NIRVANA A PERSONAL LUBRICANT

K120706 · Church & Dwight Co., Inc. · NUC · Oct 4, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120706
• Device Name: NIRVANA A PERSONAL LUBRICANT
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Oct 4, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

Tingly Warmth is 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. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

Device Story

TROJAN™ LUBRICANTS Tingly Warmth is an anhydrous, silicone-based personal lubricant. Ingredients include dimethicone, dimethiconol, menthol, and vanillyl butyl ether. Intended for OTC use to lubricate and moisturize during intimate sexual activity. Applied topically by the user. Compatible with natural rubber latex and polyisoprene condoms. Packaged in a PET bottle with a PP flip-top closure. Provides lubrication to enhance comfort and supplement natural body fluids.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (cytotoxicity, irritation, sensitization, systemic toxicity per ISO 10993) and condom compatibility (ASTM D7761-10) with natural rubber latex and polyisoprene condoms. Accelerated aging study supports a two-year shelf-life.

Technological Characteristics

Anhydrous silicone-based lubricant. Composition: dimethicone, dimethiconol, menthol, vanillyl butyl ether. Packaging: PET bottle with PP closure. Compatibility: Natural rubber latex and polyisoprene condoms per ASTM D7761-10. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for individuals requiring lubrication and moisturization for penile and/or vaginal application to enhance comfort during intimate sexual activity and supplement natural lubrication. Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane 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

• K-Y® Brand Intrigue™ Intense Warming Sensation (K072360)

Submission Summary (Full Text)

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510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

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Submitter Name: Submitter Address:

Contact Person:

Date Prepared: Device Trade Name:

Device Common Name:

Product Code:

Classification:

Predicate Device:

Intended Use:

Device Description:

# II. 510(k) Summary

Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543

Emily Perez Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543 Tel: [phone] Fax: [phone]

October 2, 2012

TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant

Personal Lubricant

NUC - Condom (21 C.F.R. § 884.5300)

Class II

K-Y® Brand Intrigue™ Intense Warming Sensation (K072360)

Tingly Warmth is 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. This product is compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms.

The TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.

OCT 4 2012

October 2, 2012

(revised)

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510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

# Technological Characteristics:

There is no difference in the fundamental technological characteristics of the TROJANTS Tingly Warmth Personal Lubricant and the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal Lubricant. TROJANTM LUBRICANTS Tingly Warmth Personal Lubricant is composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. The proposed device is substantially equivalent to the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal equivanced under 510(k) # K072360. Three of the four ingredients, dimethicone, dimethiconol and vanillyl butyl ether, in TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant are identical to those in the predicate device. The additional ingredient, menthol, does not raise new questions of safety or effectiveness.

# Biocompatibility:

Biocompatibility testing was performed in accordance with ISO 10993, Biological Evaluation of Medical Devices, 2009.

| Testing Performed | Results |
|--------------------------------|------------------------|
| Cytotoxicity | Non-cytotoxic |
| Rabbit Vaginal Irritation | Non-irritating |
| Rabbit Penile Irritation | Non-irritating |
| Acute Systemic Toxicity | Non-systemically toxic |
| Guinea Pig Maximization | Non-sensitizing |
| Primary Rabbit Skin Irritation | Non-irritating |

Testing Performed:

# Condom Compatibility:

Condom Compatibility Testing was performed using TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant and ASTM D7761-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" which was modified to include pre-lubricated and un-lubricated dry condoms. Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested.

Condom compatibility testing results demonstrate that the TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with commercially available natural rubber latex condoms and polyisoprene condoms.

(continued)

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# Shelf-life:

TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant has a two-year shelf-life based on the results of an accelerated aging study.

. A Real-time aging study is being performed in order to verify results of the accelerated aging study.

#### Substantial Equivalence:

Based on non-clinical performance data, biocompatibility review and testing and safety data, the proposed device is substantially equivalent to K-Y® Brand Intrigue™ Intense Warming Sensation in technology, intended use, safety and effectiveness.

### Conclusion:

The results from laboratory testing and non-clinical evaluations of human use testing show that the proposed device performs equivalently to the predicate device and is safe for use as a personal lubricant.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Ms. Emily Perez Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street PRINCETON NJ 08543

OCT - 4 2012

Re: K120706

Trade/Device Name: TROJAN™ LUBRICANTS TINGLY WARMTH Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 29, 2012 Received: August 31, 2012

. Dear Ms. Perez:

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 (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 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.

Sincerely yours,

Benjamin R. Tucker

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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Confidential August 29, 2012

510(k) Premarket Notification Church & Dwight Co., Inc. Nirvana A Personal Lubricant

# I. Indications For Use

510(k) Number (if known): K120706

Device Name: TROJAN™ LUBRICANTS TINGLY WARMTH Personal Lubricant

# INDICATIONS FOR USE:

TINGLY WARMTH is 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. This product is componently with natural rubber latex
supplement the body's natural lubrication. This product is compons supplement the body s natural fabrication. This polyurethane or other condoms.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 C.F.R. 801 Subpart D) OR

Over-The-Counter Use × (21 C.F.R. 801 Subpart C)

Tomi McWhay

ductive, Gastro-Renal, and