Revaree Plus Vaginal Suppositories

{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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 21, 2022 Farma-Derma S.R.L. Mara Calzolari Business Development Manager Via Dell'artigiano 6-8 Sala Bolognese, Bologna 40010 Italy Re: K213220 > Trade/Device Name: Revaree plus vaginal suppositories Regulation Number: 21 CFR§ 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: May 11, 2022 Received: May 16, 2022 Dear Mara Calzolari: 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, 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) K213220 Device Name Revaree plus vaginal suppositories #### Indications for Use (Describe) Revaree plus 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 for Revaree plus vaginal suppositories # K213220 ### 1. General Information 2. Regulatory Class: Product Code: | Submitter: | FARMA-DERMA S.r.l. | |----------------------------|-------------------------------------| | | Via dell' Artigiano, 6-8 | | | 40010 Sala Bolognese (BO) | | | Italy | | | | | Contact Person: | Ms. Mara Calzolari | | | FARMA-DERMA srl | | | Via dell' Artigiano, 6-8 | | | 40010 Sala Bolognese (BO) | | | Italy | | | | | | Mobile: +39 3486914895 | | | Office: +39 0516814181 | | | Fax: +39 0516814833 | | | Email: mara.calzolari@farmaderma.it | | | | | Additional Contact Person: | Ms. Giulia Canzano | | | FARMA-DERMA srl | | | Via dell' Artigiano, 6-8 | | | 40010 Sala Bolognese (BO) | | | Italy | | | Mobile: +39 3486914892 | | | Office: +39 0516814181 | | | Fax: +39 0516814833 | | | Email: giulia.canzano@farmaderma.it | | | | | Preparation Date: | June 21, 2022 | | | | | Device Information | | | Trade Name: | Revaree plus vaginal suppositories | | Common Name: | Personal Lubricant | | Regulation Number: | 21 CFR 884.5300 | | Regulation Name: | Condom | II NUC (lubricant, personal) {4}------------------------------------------------ #### 3. Predicate Device Repagyn vaginal suppositories (K153372) The predicate device has not been subject to a design-related recall. ### 4. Device Description Farma-Derma's Revaree plus vaginal suppositories is a non-sterile solid preparation personal lubricant containing hyaluronic acid, sweet almond oil, and glycerides. It is presented in the form of vaginal suppositories, 2 g in weight. Each vaginal suppository is individually packed in a polyvinyl chloride (PVC)/polyethylene (PE) blister. The device is available for sale in a pack containing 10 vaginal suppositories (two blisters of 5 vaginal suppositories each) while the sample pack contains 3 vaginal suppositories (one blister). Due to its shape the device can be easily introduced into the vaginal cavity by finger. When the vaginal suppository is in contact with the vaginal mucosa, it melts due to body temperature and becomes a viscous mass which remains in contact with the vaginal mucosa, creating a moist environment to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. | Parameter | Specification | |-----------------------------------------------------------------------|----------------------------------------| | Appearance | Off-white opaque vaginal suppositories | | Odor | Practically odorless | | Disintegration time | ≤ 30 minutes<br>(according to Eu. Ph.) | | Average weight | 2 g | | Uniformity of weight | According to Eu. Ph. | | Content of HA | 10 mg | | TAMC | ≤100 cfu/g | | TYMC | ≤10 cfu//g | | Pseudomonas Aeruginosa,<br>Staphylococcus Aureus, Candida<br>Albicans | Absent/g | The specifications for Revaree plus vaginal suppositories are provided in the table below. Furthermore, the endotoxin level will be checked according to Kinetic test (LAL test) on each lot of finished product. {5}------------------------------------------------ ### 5. Indications for Use Revaree plus 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. # 6. Substantial Equivalence Discussion The following table compares the intended use and key technological characteristics of the subject and predicate device. | | Revaree plus vaginal | Repagyn vaginal | |----------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | suppositories | suppositories (K153372) | | Indications for<br>Use | 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<br>not compatible with natural<br>rubber latex, polyurethane,<br>and polyisoprene condoms. | Repagyn is 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. | | Base type | Glyceride | Glyceride | | Ingredients | HA, glycerides, and sweet<br>almond oil | HA and glycerides | | Appearance | Off-white opaque vaginal<br>suppositories | Off-white opaque vaginal<br>suppositories | | Average<br>weight | 2 g | 2 g | | Content of HA | 10 mg | 5 mg | | TAMC | ≤100 cfu/g | ≤100 UFC/g | | TYMC | ≤10 cfu/g | ≤10 UFC/g | | Absence of<br>Pseudomonas<br>Aeruginosa,<br>Staphylococcus<br>Aureus | Absent/g | Absent/g | {6}------------------------------------------------ | Candida<br>Albicans | | | |-------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------| | Condom<br>Compatibility | Not compatible with natural<br>rubber latex, polyisoprene,<br>and polyurethane condoms | Not compatible with natural<br>rubber latex, polyisoprene, and<br>polyurethane condoms | | Packaging | PVC/PE blister of 3 or 5<br>vaginal suppositories | PVC/PE blister of 3 or 5<br>vaginal suppositories | The subject and the predicate device have similar 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, include different formulations and device specifications. The different technological characteristics do not raise different questions of safety and effectiveness. ### 7. Performance Data #### Biocompatibility Biocompatibility studies including cytotoxicity, sensitization, vaginal irritation, and acute systemic toxicity were 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 10993-1:2018, as follows: - Acute systemic toxicity, ISO 10993-11:2017 . - Cytotoxicity, ISO 10993-5:2009 ● - Vaginal Irritation Testing, ISO 10993-10:2010 ● - Guinea pig maximization test (GPMT), ISO 10993-10:2010 ● The results demonstrated that the subject lubricant is non-cytotoxic, non-irritating, nonsensitizing and not systemically toxic. #### Shelf Life The shelf life of Revaree plus vaginal suppositories is 24 months. This is based on the results of intermediate and real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life. #### Condom Compatibility Condom compatibility testing was not conducted for the subject device. Therefore, Revaree plus is not compatible with natural rubber latex, polyisoprene, and polyurethane condoms. # 8. Conclusions {7}------------------------------------------------ The results of the testing described above demonstrate that Revaree plus vaginal suppositories are as safe and effective as the predicate device and supports a determination of substantial equivalence.