K-Y Silicone

{0}------------------------------------------------ January 12, 2018 Reckitt Benckiser LLC Elizabeth Viguerie, MPH Sr. Regulatory Associate 399 Interpace Parkway Parsippany, NJ 07054 Re: K173504 Trade/Device Name: K-Y® Silicone Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: November 10, 2017 Received: November 13, 2017 Dear Elizabeth Viguerie: 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. Iisting 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. 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, 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}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {3}------------------------------------------------ #### 510(k) Summary - K173504 | Submitted by: | Reckitt Benckiser, LLC<br>Morris Corporate Center IV<br>399 Interpace Parkway<br>Parsippany, NJ 07054-0224<br>973-404-2715<br>973-404-5702 | |----------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Elizabeth Viguerie, MPH, Senior Regulatory Associate, Reckitt Benckiser, LLC | | Date Prepared: | January 11, 2018 | | Proprietary Name: | K-Y® Silicone | | Trade Name: | K-Y® Silicone | | Common Name: | Personal Lubricant | | Classification Name: | Condom (21 CFR §884.5300) | | Product Code: | NUC (lubricant, personal) | | Regulatory Class: | II | | Predicate Device(s): | Durex Silicone (K143532) | The predicate device has not been subject to a design-related recall. ## Description of the Device: K-Y® Silicone is a non-sterile, odorless, and anhydrous personal lubricant that provides personal lubrication during intimate sexual activity and is compatible with condoms made of natural rubber latex, polyurethane and polyisoprene. This product is composed of 100% Dimethicone. The product is packaged in a 50mL (1.69 FL oz.) HDPE bottle with a polypropylene pump. K-Y @ Silicone is identical in formulation and specifications to the predicate device (Durex Silicone, K143532). {4}------------------------------------------------ | Property | Specification | |-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Color | Colorless | | Odor | Odorless | | Viscosity | 80-110 cps | | TAMC (EP 2.6.12<br>harmonized to USP <61>) | <10 cfu/g | | TYMC (EP 2.6.12<br>harmonized to USP <61>) | Absent | | Absence of Pathogenic<br>Organisms (Candida<br>albicans, Pseudomonas<br>aeruginosa, Staphylococcus<br>aureus) (EP 2.6.13<br>harmonized to USP <62>) | Absent | Specifications for the K-Y® Silicone personal lubricant are shown in the table below: # Indication for Use: K-Y® Silicone is indicated for penile, vaginal and/or anal 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, polyisoprene, and polyurethane condoms. # Predicate Device Comparison: ### Intended Use: The indications for use for the subject and predicate devices are shown in the table below: | K-Y® Silicone | Durex Silicone | |---------------------------------------------|-------------------------------------------------| | K173504 | K143532 | | K-Y® Silicone is indicated for penile, | Durex Silicone is indicated for penile and/or | | vaginal and/or anal application, intended | vaginal application, intended to moisturize and | | to moisturize and lubricate, to enhance the | lubricate, to enhance the ease and comfort of | | ease and comfort of intimate sexual | intimate sexual activity and supplement the | | activity and supplement the body's natural | body's natural lubrication. This product is | | lubrication. This product is compatible | compatible with natural rubber latex, | | with natural rubber latex, polyisoprene, | polyisoprene, and polyurethane condoms. | | and polyurethane condoms. | | {5}------------------------------------------------ The subject and predicate device have similar indications for use. However, the indication for the subject device has been expanded from the current penile and vaginal use to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. Additionally, FDA has cleared otherpersonal lubricants with comparable indications including penile, vaginal, and anal use. ## Technological Characteristics: The technological characteristics of the K-Y@ Silicone personal lubricant are identical to the predicate device as both devices are made from the same material, have the same packaging, and have the same specifications. ## Summary of Performance Data This submission relies on the performance testing provided in the predicate submission for the Durex Silicone personal lubricant (K143532) as the subject device is identical to the predicate device. Data from the predicate submission used to support the subject device is summarized below: Biocompatibility: Testing was conducted in accordance with ISO 10993-1:2009. The following endpoints were assessed in the testing conducted: - Cytotoxicity (ISO 10993-5:2009) - Sensitization (ISO 10993-10:2010) ● - . Irritation (ISO 10993-10:2010) - Systemic Toxicity (ISO 10993-11:2011 ● The results of this testing demonstrated that the subject lubricant is biocompatible. Condom Compatibility: Testing was done in accordance with ASTM method D7661-10 on condoms made of natural rubber latex. polyisoprene, and polyurethane. The results of testing showed compatibility of the lubricant with natural rubber latex, polyisoprene, and polyurethane condoms. Shelf-Life: K-Y@ Silicone is a non-sterile personal lubricant with a 24 month shelf-life based on the results of accelerated a and real-time stability studies. Testing showed that devices were able to meet the device specifications shown in the Device Description section of this summary over the 24-month shelflife period. ### Conclusion As K-Y® Silicone is identical to the predicate Durex Silicone personal lubricant, the performance data described above demonstrates that the K-Y® Silicone personal lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.