K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME

K081236 · Mcneil-Ppc, Inc. · NUC · Sep 25, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K081236
• Device Name: K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME
• Applicant: Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The intended use of this device is as a non-therapeutic body massage and personal lubricant compatible with latex condom.

Device Story

Device is a topical crème for non-therapeutic body massage and personal lubrication; compatible with latex condoms. Imparts warming sensation upon skin application. Used by consumers in home settings to enhance comfort during intimate activity. Product functions as a lubricant to supplement natural moisture. Safety and performance established via laboratory testing for condom compatibility and human use data.

Clinical Evidence

Evidence includes laboratory testing, pre-clinical evaluations, and human use data. Laboratory testing confirmed compatibility with leading commercial latex condom brands and effective lubricity. Pre-clinical and human use data demonstrated the product is safe for its intended use as a personal lubricant. No specific clinical trial metrics (e.g., p-values, AUC) were reported.

Technological Characteristics

Personal lubricant and massage crème. Formulated for topical application. Compatible with latex condoms. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for use as a personal lubricant to enhance the ease and comfort of intimate sexual activity, supplement natural lubrication, and as a non-therapeutic body massage product. Compatible with latex condoms.

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 Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant

Submission Summary (Full Text)

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J&J Healthcare Products, Division of McNeil - PPC, Inc.

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K 081236

Traditional 510(k)

| Submitter | Johnson & Johnson Healthcare Products, Division of McNeil - PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558 |
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| Contact | Nader Fotouhi, Ph.D.<br>Manager, Regulatory Affairs<br>J&J Consumer & Personal Products Worldwide<br>199 Grandview Road<br>Skillman, NJ 08558<br>Phone: [phone]<br>Fax: [phone] |
| Date | April 29, 2008 |
| Trade Name | K-Y® Brand IntrigueTM 2-in-1 Massage CrèmeTM |
| Common Name | Personal Lubricant |
| Classification<br>Name | NUC - condom compatible personal lubricant |
| Statement | This proposed device is substantially equivalent to predicate device, K-Y®<br>Brand Touch MassageTM 2-in-1 Warming® body massage + Personal lubricant. |
| Device<br>description | This device is developed for non-therapeutic body massage and personal<br>lubricant compatible with latex condom that imparts a warming sensation<br>upon the skin. |
| Intended use | The intended use of this device is as a non-therapeutic body massage and<br>personal lubricant compatible with latex condom. |
| Indications<br>statement | This device and predicate device have similar indications, by being applied to<br>the vaginal area or a condom in order to enhance comfort and ease of intimate<br>activity. They may also be used as a non-therapeutic body massage product. |
| Technological<br>characteristics | The proposed device has the same technological characteristics as currently<br>marketed condom compatible personal lubricants. |
| Performance<br>data | The results from laboratory testing, pre-clinical evaluations and testing, and<br>human use show that the proposed device performs equivalently to the<br>predicate devices. Laboratory test results demonstrated that the proposed<br>device is compatible with the leading commercial brands of latex condoms<br>and provides lubricity for use as a personal lubricant.<br>The pre-clinical evaluation and testing as well as human use data show that<br>the proposed device is safe for use as a personal lubricant. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed<br>products in technology, intended use, safety, and suitability characteristics. |

SEP 2 5 2008

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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## 510(k) Summary of Safety and Effectiveness (Continued)

## [INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 5 2008

Nader Fotouhi, Ph.D. Manager, Regulatory Affairs McNeil-PPC, Inc. Consumer Healthcare Products 199 Grandview Road SKILLMAN NJ 08558

Re: K081236

> Trade Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 17, 2008 Received: September 18, 2008

Dear Dr. Fotouhi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely vours.

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Consumer Healthcare Products Division of McNeil - PPC, Inc.

## Section 4 - Indications for Use Statement

510(k) Number, if known

K081236

Device Name: K-Y® Brand Intrigue™ 2-in-1 Massage Crème™

Indications for Use:

Interections of 2-in-1 Massage Crème™ is a personal lubricant, to enhance the ease and comfort of intimate sexual activity and supplement the body's in ural. lubrication.

This product is 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)

Prescription Use______________________________________________________________________________________________________________________________________________________________

Hulu Remer

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices

510(k) Number K081236