(220 days)
Repagyn is a personal lubricant, for vaginal application, intended to moisturize, 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.
The Farma-Derma Repagyn Vaginal Suppositories are a non-sterile hyaluronic acid and glycerides based semi-solid preparation presented in the form of vaginal suppositories of 2 g in weight 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 specific shape the device can be introduced into the vaginal cavity using a finger.
Repagyn Vaginal Suppositories are a Hyaluronic acid (HA) based product; the HA is mixed in with semi-synthetic glycerides that represent the major quantity of material used in the formulation.
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.
It acts similarly to other vaginal creams or gels for topical application with Hyaluronic acid based formulations.
This document is a 510(k) premarket notification for a medical device called "Repagyn Vaginal Suppositories." It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.
The document does not contain information related to software or AI-based medical devices. It describes a physical medical device (vaginal suppositories) and its performance data, which focuses on biocompatibility, shelf life, and condom compatibility.
Therefore, I cannot provide the requested information regarding acceptance criteria, study details for AI/software performance, sample sizes for test/training sets, expert consensus, MRMC studies, or standalone algorithm performance. The questions in your prompt are geared towards evaluating AI/software performance, which is not applicable to the content of this document.
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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 30, 2016
Farma-Derma s.r.1. Mara Calzolari Business Development Manager Via Dei Bersaglieri, 10 40010 Sala Bolognese Bologna, Italy
Re: K153372
Trade/Device Name: Repagyn Vaginal Suppositories Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: Class II Product Code: NUC Dated: Mav 31, 2016 Received: June 2, 2016
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Repagyn vaginal suppositories
Indications for Use (Describe)
Reparyn is a personal lubricant, for vaginal application, intended to moisturize, 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)
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510(k) Summary for Repagyn Vaginal Suppositories
This 510(k) Summary is being submitted in accordance with the requirements of 21 C.F.R. 807.92.
General Information 1.
| Submitter: | FARMA-DERMA S.r.l.Via dei Bersaglieri, 1040010 Sala Bolognese (BO)ITALY |
|---|---|
| Contact person: | Ms. Mara CalzolariFARMA-DERMA srlVia dei Bersaglieri 1040010 Sala Bolognese (BO)ItalyMobile: +39 3486914895Office: +39 051221606Fax: +39 0516814833Email: mara.calzolari@farmaderma.it |
| Additional contact person: | Ms. Giulia CanzanoFARMA-DERMA srlVia dei Bersaglieri 1040010 Sala Bolognese (BO)ItalyMobile: +39 3486914892Office: +39 0516814181Fax: +39 0516814833Email: giulia.canzano@farmaderma.it |
| Summary Preparation Date: | November 19, 2015 |
| 2. Names | |
| Device Name: | Repagyn Vaginal Suppositories |
| Regulation number: | 21 C.F.R. 884.5300 |
| Classification: | II |
| Product Code: | NUC |
| Common Name: | Lubricant Personal |
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3. Predicate Devices
Repagyn Vaginal Suppositories are substantially equivalent to Hyalo Gyn, K094039, registered by Fidia Pharmaceuticals.
4. Device Description
The Farma-Derma Repagyn Vaginal Suppositories are a non-sterile hyaluronic acid and glycerides based semi-solid preparation presented in the form of vaginal suppositories of 2 g in weight 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 specific shape the device can be introduced into the vaginal cavity using a finger.
Repagyn Vaginal Suppositories are a Hyaluronic acid (HA) based product; the HA is mixed in with semi-synthetic glycerides that represent the major quantity of material used in the formulation.
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.
It acts similarly to other vaginal creams or gels for topical application with Hyaluronic acid based formulations.
The specifications for Repagyn Vaginal Suppositories are described in Table 1.
| Specifications | |
|---|---|
| Appearance | Off-white opaque vaginalsuppositories |
| Disintegration time | According to Eu. Ph. |
| Average weight | 2 g |
| Uniformity of weight | According to Eu. Ph. |
| Content of HA | 5 mg |
| TAMC | ≤100 UFC/g |
| TYMC | ≤10 UFC/g |
| Pseudomonas Aeruginosa,Staphilococcus Aureus, CandidaAlbicans | Absent/g |
Table 1: Repagyn Vaginal Suppositories specifications
Furthermore the endotoxins level will be checked according to the kinetic test (LAL test) on each lot of finished product.
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5. Indications for Use
The intended use for Repagyn vaginal suppositories is:
"Repagyn is 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. Technological Characteristics
comparison between the technological characteristics of Repagyn vaginal র suppositories and the predicate device Hyalo Gyn is provided in Table 2.
| Repagyn VaginalSuppositories | Hyalo Gyn(Predicate DeviceK094039) | |
|---|---|---|
| Base type | Glycerides | Water |
| Primary ingredient | Glycerides | Propylene glycol and water |
| Condom compatibility | Not compatible with naturalrubber latex, polyisoprene,and polyurethane condoms | Compatible withlubricated/non-lubricatedlatex, lubricatedpolyurethane, lubricatednatural skin condoms |
| Packaging | PVC/PE blister of 3 or 5vaginal suppositories | Tube |
Table 2: Technological characteristics - Comparison between Repagyn vaginal suppositories and Hyalo Gyn
Repagyn Vaginal Suppositories and Hyalo Gyn differ in their shape, Repagyn is in the form of vaginal suppositories and Hyalo Gyn is an aqueous gel. However, when the suppositories are introduced in the vaginal cavity, they melt because of body temperature and become a viscous mass that act in the same way as the predicate device.
The components used for the predicate device are similar to the ones used for Repagyn vaginal suppositories.
The area of application for both medical devices is the vaginal mucosa. The only difference is that the predicate device Hyalo Gyn (K094039) can be applied also on the penis during sexual intercourses while Repagyn is designed for vaginal application only.
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7. Performance Data
Biocompatibility:
Biocompatibility studies including acute system toxicity, vaginal irritation, cytotoxicity, and guinea maximization sensitization were performed according to the ISO standards as described below:
- Acute Systemic Toxicity: ISO 10993-11:2006 ●
- Cytotoxicity: ISO 10993-5:2009
- Vaginal Irritation Testing: ISO 10993-10:2010 ●
- Guinea Pig Maximization Test (GPMT): ISO 10993-10:2010. ●
- Endotoxin levels determination: USP <85> ●
Shelf Life:
The shelf life of Repagyn vaginal suppositories is 24 months. This is based on the results of real time aging studies that demonstrated that the device maintains its specifications over the duration of its shelf life.
Condom Compatibility:
Condom compatibility was performed using the FDA recognized consensus standard ASTM D7661-10 Standard Test Method for Determining Compatibility of Personal Lubricants with Natural Rubber Latex Condoms. The Repagyn Vaginal Suppositories were found to be not compatible with natural rubber latex, polyisoprene and polyurethane condoms.
8. Conclusion
Repagyn Vaginal Suppositories are substantially equivalent to the predicate device, Hyalo Gyn.
§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.