OneTouch Lubricant Gel

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 30, 2015 Thai Nippon Rubber Industry Co., Ltd. % Stuart Goldman Senior Consultant Emergo Group 816 Congress Avenue Suite 1400 Austin, Texas 78701 Re: K142790 > Trade/Device Name: OneTouch Lubricant Gel Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 30, 2015 Received: July 1, 2015 Dear Stuart Goldman, 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 device {1}------------------------------------------------ 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. 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, Joyce M. Whang -S for Benjamin 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) K142790 Device Name OneTouch™ Lubricant Gel #### Indications for Use (Describe) OneTouch™ Lubricant Gel is a personal lubricant, 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) Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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}------------------------------------------------ # 510(k) Summary for # OneTouch™ Lubricant Gel ### 1. Submission Sponsor Thai Nippon Rubber Industry Company, Ltd. ("TNR") 789/139 Pinthong Industrial Estate, Nongkham Sriracha, Chonburi, 20110 Thailand Phone: + 66 38 317 999 Fax: + 66 38 317 950 Contact: Mr. Pisut Chanwatarungkull, Quality Management System Manager Email: pisut c@tnrcondom.com; tnrfact@tnrcondom.com ### 2. Submission Correspondent Emergo Group 816 Congress Avenue, Suite 1400 Austin, TX 78701, USA Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Stuart R. Goldman, Senior Consultant, RA/QA Email: project.management@emergogroup.com ### 3. Date Prepared July 30, 2015 ## 4. Device Identification | Trade/Proprietary Name: | OneTouch™ Lubricant Gel | |----------------------------|-------------------------| | Common/Usual Name: | Lubricant, Personal | | Classification Name: | Condom | | Classification Regulation: | §884.5300 | | Product Code: | NUC | | Device Class: | Class II | | Classification Panel: | Obstetrics/Gynecology | ## 5. Legally Marketed Predicate Device(s) Global Protection Corp. [ONE® Oasis (K110691)] Ansell Healthcare Products [LifeStyles® Smooth™ 2-in-I Massage & Lubricant (K122476)] ## 6. Device Description One Touch™ Lubricant Gels by Thai Nippon Rubber Industry Company, Ltd. ("TNR") are a line of personal lubricants, 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. These lubricants are compatible with natural rubber latex and {4}------------------------------------------------ polyisoprene condoms, and are not a contraceptive and do not contain a spermicide. One Touch™ Lubricant Gels are made available in three (3) different versions: One Touch™ Plain, One Touch™ Flavored and One Touch™ Colored, and come packaged in either single-use disposable application film/foil sachets, or in multiple application polyethylene tubes with a flip-top closure. OneTouch™ Lubricant Gels use hydroxyethyl cellulose and refined glycerin as the lubricating agent, with the methyl paraben, propyl paraben and cremophor acting as the antiseptic and preservative additives. ## 7. Indication for Use Statement OneTouch™ Lubricant Gel is a personal lubricant, 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. ## 8. Substantial Equivalence Discussion TNR has chosen two predicate devices in the 510(k) submission for their OneTouch™ Lubricant Gel, those being ONE® Oasis by Global Protection Corp. (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant by Ansell Healthcare Products (K122476). The following table 5-1 compares OneTouch™ Lubricant Gels to the predicate devices with respect to intended use, technological characteristics and principles of operation, thus providing more detailed information regarding the basis for the determination of substantial equivalence in this 510(k) submission. | Device | OneTouch™<br>Lubricant Gel | ONE® Oasis | LifeStyles®<br>Smooth™<br>2-in-1 Massage<br>& Lubricant | Differences | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k): | Pending | K110691 | K122476 | - | | Manufacturer: | Thai Nippon<br>Rubber Industry<br>Company, Ltd. | Global<br>Protection Corp. | Ansell Healthcare<br>Products | - | | Product Code: | NUC | NUC | NUC | Same. The subject<br>and predicate<br>devices share the<br>same FDA product<br>code. | | Regulation: | §884.5300 | §884.5300 | §884.5300 | Same. The subject<br>and predicate<br>devices share the<br>same FDA<br>regulation number. | | Class: | II | II | II | Same. The subject<br>and predicate<br>devices share the<br>same FDA device<br>classification. | | Prescription or<br>OTC Use: | OTC | OTC | OTC | Same. The subject<br>and predicate | | | | | | devices are sold<br>OTC. | | Intended Use: | OTC personal<br>lubricant. | OTC personal<br>lubricant. | OTC personal<br>lubricant. | Same. The subject<br>and predicate<br>devices are sold<br>OTC and intended<br>be used as a<br>personal lubricant. | | Indications for<br>Use: | OneTouch™<br>Lubricant Gel is a<br>personal lubricant<br>for penile and/or<br>vaginal application,<br>intended to<br>moisturize and<br>lubricate, to<br>enhance the ease<br>and comfort of<br>intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubricant. This<br>product is<br>compatible with<br>natural rubber<br>latex, polyisoprene,<br>and polyurethane<br>condoms. | ONE® Oasis is a<br>personal lubricant,<br>for penile and/or<br>vaginal application,<br>intended to<br>moisturize and<br>lubricate, to<br>enhance the ease<br>and comfort of<br>intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubrication. This<br>product is<br>compatible with<br>natural rubber<br>latex,<br>polyisoprene, and<br>polyurethane<br>condoms. | Indications for Use:<br>LifeStyles®<br>Smooth™ 2-in-l<br>Massage &<br>Lubricant is a<br>personal<br>Lubricant, for<br>penile and/or<br>vaginal application,<br>intended to<br>moisturize and<br>lubricate, to<br>enhance the ease<br>and comfort of<br>intimate sexual<br>activity and<br>supplement the<br>body's natural<br>lubrication. This<br>product is<br>compatible with<br>natural rubber<br>latex,<br>polyurethane, and<br>polyisoprene<br>condoms. | Similar. The subject<br>and predicate<br>devices have<br>virtually the same<br>indications for use;<br>any minor wording<br>differences<br>between them are<br>insignificant to<br>their intended use<br>and do not affect<br>the safety or<br>efficacy. | | Mode of<br>Operation<br>(Lubricating<br>Agent): | hydroxyethyl<br>cellulose | hydroxyethyl<br>cellulose | hydroxyethyl<br>cellulose | Similar. The subject<br>and predicate<br>devices use<br>hydroxyethyl<br>cellulose as the<br>main lubricating<br>agent in their<br>product<br>formulation; overall<br>ingredient % may<br>vary. | | Water Based<br>Lubricant: | Yes | Yes | Yes | Same. The subject<br>and predicate<br>devices are water-<br>based personal<br>lubricants. | | Sterile: | No | No | No | Same. The subject<br>and predicate<br>devices are not<br>provided sterile or | | | | | | intended to be<br>sterilized by the<br>user. | | Body Location<br>Target Area: | for penile and/or<br>vaginal application | for penile and/or<br>vaginal application | for penile and/or<br>vaginal application | Same. The subject<br>and predicate<br>devices are for<br>penile and/or<br>vaginal application. | | Single Use: | Yes | Yes | Yes | Same. The subject<br>and predicate<br>devices are applied,<br>as needed, to the<br>target area. | | Packaging: | Single use film/foil<br>sachets and<br>multiple use tubes. | Multiple use tubes. | Multiple use<br>plastic pump<br>dispenser. | Similar. The subject<br>and predicate<br>devices use<br>somewhat different<br>sizes and shapes for<br>their OTC<br>packaging, but<br>these differences<br>are minor and have<br>no impact on the<br>safety or efficacy of<br>the personal<br>lubricant. | | Shelf-life: | 3 years | 1 year | 3 years | Similar. The subject<br>and predicate<br>devices have the<br>same or similar<br>shelf-life for their<br>OTC packaging, but<br>these differences<br>are minor and have<br>no impact on the<br>safety or efficacy of<br>the personal<br>lubricant. | | Biocompatibility<br>Testing<br>Performed: | Yes<br>ISO 10993-1<br>(-5, -10, -11) | Yes<br>ISO 10993-1<br>(-5, -10, -11) | Yes<br>ISO 10993-1<br>(-5, -10, -11) | Same. The subject<br>and predicate<br>devices have<br>undergone<br>biocompatibility in<br>accordance with<br>the applicable parts<br>of ISO 10993-1. | | Condom<br>Compatibility<br>Testing<br>Performed: | Yes<br>ASTM D7661-10 | Yes<br>ASTM D7661-10 | Yes<br>ASTM D7661-10 | Same. The subject<br>and predicate<br>devices have been<br>tested for condom<br>compatibility in<br>accordance with<br>ASTM D7661-10. | | Microbiological | Yes | Not known | Yes | Same. The subject | | Examination of<br>Non-sterile<br>Products<br>Testing: | USP 37<br>(<61>/<62>) | USP | and one of the<br>predicate devices<br>(K122476) have<br>been tested for<br>microorganism<br>contamination in<br>accordance with<br>the applicable parts<br>of the USP. | | Table 5-1 OneTouch™ Lubricant Gels vs. Predicate Devices - Similarities and Differences {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## 9. Non-Clinical Performance Data As part of demonstrating the safety and effectiveness of OneTouch™ Lubricant Gel and in showing substantial equivalence to the predicate devices, TNR completed a number of tests on their device to prove this. OneTouch™ Lubricant Gel meets all the requirements for overall design, biocompatibility, condom compatibility, microbial contamination, package shelf-life and device risk, which confirms that the outputs meets the design inputs and specifications for the device. OneTouch™ Lubricant Gel passed all the testing in accordance with national and international standards shown below to support substantial equivalence to the predicate devices. - Biocompatibility Testing (Per ISO 10993-1) ● - Condom Compatibility Testing (Per ASTM D7661) - Total Aerobic Microbial Counts (Per USP 37 <61>/<62>) - Total Combined Yeast and Mold Counts (Per USP 37 <61>/<62>) - Package Shelf-Life (Per ASTM F1980) - Device Risk Analysis (Per ISO 14971) ● ## 10. Clinical Performance Data There was no human clinical testing required to support OneTouch™ Lubricant Gel as the indications for use is equivalent to the predicate devices. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the intended use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of OneTouch™ Lubricant Gel to the predicate devices. ## 11. Statement of Substantial Equivalence By definition, a device is substantially equivalent to a predicate device when the subject device has the same intended use and the same technological characteristics as the previously cleared device, or has the same intended use and different technological characteristics, but it can be demonstrated that the new device is substantially equivalent to the predicate device, and that the new device does not raise any questions regarding its safety and effectiveness when compared to the predicate device. OneTouch™ Lubricant Gel and the predicate devices that are the subject of this 510(k) submission, all function as a personal lubricant for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and to supplement the body's natural lubricant, and are all compatible with natural {8}------------------------------------------------ rubber latex, polyisoprene, and polyurethane condoms, but are not a contraceptive and do not contain a spermicide. Therefore, based on the substantial equivalence analysis described above, OneTouch™ Lubricant Gel, as designed, developed, manufactured, packaged and tested by TNR, is determined to be substantially equivalent to ONE® Oasis (K110691) and LifeStyles® Smooth™ 2-in-1 Massage & Lubricant (K122476) personal lubricants regulated by the FDA as a Class II medical device under Product Code NUC and §884.5300.