Sage 2-in-1 Personal Lubricant and Moisturizer

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July 16, 2019 Fairhaven Health, LLC Suzanne Munson VP of Product Development/Compliance 1410 11th St Bellingham, WA 98225 Re: K190150 Trade/Device Name: Sage 2-in-1 Personal Lubricant and Moisturizer™ Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: June 6, 2019 Received: June 17, 2019 Dear Suzanne Munson: 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. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 medical devices and radiation-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 Sharon Andrews Assistant Division 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) K190150 Device Name Sage 2-in-1 Personal Lubricant and Moisturizer™ Indications for Use (Describe) Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | | 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 - K190150 Sage 2-in-1 Personal Lubricant and Moisturizer™ #### Submitter: | Applicant: | Fairhaven Health, LLC<br>1410 11th Street<br>Bellingham, WA 98225 | |-----------------------------------------|-------------------------------------------------------------------| | Telephone:<br>Email:<br>Contact Person: | 360-543-7888<br>suzanne@fairhavenhealth.com<br>Suzanne Munson | | Date Prepared: | July 15, 2019 | #### Device Information: | Device Name | Sage 2-in-1 Personal Lubricant and MoisturizerTM | |--------------------|--------------------------------------------------| | Common Name: | Personal Lubricant | | Regulation Number: | 21 CFR 884.5300 | | Regulation Name: | Condom | | Product Code: | NUC (Lubricant, Personal) | | Regulatory Class: | II | ### Predicate Devices Good Clean Love Bio-pHresh (K162207) manufactured by Good Clean Love, Inc Eugene, OR. The predicate device has not been subject to any design-related recall. #### Indications for Use Sage 2-in-1 Personal Lubricant and Moisturizer is 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 condoms. This product is not compatible with polyisoprene or polyurethane condoms ### Description of Device Sage 2-in-1 Personal Lubricant and Moisturizer™ is a non-sterile, water-soluble personal lubricant for over-the-counter (OTC) use. The lubricant will be provided in a 1.6 oz tube and will also be supplied with a low-density polyethylene applicator. The device specifications are listed in the table below: {4}------------------------------------------------ | Parameter | Test Method | Specification | |----------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appearance | Visual<br>inspection | Opaque Gel | | Odor | Odor via<br>smell of gel | Slight rose and sage odor | | pH | USP <791> | 4.25-5.5 | | Viscosity | USP <91> | 3000-12000cps | | Osmolality | USP <785> | 240-370 mOsmo/kg | | Antimicrobial Effectiveness | USP <51> | Bacteria: Not less than 2.0<br>log reduction from the<br>initial count at 14 days,<br>and no increase<br>from the 14 days' count at<br>28 days<br>Yeast and Molds: No<br>increase at 14 and 28<br>relative to initial count. | | Total Aerobic Microbial Count<br>(TAMC) | USP <61> | < 100 cfu/ml | | Total Fungal/Yeast/Mold Limits<br>(TYMC) | USP <61> | < 10 cfu/ml | | Absence of Pathogenic<br>Organisms (P.aeruginosa, S.<br>aureus, E. Coli,<br>Salmonella sp., C. albicans) | USP <62> | Absent | # Summary of technological characteristics compared to predicate device: | Subject &<br>Predicate<br>Devices: | K190150<br>Subject Device | K162207<br>Predicate Device | |------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | General Device<br>Characteristics | | | | Personal<br>Lubricant | | | | Sponsor | Fairhaven Health LLC | Good Clean Love | | Indication for<br>Use Statement | Sage 2-in-1 Personal Lubricant and<br>Moisturizer is for penile and/or<br>vaginal application, intended to<br>moisturize and lubricate, to enhance<br>the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. This<br>product is compatible with natural<br>rubber latex condoms. This product<br>is not compatible with polyisoprene | Good Clean Love BIO-<br>pHRESH is a personal<br>lubricant for penile and/or<br>vaginal application<br>intended to moisturize and<br>lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the<br>body's natural lubrication. This<br>product is compatible with | | | or polyurethane condoms. | natural rubber latex and<br>polyisoprene condoms. It is<br>not compatible with<br>polyurethane condoms | | Regulation<br>Number<br>Product Code<br>Device Class | 884.5300 | 884.5300 | | Condom<br>Compatibility | Natural rubber latex | Natural rubber latex and<br>polyisoprene | | Base Type | Water based | Aloe vera (water based) | | Formulation | Purified Water<br>Hypromellose (HPMC)<br>Carbomer<br>homopolymer type b<br>Phenethyl alcohol<br>Caprylyl glycol<br>Salvia Sclarea<br>Sodium Chloride<br>L-Lactic Acid<br>d-Xylose<br>Sodium Hydroxide<br>Monobasic Sodium Phosphate<br>anhydrous<br>Potassium Phosphate anhydrous | Aloe Vera<br>Xanthan<br>Potassium Sorbate<br>Sodium Benzonate | | Characteristics | | | | pH | 4.25-5.5 | - | | Viscosity | 3000-12000 Cps | - | | Osmolality | 240-370 mOsm/kg | - | | Antimicrobial<br>Effectiveness | Bacteria: Not less than 2.0 log<br>reduction from the initial count<br>at 14 days, and no increase<br>from the 14 days' count at 28<br>days<br>Yeasts and Mold: No increase at 14<br>and 28 relative to initial count. | Category 2 (Products for<br>mucosal application). Bacteria<br>>=2.0 log reduction at day 14<br>relative to initial count. No<br>increase at day 28 relative to<br>day-14 count. Yeasts and<br>Mold: No increase at 14 and<br>28 relative to initial count. | | Total Microbial<br>Count | < 100 cfu/g | <10 cfu/g | | Fungal/Yeast/M<br>old Limits | <10 cfu/g | < 10 cfu/g | | Absence of<br>Pathogenic<br>Organisms | Absent | Absent | | Applicator | Yes | Yes | {5}------------------------------------------------ {6}------------------------------------------------ The subject and predicate devices have same indications for use statements with the exception of the types of condoms they are compatible with. The difference in condom compatibility type do not impact the overall intended use of these devices, which is the same (i.e., lubrication during intimate sexual activity). The subject and predicate devices have similar technological characteristics (e.g., base type, osmolality, packaging, etc.); however, differences in specifications and formulation exist. The differences in technological characteristics described above between the subject and predicate devices do not raise different questions of safety and effectiveness. In addition, the specifications for the subject device are comparable to other devices of this type. #### Summary of non-clinical performance testing: #### Biocompatibility: Biocompatibility studies of the lubricant and applicator 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: - Cytotoxicity (ISO 10993-5:2009) O - Sensitization (ISO 10993-10:2010) O - Vaginal Irritation (ISO 10993-10:2010) O - Acute Systemic Toxicity (ISO 10993-11:2006) this test only conducted on о the personal lubricant component ### Condom Compatibility: Condom compatibility testing was performed in accordance with ASTM D7661-10 "Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms." The results of testing demonstrated that the subject device is compatible with natural rubber latex condoms and is not compatible with polyisoprene and polyurethane condoms. ### Shelf-Life: The shelf-life of the device is 16 months in accordance with the results of an accelerated aging study. All device specifications (see table on page 2 of this summary) were met at all timepoints assessed (equivalent to 0-16 months of real-time aging). ### Substantial Equivalence: The results of the performance testing described above demonstrate that the Sage-2 in-1 Personal Lubricant and Moisturizer is as safe and effective as the predicate device and supports a determination of substantial equivalence.