LUBi Water Based Personal Lubricant

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 23, 2020 Boya Biotechnology Co., Ltd. % Joyce Yang Consultant Shenzhen Jovantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518100 CHINA Re: K203257 > Trade/Device Name: LUBi Water Based Personal Lubricant Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: August 10, 2020 Received: November 4, 2020 Dear Joyce Yang: 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 (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 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203257 Device Name LUBi Water Based Personal Lubricant #### Indications for Use (Describe) LUBi Water Based 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. 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 Date Prepared: December 22, 2020 ## 1. Submission Sponsor | Applicant Name | Boya Biotechnology Co., Ltd. | |----------------|-------------------------------------------------------------------------------------| | Address | Floor 3, #7, Changfu Rd., Ludong Community,<br>Humen Town, Dongguan, China (523935) | | Contact person | Jason Lau | | Phone | +86-769-82881368 | # 2. Submission correspondent | Name | Shenzhen Joyantech Consulting Co., Ltd | |----------------|------------------------------------------------------------------------------------------| | Address | 1713A, 17th Floor, Block A, Zhongguan Times<br>Square, Nanshan District, Shenzhen, China | | Post Code | 518000 | | Phone | +86-755-86069197 | | Contact person | Joyce Yang | | Email | joyce@cefda.com | #### Devices Identification 3. | Trade Name: | LUBi Water Based Personal Lubricant | |--------------------|-------------------------------------| | Common name: | Personal Lubricant | | Regulation Number: | 884.5300 | | Regulation Name: | Condom | | Regulatory Class: | II | | Product Code: | NUC (lubricant, personal) | #### Legally Marketed Predicate Device 4. | Trade Name | Agape Warming Personal Lubricant | |-------------------|----------------------------------| | Manufacturer | CC Wellness LLC | | 510(k) Number | K200208 | | Common name: | Personal Lubricant | | Regulation Number | 884.5300 | | Regulation Name | Condom | | Regulatory Class | II | | Product Code | NUC (lubricant, personal) | The predicate device has not been subject to a design-related recall. {4}------------------------------------------------ ### 5. Device Description LUBi Water Based Personal Lubricant is a clear, colorless, moderate sweet perfume and viscous 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, 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 sold as an over-the-counter (OTC) product in an 8.54 fl. oz. / 250 mL size. This product is provided in a clear polyethylene terephthalate (PET) cylinder bottle. The bottles are capped with silver disc tops. The individual bottles are hermetically sealed during the production process. The device is composed of water (aqua), glycerin, propylene glycol, hydroxyethyl cellulose, sodium hyaluronate, potassium sorbate, citric acid, disodium ethylenediaminetetraacetic acid (EDTA). The device specifications are listed in Table 1 below: | Property | Specification | |---------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------| | Appearance | Highly viscous liquid | | Color | Clear | | Odor | Moderate sweet perfume | | Viscosity per USP<911> | 28,500-30,000 mPa.s | | pH per USP <791> | 7.5-8.0 | | Osmolality per USP<785> | 1,000-1,100 mOsm/kg | | Antimicrobial effectiveness per USP<51> | | | Escherichia coli, Pseudomonas aeruginosa,<br>Staphylococcus aureus, | No less than a 2.0 log reduction from initial<br>count at 14 days and no increase from the 14<br>day count at 28 days | | Candida albicans, Aspergillus niger | No increase from the initial calculated count<br>at 14 and 28 days | | Total aerobic microbial count (TAMC) per<br>USP<61> and <1111> | <100 CFU/g | | Total yeast and mold count (TYMC) per USP<br><61> and <1111> | <10 CFU/g | | Absence of Pathogenic Organisms per<br>USP<62> | | | Staphylococcus aureus | Absent | | Table 1 - Device Specifications for LUBi Water Based Personal Lubricant (Subject | | |----------------------------------------------------------------------------------|--| | Device) | | {5}------------------------------------------------ | Property | Specification | |------------------------|---------------| | Salmonella spp. | Absent | | Escherichia coli | Absent | | Pseudomonas aeruginosa | Absent | | Clostridia | Absent | | Candida albicans | Absent | #### 6. Intended Use/ Indications for Use LUBi Water Based 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. ### 7. Comparison of technological characteristics A comparison of the technological features of the subject and predicate devices is provided in Table 2 below: | Table 2 – Technological Characteristics of Subject Device Compared to Predicate<br>Device | | | |-------------------------------------------------------------------------------------------|---------------------------|-----------------------------| | Comparison<br>item | K203257<br>Subject Device | K200208<br>Predicate Device | | Comparison<br>item | K203257<br>Subject Device | K200208<br>Predicate Device | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | LUBI Water Based Personal<br>Lubricant | Agape Warming Personal Lubricant | | Indications for<br>Use | LUBI Water Based Personal<br>Lubricant is a personal lubricant for<br>penile and/or vaginal<br>application, intended to moisturize<br>and lubricate, to enhance the ease<br>and comfort of intimate sexual<br>activity and supplement the body's<br>natural lubrication. This product is<br>compatible with natural rubber latex<br>and polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | Agape Warming Personal Lubricant is<br>a personal lubricant for penile, anal<br>and/or vaginal application, intended to<br>lubricant and moisturize, to enhance<br>the ease and comfort of intimate<br>sexual activity and supplement the<br>body's natural lubrication. This product<br>is compatible with natural rubber latex<br>and polyisoprene condoms. This<br>product is not compatible with<br>polyurethane condoms. | | Water-based | Yes | Yes | | Primary<br>ingredients | Water (Aqua), Glycerin, Propylene<br>Glycol, Hydroxyethyl Cellulose,<br>Sodium Hyaluronate, Potassium<br>Sorbate, Citric Acid, Disodium<br>EDTA | Water (Aqua), Propanediol,<br>Gluconolactone,<br>Hydroxyethylcellulose, Sodium<br>Benzoate, Polysorbate 20, Citric Acid<br>and Capsicum Oleoresin | | Sterile | No | No | {6}------------------------------------------------ | Comparison<br>item | K203257<br>Subject Device | K200208<br>Predicate Device | |----------------------------|--------------------------------------|--------------------------------------| | Condom<br>Compatibility | Natural Rubber Latex<br>Polyisoprene | Natural Rubber Latex<br>Polyisoprene | | Antimicrobial<br>Tested | Yes | Yes | | Biocompatibility<br>Tested | Yes | Yes | | Shelf-life | 3 years | 3 years | | OTC use | Yes | Yes | The subject and predicate device do not have identical indications for use statements. The subject device does not include anal use. This change does not represent a new intended use as the intended use of the device is the same as the predicate device, i.e., lubrication during intimate sexual activity. The subject and predicate device have different technological characteristics, including their formulation. The differences in technological characteristics between the subject and predicate device do not raise different questions of safety and effectiveness. #### 8. Summary of Performance Data #### *Biocompatibility The biocompatibility evaluations were conducted in accordance with the 2020 FDA quidance 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: - * Cytotoxicity (ISO 10993-5:2009) - * Sensitization (ISO 10993-10:2010) - * Vaginal Irritation (ISO 10993-10:2010) - * Acute Systemic Toxicity (ISO 10993-11:2017) The results of this testing demonstrated that the subject lubricant is non-cytotoxic, nonsensitizing, non-irritating, and non-systemically toxic. #### *Shelf Life The subject device is a non-sterile personal lubricant with a 3 years shelf life in accordance with the results of real time aging studies. All device specifications listed in Table 1 were tested and met the device specifications across the shelf life duration. #### *Condom Compatibility The compatibility of the subject device with 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 the subject device {7}------------------------------------------------ is compatible with natural rubber latex and polyisoprene condoms. The subject device is not compatible with polyurethane condoms. ## 9. Conclusions The results of the performance testing described above demonstrate that the LUBi Water Based Personal Lubricant is as safe and effective as the predicate device and supports a determination of substantial equivalence.