This 510(k) submission is for two personal lubricant products: Trojan Nirvana B Continuous Silkiness - Warm & Tingling Personal Lubricant and Trojan Nirvana B Continuous Silkiness Personal Lubricant. Both lubricants contain similar base ingredients to the predicate Trojan Crystal Clear Liquid Personal Lubricant, including water, propylene glycol, and preservatives. Additional ingredients in the proposed lubricants are considered safe. Testing showed the lubricants are non-irritating, non-sensitizing, non-toxic, and compatible with natural rubber latex and polyisoprene condoms. Clearance is requested as the lubricants are substantially equivalent to the predicate device for lubricating
This 510(k) submission is for two personal lubricant products: Trojan Nirvana B Continuous Silkiness - Warm & Tingling Personal Lubricant and Trojan Nirvana B Continuous Silkiness Personal Lubricant. Both lubricants contain similar base ingredients to the predicate Trojan Crystal Clear Liquid Personal Lubricant, including water, propylene glycol, and preservatives. Additional ingredients in the proposed lubricants are considered safe. Testing showed the lubricants are non-irritating, non-sensitizing, non-toxic, and compatible with natural rubber latex and polyisoprene condoms. Clearance is requested as the lubricants are substantially equivalent to the predicate device for lubricating
This 510(k) submission is for two personal lubricant products: Trojan Nirvana B Continuous Silkiness - Warm & Tingling Personal Lubricant and Trojan Nirvana B Continuous Silkiness Personal Lubricant. Both lubricants contain similar base ingredients to the predicate Trojan Crystal Clear Liquid Personal Lubricant, including water, propylene glycol, and preservatives. Additional ingredients in the proposed lubricants are considered safe. Testing showed the lubricants are non-irritating, non-sensitizing, non-toxic, and compatible with natural rubber latex and polyisoprene condoms. Clearance is requested as the lubricants are substantially equivalent to the predicate device for lubricating
This 510(k) submission is for two personal lubricant products: Trojan Nirvana B Continuous Silkiness - Warm & Tingling Personal Lubricant and Trojan Nirvana B Continuous Silkiness Personal Lubricant. Both lubricants contain similar base ingredients to the predicate Trojan Crystal Clear Liquid Personal Lubricant, including water, propylene glycol, and preservatives. Additional ingredients in the proposed lubricants are considered safe. Testing showed the lubricants are non-irritating, non-sensitizing, non-toxic, and compatible with natural rubber latex and polyisoprene condoms. Clearance is requested as the lubricants are substantially equivalent to the predicate device for lubricating
Trojan Nirvana B Personal Lubricant (revised) 1. 510(k) Summary OCT ~32012
Submitter Name: Church & Dwight Co., Inc.
Submitter Address: 469 North Harrison Street
Princeton, NJ 08543 Contact Person: Emily Perez Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street Princeton, NJ 08543 Tel: (609) 688-5347 Fax: (609) 497-7179 Date Prepared: October 2, 2012
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) 510(k) Premnarket Notification Confidential Church & Dwight Co., Inc. October 2, 2012 Trojan Nirvana B Personal Lubricant (revised)
Device Description: The device will be available in two forms - as the TROJAN TM LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant and as the TROJANIM LUBRICANTS Continuous Silkiness Personal Lubricant - each an aqueous, non-sterile, clear personal lubricant compatible with natural rubber latex and polyisoprene condoms. TROJANTM LUBRICANTS Continuous Silkiness- Warm & Tingling Personal Lubricant consists of low levels of sensory ingredients. TROJAN TM LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dlimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propylparaben, TROJANTM 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 vaniliyl butyl ether. Each product is not a sperm icide 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 TROJANTM
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, dlimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, menthol, propylparaben, and vanillyl butyl ether and TROJANTM LUBRICANTS Continuous Silkiness Personal Lubricant is composed of propylene glycol, water, dimethicone, dimethicone/vinyl dlimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer, methylparaben, and propylparaben. The proposed lubricant is substantially equivalent to the predicate Trojan TM Crystal Clear Liquid Personal Lubricant cleared under 5 10(k) # K0 13614.
(continued) 51Q(k) premnarket Notification Confidential Church & Dwight Co., Inc. October 2, 2012 Trojan Nirvana B Personal Lubricant (revised)
TROJA'M LUBRICANTS Continuous Silkiness Personal Lubricant:
TROJANTM LUBRICANTS Continuous Silkiness Personal Lubricant is composed of
propylene glycol, water, dimethicone, dimethicone/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, sodium acryloyl diniethy! 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/vinyl dimethicone crosspolymer, hydroxyethyl acrylate, and sodium acryloyl dimethyl taurate copolymer, are safe and do not raise new questions of safety or effectiveness.
TROJANTM LUBRICANTS Continuous Silkiness- Warm & Tingling 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. The following ingredients, water, propylene glycol, methylparaben, and propylparaben are present in the predicate device. The additional ingredients, dimethicone, dimethicone/vinyl dimethicone crosspoiymer, hydroxyethyl acrylate, sodium acryloyl dimethyl taurate copolymer,menthol and vanillyl butyl ether are safe and do not raise new questions of safety or effectiveness.
lBiocompatibility: Biocompatibility testing was performed in accordance with IS0 10993, Biological Evaluation of Medical Devices, 2009. Testing Performed:
Testing Performed Results
Cytotoxicity Cytotoxicity profile similar to currently 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 510(k) Premnarket Notification Confidential Church & Dwight Co., Inc. October 2, 2012 Trojan Nirvana B Personal Lubricant (revised)
Condom Compatibility:
Condom Compatibility Testing was performed using TROJANTM 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 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.
Both 5 10(k)- subject formulas consist of the the same base ingredients; therefore the evaluation for condom compatibility was done with TROJANTM LUBRICANTS Continuous Silkiness- Warm & Tingling because it was considered the most challenging of the two 5 10(k)-subject formulas due to the inclusion of sensory ingredients vanillyl butyl ether and menthol,
Condom compatibility testing for TROJANTM LUBRICANTS [Continuous Silkiness-
Warm & Tingling] [Continuous Silkiness] Personal Lubricant show that each is compatible with commercially available natural rubber latex condoms and polyisoprene condoms.
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 TM 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. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
*Food and Drug Administration
10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, NO 20993-0002
Ms. Emily Perez OCT
Regulatory Affairs Specialist Church & Dwight Co., Inc. 469 North Harrison Street PRINCETON NJ 08543
We have reviewed your Section 5 10(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 Page 2 -
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://wvv*fda.gov/AboutFDA/CentersOffices/CDRHICDRHOffice/ucm I15809.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" (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/SafeylReplortaProblem/idefault.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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://",ww.fda.gov/MedicalDevices/ResourcesforYoLlndustv/default.htm.r
Sincerely tirs,
Benj n R. Fisher, Ph.D.
Dirc r Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure 5 i 0(k) Premarket Notification Confidential Church & Dwight Co., Inc. August 29, 2012 TrojanTM Nirvana B Personal Lubricant
1. Indications For Use
510(k) Number (if known): K120751
Device Name: TROJANTM 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 CDRT, Office of Device Evaluation (ODE)
Prescription Use ___OR Over-The-Counter Use -X
(Part 21 C.F.R. 801 part D) (21 C.F.R. 801 Subpart C)
