HydraDose Vaginal Suppositories

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 23, 2023 MD Labs, LLC % Louie Goryoka Sr. RA/QA Consultant Med-Device Consulting, Inc. 5804 Rainbow Hill Road Agoura Hills, CA 91301 Re: K230518 > Trade/Device Name: HydraDose Vaginal Suppositories Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 19, 2023 Received: May 22, 2023 Dear Louie Goryoka: 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, # Monica D. Garcia -S 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) K230518 Device Name HydraDose Vaginal Suppositories ### Indications for Use (Describe) HydraDose Vaginal Suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene 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 – K230518 HydraDose Vaginal Suppositories #### l. General Information on Submitter | Applicant: | MD Labs LLC | |-----------------|----------------------------------------------------------------------------| | Address: | 780 Lakefield Road, Suite H<br>Westlake Village, California,<br>91361-2628 | | Telephone: | 818-585-7488 | | Contact Person: | Louie Goryoka | | Contact Title: | Sr. Regulatory and Quality<br>Consultant<br>Med-Device Consulting, Inc | | Email: | mdci@m-dci.us | | Date Prepared: | June 21, 2023 | #### II. General Information on Device | Proprietary Name: | HydraDose Vaginal Suppositories | |--------------------|---------------------------------| | Common Name: | Personal Lubricant | | Regulation Name: | Condom | | Regulation Number: | 21 CFR 884.5300 | | Regulatory Class: | II | | Product Code: | NUC (Lubricant, Personal) | #### lll. Predicate Device | Predicate Device | 510(k) Number | |------------------------------------|---------------| | Revaree Plus Vaginal Suppositories | K213220 | This predicate device has not been subject to a design-related recall. #### IV. Description of Device HydraDose Vaginal Suppositories is a glyceride-based personal lubricant for over-thecounter use. The subject device is a non-sterile solid preparation containing hyaluronic acid, cocoa butter, triglycerides, and cera alba. The subject device is packaged in sets of five a polyvinyl chloride (PVC)/polyethylene (PE) blister pack. The lubricant is not compatible with natural rubber latex, polyisoprene condoms, and polyurethane condoms. {4}------------------------------------------------ The specifications for HydraDose Vaginal Suppositories are described in Table 1. | Parameter | Test Method | Specification | |------------------------------------------------------------------------------------------------------------------|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Appearance | Visual | Solid; yellowish to white color | | Odor | Olfactory | None | | pH | N/A | N/A | | Viscosity | N/A | N/A | | Osmolality | N/A | N/A | | Antimicrobial<br>Effectiveness | USP <51> | Meets USP <51> acceptance<br>criteria for Category 2<br>products. Category 2,<br>bacteria should show not less<br>than 2.0 log reduction at 14<br>days and no increase from<br>the 14-day count to the 28-<br>day count. Yeast and molds<br>should show no increase<br>from the initial calculated<br>count at 14 and 28 days | | Total Microbial Count | USP <61> and<br><1111> | <100 cfu/g | | Fungal/Yeast/Mold<br>Limits | USP <61> and<br><1111> | <10 cfu/g | | Absence of Pathogenic<br>Organisms<br>(Staphylococcus<br>Aureus, Pseudomonas<br>Aeruginosa, Candida<br>Albicans) | USP <62> | Absent | | Content of hyaluronic<br>acid | Spectrophotometric | 0.25 - 2% | | Disintegration time | USP <701> and<br><2040> | 12 minutes 21 seconds;<br>37.5°C | | Average weight | Analytical balance | 2g | ## Table 1. Device Specifications #### V. Indications for Use HydraDose Vaginal Suppositories are a personal lubricant, for 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 not compatible with natural rubber latex, polyurethane, and polyisoprene condoms. #### VI. Substantial Equivalence Discussion {5}------------------------------------------------ A comparison of the intended use and technological features of the subject and predicate devices is provided in Table 2 below: Table 2. Intended Use and Technological Characteristics of Subject Device Compared to Predicate Device | Characteristic /<br>Feature | HydraDose Vaginal<br>Suppositories (subject<br>device) | Revaree Plus Vaginal<br>Suppositories (predicate<br>device) - K213220 | Comparison | |-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indication for use | HydraDose Vaginal<br>Suppositories are a personal<br>lubricant, for vaginal<br>application, intended to<br>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 not<br>compatible with natural rubber<br>latex, polyurethane, and<br>polyisoprene condoms. | Revaree plus vaginal<br>suppositories are a personal<br>lubricant for vaginal<br>application, intended to<br>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 not<br>compatible with natural rubber<br>latex, polyurethane, and<br>polyisoprene condoms. | Same | | Percentage of<br>Hyaluronic Acid | 0.25-2% | 0.5% | Different | | Over the Counter | Yes | Yes | Same | | Not a<br>contraceptive or<br>Spermicide | Yes | Yes | Same | | Non-sterile | Yes | Yes | Same | | Primary<br>Ingredients | Hyaluronic acid, cocoa butter,<br>triglycerides, cera alba | Hyaluronic acid, glycerides,<br>sweet almond oil | Different: The ingredients of the<br>predicate device are different;<br>the ingredients do not raise<br>different questions of Safety &<br>Effectiveness (S & E) | | Microbial Limits | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Total mold/yeast count <10<br>cfu/mL<br>Total aerobic microbial count<br><100 cfu/mL<br>Absence of pathogens<br>(Candida albicans,<br>Pseudomonas aeruginosa,<br>Staphylococcus aureus) | Same | | Condom<br>Compatibility | Not compatible with natural<br>rubber latex, polyisoprene<br>condoms, and polyurethane<br>condoms | Not compatible with natural<br>rubber latex, polyisoprene<br>condoms, and polyurethane<br>condoms | Same | {6}------------------------------------------------ The subject and predicate devices have identical indications for use and have the same intended use - to provide lubrication during intimate sexual activity. The subject and predicate devices have different technological characteristics, including different formulations and device specifications. The different technological characteristics do not raise different types of safety and effectiveness questions. #### VII. 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" and ISO 10993-1:2009 as follows: - Cytotoxicity (ISO 10993-5:2009/(R)2014) ● - Guinea Pig Maximization Sensitization Test (ISO 10993-10: 2010) ● - Vaqinal Irritation (ISO 10993-23: 2021) ● - Acute Systemic Toxicity (ISO 10993-11:2017) . The results of this testing demonstrate that the subject lubricant is non-cytotoxic, nonirritating, non-sensitizing, and not systemically toxic. # Shelf Life The subject device is a non-sterile personal lubricant weighing 2g and packaged in blister packs with an 8.5-month shelf-life in accordance with the results of an accelerated aging study, conducted for 3 months at 40°C per ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. The device specifications listed in Table 1 were tested across the device shelf-life and the subject device met the specifications at all time points. ## Condom Compatibility Condom compatibility testing was not conducted for the subject device. Therefore, HydraDose Vaginal Suppositories is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms #### VIII. Conclusion The results of the testing described above demonstrate that HydraDose Vaqinal Suppositories are as safe and effective as the predicate device and supports a determination of substantial equivalence.