Trojan Riviera Personal Lubricant

K150886 · Church & Dwight Co., Inc. · NUC · Jul 20, 2015 · Obstetrics/Gynecology

Device Facts

• Record ID: K150886
• Device Name: Trojan Riviera Personal Lubricant
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jul 20, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

A personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

Device Story

Anhydrous, silicone-based personal lubricant with fragrance; intended for penile and/or vaginal application to enhance comfort during sexual activity. Packaged in PET bottle with PP closure and induction seal. Used by consumers in home settings. Supplements natural lubrication; compatible with natural rubber latex and polyisoprene condoms. Not a contraceptive or spermicide.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (2009) including cytotoxicity (Grade 2), acute systemic toxicity, skin/vaginal/penile irritation, and sensitization. Condom compatibility testing performed per ASTM D7761-10 on natural rubber latex and polyisoprene condoms. Shelf-life validated via accelerated stability study (viscosity, odor, color, appearance, and USP microbial testing).

Technological Characteristics

Anhydrous silicone-based lubricant with fragrance. Packaged in PET bottle with PP closure. Biocompatibility per ISO 10993. Condom compatibility per ASTM D7761-10. Shelf-life stability testing per USP standards for microbial limits.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhancing ease and comfort of intimate sexual activity and supplementing natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane or other condoms. Not a spermicide or contraceptive.

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™ Tingly Warmth Personal Lubricant (K120706)

Submission Summary (Full Text)

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

July 20, 2015

Charles & Dwight Co., Inc. Lisa Burns Senior Regulatory Affairs Specialist 500 Charles Ewing Blvd. Ewing. NJ 08628

Re: K150886 Trade/Device Name: Trojan Riviera Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 22, 2015 Received: June 23, 2015

Dear Lisa Burns,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert P. Lerner -S

for

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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## II. 510(k) Summary Trojan™ Riviera™ Personal Lubricant

| Submitter Name: | Church & Dwight Co., Inc. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628 |
| Contact Person: | Lisa Burns<br>Senior Regulatory Affairs Specialist<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Tel: [phone]<br>Fax: [phone] |
| Date Prepared: | March 31, 2015 |
| Device Trade Name: | Trojan™ Riviera™ Personal Lubricant |
| Device Common Name: | Personal Lubricant |
| Product Code: | NUC - Condom (21 CFR § 884.5300) |
| Classification: | Class II |
| Predicate Device: | Trojan™ Tingly Warmth Personal Lubricant (K120706) |
| Intended Use: | A personal lubricant for penile and/or vaginal application,<br>intended to lubricate and moisturize, to enhance the ease and<br>comfort of intimate sexual activity and supplement the body's<br>natural lubrication. The product is compatible with natural<br>rubber latex and polyisoprene condoms. Not compatible with<br>polyurethane or other condoms. |

Device Description:

The Trojan™ Riviera™ Personal Lubricant is an anhydrous, clear silicone-based personal lubricant with fragrance that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.

The Riviera™ Personal Lubricant is packaged in a polyethylene terephthalate (PET) bottle with a screw on, flip top polypropylene (PP) closure. An induction seal will be placed over the bottle for tamper resistance. One bottle is packaged in a carton.

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Technological Characteristics:

There is no difference in the fundamental technological characteristics of Riviera™ Personal Lubricant and the predicate Trojan™ Tingly Warmth Personal Lubricant (K120706). The 510(k)-subject device contains a similar silicone base as the legally marketed predicate, and the addition of fragrance does not raise new questions of safety or effectiveness.

Biocompatibility:

Biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.

| Test Performed | Results |
|----------------------------------|---------------------------|
| Cytotoxicity | Mild Reactivity (Grade 2) |
| Acute Systemic Toxicity | Non-systemically toxic |
| Primary Rabbit Skin Irritation | Negligible irritant |
| Rabbit Vaginal Irritation | Non-irritant |
| Rabbit Penile Irritation | Non-irritant |
| Guinea Pig Maximum Sensitization | Non-sensitizer |

Condom compatibility:

Condom Compatibility Testing was performed with Riviera™ Personal Lubricant according to ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" with a modification to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested. Condoms made from polyisoprene were included to represent an alternative to natural rubber latex that may be used with the 510(k)-subject lubricant.

Condom compatibility testing demonstrates that Riviera™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms.

## Shelf Life:

Riviera™ Personal Lubricant has a two year shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count, Total Yeast and Mold count, and Absence of Pathogens. The results were satisfactory for all parameters.

A real-time stability study is being performed in order to verify results.

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Substantial Equivalence:

Based on non-clinical performance data, biocompatibility review and testing and safety data, Riviera™ Personal Lubricant is substantially equivalent to the predicate device, Trojan™ Tingly Warmth Personal Lubricant in technology, intended use, safety and effectiveness.