JO Agapé 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 the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. November 21, 2019 United Consortium Stephanie Morris RA/QA Specialist 29000 N. Hancock Pkwy Valencia, California 91355 Re: K171021 Trade/Device Name: JO Agapé Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: June 29, 2017 Received: July 6, 2017 Dear Stephanie Morris: This letter corrects our substantially equivalent letter of July 18, 2017. 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. {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Monica D. Garcia -S Monica D. Garcia, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive, Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K171021 Device Name JO Agapé Personal Lubricant #### Indications for Use (Describe) JO Agapé Personal Lubricant is a water-based personal lubricant for penile 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. Type of Use (Select one or both, as applicable): | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">❍</span> | |----------------------------------------------|-----------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☑</span> | #### 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. 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Below the logo, the words 'UNITED CONSORTIUM' are written in small, sans-serif font. ## 510(k) Summary – K171021 | 510(k) Owner: | United Consortium | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Street Address: | 29000 Hancock Parkway<br>Valencia, CA 91355 | | Establishment Registration Number: | 3005691625 | | Contact Person: | Stephanie Morris<br>RA/QA Specialist | | | Bruce Albert<br>Head of Technical Services | | Contact Numbers: | Phone: (661) 295-1700, ext. 232<br>Phone: (661) 295-1700, ext. 231<br>FAX: (661) 295-1800 | | Summary Preparation Date: | July 18, 2017 | | Trade Name: | JO Agapé Personal Lubricant | | Common Name: | Personal Lubricant | | Device Classification: | Classification Name: Condom<br>Product Code: NUC (lubricant, personal)<br>Regulation: 21 CFR § 884.5300 (Condom)<br>Device Class: Class II | | Predicate Device: | Product Name: Wet Original® Personal Lubricant<br>510(k) Number: K160211<br>Manufacturer: Trigg Laboratories, Inc.<br>Product Code: NUC<br>Device Class: Class II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image features a stylized logo consisting of two overlapping shapes. The primary shape is a thick, curved line in a dark purple or blue hue, forming a 'U' or 'C' shape. Overlapping the top portion of this shape is a gray, curved element that adds depth and dimension to the logo. Below the logo, the words 'UNITED CONSORTIUM' are printed in a simple, sans-serif font, indicating that this is the symbol for a united group or organization. #### Device Description: The JO Agapé Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. It is not compatible with polyurethane condoms. The device is a non-sterile lubricant for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene Terephthalate (PET) bottles fitted with Polypropylene caps. The individual bottles are sealed using an induction seal constructed of aluminized mylar. The device specifications are listed in the table below: | Property | Specification | |--------------------------------------------------------------|------------------------------------------------------------| | Appearance | Clear, semi-viscous liquid | | Color | Clear, colorless | | Odor | Odorless | | Viscosity (cps) | 2400 cps to 3100 cps | | Specific Gravity | 1.020 to 1.026 | | pH | 3.60 to 4.30 | | Osmolality | 250 to 350 mOsm/kg | | Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for Category 2 products | | Total aerobic microbial count (TAMC) per USP <61> and <1111> | Less than 10 cfu/g | | Total yeast and mold count (TYMC) per USP <61> and <1111> | Less than 10 cfu/g | | Presence of Pathogens per USP <62> | Specification | | Pseudomonas aeruginosa | Absent | | Staphylococcus aureus | Absent | | Salmonella | Absent | | Candida albicans | Absent | #### Table 1: Device Specifications for JO Agapé Personal Lubricant #### Indications for Use: JO Agapé Personal Lubricant is a water-based personal lubricant for penile 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. #### Predicate Device Comparison: The table below lists the comparative intended use and technological characteristics of the subject and predicate device. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter 'U' formed by two curved lines. The left side of the 'U' is a dark purple color, while the top part is gray. Below the symbol, the words 'UNITED CONSORTIUM' are written in small, sans-serif font. ### Table 2: Comparator Table for Subject Device – JO Agapé Personal Lubricant and Predicate Device Wet Original® Personal Lubricant | Feature | JO Agapé Personal Lubricant (K171021) | Wet Original® Personal Lubricant<br>(K160211) | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Classification Name | Lubricant, Personal | Lubricant, Personal | | Product Code | NUC | NUC | | Intended Use | JO Agapé Personal Lubricant is a water-<br>based personal lubricant for penile<br>and/or vaginal application, intended to<br>lubricate and moisturize, to enhance the<br>ease and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber latex and<br>polyisoprene condoms. This product is<br>not compatible with polyurethane<br>condoms. | The Trigg Laboratories Wet<br>Original® Personal Lubricant is a<br>personal lubricant for penile and/or<br>vaginal application, intended to<br>moisturize and lubricate, to<br>enhance the ease and comfort of<br>intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber<br>latex, polyisoprene, and<br>polyurethane condoms. | | Water soluble | Yes | Yes | | Contains water | Yes | Yes | | Primary ingredients | Propanedile, hydroxyethylcellulose,<br>water, gluconolactone, sodium benzoate,<br>citric acid | Glycerin, water, pentylene glycol,<br>potassium sorbate, sodium<br>carboxymethylcellulose | | Over the counter use | Yes | Yes | | Sterile | No | No | | Condom Compatibility | Latex, Polyisoprene | Latex, Polyisoprene, Polyurethane | | Biocompatibility Tested | Yes | Yes | | Antimicrobial Tested | Yes | Yes | | Shelf life | 3 years | 2 years | The subject and predicate device have the same intended use - for penile 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. The subject and predicate device have different technological characteristics, including different formulation and shelf life. The different technological characteristics of the subject device do not raise different types of safety and effectiveness questions. All personal lubricants must independently demonstrate they are biocompatible, compatible with condoms, and can maintain their specifications for their expected shelf life. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a logo for United Consortium. The logo features a stylized letter "U" formed by two overlapping shapes. The lower shape is a dark purple color, while the upper shape is gray. Below the shape is the text "UNITED CONSORTIUM" in a simple sans-serif font. The logo has a clean and modern design. #### Summary of Performance Data: #### Biocompatibility Independent third-party laboratories conducted biocompatibility studies, including Acute Systemic Toxicity, Vaginal Irritation Testing, Penile Irritation Testing, Cytotoxicity and Skin Sensitization testing; each were performed in accordance with 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: - · Cytotoxicity (ISO Agarose Overlay Method, ISO 10993-5:2009) - · Sensitization (ISO Guinea Pig Maximization Sensitization, ISO 10993-10:2010) - Vaginal Irritation (ISO Vaginal Irritation Study in Rabbits, ISO 10993-10:2010) - Penile Irritation (ISO Penile Irritation Study in Rabbits, ISO 10993-10:2010) - Acute Systemic Toxicity (ISO Tests for Systemic Toxicity, ISO 10993-11:2006) The results of this testing demonstrated that the subject lubricant is biocompatible. #### Shelf-Life: The proposed device, JO Agapé Personal Lubricant, is a non-sterile personal lubricant with a 36-month (three 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, 2, 2, and 3 years. The subject device met the device specifications at all time points. #### Condom Compatibility: The compatibility of the subject device, JO Agapé Personal Lubricant, was evaluated with natural rubber latex, polyisoprene and polyurethane condoms 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 indicate that the JO Agapé Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane condoms. #### Conclusion: The results of the performance testing described above demonstrate that the JO Agapé Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.