TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT

K120249 · Church & Dwight Virginia Co., Inc. · HIS · May 11, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120249
• Device Name: TROJAN MAGNUM CONDOM WITH WARMING LUBRICANT
• Applicant: Church & Dwight Virginia Co., Inc.
• Product Code: HIS · Obstetrics/Gynecology
• Decision Date: May 11, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

The TROJAN® MAGNUM® Condom with WARMING™ 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. Features glycol-based lubricant coating designed to provide mild warming sensation during use. Intended for over-the-counter use to aid in contraception and prevention of sexually transmitted infections. Device functions as physical barrier; lubricant provides vaginal lubrication and sensory enhancement. Safety established via biocompatibility testing and physical performance testing per ASTM standards.

Clinical Evidence

Bench testing only. Biocompatibility studies included in vitro cytotoxicity, vaginal irritation, acute systemic toxicity, sensitization, bacterial reverse mutation, and mouse lymphoma assays. Physical testing performed on three lots per ASTM D 3492-08. Shelf-life and chemical compatibility established via stability testing following 21 CFR §801.435.

Technological Characteristics

Material: Natural rubber latex. Design: Taper-walled, nipple-end, integral formed ring. Lubricant: Glycol-based. Standards: ASTM D 3492-08 (Rubber Contraceptives). Regulatory: Class II, Product Code HIS.

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® MAGNUM® Latex Condom with Spermicidal Silicone Lubricant (K895640)
• TROJAN® THINTENSITY™ Latex Condom with Warm Sensations™ Lubricant (K073016)
• TROJAN® EXTENDED PLEASURE™ Latex Condom with Climax Control Lubricant (K000748)

Submission Summary (Full Text)

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May 9, 2012

# MAY 1 1 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 9, 2012 |
| Proprietary Name: | TROJAN® MAGNUM® Condom with WARMING™ Lubricant |
| Common Name: | Natural Rubber Latex Condom with Lubricant |
| Classification Name: | Condom [21CFR §884.5300] HIS |
| Predicate Device: | TROJAN® MAGNUM® Latex Condom with Spermicidal Silicone<br>Lubricant (K895640)<br>TROJAN® THINTENSITY™ Latex Condom with Warm Sensations™<br>Lubricant (K073016)<br>TROJAN® EXTENDED PLEASURE™ Latex Condom with Climax<br>Control Lubricant (K000748) |

#### Description of Device

The TROJAN® MAGNUM® Condom with WARMING™ Lubricant is a male condom consisting of a sheath of natural rubber latex with a lubricated coating consisting of a glycol-type base to create a perception of warming. The condom is a taper-walled, non-textured, nipple-end condom as described in K 895640. The 510(k)-subject condom's physical specifications are substantially equivalent to the predicate device, the lubricant has been modified.

(continued)

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

Technological Characteristics: There is no difference in the fundamental technological characteristics of the 510(k)-subject MAGNUM condom and the predicate MAGNUM condom. The 510(k)-subject MAGNUM condom is substantially equivalent to the predicate MAGNUM condom cleared under 510(k) K 895640 both in design (taper-walled, nipple-end, lubricated condoms with an integral formed ring at the open-end) and material (natural rubber latex). The base lubricant systems differ in that the predicate MAGNUM condom lubricant was silicone-based and the 510(k)-subject MAGNUM condom lubricant is glycol-based. This glycol-type base formulation is similar to the secondary predicates, TROJAN® THINTENSITY" with Warm Sensations" (K073016) and TROJAN® Extended Pleasure™ (K000748). 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 condom is to provide vaginal lubrication during sexual intercourse; sometimes additional components are added for secondary purposes, e.g., nonoxynol-9 for spermicidal effect, benzocaine for male genital desensitizing, and in the 510(k)-subject device, the lubricant provides a mild, warm sensation for both partners.

#### Summary of Studies

Safety Studies - Biocompatibility studies applicable to the TROJAN® MAGNUM® Latex Condom with Warming" Lubricant were performed on the 510(k)-subject device. These studies include in vitro cytotoxicity extract test; vaginal irritation test; acute systemic toxicity; sensitization test; bacterial reverse mutation assay; mouse lymphoma assay. TROJAN® MAGNUM® Latex Condom with Warming™ Lubricant is considered safe for consumer use under normal and reasonably forseeable misuse conditions.

Physical testing data - Three (3) lots of condoms with the WARMING™ lubricant were tested and met the specifications of ASTM D 3492-08 Standard Specifications for Rubber Contraceptives (Male Condoms) as recognized by the FDA.

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 8801.435. This testing also established the chemical compatibility between the latex condom and the lubricant.

Accordingly, when compared to the predicate MAGNUM male latex condom, the TROJAN® MAGNUM® Condom with WARMING" 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 predicate MAGNUM 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 a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the symbol.

#### Public Health Service

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

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

MAY 1 1 2012

Re: K120249

Trade/Device Name: TROJAN® MAGNUM® Condom with WARMING™ 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 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); 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] от [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély vours,

Benjamin K. Evanko

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:

K120249

Device Name:

Indications for Use:

K120249

TROJAN® MAGNUM® Condom with WARMING™ Lubricant

TROJAN® MAGNUM® Condom with WARMING™ 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)

Quain H. Buysken for Benjamin Fisher

ctive. Gastro-Renal, a

Image /page/4/Picture/15 description: The image shows the logo for Trojan brand condoms. The logo features the word "TROJAN" in large, bold letters, with the words "BRAND CONDOMS" in smaller letters underneath. To the right of the word "TROJAN" is an image of a Trojan warrior helmet.

Church & Dwight Co., Inc.