FuckWater

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines above them. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 7, 2017 Non-Friction Products Inc. % James W. Monroe CEO Monroe Medical Device Consulting, LLC 319 Shilling Drive Somerset, NJ 08873 Re: K171730 Trade/Device Name: FuckWater Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 9, 2017 Received: June 12, 2017 Dear James W. Monroe: 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. {1}------------------------------------------------ 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 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 contact the Division of Industry and Consumer Education (DICE) 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 (DICE) 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, 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}------------------------------------------------ ## 510k Summary: FuckWater Personal Lubricant ## Submitter Information #### Submitter: Marc Barrette President, Non-Friction Products Inc. 551 Church Street Toronto, ON M4Y 2E2 Canada Phone: (416) 817-1745. Facsimile: (416) 967-0224 marc@nonfrictionproducts.com #### Contact Person: James W. Monroe CEO, Monroe Medical Device Consulting, LLC 319 Shilling Drive Somerset, NJ 08873 USA Phone: (908) 809-0081, Facsimile: (888) 834-1696 wmonroe@monroemdc.com Date Prepared: August 23, 2017 #### Device Information Device Name: FuckWater Common or Usual Name: Personal lubricant Classification: 21 CFR 884.5300; condom Product Code: NUC; lubricant, personal Device Class: II Predicate: Glycerin and Paraben Free Astroglide, K072647 The predicate has not been the subject of a design-related recall. # Intended Use / Indications for Use FuckWater is a water-based personal lubricant for penile and/or rectal and/or rectal 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. {3}------------------------------------------------ # Device Description FuckWater is a non-sterile, home-use, water-based, personal lubricant. It is packaged in 20z, 40z, 8oz and 16oz bottles. The device is intended to be applied to the penis, vagina or rectum to reduce friction during sexual activity. The device is compatible with natural rubber latex and polyisoprene condoms. The device is not compatible with polyurethane condoms. The device has the following specifications: | Parameter | Specification | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------| | Appearance | Viscous, Semi-Opaque Fluid | | Color | Off-White | | Odor | Light Medicinal | | pH | 7.2 - 7.6 | | Osmolality | 2,300-3,400 mOsm/kg | | Viscosity | 20,000 - 26,000 cP | | Antimicrobial effectiveness<br>(USP <51>) | Bacteria: Not less than 2.0 log reduction from the initial count<br>at 14 days, and no increase from the 14 days' count at 28 days | | | Yeast and Mold: No increase from the initial calculated count<br>at 14 and 28 days | | Total Aerobic Microbial<br>Count (USP <61>, <62>) | < 10 cfu/g | | | Total Yeast and Mold Count<br>(USP <61>, <62>) | | Absence of Pathogenic<br>Organisms (USP <61>, <62>) | | # Comparison to Predicate Device FuckWater is substantially equivalent to the predicate device listed below with respect to intended use/indications for use, principles of operation and technological characteristics. #### Substantial Equivalence Table | Attribute | Fuck-Water<br>(Subject Device) | Glycerin and Paraben<br>Free Astroglide<br>(Predicate) | Equivalence | |-------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) | K171730 | K072647 | N/A | | Product Code | NUC | NUC | Same | | Indications for Use | FuckWater is a water-<br>based personal<br>lubricant, for penile,<br>vaginal and/or rectal<br>application, intended to<br>moisturize and<br>lubricate, enhance the<br>ease and comfort of<br>intimate sexual activity<br>and supplement the<br>body's natural<br>lubrication. This<br>product is compatible<br>with natural rubber<br>latex and polyisoprene<br>condoms. This product<br>is not compatible with<br>polyurethane condoms. | Glycerin and Paraben<br>Free Astroglide® is a<br>personal lubricant, for<br>penile, anal, or vaginal<br>application, intended to<br>moisturize and<br>lubricate, to enhance<br>the ease and comfort of<br>intimate sexual activity<br>and supplement the<br>body's natural<br>lubrication. This<br>product is compatible<br>with latex condoms. | Similar; minor<br>differences do<br>not change the<br>intended use<br>and do not<br>raise different<br>questions of<br>safety and<br>effectiveness. | | Condom<br>Compatibility | Natural Rubber Latex<br>Polyisoprene | Natural Rubber Latex | Different;<br>differences in<br>condom<br>compatibility<br>do not raise<br>different<br>questions of<br>safety and<br>effectiveness. | | Over-The-Counter<br>Use | Yes | Yes | Same | | Ingredients | Water, Propylene<br>Glycol, Isopropyl<br>Palmitate,<br>Dimethicone,<br>Hydroxyethyl<br>Cellulose, Polysorbate<br>20, Sorbitan Stearate,<br>Cetearyl Alcohol,<br>Glyceryl Stearate,<br>Sodium Benzoate,<br>Gluconolactone | Water, Butylene<br>Glycol, Xylitol,<br>Propylene Glycol,<br>Polyquaternium 15 | Different;<br>differences in<br>formulation do<br>not raise<br>different<br>questions of<br>safety and<br>effectiveness. | | Biocompatibility<br>Tested | Yes | Yes | Same | | Sterile | No | No | Same | | Microbial Quality<br>and Antimicrobial<br>Effectiveness<br>Tested | Yes | Yes | Same | {4}------------------------------------------------ {5}------------------------------------------------ As noted in the table above, the differences between the subject and predicate devices include the indications for use, condom compatibility and ingredients. These differences do not alter the intended use or the fundamental technology of the subject device as compared to the predicate, and do not raise different questions of safety or effectiveness. The technological differences between the subject device and predicate were evaluated through performance testing as described in the section below. # Summary of Non-Clinical Performance Data ## Biocompatibility The subject device is intended to come into direct contact with the mucosa of patients for a limited (< 24hr) duration. Therefore, biocompatibility testing was conducted to evaluate vaginal and rectal irritation, systemic toxicity, hypersensitivity and cytotoxicity in accordance with ISO 10993 as described below. ### Cytotoxicity The purpose of this test was to examine the test article under evaluation for cytotoxic potential. This test was performed per ISO 10993-5:2009. Based on qualitative evaluation of the mouse fibroblast cells exposed to the test article, the test article was demonstrated to be noncytotoxic. ### Hypersensitivity The purpose of this test was to determine to what extent a test article has the potential to act as a contact sensitizer in guinea pigs. The assay was conducted according to the methods detailed in the ISO 10993-10:2010, Guinea Pig Maximization. Results from treated animals support that the test article is non-sensitizing. Under similar treatment conditions, all positive control animals used in the historical positive control study exhibited a strong sensitization response to the challenge dose compared to that of the control animals. The results from the historical positive control study demonstrate that the guinea pigs in the study reacted as expected when exposed to a known sensitizer (i.e., DNCB) and the results validate the sensitivity of this test. #### Vaginal Mucosal Irritation The purpose of this test was to assess the potential of the test material to produce irritation of the vaginal mucosal tissue in New Zealand White rabbits. This test was performed according to ISO 10993-10:2010. Vaginal Irritation Test. Based on the Irritation Index, the test article was considered a non-irritant to the vaginal mucosa. #### Rectal Irritation The purpose of this test was to assess the potential of the test material to produce irritation of the rectal mucosal tissue in New Zealand White rabbits. This test was performed according to ISO 10993-10:2010, Rectal Irritation Test. Based on the Irritation Index, the test article was considered a non-irritant to the rectal mucosa. #### Acute Systemic Toxicity The purpose of this test was to evaluate systemic responses to the test article following injection into mice. This test was conducted according to ISO 10993-11:2006, Acute Systemic Toxicity. Testing demonstrated that the subject device is not acutely toxic. {6}------------------------------------------------ #### Bench Performance Testing The following non-clinical testing was conducted: Condom compatibility in accordance with ASTM D7661:10 and age testing (ASTM F1980-16) to justify claims of 522 days shelf-life. #### Shelf Life Shelf life for the subject device is claimed to be 522 days. Accelerated aging testing was conducted per ASTM F1980-16, which demonstrated that the device met specifications for the proposed shelf-life. #### Condom Compatibility Condom compatibility was conducted in accordance with ASTM D7661-10 - Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex. The subject device was found to be compatible with male natural rubber latex and polyisoprene condoms and incompatible with male polyurethane condoms. ## Summary of Clinical Performance Data No clinical data were submitted to support substantial equivalence. ## Conclusion The subject device has very similar indications for use to the predicate. Minor differences in the indications statements do not alter the intended use of the subject device. The subject device and the predicate have the same basic technological characteristics. Minor differences in technology do not alter the intended use or fundamental technology, and do not raise different questions of safety and effectiveness. The technological differences between the subject and predicate device were evaluated through performance testing, including biocompatibility, condom compatibility, and shelf-life. The results from performance testing support that the subject device is as safe and effective as the predicate. Therefore, the subject device is substantially equivalent to the predicate device. {7}------------------------------------------------ # 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. 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