JO H2O Jelly Original Personal Lubricant

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. April 17, 2019 United Consortium Stephanie Morris Global Regulatory Specialist 29000 N. Hancock Pkwy. Valencia, CA 91355 Re: K183584 > Trade/Device Name: JO H2O Jelly Original Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: March 15, 2019 Received: March 18, 2019 Dear Stephanie Morris: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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, Jason Roberts -S 2019.04.17 15:32:11 -04'00' 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) K183584 Device Name JO H2O Jelly Original Personal Lubricant Indications for Use (Describe) JO H2O Jelly Original Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. 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 - K183584 #### 1. Submitter Information | Applicant: | United Consortium | |------------|------------------------------| | Contact: | Stephanie Morris | | | Global Regulatory Specialist | Bruce Albert Head of Technical Services Address: 29000 N. Hancock Parkway Valencia. CA 91355 Phone: (661) 295-1700, ext. 232 Phone: (661) 295-1700, ext. 231 FAX: (661) 295-1800 ## 2. Correspondent Information | Contact: | Stephanie Morris | |----------|------------------------------------------------| | Address: | 29000 N. Hancock Parkway<br>Valencia, CA 91355 | | Phone: | (661) 295-1700, ext. 232 | | Fax: | (661) 295-1800 | | Email: | smorris@systemjo.com | #### 3. Date prepared: April 16, 2019 ## 4. Device Information | Device Name: | JO H2O Jelly Original Personal Lubricant | |--------------------|------------------------------------------| | Common Name: | Personal Lubricant | | Regulation Number: | 21 CFR 884.5300 | | Regulation Name: | Condom | | Regulatory Class: | Class II | | Product Code: | NUC (lubricant, personal) | ## 5. Predicate Device Information | Device Name: | JO Agapé Personal Lubricant | |-------------------|-----------------------------| | 510(k) Number: | K171021 | | Manufacturer: | United Consortium | | Regulatory Class: | Class II | | Product Code: | NUC (lubricant, personal) | The predicate device has not been subject to a design-related recall. ## 6. Device Description JO H2O Jelly Original Personal Lubricant is a clear/water white, viscous gel-type personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. This product is not compatible with polyurethane condoms. This device is a non-sterile personal lubricant for penile, anal and/or vaginal application, to lubricate and moisturize, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is provided in clear, polyethylene (PE) tubes. These 4 oz. size tubes are capped with silver, glossy, polypropylene (PP) flip tops. The individual tubes are hermetically sealed during the production process. The device specifications are listed in the table below: {4}------------------------------------------------ | Property | Specification | |-----------------------------------------------------------------|--------------------------------------------------------------| | Appearance | Viscous gel | | Color | Clear, water white | | Odor | Odorless | | Viscosity (cps) | 15,500 cps to 35,000 cps | | pH | 4.00 to 5.00 | | Specific Gravity | 1.000 to 1.200 | | Osmolality | 1050 to 1250 mOsm/kg | | Antimicrobial effectiveness per USP <51> | Meets US <51> acceptance criteria for<br>Category 2 products | | Total aerobic microbial count (TAMC) per<br>USP <61> and <1111> | Less than 10 cfu/g | | Total yeast and mold count (TYMC) per<br>USP <61> and <1111> | Less than 10 cfu/g | | Presence of Pathogens per USP <62> | Specification | | Pseudomonas aeruginosa | Absent | | Staphylococcus aureus | Absent | | Salmonella/Shigella | Absent | | Escherichia coli | Absent | | Candida albicans | Absent | Table 1: Device Specifications for JO H2O Jelly Original Personal Lubricant # 7. Indications for Use JO H2O Jelly Original Personal Lubricant is a personal lubricant for penile, anal and/or vaginal application, intended to lubricate and moisturize, 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. Comparison of Intended Use and Technological Characteristics with the Predicate Device The table below lists the comparative indications for use and technological characteristics of the subject and predicate device. # Table 2: Comparator Table for Subject Device - JO H2O Jelly Original Personal Lubricant and Predicate Device JO Agapé Personal Lubricant | Feature | JO H2O Jelly Original<br>Personal Lubricant | JO Agapé Personal<br>Lubricant (K171021) | |-------------------------------|---------------------------------------------|------------------------------------------| | Device Classification<br>Name | Lubricant, Personal | Lubricant, Personal | | Product Code | NUC | NUC | {5}------------------------------------------------ | Feature | JO H2O Jelly Original<br>Personal Lubricant | JO Agapé Personal<br>Lubricant (K171021) | |-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | JO H2O Jelly Original Personal<br>Lubricant is a personal lubricant<br>for penile, anal and/or vaginal<br>application, intended to lubricate<br>and moisturize, to enhance the<br>ease and comfort of intimate<br>sexual activity and supplement<br>the body's natural lubrication.<br>This product is compatible with<br>natural rubber latex and<br>polyisoprene condoms.<br>This product is not compatible<br>with polyurethane condoms. | JO Agapé Personal Lubricant is<br>a water-based personal<br>lubricant for penile and/or<br>vaginal application, intended to<br>lubricate and moisturize, to<br>enhance the<br>ease and comfort of intimate<br>sexual activity and supplement<br>the body's natural lubrication.<br>This product is compatible with<br>natural rubber latex and<br>polyisoprene condoms. This<br>product is<br>not compatible with<br>polyurethane condoms. | | Water soluble | Yes | Yes | | Contains water | Yes | Yes | | Primary ingredients | Glycerine USP, Natrosol 250<br>HHX, Aqualon Sodium<br>Carboxymethyl Cellulose 7H<br>35F, Water (Aqua), Norsene<br>100, Sodium Benzoate,<br>Potassium Sorbate, PREMIX<br>Citric<br>Acid 50% Blend | Propanedile,<br>Hydroxyethylcellulose,<br>Water (Aqua),<br>Gluconolactone, Sodium<br>Benzoate, Citric Acid | | Over the counter use | Yes | Yes | | Sterile | No | No | | Condom Compatibility | Natural Rubber Latex,<br>Polyisoprene | Natural Rubber<br>Latex, Polyisoprene | | Biocompatibility Tested | Yes | Yes | | Antimicrobial Tested | Yes | Yes | | Shelf life | 2 years | 3 years | The subject and predicate device have similar indications for use. The indication for the subject device has been expanded to also include anal use. This change does not represent a new intended use as the intended use of this device is the same as the predicate device, i.e., lubrication of an orifice during intimate sexual activity. The subject and predicate device have similar technological characteristics, including similar formulation. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. ## 9. Summary of Non-Clinical Performance Testing ## Biocompatibility Biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Sensitization testing were performed in accordance with the 2016 FDA guidance document Use of International Standard ISO 10993-1, "Biological Evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993- 1:2009 as follows: {6}------------------------------------------------ - Cytotoxicity (ISO 10993-5:2009) ● - Sensitization (ISO 10993-10:2010) ● - Vaginal Irritation (ISO 10993-10:2010) - Penile Irritation (ISO 10993-10:2010) - Acute Systemic Toxicity (ISO 10993-11:2006) The results of this testing demonstrated that the subject lubricant is biocompatible. ## Shelf-Life The subject device is a non-sterile personal lubricant with a two-year shelf-life in accordance with the results of a real time and accelerated aging study. All device specifications listed in Table 1 were tested at 0, 1 and 2 years. The subject device met the device specifications at all time points. #### Condom Compatibility The compatibility of the subject device with natural rubber latex, polyisoprene and polyurethane condoms was evaluated in accordance with ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The results of this test indicated that JO H2O Jelly Original Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This device is not compatible with polyurethane condoms. #### 10. Conclusion The results of the performance testing described above demonstrate that the JO H2O Jelly Original Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.