DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS

K060098 · Ssl Americas, Inc. · NUC · Jun 8, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K060098
• Device Name: DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS
• Applicant: Ssl Americas, Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 8, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

Device Story

Durex Play™ Temptations Assorted Lubricants are clear, colorless, water-soluble personal lubricants. Designed for over-the-counter use by consumers to alleviate vaginal dryness and facilitate intimate sexual activity, including use with condoms. The device functions as a topical lubricant applied to the vaginal entry. It provides moisture and reduces friction during intercourse, enhancing comfort for the user. No complex technology, software, or electronic components are involved.

Clinical Evidence

No clinical data provided; device is a personal lubricant with established safety profile based on similarity to predicate formulations.

Technological Characteristics

Water-soluble, clear, colorless personal lubricant. Condom-compatible formulation. No electronic, mechanical, or software components.

Indications for Use

Indicated for individuals experiencing vaginal dryness or requiring personal lubrication to facilitate sexual activity and enhance condom use. Over-the-counter use.

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™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.

K060098

JUN - 8 2006

## Section VIII: Durex Play™ Temptations Assorted lubricants Premarket approval [510(k)] Application Summary.

#### Section VIII.1 Submitter Information

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. 770-582-2222 Phone: Fax: [phone] Contact Person: Chris Robinson, Controller Head of Regulatory Affairs, SSL Americas. Date of summary: 22nd December 2005.

#### Section VIII.2 General Device Information

Device trade Name: Durex Play™ Temptations Assorted lubricants. 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™ Temptations Assorted personal lubricants are clear, colorless, water soluble personal lubricants.

The Tingle and Warming lubricants are already covered under K042958 and K042563 respectively.

Cont.

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Durex Play™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.

### Section VIII.5 Intended Use

Indications: Durex Play ™ Temptations Assorted Lubricants are intended as moisturizers for vaginal dryness and personal lubrication of the vaginal entry to enhance condom use and to facilitate ease and comfort during intimate sexual activity.

# Section VIII.6 Substantial Equivalence

The product Durex Play ™ Temptations Assorted Lubricants 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 and are condom compatible formulations.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 8 2006

Mr. Chris Robinson Head of Regulatory Compliance SSL Americas, Inc. Office of Regulatory Affairs 3585 Engineering Drive, Suite 200 NORCROSS GA 30092-9214

Re: K060098

Trade/Device Name: Durex Play™ Temptations Assorted Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 11, 2006 Received: May 15, 2006

Dear Mr. 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 (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 logo for the FDA Centennial, celebrating 1906-2006. The logo is circular with the letters FDA in the center. The words "Centennial" and three stars are below the letters FDA. The text "Protecting and Promoting Public Health" is at the bottom of the image.

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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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Cbrogdon

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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Durex Play™ Temptations Assorted Lubricants Premarket Approval 510(K) Application.

Section IV.3 Indications for Use

510(k) Number (if known):

Durex Play™ Temptations Assorted Lubricants Device Name:

Durex Temptations Assorted Lubricants are 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR Over-The-Counter Use X

(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)

Nancy C. Broodon

510/k) Numbe

Section V. Substantial Equivalence

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