DUREX PLAY MASSAGE GEL LUBRICANT

K063385 · Ssl Americas, Inc. · NUC · Mar 10, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K063385
• Device Name: DUREX PLAY MASSAGE GEL LUBRICANT
• Applicant: Ssl Americas, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Durex Play™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.

Device Story

Durex Play™ Massage gel is a clear, colorless, water-soluble personal lubricant. Intended for over-the-counter use to alleviate vaginal dryness and provide lubrication during intimate sexual activity. Enhances comfort and facilitates condom use. Compatible exclusively with natural rubber latex and synthetic polyisoprene condoms. Applied topically by the user.

Technological Characteristics

Water-soluble gel formulation. Compatible with natural rubber latex and synthetic polyisoprene condoms.

Indications for Use

Indicated for individuals experiencing vaginal dryness or requiring personal lubrication to facilitate sexual activity and enhance condom use. Compatible only with natural rubber latex and synthetic polyisoprene 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 Jelly Personal lubricant (K955648)
• Astroglide (K935299)
• Durex Play™ Warmer lubricant (K042563)
• Durex Play™ Personal Lubricant (K032124)

Submission Summary (Full Text)

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Durex Play ! M Massage Lubricant Pre-market Notitication 510(k) submission.

## Section VIII: Durex Play™ Massage gel lubricant Premarket approval [510(k)] Application Summary.

# Section VIII.1 Submitter Information

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. Fax: [phone] Phone: [phone] Contact Person: Chris Robinson, Controller Head of Regulatory Affairs, SSL Americas. Date of summary: original 1 November 2006 , amended 10 March 2008.

# Section VIII.2 General Device Information

Device trade Name: Durex Play™ Massage gel Device common name: Personal Lubricant Classification: Patient Lubricant

# Section VIII.3 Predicate devices.

K-Y Jelly Personal lubricant (K955648) Astroglide (K935299) Durex Play™ Warmer lubricant (K042563) Durex Play™ Personal Lubricant (K032124)

## Section VIII.4 Device Description

Durex Play™ Massage gel personal lubricant is a clear, colorless, water soluble personal lubricant.

Cont.

Ko63385

MAR 1 0 2008

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## Section VIII.5 Intended Use

Indications: Durex Play ™ Massage gel is intended as a moisturiser for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity. This lubricant has been shown to be compatible only with condoms made from natural rubber latex and synthetic polyisoprene.

# Section VIII.6 Substantial Equivalence

The product Durex Play ™ Massage gel is substantially equivalent in intended use to K-Y Jelly, Astroglide and Durex Play ™ personal lubricants. The formulations are very similar to the existing Durex Play™ formulations Durex Play™ and Durex Play Warmer™ All these products are sold Over-the-Counter.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its back, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### MAR 1 0 2008

Mr. Chris Robinson Controller-Head of Global Regulatory Affairs SSL Americas. Inc. 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-2891

K063385 Re:

Trade/Device Name: Durex Play™ Massage Gel Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: February 19, 2008 Received: February 29, 2008

Mr. Chris Robinson:

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/cdrh/industry/support/index.html.

Sincerely yours,

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 IV.3

Indications for Use

510(k) Number (if known):

Device Name: Durex Play™ Massage Gel Lubricant

Durex Play™Massage gel lubricant is intended as a moisturizer for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

This lubricant has been shown to be compatible only with condoms made of natural rubber latex and synthetic polyisoprene.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helmut Lense

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