NIRVANA B PERSONAL LUBRICANT

K120751 · Church & Dwight Co., Inc. · NUC · Oct 3, 2012 · Obstetrics/Gynecology

Device Facts

• Record ID: K120751
• Device Name: NIRVANA B PERSONAL LUBRICANT
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

is as 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

Aqueous, non-sterile personal lubricants designed for penile and/or vaginal application to supplement natural lubrication and enhance comfort during sexual activity. Available in two formulations: 'Continuous Silkiness' and 'Continuous Silkiness - Warm & Tingling' (containing menthol and vanillyl butyl ether). Applied topically by the user. Compatible with natural rubber latex and polyisoprene condoms. Packaged in PET bottles with polypropylene flip-top closures. Provides physical lubrication to reduce friction during intimate activity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993:2009, including cytotoxicity, rabbit vaginal/penile irritation, acute systemic toxicity, guinea pig maximization, and primary rabbit skin irritation; all results indicated non-irritating and non-sensitizing profiles. Condom compatibility testing performed per modified ASTM D7761-10 using natural rubber latex and polyisoprene condoms confirmed compatibility. Shelf-life established via accelerated aging studies.

Technological Characteristics

Aqueous, non-sterile personal lubricant. Ingredients: propylene glycol, water, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, propylparaben; 'Warm & Tingling' version adds menthol and vanillyl butyl ether. Packaging: PET bottle with polypropylene closure. Tested per ISO 10993 and ASTM D7761-10.

Indications for Use

Indicated for individuals requiring personal lubrication for penile and/or vaginal application to enhance comfort during sexual activity. Compatible with natural rubber latex and polyisoprene condoms; contraindicated for use with polyurethane or other condom types.

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™ Crystal Clear Liquid (K013614)

Submission Summary (Full Text)

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K12075)

Confidential

(revised)

October 2, 2012

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

II. 510(k) Summary

OCT Э 2012 Church & Dwight Co., Inc. Submitter Name: 469 North Harrison Street Submitter Address: Princeton, NJ 08543 Emily Perez Contact Person: Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543 Tel: [phone] Fax: [phone] October 2, 2012 Date Prepared: TROJAN™ LUBRICANTS Continuous Silkiness - Warm & Device Trade Name: Tingling Personal Lubricant TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant Personal Lubricant Device Common Name: NUC - Condom (21 C.F.R. § 884.5300) Product Code: Class II Classification: TROJANTM Crystal Clear Liquid (K013614) Predicate Device: [Continuous Silkiness - Warm & Tingling] [Continuous Silkiness] Intended Use: is as 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.

(continued)

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Device Description:

The device will be available in two forms - as the TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant and as the TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant - each an aqueous, non-sterile, clear personal lubricant compatible with natural rubber latex and polyisoprene condoms. TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant consists of low levels of sensory ingredients.

TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propy|paraben, TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanillyl butyl ether. Each product is not a spermicide or a contraceptive and 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.

#### Technological Characteristics:

There is no difference in the fundamental technological characteristics of the TROJAN™ LUBRICANTS [Continuous Silkiness- Warm & Tingling] [Continuous Silkiness] and the predicate TROJANTM Crystal Clear Liquid Personal Lubricant. TROJANTM LUBRICANTS Continuous Silkiness- Warm & Tingling is composed of propylene glycol, water, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanilly! butyl ether and TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propylparaben. The proposed lubricant is substantially equivalent to the predicate Trojan™ Crystal Clear Liquid Personal Lubricant cleared under 510(k) # K013614.

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# TROJANTM LUBRICANTS Continuous Silkiness Personal Lubricant:

TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propylparaben. The following ingredients, water, propylene glycol, methylparaben, and propylparaben are present in the predicate device. The additional ingredients, dimethicone, dimethicone/viny| dimethicone crosspolymer, hydroxyethyl acrylate, and sodium acryloyl dimethyl taurate copolymer, are safe and do not raise new questions of safety or effectiveness.

# TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling:

TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling is composed of propylene glycol, water, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanillyl butyl ether. The following ingredients, water, propylene glycol, methylparaben, and propylparaben are present in the predicate device. The additional ingredients, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer,menthol and vanillyl butyl ether are safe and do 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:

| Testing Performed | Results |
|--------------------------------|---------------------------------------------------------------------------|
| Cytotoxicity | Cytotoxicity profile similar to currently<br>marketed personal lubricants |
| 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 |

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

Confidential October 2, 2012 (revised)

## Condom Compatibility:

Condom Compatibility Testing was performed using TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling 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 unlubricated dry condoms. Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested.

Both 510(k)- subject formulas consist of the the same base ingredients; therefore the evaluation for condom compatibility was done with TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling because it was considered the most challenging of the two 510(k)-subject formulas due to the inclusion of sensory ingredients vanillyl butyl ether and menthol,

Condom compatibility testing for TROJAN™ LUBRICANTS [Continuous Silkiness-Warm & Tingling] [Continuous Silkiness] Personal Lubricant show that each is compatible with commercially available natural rubber latex condoms and polyisoprene condoms.

### Shelf-life:

TROJAN™ LUBRICANTS [Continuous Silkiness- Warm & Tingling] [Continuous Silkiness] Personal Lubricant each 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 nonclinical performance data, biocompatibility review and testing, and safety data, the proposed devices are substantially equivalent to Trojan™ Crystal Clear Liquid in technology, intended use, and safety.

#### Conclusion:

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

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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

OCT 3 2012

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

Re: K120751

Trade/Device Name: TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant

TROJAN™ LUBRICANTS Continuous Silkiness 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 (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.

Sincerely yours,

Benjamin R. Ticho

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

Confidential August 29, 2012

## I. Indications For Use

510(k) Number (if known): K120751

Device Name: TROJAN™ LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant TROJAN™ LUBRICANTS Continuous Silkiness Personal Lubricant

## INDICATION FOR USE:

[Continuous Silkiness - Warm & Tingling][Continuous Silkiness] 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use **__** OR Over-The-Counter Use X
(Part 21 C.F.R. 801 Subpart D) (21 C.F.R. 801 Subpart C)

(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K120751

Concurrence of CDRH, Office of Device Evaluation (ODE)