K-Y BRAND YOURS+MINE

K072421 · Mcneil-Ppc, Inc. · NUC · Mar 6, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K072421
• Device Name: K-Y BRAND YOURS+MINE
• Applicant: Mcneil-Ppc, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

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

Device Story

K-Y® Brand YOURS+MINE™ consists of two personal lubricants packaged together. The device is applied to vaginal or penile areas or to a condom to enhance comfort and pleasure during intimate activity. It is intended for over-the-counter use. The device is compatible with latex condoms. Performance is verified through laboratory testing for lubricity and condom compatibility, as well as pre-clinical and human use evaluations to ensure safety.

Clinical Evidence

Evidence includes laboratory testing, pre-clinical evaluations, and human use data. Laboratory testing confirmed compatibility with leading commercial brands of latex condoms and demonstrated that lubricity is comparable to predicate devices. Pre-clinical and human use data support the safety of the device 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.

Indications for Use

Indicated for use as a personal lubricant for vaginal or penile application, or for application to a condom, to enhance comfort, ease, and pleasure of intimate activity. 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.

Submission Summary (Full Text)

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/<072421

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

Traditional 510(k)

:

# Section 5 - 510(k) Summary

MAR - 6 2008

| Submitter | McNeil - PPC, Inc., Johnson & Johnson Healthcare Products Division<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 27, 2007 | | |
| Trade Name | K-Y® Brand YOURS+MINE™ | | |
| Common Name | Personal Lubricant | | |
| Classification<br>Name | NUC - Condom (21CFR 884.5300) | | |
| Statement | This proposed device consists of two personal lubricants packaged together.<br>Each product is substantially equivalent to a K-Y® Brand product previously<br>cleared by the Food and Drug Administration. | | |
| Device<br>description | The devices are personal lubricants compatible with latex condom. | | |
| Intended use | The intended use of the device is as a personal lubricant compatible with latex<br>condom. | | |

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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K072421

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

·

## Section 5 - 510(k) Summary (Continued)

| Indications<br>statement | The proposed device and predicate device have similar indications, being<br>applied to the vaginal or penile areas or a condom in order to enhance<br>comfort, ease and pleasure of intimate activity. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 device. Laboratory test results demonstrated that the proposed<br>device is compatible with the leading commercial brands of latex condoms.<br>Lubricity of the proposed device is comparable to the lubricity of predicate<br>device. |
| | The pre-clinical evaluation and testing and human use data show that the<br>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. |

[INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL]

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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 (HHS). The logo consists of a stylized caduceus, which is a symbol often associated with healthcare, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the symbol. The caduceus in the logo is depicted with three lines forming the wings and a snake-like form at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAR - 6 2008

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

Re: K072421

Trade/Device Name: K-Y® Brand YOURS+MINE Regulation Number: 21 CFR §884,5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 28, 2008 Received: February 29, 2008

Dear Dr. Fatouhi:

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 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/cdrb/industry/support/index.html,

Sincerely vours.

Nancy C. 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

KO72421

Device Name: K-Y® Brand YOURS+MINE ™

Indications for Use: K-Y® Brand YOURS+MINE™ 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 X

Hulen Remer

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