TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and includes the words "FDA U.S. FOOD & DRUG ADMINISTRATION". August 1, 2018 Church & Dwight Co., Inc. Joelle Reinson Senior Regulatory Affairs Specialist 500 Charles Ewing Blvd. Ewing, NJ 08628 Re: K180764 Trade/Device Name: Troian™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) Regulation Number: 21 CFR& 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 27, 2018 Received: June 28, 2018 Dear Joelle Reinson: 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. {1}------------------------------------------------ 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 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. 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Sharon M. Andrews -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 {2}------------------------------------------------ TrojanTM Azul Personal Luricant (H2O Sensitive Touch Personal Lubricant) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) #### K180764 Device Name Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) #### Indications for Use (Describe) Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) 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. This product is not compatible with polyurethane condoms. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to; > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." March 22, 2018 Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ #### 510(k) SUMMARY: | Submitter Name: | Church & Dwight Co., Inc. | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter Address: | 500 Charles Ewing Boulevard<br>Ewing, NJ 08628<br>Phone: 609-806 1200 | | Contact Person: | Joelle Reinson<br>Senior Regulatory Affairs Specialist<br>Church & Dwight Co., Inc.<br>469 North Harrison Street<br>Princeton, NJ 08543<br>Email: Please add<br>Tel: (609) 806.1671<br>Fax: (609) 403.7415 | | Date Prepared: | July 31, 2018 | | Device Trade Name: | Trojan™ Azul Personal Lubricant (H2O Sensitive Touch<br>Personal Lubricant) | | Device Common Name: | Personal Lubricant | | Product Code: | NUC (lubricant, personal) | | Classification: | Class II, Condom (21 CFR § 884.5300) | | Predicate Device: | K141034: TROJAN™ Azul Personal Lubricant (H2O<br>Sensitive Touch Personal Lubricant) | ## Description of Device: The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is a hydrous, clear water-based personal lubricant with aloe and vitamin E that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. It is a clear, colorless viscous gel. The lubricant formula is thickened using sodium hyaluronate and hydroxyethylcellulose. It contains a pH buffer system to maintain a slightly acidic pH of 5.9 to 6.9, and is preserved using Symocide pH (Phenoxyethanol, Hydroxyacetophenone, Caprylyl Glycol, and Water). {4}------------------------------------------------ The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) may be packaged in two (2) types of polyethylene terephthalate (PET) bottles. One bottle (PET), 5.5 fl. oz. with a screw on, flip-top polypropylene (PP) closure. An induction seal will be placed over the bottle. The second bottle (PET), 4.5 fl. oz., will be the same bottle material with a pump in the bottle. The pump and nozzle will be made of the same material as the flip-top cap (PP). The pump bottle will have a shrink band over the pump. The following parameters are included as part of the device specifications: - Appearance ● - o Color - Odor ● - pH - Viscosity ● - SymOcide pH Assay - Osmolality - Antimicrobial effectiveness ● - Total Aerobic Microbial Count (TAMC) ● - Total Yeast and Mold Count (TYMC) ● - Absence of Pathogenic Organisms (at minimum Pseudomonas ● aeruginosa, Staphylococcus aureus, and Candida albicans) | Device & Predicate Device(s): | K180764 | K141034 | |--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for Use | Trojan Azul personal<br>lubricant (H2O sensitive<br>touch personal lubricant) is<br>a personal lubricant for<br>penile and/or vaginal<br>application, intended to<br>lubricate and moisturize, to<br>enhance to ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>This product is compatible<br>with natural rubber latex<br>and polyisoprene condoms.<br>This product is not<br>compatible with<br>polyurethane condoms. | Azul personal lubricant is a personal<br>lubricant for penile and/or vaginal<br>application, intended to lubricate and<br>moisturize, to enhance to ease and<br>comfort of intimate sexual activity and<br>supplement the body's natural lubrication.<br>This product is compatible with natural<br>rubber latex and polyisoprene condoms.<br>This product is not compatible with<br>polyurethane condoms. | | General Device Characteristics | | | | Sponsor | Church & Dwight Co., Inc. | Church & Dwight Co., Inc. | | Regulation Number | 884.5300 | 884.5300 | | Product Code | NUC | NUC | | Device Class | II | II | | Condom Compatibility | NRL and polyisoprene | NRL and polyisoprene | {5}------------------------------------------------ | Base Type | Water | Water | |---------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------| | Primary Ingredients | Deionized Water | Deionized Water | | | Glycerin, USP | Glycerin, USP | | | Symocide pH<br>(Phenoxyethanol,<br>Hydroxyacetophenone,<br>Caprylyl Glycol, Water) | Methylparaben, NF | | | Hydroxyethyl-<br>Cellulose | Hydroxyethyl Cellulose (Natrosol 250<br>HX PHARM) | | | Sodium Hyaluronate | Sodium Hyaluronate | | | Sodium Citrate, USP | Sodium Citrate, USP | | | Sodium Chloride, USP | Sodium Chloride, USP | | | Citric Acid, USP | Citric Acid, USP | | | Sodium Hydroxide | Sodium Hydroxide | | | Vitamin E TPGS<br>(Tocophersolan) | Vitamin E TPGS | | | Veragel 200 | Aloe | | | Standardized (Aloe<br>Barbadensis Leaf<br>Extract) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Appearance | Clear Gel | Clear Gel | | Color | Clear and colorless | Clear and colorless | | Odor | Characteristic odor | Characteristic odor | | pH | 5.9-6.9 | 5.9-6.9 | | Viscosity | 1500-7500 | 1500-7500 | | Osmolality | 250 - 550 (S001) | 250 - 550 (S001) | | Antimicrobial effectiveness | Meets Requirement | Meets Requirement | | TAMC | < 100 cfu/g | < 100 cfu/g | | TYMC | <10 cfu/g | <10 cfu/g | | Absence of pathogenic organisms | Absent | Absent | The indication for use statement of the subject device is identical to that of the predicate device. The only difference in the technological characteristics between the subject and predicate device is the inclusion of Symocide instead of Methylparaben. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions as compared to the predicate device. These differences can be address through non-clinical testing. ## Performance Data: The performance testing results are summarized below. #### Biocompatibility: The following biocompatibility testing was performed on the final 510(k)-subject device in accordance with ISO 10993, Biological Evaluation of Medical Devices. {6}------------------------------------------------ | Test Performed | Standard | |---------------------------------------------|--------------| | Cytotoxicity with Agarose Overlay | ISO 10993-5 | | Rabbit Vaginal Irritation Study | ISO 10993-10 | | Acute Systemic Toxicity Study | ISO 10993-11 | | Guinea Pig Maximization Sensitization Study | ISO 10993-10 | ## Condom Compatibility: The results for laboratory testing used a modification of the methodology found in ASTM D7661; Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. Laboratory test results demonstrated that the proposed device is compatible with leading commercial brands of natural rubber latex and polyisoprene condoms, but not compatible with polyurethane condoms. ## Shelf Life: The Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) has a validated shelf life based on results of an accelerated aging stability study. Evaluation of Odor, Color, Viscosity. Osmolality, and pH was conducted. Microbial evaluation was conducted via USP testing and results were met for all parameters ## Substantial Equivalence: Based on the results of performance testing, the Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) is substantially equivalent to the predicate device, Trojan™ Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant), K141034.