K-Y BRAND INTRIGUE

K062796 · Personal Products Co. · NUC · Dec 8, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K062796
• Device Name: K-Y BRAND INTRIGUE
• Applicant: Personal Products Co.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

Device Story

K-Y® Brand Intrigue™ is a personal lubricant designed for penile and vaginal application. It is compatible with latex condoms. The device is intended for over-the-counter use by consumers to provide lubrication during sexual activity.

Technological Characteristics

Personal lubricant; compatible with latex condoms.

Indications for Use

Indicated for use as a personal lubricant for penile and vaginal application; 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 ULTRA GEL™

Submission Summary (Full Text)

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Personal Product Company Division of McNeil - PPC, Inc. Traditional 510(k)

K062796

## (Appendix A) 510(k) Summary of Safety and Effectiveness

DEC - 8 2006

| Submitter | Personal Products Company<br>Division of McNeil - PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Nader Fotouhi, Ph.D.<br>Manager, Regulatory Affairs<br>Personal Product Company<br>Division of McNeil - PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558<br>Phone: [phone]<br>Fax: [phone] |
| Date | September 15, 2006 |
| Trade Name | K-Y® Brand Intrigue™ |
| Common Name | Personal Lubricant |
| Classification<br>Name | HIS - Condom (21CFR 884.5300)<br>MMS - Patient Lubricant (21CFR 880.6375) |
| Statement | This proposed device is substantially equivalent to currently marketed<br>predicate device, K-Y® Brand ULTRA GEL™. |
| Device<br>description | This device is a personal lubricant compatible with latex condom. |

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

DEC - 8 2003

, ,

Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558-9418

Re: K062796

> Trade/Device Name: K-Y® Brand Intrigue™ Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: September 15, 2006 Received: September 19, 2006

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 cither class II (Special Controls) or class III (Premarket Approval), 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.

Image /page/1/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are in the center of the logo. There are three stars below the word "Centennial". The logo appears to be for the centennial anniversary of the Food and Drug Administration.

1 Promoting Public It

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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). 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/cdr.h/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Personal Product Company Division of McNeil - PPC, Inc.

## (Appendix C)

## Indications for Use Statement

510(k) Number, if known

K062796 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: K-Y® Brand Intrigue™

Indications for Use:

Indications for 000:
K-Y® Brand Intrigue™ is intended as a personal lubricant for penile and vaginal application compatible with latex condom.

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR Over-the-Counter Use | <div> <span></span> </div> |
|------------------|-------------------------|----------------------------|
|------------------|-------------------------|----------------------------|

Nancy c Brogdon

(Division Sign-Off)

Division of Reproductive, Abdominal, and

Radiological Devices

| 510(k) Number | K062796 |
|---------------|---------|
|---------------|---------|

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL|