K-Y BRAND WARMING LIQUID

K070545 · Personal Products Co. · NUC · Mar 23, 2007 · Obstetrics/Gynecology

Device Facts

• Record ID: K070545
• Device Name: K-Y BRAND WARMING LIQUID
• Applicant: Personal Products Co.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 23, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

K-Y® Brand Warming Liquid is intended as a personal lubricant compatible with latex condom.

Device Story

K-Y® Brand Warming Liquid is a personal lubricant designed to produce a warming sensation upon contact with moist skin or mucosal membranes. It is applied topically to the vaginal area or to a latex condom to enhance comfort during intimate activity. The device is intended for over-the-counter use by consumers. It functions by providing lubrication and a warming effect, aiding in the ease of intimate activity and potentially increasing user comfort.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing, pre-clinical evaluations, human Repeat Insult Patch Testing (RIPT), and consumer use testing. Laboratory testing confirmed compatibility with leading latex condom brands and comparable lubricity to the predicate. Pre-clinical evaluation confirmed ingredients are Generally Recognized as Safe (GRAS). Human RIPT demonstrated the product is non-sensitizing. Consumer use testing confirmed the product meets its warming claim.

Technological Characteristics

Personal lubricant formulation containing GRAS ingredients. Designed to produce a warming sensation on mucosal membranes. Compatible with latex condoms. Non-sensitizing formulation.

Indications for Use

Indicated for use as a personal lubricant compatible with latex condoms to enhance comfort and ease of intimate activity. Intended for application to the vaginal area or a condom.

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 (K070545)

Submission Summary (Full Text)

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Personal Product Company Division of McNeil - PPC, Inc.

(Appendix A)

K070545

Special 510(k) Device Modification

MAR 2 3 2007

### 510(k) Summary of Safety and Effectiveness Personal Products Company Submitter Division of McNeil - PPC, Inc. 199 Grandview Road Skillman, NJ 08558 Nader Fotouhi, Ph.D. Contact Manager, Regulatory Affairs J&J Consumer & Personal Products Worldwide 199 Grandview Road Skillman, NJ 08558 Phone: [phone] Fax: [phone] February 23, 2007 Date Trade Name K-Y® Brand Warming Liquid Common Name Personal Lubricant Classification NUC Condom (21CFR 884.5300) Name This modification of the device is substantially equivalent to currently Statement marketed predicate devices, K-Y® Brand Warming Liquid. Device This device is a condom compatible personal lubricant that has been description specifically developed to produce a warming sensation when in contact with moist skin and mucosal membrane.

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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Personal Product Company Division of McNeil - PPC, Inc.

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

| Intended use | The intended use of this device is as a personal lubricant compatible with latex condom. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications statement | This device and predicate devices have similar indications, by being applied to the vaginal area or a condom in order to enhance comfort and ease of intimate activity. |
| Technological characteristics | The device has the same technological characteristics as the currently marketed condom compatible personal lubricants. |
| Performance data | The results from laboratory testing, pre-clinical evaluations, human RIPT and use test show that the proposed device performs equivalently to the predicate devices. 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. |
| | The ingredients used in the formulation of the proposed device are generally recognized as safe (GRAS) and the pre-clinical evaluation of the ingredients has determined that they are safe for use in personal lubricant products. The consumer use test has shown that the product meets its warming claim. The human RIPT shows that the proposed device is non-sensitizing. |
| Conclusion | The proposed device is substantially equivalent to the currently marketed products in technology, intended use, safety, and suitability characteristics. |

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

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

Re: K070545

Trade/Device Name: K-Y0 Brand WARMING LIOUID Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 23, 2007 Received: February 26, 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 (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/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "FDA Centennial" in the center. The letters "FDA" are prominently displayed in a bold, sans-serif font. Three stars are arranged below the word "Centennial". The logo is surrounded by text that follows the circular shape.

*Protecting and Promoting Public Health*

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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.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" (21 CFR 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/cdrh/industry/support/index.html

http://www.lda.gov/rcam/industry/support/index.html

Sincerely yours,

Nancy C. Broydon

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

K070 545

Device Name: K-Y® Brand WARMING LIQUID

Indications for Use: K-Y® Brand Warming Liquid is intended as a personal lubricant 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

David A. Ingram

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number.

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL ]

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