K-Y BRAND TOUCH MASSAGE 2-IN-1 TINGLING

{0}------------------------------------------------ 062535 Personal Product Company Division of McNeil - PPC, Inc. (Appendix A) Traditional 510(k) ## 510(k) Summary of Safety and Effectiveness JAN 2 6 2007 | Submitter | Personal Products Company<br>Division of McNeil - PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558 | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact | Nader Fotouhi, Ph.D.<br>Manager, Regulatory Affairs<br>Personal Product Company<br>Division of McNeil - PPC, Inc.<br>199 Grandview Road<br>Skillman, NJ 08558<br>Phone: (908) 904-3730<br>Fax: (908) 904-3748 | | Date | August 28, 2006 | | Trade Name | K-Y® Brand Touch Massage® 2-in-1 Tingling™ | | Common Name | Personal Lubricant | | Classification<br>Name | HIS - Condom (21CFR 884.5300)<br>MMS - Patient Lubricant (21CFR 880.6375) | | Statement | This proposed device is substantially equivalent to currently marketed<br>predicate device, K-Y® Brand ULTRA GEL™ | | Device<br>description | This device is a body massage + personal lubricant compatible with latex<br>condom that has been specifically developed produce a tingling sensation and<br>a minty scent. | [INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL] {1}------------------------------------------------ ## 510(k) Summary of Safety and Effectiveness (Continued) | Intended use | The intended use of this device is as a personal lubricant compatible with<br>latex condom. It may also be used as a body massage product. | |----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications<br>statement | This device and predicate device have similar indications, by being applied to<br>the vaginal area or a condom in order to enhance comfort and ease of intimate<br>activity. | | Technological<br>characteristics | The proposed device has the same technological characteristics as currently<br>marketed condom compatible personal lubricants. | | Performance<br>data | The results from laboratory testing, pre-clinical evaluations and testing,<br>human RIPT and use test show that the proposed device performs<br>equivalently to the predicate device. Laboratory test results demonstrated that<br>the proposed device is compatible with the leading commercial brands of<br>latex condoms. Lubricity of the proposed device is comparable to the<br>lubricity of predicate device.<br><br>The ingredients used in the formulation of the proposed device are generally<br>recognized as safe (GRAS) and the pre-clinical evaluation of ingredients, as<br>well as, testing of prototypes of the proposed device have determined that it is<br>safe for use in personal lubricant products. The human RIPT shows that the<br>proposed device is non-sensitizing. | | Conclusion | The proposed device is substantially equivalent to the currently marketed<br>products in technology, intended use, safety, and suitability characteristics. | . . . . . . {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 Nader Fotouhi, Ph.D. Manager, Regulatory Affairs Personal Products Company Division of McNeil-PPC, Inc. 199 Grandview Road SKILLMAN NJ 08558-9418 JAN 2 6 Re: K062535 Trade/Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™ Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulation Number: 21 CFR §880.6375 Regulation Name: Patient lubricant Regulatory Class: II Product Code: NUC Dated: December 14, 2006 Received: December 18, 2006 Dear Dr. Fotouhi: 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. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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. Image /page/2/Picture/11 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. Three stars are arranged below the word "Centennial". The logo is surrounded by text that appears to be part of a circular border. Protesting and Promoting Public Health {3}------------------------------------------------ Page 2 - 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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |----------------|----------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely vours. Nancy Chogdon Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Personal Product Company Division of McNeil - PPC, Inc. ## (Appendix C) ## Indications for Use Statement 510(k) Number, if known KO62535 Device Name: K-Y® Brand Touch Massage® 2-in-1 Tingling™ Indications for Use: indications for Use. K-Y® Brand Touch Massage® 2-in-1 Tingling™ is intended as a body massage + personal IN-1 - Drain For penile and vaginal application compatible with latex condom. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use ***_*** OR Over-the-Counter Use **_** David B. hayes (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number. [INFORMATION IN BRACKETS IS CONSIDERED CONFIDENTIAL] Page 42 of 47