TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM

K050828 · Church & Dwight Co., Inc. · MOL · Feb 28, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K050828
• Device Name: TROJAN SUPRA LUBRICATED POLYURETHANE MALE CONDOM
• Applicant: Church & Dwight Co., Inc.
• Product Code: MOL · Obstetrics/Gynecology
• Decision Date: Feb 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Device Story

TROJAN SUPRA® is a straight-walled, nipple-end male condom made of polyurethane with a lubricant coating. Nominal length 190 mm; flatwidth 58 mm. Used for contraception and prophylactic protection against STDs. Device is intended for over-the-counter use by the general population. Functions as a physical barrier to prevent exchange of bodily fluids during intercourse. Clinical performance evaluated via slippage and breakage studies compared to latex controls.

Clinical Evidence

Clinical slippage and breakage study conducted in France with 206 couples. Subject polyurethane condom compared to standard latex control. Breakage rate: 0.6% (polyurethane) vs 1.3% (latex). Clinically significant slippage: 1.1% (polyurethane) vs 0.5% (latex). Differences not statistically significant. Biocompatibility testing included in vitro cytotoxicity, sensitization, vaginal irritation, acute systemic toxicity, and penile irritation.

Technological Characteristics

Polyurethane resin sheath; straight-walled, nipple-end design; integral formed ring at open-end; lubricated. Dimensions: 190 mm length, 58 mm flatwidth. Non-latex material.

Indications for Use

Indicated for contraception and reduction of risk of pregnancy and transmission of STDs in individuals using male 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

• TROJAN SUPRA® Lubricated Polyurethane Male Condom (K042607)

Submission Summary (Full Text)

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

FEB 2 8 2006

April 1, 2005 Page 3

## 510(k) Summarv

K050828

| Submitted by: | Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543 |
|----------------------|-------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky<br>Director, Regulatory Affairs<br>[phone] |
| Date Prepared: | April 1, 2005 |
| Proprietary Name: | TROJAN SUPRA® Lubricated Polyurethane Male Condom |
| Common Name: | Polyurethane Condom |
| Classification Name: | Condom [21 CFR §884.5300] |
| Predicate Device: | TROJAN SUPRA® Lubricated Polyurethane Male Condom<br>510(k) #K042607 |

Description of Device: The TROJAN SUPRA® Lubricated Polyurethane Condom is a male condom consisting of a sheath of polyurethane with a lubricant coating. The condom is a straight-walled, nipple-end condom with a nominal length of 190 mm and an approximate flatwidth of 58 mm.

Intended Use of the Device: The 510(k)-subject condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

Technological Characteristics: There is no difference in the basic technological characteristics of the 510(k)-subject condom and the predicate condom. Both the 510(k)-subject condom and the predicate condom are of the same basic design, both are straight-walled, nipple-ended, lubricated condoms with an integral formed ring at the open-end. The 510(k)-subject condom differs from the predicate condom in the polyurethane resin material used to manufacture each condom. The labeling for the subject 510(k) device is the same as the predicate device except for the addition of the disclosure of foreign origin and name of the contract manufacturer.

## Summary of Studies

Safety Studies - Safety information regarding the component materials and the finished product are provided in the 510(k) Notification and raise no safety concerns. Biocompatibility studies on the non-lubricated condom and on the lubricated finished product include in vitro cytotoxicity extract test and direct contact test; sensitization test; vaginal irritation test; acute systemic toxicity; and penile irritation test.

In-Use Study - A slippage and breakage study following a protocol prepared to meet the FDA guidance: "Clinical Testing Guidance for New Material Male Condoms," was conducted in France using the 510(k) subject condom with a standard latex condom serving as a control. Among the 206 couples included in the study, the clinical breakage rate for the polyurethane condom was 0.6% compared to 1.3% for the control. Clinically significant slippage was 1.1% for the polyurethane condom and 0.5% for the control. Neither difference was significantly difference. The polyurethane condom was therefore significant equivalent to the latex control condom in terms of clinical failure rate.

Image /page/0/Picture/12 description: The image shows a logo for Arm & Hammer. The logo is a circle with the words "ARM & HAMMER" around the top. Inside the circle is an arm holding a hammer. The arm and hammer are in black and white.

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

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

FEB 2 8 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street Law Department, Building 100 PRINCETON NJ 08543

Re: K050828 Trade/Device Name: TROJAN® SUPRA® Polyurethane Male Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: MOL Dated: January 13, 2006 Received: January 17, 2006

Dear Mr. Kolakowsky:

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.

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.

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

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.

1f 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 nouffication" (21 CIFR 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 C. Bigelow

Nancy (). Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

## Indications for Use Statement

K050828 510(k) Number: TROJAN SUPRA® Lubricated Polyurethane Male Condom Device Name: The TROJAN SUPRA® Lubricate Polyurethane Male Condom Indications for Use: is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs). X Over-the-Counter Use _ OR Prescription Use (Per 21 CFR §8001.109) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

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

Image /page/3/Picture/6 description: The image shows a black and white logo for Arm & Hammer. The logo is circular and contains the words "ARM & HAMMER" around the top half of the circle. In the center of the circle, there is an arm holding a hammer. The word "STANDARD" is written along the bottom of the circle.