K-Y BRAND INTRIGUE INTENSE WARMING SENSATION

K072360 · Mcneil-Ppc, Inc. · NUC · Dec 12, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K072360
• Device Name: K-Y BRAND INTRIGUE INTENSE WARMING SENSATION
• Applicant: Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Dec 12, 2007
• 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 personal lubricant compatible with latex condom.

Device Story

Personal lubricant applied to vaginal area or condom; enhances comfort and ease of intimate activity. Compatible with latex condoms. Used by consumers in home setting. Provides warming sensation. Safety and efficacy established via laboratory testing, pre-clinical evaluation, and human use data demonstrating equivalence to predicate.

Clinical Evidence

Evidence includes laboratory testing, pre-clinical evaluations, and human use data. Laboratory testing demonstrated compatibility with leading commercial latex condom brands and lubricity comparable to the predicate device. Pre-clinical and human use data indicate the device is safe for its intended use as a personal lubricant.

Technological Characteristics

Personal lubricant formulated for compatibility with latex condoms. Technological characteristics are identical to currently marketed condom-compatible personal lubricants. No specific materials or software components described.

Indications for Use

Indicated for use as a personal lubricant for penile and vaginal application, compatible with latex condoms, to enhance comfort and ease of intimate activity.

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 Intrigue™

Submission Summary (Full Text)

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K 072360

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# Section 5 - 510(k) Summary

| Submitter | Johnson & Johnson Healthcare Products, Division of McNeil – PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558 | |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 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 | August 20, 2007 | |
| Trade Name | K-Y® Brand Intrigue™ Intense Warming Sensation | |
| Common Name | Personal Lubricant | |
| Classification<br>Name | NUC - Condom (21CFR 884.5300) | |
| Statement | This proposed device is substantially equivalent to currently marketed<br>predicate device, K-Y® Brand Intrigue™. | |
| Device<br>description | This device is a personal lubricant compatible with latex condom. | |
| Intended use | The intended use of this device is as a personal lubricant compatible with<br>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.<br>[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL] | |

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### 510(k) Summary of Safety and Effectiveness (Continued) K 072 360 2/2

| 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. |
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| 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 predicate device. Laboratory test results demonstrated that the proposed device is compatible with the leading commercial brands of latex condoms. Lubricity of the proposed device is comparable to the lubricity of predicate device.<br>The pre-clinical evaluation and testing and human use data show that 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. |

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

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 department's name around the perimeter. Inside the circle is a stylized graphic of an eagle or bird-like figure with three curved lines representing its wings or feathers.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K072360

Trade Name: K-Y® Brand Intrigue™ Intense Warming Sensation Regulation Number: 21 CFR 884.5300 Regulation Name: Personal lubricant (accessory to a condom) Regulatory Class: II Product Code: NUC Dated: October 24, 2007 Received: October 29, 2007

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.

DEC 1 2 2007

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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 (OS) 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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.

Nancy Brogdon

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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## Section 4 - Indications for Use Statement

510(k) Number, if known

K 072360

Device Name: K-Y® Brand Intrigue™ Intense Warming Sensation

Indications for Use:

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR Over-the-Counter Use | ✓ |
|------------------|-------------------------|---|
|------------------|-------------------------|---|

(Division
Division of
Radioio.

| 510(k) No. | K072360 |
|------------|---------|
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