TROJAN PASSION BERRY GEL

K013433 · Armkel, LLC · NUC · Mar 5, 2002 · Obstetrics/Gynecology

Device Facts

• Record ID: K013433
• Device Name: TROJAN PASSION BERRY GEL
• Applicant: Armkel, LLC
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Mar 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel is principally designed to help enhance the sexual experience by providing supplemental vaginal lubrication during sexual intercourse. The TROJAN® PASSION BERRY™ Gel may be used with condoms.

Device Story

TROJAN® PASSION BERRY™ Gel is a clear, high-viscosity, pink-colored, scented personal lubricant packaged in a 2.5 oz. tube. It functions as a water-soluble lubricant to reduce friction during sexual intercourse or the insertion of medical devices into body orifices. It is intended for over-the-counter use by consumers. The device is compatible with condoms and provides supplemental moisture to enhance sexual experience.

Clinical Evidence

No clinical data provided; substantial equivalence is based on conventional formulation and established use of similar water-soluble personal lubricants.

Technological Characteristics

Water-soluble gel formulation; high viscosity; clear, pink-colored, scented. Follows conventional formulation concepts for personal lubricants as described in Remington's Pharmaceutical Sciences (1970).

Indications for Use

Indicated for use as a personal lubricant to provide supplemental vaginal lubrication during sexual intercourse and to facilitate the entry of diagnostic or therapeutic devices into body orifices. Compatible with 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

• H•R® Lubricating Jelly
• TROJAN® FOR WOMEN Personal Lubricant (K890863)

Submission Summary (Full Text)

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K013433

510(k) Notification TROJAN® PASSION BERRYTM Gel Personal Lubricant

5 2002 MAR

October 15,

## 510(k) Summary

| Submitted by: | ArmKel LLC<br>469 North Harrison Street<br>Princeton, NJ 08543 |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen C. Kolakowsky<br>Director, Regulatory Affairs<br>Church & Dwight Co., Inc.<br>[phone] |
| Date Prepared: | October 15, 2001 |
| Proprietary Name: | TROJAN® PASSION BERRY™ Gel |
| Common Name: | Personal Lubricant |
| Classification Name: | Patient Lubricant [21 CFR §880.6375] |
| Predicate Device: | H•R® Lubricating Jelly<br>[Pre-1976 Amendments Device]<br>TROJAN® <i>FOR WOMEN</i> Personal Lubricant<br>[#K890863] |

Description of Device: The TROJAN® PASSION BERRYTM Gel personal lubricant is formulated as a clear, high viscosity gel with a pink color and lubricant is lonnalise as agrance and packaged in a clear plastic 2.5 oz. tube.

Intended Use of the Device: A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device. The TROJAN® PASSION BERRY™ Gel personal lubricant is principally intended to provide supplemental vaginal lubrication during sexual intercourse, and it may be used with condoms.

There are no exceptional technological Technological Characteristics: characteristics associated with TROJAN® PASSION BERRYTN Gel. Although a proprietary formulation, the basic formulation of TROJAN® PASSION BERRYTM Gel follows that of conventional water-soluble I Aborent bases. [e.g., Remington's Pharmaceutical Sciences, ed. XIV, 1970, Mack Publishing Co., Easton, PA., Chp 85.] Both the TROJAN® PASSION BERRYTM Gel and the predicate lubricant devices follow conventional formulation concepts.

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

FEB 2 4 2014

ARMKEL, LLC % Mr. Stephen C. Kolakowsky Director, Regulatory Affairs Church & Dwight Co., Inc. P.O. Box 1001 Half Acre Road CRANBERRY NJ 08512

Re: K013433 Trade/Device Name: TROJAN® PASSION BERRYTM Gel, Personal Vaginal Lubricant Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated (Date on orig SE ltr): January 30, 2002 Received (Date on orig SE Itr): January 31, 2002

Dear Mr. Kolakowsky:

This letter corrects our substantially equivalent letter of March 5, 2002.

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. Iisting 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

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact 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/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

## Benjamin R. Fisher -S

Beniamin 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 Statement

| 510(k) Number: | KO13433 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | TROJAN® PASSION BERRY™ Gel<br>Personal Lubricant |
| Indications for Use: | The TROJAN® PASSION BERRY™ Gel patient<br>lubricant is a device intended for medical<br>purposes that is used to lubricate a body<br>orifice to facilitate entry of a diagnostic or<br>therapeutic device. The TROJAN® PASSION<br>BERRY™ Gel is principally designed to help<br>enhance the sexual experience by providing<br>supplemental vaginal lubrication during<br>sexual intercourse. The TROJAN® PASSION<br>BERRY™ Gel may be used with condoms. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §8001.109) OR

Over-the-Counter Use X

David G. Severson

Division
Division for inductive, A terminal,
and R. Devices
510(K) Number K013433

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church & dwight co., inc.

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