Wet Essential95 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. July 7, 2022 Trigg Laboratories, Inc. Marla Bolden Regulatory/Ouality Control Manager 4220 W. Windmill Lane. Suite 140 Las Vegas, NV 89139 Re: K220534 > Trade/Device Name: Wet Essential95 Personal Lubricant Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 7, 2022 Received: June 7, 2022 Dear Marla Bolden: 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/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-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, For Monica D. Garcia, Ph.D. 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) K220534 Device Name Wet Essential95 Personal Lubricant #### Indications for Use (Describe) Wet Essential95 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) | |-------------------------------------------------| |-------------------------------------------------| | ☐ Transaction involving USDA-funded Child Nutrition Programs | ☑ Direct Farm to Consumer sales | |--------------------------------------------------------------|---------------------------------| |--------------------------------------------------------------|---------------------------------| | | 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 K220534 Wet Essential95 Personal Lubricant #### 1. Submitter Information | Company Name: | Trigg Laboratories, Inc. | |------------------|-------------------------------------------------------------------------------------------------------------------| | Company Address: | 4220 W Windmill Lane, Suite 140<br>Las Vegas, NV 89139 | | Company Phone: | (702) 957-4400 | | Contact Person: | Marla Bolden<br>Regulatory and Quality Control Manager<br>Trigg Laboratories, Inc.<br>Email: marlab@trigglabs.com | July 1, 2022 Date Prepared: #### 2. Subject Device | Device Trade Name: | Wet Essential95 Personal Lubricant | |--------------------|------------------------------------| | Common Name: | Personal Lubricant | | Regulation Name: | Condom | | Regulation Number: | 21 CFR 884.5300 | | Device Class: | Class II | | Product Code: | NUC (lubricant, personal) | - 3. Predicate Device | Device Name | Aloe Cadabra Personal Lubricant and Aloe Cadabra | |---------------|--------------------------------------------------| | | Flavored/Scented Lubricants | | 510(k) number | K124044 | | Manufacturer | Seven Oaks Ranch, Inc. | The predicate device has not been subject to a design-related recall. ## 4. Device Description The Wet Essential95 Personal Lubricant is a non-sterile, 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 device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists primarily of 95% aloe barbadensis leaf juice. Wet Essential95 Personal Lubricant is sold as an over-the-counter (OTC) product and is provided in 4 oz and 6 oz HDPE bottles. {4}------------------------------------------------ The specifications for Wet Essential95 Personal Lubricant are described in Table 1. | Property | Specification | |-----------------------------------------------------------------|---------------------------------------------------------------| | Appearance | Semi-opaque, particle-free, liquid gel | | Color | Light tan to brown | | Odor | Vanilla | | Viscosity@25°C Spindle LV#3 @20rpm (cps) | 400 cps - 3,200 cps | | Specific Gravity@25°C per USP <841> | 0.99 – 1.04 | | pH per USP <791> | 4.5 - 5.5 | | Osmolality per USP <785> | 150-300 mOsm/kg, 1:10 dilution | | Antimicrobial effectiveness per USP <51> | Meets USP <51> acceptance criteria for<br>Category 2 products | | Total aerobic microbial count (TAMC) per USP <61><br>and <1111> | <100 cfu/g | | Total yeast and mold count (TYMC) per USP <61><br>and <1111> | <10 cfu/g | | Absence of Pathogens per USP <62> | Absent | | | Table 1: Device Specifications for the Wet Essential95 Personal Lubricant | | | | |--|---------------------------------------------------------------------------|--|--|--| | | | | | | ## 5. Indication for Use Statement Wet Essential95 Personal Lubricant 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. ## 6. Comparison of Intended Use and Technological Characteristics The following table compares the intended use and technological characteristics of the subject and predicate device: | of the Subject and Predicate Device | | | | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K220534<br>Subject Device | K124044<br>Predicate Device | Comparison | | Device Name | Wet Essential95<br>Personal Lubricant | Aloe Cadabra Lubricant,<br>Aloe Cadabra<br>Flavored/scented Lubricants | | | Indications for<br>Use | Wet Essential95 Personal<br>Lubricant is a personal<br>lubricant, for penile and/or<br>vaginal application, intended<br>to moisturize and lubricate, to<br>enhance the ease and comfort<br>of intimate sexual activity and<br>supplement the body's natural<br>lubrication. This product is<br>compatible with natural rubber | Aloe Cadabra® Lubricant<br>and Aloe Cadabra®<br>Flavored/Scented<br>Lubricants are personal<br>lubricants, for penile<br>and/or vaginal<br>application, intended to<br>moisturize and lubricate,<br>to enhance the ease and<br>comfort of intimate sexual | The indications for<br>use for the subject<br>and predicate<br>device are the<br>same. Therefore,<br>the subject and<br>predicate device<br>have the same<br>intended use. | | | | | | | | latex and polyisoprene<br>condoms. This product is not<br>compatible with polyurethane<br>condoms. | activity and supplement<br>the body's natural<br>lubrication. This product is<br>compatible with natural<br>rubber latex and<br>polyisoprene condoms.<br>This product is not<br>compatible with<br>polyurethane condoms. | | | Rx/OTC | OTC | OTC | Same | | Base Type | Water | Water | Same | | Sterile | No | No | Same | | Primary<br>Ingredients | Aloe Barbadensis Leaf<br>Juice; Chamomilla Recuitita<br>(Matricaria) Extract;<br>Chamomilla Recuitita<br>(Chamomile) Flower<br>Extract; Cyamopsis<br>Tetragonoloba (Guar) Gum;<br>Xanthan Gum; Vanilla<br>Flavor; Potassium Sorbate;<br>Sodium Benzoate; Stevia<br>Rebaudiana Extract; Citric<br>Acid | 95% organic aloe<br><br>Additional formulation<br>information is not publicly<br>available | Different: The<br>subject and<br>predicate device<br>have differences in<br>formulation. These<br>differences do not<br>raise different<br>questions of safety<br>and effectiveness<br>(S&E). | | pH | 4.5-5.5 | Not publicly available | Different: The<br>subject and<br>predicate devices<br>may differ in pH<br>specification.<br>Differences in pH<br>specification do not<br>raise different<br>questions S&E. | | Osmolality | 150-300 mOsm/kg, 1:10<br>dilution | Not publicly available | Different: The<br>subject and<br>predicate devices<br>may differ in<br>osmolality<br>specification.<br><br>Differences in<br>osmolality<br>specification do not<br>raise different<br>questions of S&E. | | Viscosity | 400-3,200 cps | Not publicly available | Different: The<br>subject and<br>predicate devices<br>may differ in | | | | | | | | | | viscosity<br>specification.<br>Differences in<br>viscosity<br>specification do not<br>raise different<br>questions of S&E. | | Biocompatibility<br>Tested | Yes | Yes | Same | | Microbial Limits<br>Tested (per USP<br><61>) | Yes | Yes | Same | | Antimicrobial<br>Effectiveness<br>(per USP<br><51>) | Yes | Not tested | Different: The<br>subject device<br>underwent<br>antimicrobial<br>effectiveness testing<br>Conducting this<br>testing to ensure<br>that the device will<br>not support or<br>enhance the growth<br>of microorganisms<br>does not raise<br>different questions<br>of S&E. | | Absence of<br>Pathogenic<br>Organisms<br>per USP <62> | Yes | Yes | Same | | Condom<br>Compatibility | Compatible with natural<br>rubber latex and polyisoprene<br>condoms. Not compatible<br>with polyurethane condoms. | Compatible with natural<br>rubber latex and<br>polyisoprene condoms.<br>Not compatible with<br>polyurethane condoms. | Same | | Shelf-Life | 8.5 Months | 2 years | Different: The<br>subject and<br>predicate device<br>have different shelf-<br>life durations. These<br>differences do not<br>raise different<br>questions of S&E. | # Table 2: Intended Use and Technological Characteristics Comparison {5}------------------------------------------------ {6}------------------------------------------------ The subject and predicate devices have the same indications for use and the same intended use (i.e., to provide lubrication during intimate sexual activity). The subject and predicate devices have different technological characteristics, including different formulations, device specifications, and shelf-life. The different technological characteristics identified do not raise different questions of safety and effectiveness. {7}------------------------------------------------ ## 7. Summary of Non-Clinical Performance Testing ## Biocompatibility Biocompatibility testing on the subject lubricant was performed in accordance with the 2020 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." The following testing was conducted: - Acute Systemic Toxicity (ISO 10993-11:2017) - Cytotoxicity (Direct Contact, ISO 10993-5:2009) ● - . Sensitization (Guinea Pig Maximization Sensitization, ISO 10993-10:2010) - Irritation (Vaginal Irritation, ISO 10993-10:2010) ● The results of this testing demonstrate that the subject lubricant is non-cytotoxic, non-irritating, non-sensitizing, and non-systemically toxic. ## Condom Compatibility The compatibility of Wet Essential95 Personal Lubricant with condoms was evaluated in accordance with ASTM D7661-10(R) 2017 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of this test showed Wet Essential95 Personal Lubricant to be compatible with natural rubber latex and polyisoprene condoms. Results showed Wet Essential95 Personal Lubricant not to be compatible with polyurethane condoms. ## Shelf-Life The subject device has a shelf-life of 8.5 months. Results from accelerated testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life. ## 8. Conclusion The results of the testing described above demonstrate that Wet Essential95 Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.