprietary. The product, has The R-1 & Bland W/HGMI . Conny seristics and consists mainly of safe water-soluble no exceptional technological character. K-Y® Brand personal lubricants currently on the market.

#### Substantial Equivalence

Substantial Equivalence
K-Y® Brand WARMING Jelly Personal Lubricant has been shown, in laboratory tests, to be K-Y® Brand WARNING Jeny Personal Barrently marketed K-Y® Brand Warming LIQUID Personal substantally equivalent to the same intended use with a variation in formula ingredients. Lubrican. Both devices have the same mique feature of the K-Y® Brand WARMING lubricant products.

# Preclinical Testing of Formulation

Precimical Testing of Formation
Biocompatibility studies according to International Standard ISO 10993 and General Program Blocompationity studies abouring to and WARMING Jelly were conducted by an outside Memoratiouin G93-1 on X-1 & Blails W Practices (GLPs). Results form these studies, laboratory, in compulatice with Cood Laboratory - Pashered to be a contact sensitizing agent, nor was it associated with systemic toxicity.

### Human Clinical Testing

Human Chilital Testillie
In a Human Repeated Insult Patch Test (Modified Draize Procedure), this product was In a Human Repeared misun Paten 1000 Torming LIQUID for its potential for contact compared to the currently markets its I & TV Wanning List of contact sensitization was elicited.

A Consumer Perception Study evaluated both male and female participant's experience of A Consumer Petception Stady overance count to their genitals during an on-site visit. Overall warmin with a single application or the product as Excellent, Very Good or Good for "Warms on 75.50% of the participans face the product & incomed or reported during the course of this study.

An In Home Consumer Use Study was conducted to evaluate both consumer perception of An in Home Collisumer OSC Study was collection of the product through vulvo/vaginal warning schud activity as well well well we. Consented female subjects received speculum examinations at baseline and following the last coital episode. The study was gyneological exammations at baseme and 10.6 for Investigational Device Exemption and conducted in compunated with acy results for this study concluded that in 245 reported responses, 91.67% were positive for "Warms on Contact" and 85.01% were positive for Itesponses, 91.07% were positively to "responded positively to "experienced discomfori". Ennunces Intimate " and 0.078 roopeneuse, (with a minimal of two sexual intercourse Auditionally, ance two weeks of nome tool (with reported. Gynecological examinations encounters) there were no sorrous ac. stregular 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: K040164 Trade/Device Name: K-Y® Brand Warming Jelly Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): January 23, 2004 Received (Date on orig SE ltr): January 26, 2004

Dear Ms. Carlson:

This letter corrects our substantially equivalent letter of April 5, 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/Resourcesfor You/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): K040164

Device Name: K-Y® Brand Warming Jelly

Indications For Use:

Personal Lubricant I croomax Lubrican
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 F NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brydon

(Division Sign-Of)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K040164