DUREX PLAY SOFT & SENSUAL LUBRICANT

K071626 · Ssl Americas · NUC · Apr 1, 2008 · Obstetrics/Gynecology

Device Facts

• Record ID: K071626
• Device Name: DUREX PLAY SOFT & SENSUAL LUBRICANT
• Applicant: Ssl Americas
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Apr 1, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex condoms only.

Device Story

Durex Play Soft & Sensual is a clear, colorless, unperfumed, water-soluble, multi-dose personal lubricant. Applied topically to vaginal or penile areas by the user to supplement natural lubrication and enhance comfort during sexual activity. Device is non-sterile and chemically preserved; pH-balanced to match normal vaginal environment. Compatible with natural rubber latex condoms. Intended for over-the-counter use.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Water-soluble, chemically preserved, multi-dose personal lubricant. pH-balanced to match normal vaginal range. Non-sterile. Compatible with natural rubber latex condoms.

Indications for Use

Indicated for individuals requiring personal lubrication for vaginal or penile application to moisturize, lubricate, and enhance comfort during intimate sexual activity. Compatible with natural rubber 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.

Predicate Devices

• Durex Play™ personal lubricant (K032124)
• Durex Play™ Assorted Temptations lubricants (K060098)
• Durex Play™ Warmer lubricant (K042563)
• KY liquid (K955648)
• Lifestyles (K033076)

Submission Summary (Full Text)

{0}------------------------------------------------

#### Section VIII: Durex Play Soft & Sensual Lubricant Premarket approval [510(k)] Application Summary.

#### Section VIII.1 Submitter Information

APR - 1 2008

SSL Americas 3585 Engineering Drive Suite 200 Norcross GA 30092-9214. Phone: [phone] Fax: [phone] Contact Person: Chris Robinson, Head of Regulatory Compliance SSL Americas. Date of summary: 31st March 2008

## Section VIII.2 General Device Information

Device trade Name: Durex Play Soft & Sensual Device common name: Personal Lubricant Classification: Patient Lubricant , Patient lubricant, vaginal, latex compatible.

### Section VIII.3 Predicate devices

Durex Play™ personal lubricant (K032124) Durex Play™ Assorted Temptations lubricants (K060098) Durex Play™ Warmer lubricant (K042563) KY liquid (K955648) Lifestyles (K033076)

#### Section VIII.4 Device Description

Durex Play Soft & Sensual Lubricant is a clear, colorless, unperfumed vaginal lubricant with a pH similar to the normal pH range of the vagina.

#### Section VIII.5 Intended Use

Indications: Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with natural rubber latex condoms only.

#### Section VIII.6 Substantial Equivalence

The product; Durex Play™ Soft & Sensual Lubricant is substantially equivalent in intended use to Durex Play™ personal lubricant, Durex Play™ Assorted Temptations lubricants, Durex Play™ Warmer lubricant, KY liquid

{1}------------------------------------------------

(K955648) & Lifestyles (K033076). The proposed and predicate devices are non-sterile, water-soluble, chemically preserved, multi-dose lubricants, and compatible with natural rubber latex condoms. In addition, the proposed labelling is substantially equivalent to that previously approved for the SSL predicate devices, and all are intended to be available over the counter.

.

{2}------------------------------------------------

# 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, possibly representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### APR - 1 2008

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

K071626 Re:

Trade Name: Durex Play™ Soft & Sensual™ Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 17, 2008 Received: March 24, 2008

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 (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.

{3}------------------------------------------------

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 Actor 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 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

{4}------------------------------------------------

#### Section IV.3 Indications for Use

510(k) Number (if known). K071626

Durex Play Soft & Sensual Device Name:

Durex Play™ Soft & Sensual™ is a personal lubricant, for vaginal or penile application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication.

This product is compatible with natural rubber latex condoms only.

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) |
|--------------------------------------|--------------------------------------------------------|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, | |
| and Radiological Devices | |

510(k) Number K071624