Flip Lube

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February 5, 2018 ImQuest BioSciences, Inc. % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE Saint Petersburg, FL 33704 Re: K171516 Trade/Device Name: FLIP Lube Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: January 3. 2018 Received: January 4, 2018 Dear Paul Dryden: 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 {1}------------------------------------------------ 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, Joyce M. Whang -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) ## K171516 Device Name ## FLIP Lube Indications for Use (Describe) FLIP Lube is personal lubricant for penile, vaginal, 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) XX Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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FORM FDA 3881 (7/17) Page 1 of 1 EF PSC Publishing Services (301) 443-6740 {3}------------------------------------------------ | Submitter: | ImQuest BioSciences Inc.<br>7340 Executive Way, Suite R<br>Frederick, MD 21704<br>Tel - 301-696-0274 | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------| | Official Contact: | Karen W. Buckheit - Director, Prevention Sciences, ImQuest<br>BioSciences Inc. | | Proprietary or Trade Name: | FLIP Lube | | Common/Usual Name: | Personal Lubricant | | Classification Name | 21 CFR 884.5300 (Condom)<br>NUC (lubricant, personal)<br>Class II | | Predicate Device: | K141913 - PJUR GROUP LUXEMBOURG SA -<br>Backdoor Anal Glide /Analyse Me!<br>The predicate device has not been subject to a design related<br>recall. | #### Device Description: FLIP Lube is a water-based, personal lubricant used to provide lubrication during sexual intercourse. It is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. The specifications include appearance, color, odor, pH, viscosity, osmolality, antimicrobial effectiveness, total aerobic microbial count, total yeast and mold count, and absence of pathogenic organisms. ## Indications for Use: Flip Lube is personal lubricant for penile, vaginal, 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 synthetic polyisoprene condoms. Not compatible with polyurethane condoms. #### Substantial Equivalence Discussion: | Feature | Predicate<br>K141913<br>PJUR GROUP LUXEMBOURG SA -<br>Backdoor Anal Glide /Analyse Me! | Proposed<br>K171516<br>ImQuest BioSciences<br>FLIP Lube | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Classification | 21CFR 884.5300 - NUC - Personal Lubricant | | | Class | II / OTC | | | Indications for Use | Personal lubricants 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 | FLIP Lube is personal lubricant for penile, vaginal, 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 | {4}------------------------------------------------ | | | natural rubber latex and synthetic<br>polyisoprene condoms. Not compatible with<br>polyurethane condoms. | |----------------------|------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------| | Environment of Use | OTC – home use | OTC – home use | | Condom Compatibility | Natural rubber latex | Natural rubber latex<br>Polyisoprene<br>Not compatible with polyurethane condoms. | | Type of lubricant | Water-based<br>Silicone-based | Water-based | | Materials | Dimethicone<br>Dimethiconol<br>Simmondsia Chinensis (Jojoba) Seed Oil<br>Amyris Balsamifera Bark Oil | Water<br>Glycerol<br>Hydroxyethyl Cellulose<br>Methylparaben<br>Propylparaben<br>Sodium Phosphate | Both lubricants have the same intended use, but different technological characteristics (e.g., base type). The different technological characteristics do not raise different questions of safety and effectiveness. ## Summary of Performance Testing The following performance tests were conducted: - Shelf Life (accelerated aging equivalent to 12 months per ASTM F1980-16) ● - Condom Compatibility per ASTM D7661-10 - Biocompatibility - Cytotoxicity (ISO 10993-5:2009) O - Sensitization (ISO 10993-10:2010) о - Vaginal Irritation with Histopathology (ISO 10993-10:2010) O - Acute Systemic Toxicity (ISO 10993-11:2006) o The results of performance testing demonstrate that the proposed lubricant maintains all of its specifications over the duration of its proposed shelf life, is compatible with natural rubber latex and polyisoprene condoms, but not polyurethane condoms, and biocompatible. ## Conclusion Based upon performance testing provided, the proposed device and predicate device are substantially equivalent.