PRE' VAGINAL LUBRICANT

{0}------------------------------------------------ K051436 page 1 of 2 Image /page/0/Picture/1 description: The image shows the logo for INGferility. The tagline below the name reads "Naturally Enhancing Reproduction". The logo includes a stylized image of a plant. # 510(k) Summary Pre' Vaginal Lubricant OCT 1 3 2006 # I. General Information on Submitten | Address: | INGfertility, LLC (Subsidiary of Bio-Origyn, LLC)<br>17206 S. Spangle Creek Rd.<br>Valleyford, WA 99036 USA | |-----------------|-------------------------------------------------------------------------------------------------------------| | Telephone: | 509.443.0149 | | Fax: | 509.448.0601 | | Email: | dclifton@ingfertility.com | | Contact Person: | G. Dennis Clifton, Pharm.D. | | Date Prepared: | May 18, 2005 | ## II. General Information on Device | Proprietary Name: | Pre' Vaginal Lubricant | |----------------------|--------------------------------------------------------------------| | Classification Name: | Lubricant, Vaginal, Patient (21 CFR 880.6375-<br>Product Code MMS) | ## III. Predicate Devices | Predicate Device | 510(k) control # | |---------------------|------------------| | K-Y Brand Ultra Gel | K020827 | # IV. Description of Device This product is a non-sterile, water-based personal lubricant formulated to supplement the body's own natural lubricating fluids. This product may be used to facilitate entry of diagnostic or therapeutic devices, enhance the comfort of intimate sexual activity, or provide personal lubrication when vaginal dryness causes discomfort. The formulation does not harm sperm function and is pH balanced to match fertile cervical mucus. The product is compatible with latex and polyurethane condoms. Following is the ingredient list for Pre' Vaginal Lubricant: | Ingredients | |---------------------------| | Water | | Hydroxyethylcellulose, NF | | Pluronic 127, NF | | Sodium Chloride, USP | | Arabinogalactan | | Sodium Phosphate | | Carbopol 934P, NF | | Methyl Paraben, USP | | Sodium Hydroxide, NF | | Potassium Phosphate | The Makers of Pre-Seed® "Sperm Friendly" Intimate Moisturizer {1}------------------------------------------------ K051436 Page 2 of 2 ## V. Intended Use Pre' has the following intended uses: - > To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic devices including fertility interventions. - > As a personal lubricant to supplement the body's own natural lubricating fluids, to moisturize, relieve friction and to enhance the ease and comfort of intimate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms. # VI. Technological Characteristics of Device Compared to Predicate Device Pre' shares the following technological characteristics with the predicate device: highly lubricious, medium viscosity, water based, clear, non-irritating, non-sterile, and condom compatible. # VII. Summary of Preclinical Performance Data Preclinical biocompatibility studies in rabbits revealed no penile or vaginal irritation from Pre'. The Slug Mucosal Irritation Test of the formulation demonstrated no potential for vaginal mucosal irritation. Pre' had no detrimental effects on the ability to fertilize bovine embryos in vivo. Mouse Embryo Assay (MEA) studies with Pre' have demonstrated normal embryo development with no suggestion of toxicity. Pre' has no detrimental effects on human sperm motility parameters, sperm viability or sperm chromatin. Stability of Pre' was confirmed in accordance with FDA and International Conference on Harmonization (ICH) guidelines. The formulation is compatible with latex and polyurethane condoms. ## VIII. Summary of Clinical Performance Data Biocompatibility studies found no evidence of skin irritation or sensitization in humans. Focus groups and consumer-use testing demonstrates that Pre' is nonirritating and very effective as a personal lubricant. ## IX. Conclusion Laboratory, preclinical, and clinical testing conducted with Pre' Vaginal Lubricant has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicate device KY® Brand Ultra Gel™ Section F 510(k) Summary Pre' Vaginal Lubricant {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with flowing lines, representing movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 March 10, 2014 INGfertility, LLC G. Dennis Clifton, Pharm.D. Vice President 17206 South Spangle Creek Road Valleyford, WA 99036 Re: K051436 Trade/Device Name: Pre' Vaginal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: PEB Dated: September 14, 2006 Received: September 15, 2006 Dear Dennis Clifton, This letter corrects our substantially equivalent letter of October 13, 2006. 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. {3}------------------------------------------------ Page 2 - G. Dennis Clifton, Pharm.D. 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-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours. # Herbert P. Lerner -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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K05)436 Device Name: Pre' Vaginal Lubricant Indications for Use: - To lubricate vaginal tissues to facilitate entry of a diagnostic or therapeutic a devices including fertility interventions. - > As a personal lubricant to supplement the body's own natural lubricating As a personal labriount to cappion and to enhance the ease and comfort nfinate sexual activity. This lubricant may be safely applied to vaginal or penile tissues for lubrication and moisturization purposes. It is also compatible with latex and polyurethane condoms. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ X (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David R. Lepson Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number Page 15 of 49