K-Y Marilyn Pleasure Gel

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, layered on top of each other to create a sense of depth and unity. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 11, 2016 Reckitt Benckiser LLC Elizabeth Torre Regulatory Operations Lead 399 Interpace Parkway Parsippany, NJ 07054 Re: K151884 Trade/Device Name: K-Y® Marilyn Pleasure Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: December 2, 2015 Received: December 3, 2015 Dear Elizabeth Torre, 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K151884 Device Name K-Y® Marilyn Pleasure Gel Indications for Use (Describe) Intended for penile and/or vaginal application, intended to moisturize and lubricate, 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." {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for RB, a company focused on health, hygiene, and home products. The logo features a pink triangle pointing upwards with the letters "rb" in white inside. Below the triangle, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with small triangles separating each word. # 510(k) Summary | Submitted by: | Reckitt Benckiser, LLC | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 399 Interpace Parkway<br>Parsippany, NJ 07054-0224<br>973-404-2715<br>973-404-5702 | | Contact Person: | Elizabeth Torre, Regulatory Operations Lead, Reckitt Benckiser, LLC. | | Date Prepared: | January 4, 2016 | | Proprietary Name: | K-Y ® Marilyn Pleasure Gel | | Trade Name: | K-Y ® Marilyn Pleasure Gel | | Common Name: | Personal Lubricant | | Classification Name: | Lubricant (21 CFR §884.5300, Product Code NUC) | | Predicate Device(s): | KY® Brand Liquid Reckitt Benckiser LLC<br>Product Code: NUC<br>510(k) No.: K955648<br>Durex® Embrace Warming Sensation Gel<br>Reckitt Benckiser LLC<br>Product Code: NUC<br>510(k) No.: K140193<br>Durex® Embrace Tingling Experience Gel<br>Reckitt Benckiser LLC | Product Code: NUC 510(k) No.: K140193 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for RB, which stands for Reckitt Benckiser. The logo features a pink abstract shape resembling a stylized letter 'r' and 'b' stacked on top of each other. Below the logo, the words "HEALTH HYGIENE HOME" are written in a simple, sans-serif font, with heart symbols separating the words. #### Description of the Device: KY Marilyn is personal lubricant that is a non-sterile, water-based formulation that provides personal lubrication and stimulation during intimate sexual activity. It is made up of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, PEG-40 Hydrogenated Castor Oil, Flavor, Benzoic Acid and Sodium Hydroxide. The subject device is clear in appearance. The specifications for KY Marilyn include appearance, odor, pH, viscosity, benzoic acid, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms (Pseudomonas aeruginosa. Staphylococcus aureus, and Candida albicans) and Antimicrobial Effectiveness. The subject device will be packaged as follows: - 12 mL Polyethylene terephthalate (PET) bottle ● - Polypropylene (PP) pump ● - Polypropylene (PP) snap-on cap ● - . Outer carton The device, KY Marilyn, will be marketed as a non-prescription medical device for over-the- counter (OTC) use. Indications for Use Statement: KY Marilyn is indicated for penile and/or vaginal application, intended to moisturize and lubricate, 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. # Summary of Technological Characteristics of New Device in Comparison to Predicate: Predicate comparison can be seen in Table 1 below. | 510(k) | Device Name | Intended Use | Indications for Use | Physical | Manufacturer | |---------|-------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------| | | | | | Features | | | K151884 | KY Marilyn | The intended use of this<br>device is for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement the body's<br>natural lubrication.<br>This device is compatible<br>with natural rubber latex<br>and synthetic<br>Polyisoprene condoms.<br>This device is not<br>compatible with<br>polyurethane condoms. | Intended for penile and/or<br>vaginal application, intended<br>to moisturize and lubricate,<br>to enhance the 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 and<br>polyisoprene condoms. This<br>product is not compatible<br>with polyurethane condoms. | Homogeneous<br>Clear<br>Gel/Odorless | Reckitt<br>Benckiser<br>LLC | Table 1: Technological Characteristics of Subject Device Compared to Predicate {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo with the letters 'rb' in lowercase, stylized in a modern, sans-serif font. The letters are a vibrant pink color and are positioned above a pink, triangular shape that resembles an arrowhead pointing downwards. The overall design is simple, clean, and eye-catching, suggesting a brand identity that is contemporary and dynamic. | K955648 | KY Liquid | The intended use of this<br>device is a personal<br>lubricant (for vaginal and<br>penile application)<br>compatible with latex<br>condoms ONLY. | Intended as a personal<br>lubricant for penile and<br>vaginal application. It is<br>compatible with latex<br>condoms ONLY. | Homogeneous<br>Clear<br>Gel/Odorless | Reckitt<br>Benckiser<br>LLC | |---------|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|-----------------------------| | K140193 | Durex<br>Embrace<br>Warming<br>Sensation Gel | The intended use of this<br>device is for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity and<br>supplement the body's<br>natural lubrication.<br>This device is compatible<br>with natural rubber latex,<br>synthetic Polyisoprene<br>and polyurethane<br>condoms. | Intended for penile and/or<br>vaginal application, intended<br>to moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication.<br>Lubricant is compatible with<br>natural rubber latex.<br>synthetic polyisoprene and<br>polyurethane condoms. | Homogeneous<br>Clear<br>Gel/Odorless | Reckitt<br>Benckiser<br>LLC | | K140193 | Durex<br>Embrace<br>Tingling<br>Experience<br>Gel | The intended use of this<br>device is for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity<br>and supplement the<br>body's natural lubrication.<br>This device is compatible<br>with natural rubber latex,<br>synthetic polyisoprene<br>and polyurethane<br>condoms. | Intended for penile and/or<br>vaginal application,<br>intended to moisturize and<br>lubricate, to enhance the<br>ease and comfort of<br>intimate sexual activity<br>and supplement the body's<br>natural lubrication.<br>Lubricant is compatible<br>with natural rubber latex,<br>synthetic polyisoprene and<br>polyurethane condoms. | Homogeneous<br>Clear Gel/Odorless | Reckitt<br>Benckiser<br>LLC | Stability: KY Marilyn is shown to have a 9 month shelf life based on 9 month accelerated stability data provided for the formulation. The formulation has met the specification criteria at all temperature conditions. # Summary of Performance Data: | Standard Used | Name of Standard | Result | Conclusion | |-------------------|-----------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------| | ISO 10993-10:2009 | Biological Evaluation and<br>Biocompatibility Testing<br>of Medical Devices | The test article was considered a non-<br>irritant to vaginal tissue of the rabbit. | Device shown to<br>be non-irritating | | ISO 10993-10:2009 | Biological Evaluation and<br>Biocompatibility Testing<br>of Medical Devices | The test article solution showed no<br>evidence of causing delayed dermal<br>contact sensitization in the guinea | Device shown to<br>be non-sensitizing<br>in guinea pig<br>maximization<br>study. | #### Table 2: Summary of Performance Data {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for RB, a health, hygiene, and home company. The logo features a pink triangle with the letters "rb" in white inside. Below the triangle are the words "HEALTH, HYGIENE, HOME" in black with pink triangle bullet points separating the words. | ISO 10993-11:2009 | Biological Evaluation and<br>Biocompatibility Testing<br>of Medical Devices | The test article was not considered a<br>sensitizer in the guinea pig<br>maximization test. | Device did not<br>cause any<br>mortality or<br>systemic toxicity | |------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | USP <87> :2015 | Biological Reactivity<br>Tests, in vitro | There was evidence of slight<br>cytotoxicity to the cells exposed to<br>the test item of the subject device. | Device shown to<br>be non-cytotoxic | | ASTM D7661-10:<br>2010 | Standard Test Method for<br>Determining Compatibility<br>of Personal Lubricants<br>with Natural Rubber latex<br>Condoms | The test results indicate that KY<br>Marilyn (TDS8125708), have passed<br>the condom compatibility test for<br>510(k) condom for 3NRL and PI<br>condoms- with no tests having %<br>difference values > 20%<br>and the<br>majority of results < 10%. | The Device is<br>shown to be<br>compatible with<br>NRL and PI<br>condoms and not<br>compatible with<br>PU condoms. | Conclusion: Substantial Equivalence of proposed devices can be achieved when the proposed device and the predicate device(s) share the same intended use and the same technological characteristics or when the proposed device and the predicate device(s) share the same intended use with different technological characteristics but when the information submitted to the FDA: 1) does not raise different questions of safety and efficacy of the proposed device and 2) demonstrates that the proposed device is at least as safe and effective as the legally marketed device. In this case, the predicate devices K140193 and K955648 as well as the proposed device (K151884) share the same intended use for penile and vaginal application for personal lubrication. Based on this information the proposed device and the predicates fall under the FDA Classification NUC for personal lubricant. Both predicates (K140193 and K955648) as well as the proposed device (K151884) are compatible with NRL condoms as per ASTM D7661-10. Both the proposed device (K151884) and predicate devices K140193 and K955648 are transparent, odorless liquids. They have similar formulation profiles and all contain a thickener, humectant, pH modifier and preservatives. The proposed and predicate devices also share similar technological characteristics including pH and microbial profiles (Specified Organisms Testing). In addition to the technological characteristics, the safety profiles of the proposed and predicate devices are similar. All are non-sensitizing, non-irritating and none are shown to result in mortality or systemic toxicity. All cleared devices have the same fundamental and scientific technology, and based on presented data are considered safe and effective for use. Based on this information, it can be stated that the proposed device is substantially equivalent to the predicate devices.