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April 20, 2018United ConsortiumStephanie MorrisRegulatory Specialist29000 N. Hancock Pkwy.Valencia, California 91355Re:K180219Trade/Device Name: JO H2O Flavored Personal LubricantsRegulation Number: 21 CFR 884.5300Regulation Name: CondomRegulatory Class: Class IIProduct Code: NUCDated: January 23, 2018Received: January 25, 2018Dear Stephanie Morris:We have reviewed your Section 510(k) premarket notification of intent to market the device referencedabove and have determined the device is substantially equivalent (for the indications for use stated in theenclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, theenactment date of the Medical Device Amendments, or to devices that have been reclassified in accordancewith the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of apremarket approval application (PMA). You may, therefore, market the device, subject to the generalcontrols provisions of the Act. The general controls provisions of the Act include requirements for annualregistration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbrandingand 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 besubject to additional controls. Existing major regulations affecting your device can be found in the Code ofFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcementsconcerning your device in the Federal Register.Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDAhas made a determination that your device complies with other requirements of the Act or any Federalstatutes and regulations administered by other Federal agencies. You must comply with all the Act'srequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); goodmanufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);U.S. Food & Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993www.fda.govDoc ID# 04017.02.08
Page 2 - Stephanie MorrisK180219and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR1000-1050.Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part803), please go to oblem/default.htm for the CDRH'sOffice of Surveillance and Biometrics/Division of Postmarket Surveillance.For comprehensive regulatory information about medical devices and radiation-emitting products, includinginformation about labeling regulations, please see Device gulationandGuidance/) and CDRH Learn(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry andConsumer 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,Charles Viviano -S'PSEnclosureBenjamin R. Fisher, Ph.D.DirectorDivision of Reproductive, Gastro-Renal,and Urological DevicesOffice of Device EvaluationCenter for Devices and Radiological Health
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K180219page 1 of 5K180219 ‐ JO H2O Flavored Personal Lubricants510(k) Summary510(k) Owner:United ConsortiumStreet Address:29000 N. Hancock ParkwayValencia, CA 91355Contact Person:Stephanie MorrisRegulatory SpecialistBruce AlbertHead of Technical ServicesContact Numbers:Phone: (661) 295‐1700, ext. 232Phone: (661) 295‐1700, ext. 231FAX: (661) 295‐1800Summary PreparationDate:April 19, 2018Trade Names:JO H2O Flavored Personal LubricantsJO H2O Strawberry Kisses Flavored Personal LubricantJO H2O Cherry Burst Flavored Personal LubricantJO H2O Raspberry Sorbet Flavored Personal LubricantJO H2O Succulent Watermelon Flavored Personal LubricantJO H2O Lemon Splash Flavored Personal LubricantJO H2O Tropical Passion Flavored Personal LubricantJO H2O Juicy Pineapple Flavored Personal LubricantJO H2O Banana Lick Flavored Personal LubricantJO H2O Chocolate Delight Flavored Personal LubricantJO H2O Sweet Pomegranate Flavored Personal LubricantJO H2O Peachy Lips Flavored Personal LubricantJO H2O Tangerine Dream Flavored Personal LubricantJO H2O Red Licorice Flavored Personal LubricantJO H2O Black Licorice Flavored Personal LubricantJO H2O Vanilla Cream Flavored Personal LubricantJO H2O Green Apple Flavored Personal LubricantJO H2O Cotton Candy Flavored Personal LubricantCommon Name:Personal Lubricant
K180219page 2 of 5K180219 ‐ JO H2O Flavored Personal LubricantsDevice Classification:Predicate Device:Regulation Name:RegulationNumber:Product Code:Device Class:CondomProduct Name:510(k) Number:Manufacturer:Product Code:Device Class:Astroglide Sensual StrawberryK140590BioFilm, Inc.NUCClass II21 CFR § 884.5300NUC (lubricant, personal)Class IIThe predicate device has not been subject to a design‐related recall.Device Description:JO H2O Flavored Personal Lubricants are clear, semi‐viscous personal lubricants that arecompatible with condoms made of natural rubber latex and polyisoprene. Theseproducts are not compatible with polyurethane condoms. These devices are non‐sterilepersonal lubricants for penile, anal and/or vaginal application, to lubricate andmoisturize, to enhance the ease and comfort of intimate sexual activity and supplementthe body's natural lubrication.These products are provided in clear, Polyethylene Terephthalate (PET) cylinder bottles.The 1 oz. size bottles are capped with natural disc top dispenser caps and the 4 oz. sizebottles are capped with silver disc top dispenser caps. The individual bottles arehermetically sealed during the production process. These products are also available inpolyester‐faced laminated pouches.The device specifications are listed in the table below:Table 1: Device Specifications for JO H2O Flavored Personal LubricantsPropertyAppearanceColorOdorViscosity (cps)pHSpecific GravityOsmolalityAntimicrobial effectiveness per USP 51 Total aerobic microbial count (TAMC) per USP 61 and 1111 SpecificationClear, semi‐viscous liquidColorless to slightly yellowSweet/Characteristic1200 cps to 2500 cps5.9 to 7.11.020 to 1.200750 ‐ 900 (1:5 dilution,) 1400 ‐ 1650 (undiluted)mOsm/kgMeets US 51 acceptance criteria for Category 2productsLess than 10 cfu/g
K180219page 3 of 5K180219 ‐ JO H2O Flavored Personal LubricantsTotal yeast and mold count (TYMC) per USP 61 and 1111 Presence of Pathogens per USP 62 Pseudomonas aeruginosaStaphylococcus aureusSalmonella/ShigellaEscherichia coliCandida AlbicansLess than 10 dications for Use:JO H2O Flavored Personal Lubricants are water‐based personal lubricants for penile,anal and/or vaginal application, intended to lubricate and moisturize, to enhance theease and comfort of intimate sexual activity and supplement the body’s naturallubrication. These products are compatible with natural rubber latex and polyisoprenecondoms. These products are not compatible with polyurethane condoms.Predicate Device Comparison:The table below lists the comparative indication for use and technologicalcharacteristics of the subject and predicate devices.Table 2: Comparator Table for Subject Device – JO H2O Flavored Personal Lubricantsand Predicate Device Astroglide Sensual StrawberryFeatureDevice Classification NameProduct CodeIndication for UseWater solubleContains waterPrimary ingredientsJO H2O Flavored PersonalLubricantsLubricant, PersonalNUCJO H2O Flavored PersonalLubricants are water‐basedpersonal lubricants for penile, analand/or vaginal application,intended to lubricate andmoisturize, to enhance the easeand comfort of intimate sexualactivity and supplement the body’snatural lubrication. These productsare compatible with natural rubberlatex and polyisoprene condoms.These products are not compatiblewith polyurethane condoms.Astroglide Sensual Strawberry(K140590)Lubricant, PersonalNUCThe BioFilm, Inc. AstroglideSensual Strawberry is a personallubricant for penile and/or vaginalapplication, intended tomoisturize and lubricate, toenhance the ease and comfort ofintimate sexual activity andsupplement the body's naturallubrication. This product iscompatible with natural rubberlatex, polyisoprene andpolyurethane condoms.YesYesGlycerin, Water (Aqua), Flavor(Aroma), araben, Masking AgentYesYesWater (Aqua), Glycerin, PropyleneGlycol, Hydroxyethylcellulose,Natural and Artificial StrawberryFlavor, Sodium Gluconate, SodiumSaccharin, Methylparaben, SodiumBenzoate, Citric Acid
K180219page 4 of 5K180219 ‐ JO H2O Flavored Personal LubricantsFeatureOver the counter useSterileCondom CompatibilityBiocompatibility TestedAntimicrobial TestedShelf lifeJO H2O Flavored PersonalLubricantsYesNoLatex, PolyisopreneYesYes3 yearsAstroglide Sensual Strawberry(K140590)YesNoLatex, Polyisoprene, PolyurethaneYesYes2 yearsThe subject and predicate devices have similar indications for use. The indication for thesubject devices has been expanded to also include anal use. This change does notrepresent a new intended use as the intended use of these devices is the same as thepredicate device, i.e., lubrication of an orifice during intimate sexual activity. Thesubject and predicate devices have different technological characteristics, includingdifferences in formulation, condom compatibility, and shelf‐life. The differenttechnological characteristics of the subject devices do not raise different types of safetyand effectiveness questions.Summary of Performance Data:BiocompatibilityBiocompatibility studies, including Acute Systemic Toxicity, Vaginal IrritationTesting, Penile Irritation Testing, Cytotoxicity and Sensitization testing wereperformed in accordance with the 2016 FDA guidance document Use ofInternational Standard ISO 10993‐1, “Biological Evaluation of Medical Devices – Part1: Evaluation and testing within a risk management process” and ISO 10993‐1:2009as follows: Cytotoxicity (ISO 10993‐5:2009)Sensitization (ISO 10993‐10:2010)Vaginal Irritation (ISO 10993‐10:2010)Penile Irritation (ISO 10993‐10:2010)Acute Systemic Toxicity (ISO 10993‐11:2006)The results of this testing demonstrated that the subject lubricants are non‐cytotoxic, non‐irritating, non‐sensitizing, and non‐systemically toxic.Shelf‐Life:The subject devices are non‐sterile personal lubricants with a three‐year shelf‐life inaccordance with the results of a real time aging study. All device specificationslisted in Table 1 were tested at 0, 1, 2 and 3 years. The subject devices met thedevice specifications at all time points.Condom Compatibility:The compatibility of the subject devices with natural rubber latex, polyisopreneand polyurethane condoms was evaluated in accordance with ASTM D7661‐10
K180219page 5 of 5K180219 ‐ JO H2O Flavored Personal LubricantsStandard Test Method for Determining Compatibility of Personal Lubricants withNatural Rubber Latex Condoms. The results of this test indicate that JO H2OFlavored Personal Lubricants are compatible with natural rubber latex andpolyisoprene condoms. These devices are not compatible with polyurethanecondoms.Conclusion:The results of the performance testing described above demonstrate that the JO H2OFlavored Personal Lubricants are as safe and effective as the predicate device andsupports a determination of substantial equivalence.
510(k) Summary 510(k) Owner: United Consortium 29000 N. Hancock Parkway Valencia, CA 91355 Stephanie Morris Regulatory Specialist Bruce Albert Head of Technical Services Phone: (661) 295‐1700, ext. 232 Phone: (661) 295‐1700, ext. 231 FAX: (661) 295‐1800 April 19, 2018
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