NIRVANA D PERSONAL LUBRICANT (TBD)

K123427 · Church & Dwight Co., Inc. · NUC · Jun 28, 2013 · Obstetrics/Gynecology

Device Facts

• Record ID: K123427
• Device Name: NIRVANA D PERSONAL LUBRICANT (TBD)
• Applicant: Church & Dwight Co., Inc.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: Jun 28, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Indications for Use

Nirvana D 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

Nirvana D is an anhydrous, silicone-based personal lubricant containing dimethicone, dimethiconol, vanillyl butyl ether, and hexyl nicotinate. Intended for over-the-counter use, it is applied topically to the penis or vagina to provide lubrication and moisture during sexual activity. The device is packaged in a PET bottle with a polypropylene flip-top closure. It is not a spermicide or contraceptive. The lubricant is compatible with natural rubber latex and polyisoprene condoms, aiding in the ease and comfort of sexual intercourse. It is not compatible with polyurethane condoms.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (cytotoxicity, vaginal/penile irritation, systemic toxicity, sensitization, skin irritation) and condom compatibility testing per ASTM D7761-10. Accelerated aging studies confirmed a two-year shelf-life.

Technological Characteristics

Silicone-based lubricant; ingredients: dimethicone, dimethiconol, vanillyl butyl ether, hexyl nicotinate. Packaging: PET bottle with polypropylene closure. Compatibility: Natural rubber latex and polyisoprene condoms per ASTM D7761-10. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for penile and/or vaginal application to lubricate and moisturize, enhancing comfort during intimate sexual activity and supplementing natural lubrication. 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

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

Submission Summary (Full Text)

{0}------------------------------------------------

K123427
Page 1 of 3

## 510(k) Submission
Church & Dwight Co., Inc. Nirvana D Personal Lubricant

## II. 510(k) Summary

| Submitter Name: | Church & Dwight Co., Inc. | JUN 2 8 2013 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter Address: | 469 North Harrison Street<br>Princeton, NJ 08543 | |
| Contact Person: | Emily Perez<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: | May 28, 2013 | |
| 510(k) Number: | K123427 | |
| Device Trade Name: | Nirvana D Personal Lubricant | |
| Device Common Name: | Personal Lubricant | |
| Product Code: | NUC - Condom (21 C.F.R. § 884.5300) | |
| Classification: | Class II | |
| Predicate Device: | K-Y® Brand Intrigue™ Intense Warming Sensation (K072360) | |
| Intended Use: | Nirvana D is a personal lubricant for penile and/or vaginal<br>application, intended to lubricate and moisturize, to enhance the<br>ease and comfort of intimate sexual activity and supplement the<br>body's natural lubrication. This product is compatible with natural<br>rubber latex and polyisoprene condoms. Not compatible with<br>polyurethane or other condoms. | |
| Device Description: | The Nirvana D Personal Lubricant is an anhydrous, non-sterile,<br>clear silicone-based personal lubricant composed of dimethicone,<br>dimethiconol, vanillyl butyl ether ("VBE") and hexyl nicotinate.<br>Nirvana D Personal Lubricant is compatible with natural rubber<br>latex and polyisoprene condoms. This product is not a spermicide<br>or a contraceptive. The product is packaged in a polyethylene<br>terephthalate (PET) bottle with a screw-on, flip top polypropylene<br>(PP) closure constituting the device's primary packaging. One<br>bottle is packaged into a cardboard carton, which constitutes the<br>device outer packaging | |

{1}------------------------------------------------

510(k) Submission Church & Dwight Co., Inc. Nirvana D Personal Lubrican

June 21, 2013 Page 2 of 320 (revised)

#### Technological Characteristics:

There is no difference in the fundamental technological characteristic of the Nirvana D Personal Lubricant and the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal Lubricant. Nirvana D Personal Lubricant is composed of dimethicone, dimethiconol, vanilly butyl ether, and hexyl nicotinate. The proposed device is substantially equivalent to the predicate K-Y® Brand Intrigue™ Intense Warming Sensation Personal Lubricant cleared under 510(k) # K072360. Three of the four ingredients, dimethicone, dimethiconol, and vanillyl butyl ether, in Nirvana D Personal Lubricant are identical to those in the predicate device. The additional ingredient, hexyl nicotinate, 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:

| 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 |

#### Condom Compatibility:

Condom Compatibility Testing was performed with Nirvana D Personal Lubricant and ASTM D7761-10 "Standard Testing Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms" which was modified to include prelubricated 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 Nirvana D Personal Lubricant is compatible with commercially available natural rubber latex condoms and polyisoprene condoms.

{2}------------------------------------------------

June 21, 2013 Page 2 of 320 (revised)

#### Shelf-life:

In order to establish the stability of the proposed device for its intended shelf-life, an accelerated aging stability test was conducted. 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 Microbial Pathogens. Satisfactory results were obtained for all parameters evaluated.

Based on the results of the accelerated aging study and microbial testing, Nirvana D Personal Lubricant has a proposed shelf-life of two-years.

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

#### Substantially 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 evaluation of human use testing show that the proposed device performs equivalently to the predicate device and is safe for use as a personal lubricant.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a circular design with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem, which is a symbol representing human services.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G6(19 Silver Spring, MD 20993-0002

#### June 28, 2013

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

Re: K123427

Trade/Device Name: Nirvana D Personal Lubricant Regulation Number: 21 CFR& 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 28, 2013 Received: May 30, 2013

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 Cosmelic 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 warrantics. 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.

{4}------------------------------------------------

Page 2 - Ms. Emily Perez

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 (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/CentersOfTices/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/Reportal?roblem/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.htm1.

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

{5}------------------------------------------------

## I. Indications For Use

510(k) Number (if known): K123427

Device Name: Nirvana D Personal Lubricant

### INDICATIONS FOR USE:

Nirvana D 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 (Part 21 C.F.R. 801 Subpart D)

OR

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

## Herbert P. Lerner -S

K123427

CONSUMER PRODUCTS

Image /page/5/Picture/15 description: The image shows a black and white logo for Arm & Hammer. The logo is circular and contains the words "ARM & HAMMER" around the top half of the circle. In the center of the circle is an arm holding a hammer. The arm is bent at the elbow, and the hammer is raised above the arm.

SPECIALTY PRODUCTS