TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT

K120287 · Church & Dwight Co., Inc. · HIS · May 16, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120287
• Device Name: TROJAN MAGNUM CONDOM WITH FIRE & ICE LUBRICANT
• Applicant: Church & Dwight Co., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 16, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Device Story

Male condom consisting of natural rubber latex sheath; taper-walled, non-textured, nipple-end design with integral formed ring at open end. Coated with glycol-based lubricant containing sensory ingredients for warming and tingling sensations. Used by consumers for contraception and STI prevention. Device provides physical barrier; lubricant enhances user experience. Safety established via biocompatibility testing and adherence to ASTM D 3492-08 standards.

Clinical Evidence

Bench testing only. Biocompatibility studies included in vitro cytotoxicity, vaginal irritation, acute systemic toxicity, sensitization, and bacterial reverse mutation assay. Physical testing performed on three lots per ASTM D 3492-08. Shelf-life stability established via physical testing per 21 CFR §801.435, supporting 36-month initial expiration with 5-year real-time verification plan.

Technological Characteristics

Natural rubber latex sheath; glycol-based lubricant with sensory additives. Taper-walled, non-textured, nipple-end form factor with integral formed ring. Complies with ASTM D 3492-08. No electronic components or software.

Indications for Use

Indicated for contraception and prevention of pregnancy and sexually transmitted infections 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® THINTENSITY™ Latex Condom with Warm Sensations™ Lubricant (K073016)
• Billy Boy Special Comfort Male Latex Condom (K103119)

Submission Summary (Full Text)

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Ki20287

TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant Special 510(k) Notification

May 15, 2012

MAY 1 6 2012

## 510(k) Summary

| Submitted by: | Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Joseph Ciccone<br>Manager, Regulatory Affairs<br>Phone: [phone]<br>Fax: [phone]<br>eMail: [e-mail] |
| Date Prepared: | May 15, 2012 |
| Proprietary Name: | TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant |
| Common Name: | Natural Rubber Latex Condom with Lubricant |
| Classification Name: | Condom [21CFR §884.5300] HIS |
| Predicate Device: | TROJAN® THINTENSITY™ Latex Condom with Warm Sensations™<br>Lubricant (K073016)<br>Billy Boy Special Comfort Male Latex Condom (K103119) |

## Description of Device:

TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is a male condom consisting of a sheath of natural rubber latex which covers the penis with a fitted membrane, coated with a lubricant consisting of low levels of sensory ingredients to create a perception of warming and tingling. The condom is a taper-walled, non-textured, nipple-end condom with an integral formed ring at the open end.

Indications for Use: TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

(continued)

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Technological Characteristics: Both the predicate TROJAN® THINTENSITY™ Latex Condom with Warm Sensations " Lubricant (K073016) and the 510(k)-subject device are made from natuval rubber latex and are coated with a glycol-based lubricant. The lubricant of the 510(k)-subject MAGNUM condom differs from that of the predicate condom in that it contains low levels of sensory ingredients to create a perception of warming and tingling

The 510(k)-subject MAGNUM condom is substantially equivalent to the predicate Billy Boy Special Comfort Male Latex Condom cleared under 510(k) K103119 both in design (taper-walled, nippe-eund, lubricated condoms with an integral formed ring at the open-end) and material (natural rubber myphers).

Labeling for the 510(k)-subject device is consistent with the Special Controls provisions of 21 CFR \$884.5300 and that of the predicate device. The primary purpose of lubricant on a contom is Is provide vaginal lubrication during sexual intercourse; sometimes additional components are added for to provided purposes, e.g., nonoxynol-9 for spermicidal effect, benzocaine for male genital desensitizing, and in the 510(k)-subject device, the secondary components provide a lubricant with warming and themiling, inn sensations for both partners.

## Summary of Studies

Safety Studies – Biocompatibility studies applicable to the TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant were performed on the 510(k)-subject device. These studies include in viro cytotoxicity extract test; vaginal irritation test; acute systemic toxicity; sensitive toxitization test; bacterial reverse mutation assay. TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is considered safe for consumer use under normal and reasonably foreseeable misuse conditions.

Physical testing data – Three (3) lots of condoms with the FIRE & ICE™ lubricant were tested and met the specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms).

Shelf-life - Stability of the 510(k)-subject device was established from results of physical testing data using a protocol that followed 21 CFR §801.435 as a guide. Based on the evaluation of the results of the physical testing data, the expiration date has been initially set at 36 months and will be then verified through real-time stability through five (5) years in compliance with FDA expiration date labeling requirements in 21 CFR §801.435. This testing also established the chemical compatibility between the latex condom and the lubricant.

Accordingly, when compared to the predicate male latex condoms, the TROJAN® MAGNUM® Latex Condom with FIRE & ICE Lubricant does not incorporate any significant changes in intended use, method of operations, materials, or design that could affect the safety and effectiveness; therefore, the 510(k)-subject condom is expected to perform as well, or better, than the predicates - TROJAN® THINTENSITY" Latex Condom with Warm Sensations " and Billy Boy Special Comfort male latex condom.

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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 features the department's name encircling a symbol. The symbol is a stylized representation of an eagle or bird, with three horizontal lines forming the body and head. The logo is black and white.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Joseph A. Ciccone Manager, Regulatory Affairs Church & Dwight Co., Inc. 469 North Harrison Street PRINCETON NJ 08543

MAY 1 6 2012

Re: K120287

Trade/Device Name: TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant

Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: HIS Dated: February 21, 2012 Received: February 24, 2012

## Dear Mr. Ciccone:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 that I DA has made a wond regulations administered by other Federal agencies. You must or any Fourth Barates and weeks including, but not limited to: registration and listing Compy with an the 100 org (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. \

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély vours,

Benjamin K. Kirk

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal,

and Urological Devices

Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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# Indications for Use

### 510(k) Number:

K120287

Device Name:

Indications for Use:

K120287

TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant

TROJAN® MAGNUM® Latex Condom with FIRE & ICE™ Lubricant is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted infections).

Prescription Use _

OR

X Over-the-Counter Use _

(Per 21 CFR §8001.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lemon

Gastro-Renal, and

Image /page/4/Picture/15 description: The image shows the logo for Trojan brand condoms. The word "TROJAN" is written in large, bold letters. Below the word "TROJAN" are the words "BRAND CONDOMS" in smaller letters. To the right of the word "TROJAN" is an image of a Trojan warrior's head.

Church & Dwight Co., Inc.