HYALO GYN

K094039 · Fidia Farmaceutici S.P.A. · NUC · May 7, 2010 · Obstetrics/Gynecology

Device Facts

• Record ID: K094039
• Device Name: HYALO GYN
• Applicant: Fidia Farmaceutici S.P.A.
• Product Code: NUC · Obstetrics/Gynecology
• Decision Date: May 7, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.5300
• Device Class: Class 2

Intended Use

HYALO GYN 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 condoms: lubricated/non-lubricated latex, lubricated polyurethane, lubricated natural skin.

Device Story

HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel; contains Hydeal-D (partial benzyl ester of hyaluronic acid), propylene glycol, carbomer, preservatives, and sodium hydroxide. Acts as moisturizer and lubricant via strong hydrating properties of hyaluronic acid derivative; mucoadhesive properties allow adherence to vaginal mucosa, enhancing residence time, hydration, and tissue protection. Used by patients for personal lubrication; applied penially or vaginally. Provides moisturizing effects; enhances ease and comfort of sexual activity; supplements natural lubrication. Compatible with latex, polyurethane, and natural skin condoms.

Clinical Evidence

Pilot, open, uncontrolled clinical study (n=80 women) conducted in Italy. Subjects used product every three days for 30 days. Primary endpoints: safety and effectiveness (moisturizing effects). Results: demonstrated moisturizing effects on vaginal mucosa; excellent safety profile with no adverse events; 98.7% tolerability score; no alterations to vaginal ecosystem.

Technological Characteristics

Aqueous gel containing Hydeal-D (partial benzyl ester of hyaluronic acid), propylene glycol, carbomer, preservatives (methyl/propyl-p-hydroxybenzoate), and sodium hydroxide. pH 5.5-6.5. Shelf life 36 months. Components meet USP/NF specifications. Compatible with latex, polyurethane, and natural skin condoms.

Indications for Use

Indicated for individuals requiring personal lubrication and vaginal moisturization to enhance comfort during intimate sexual activity. Compatible with latex, polyurethane, and natural skin condoms.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Glycerin & Paraben Free Astroglide (K072647)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| 510(k) Owner: | Fidia Farmaceutici, S.p.A.<br>Via Ponte dell Fabbrica 3/A<br>35031 Abano Terme<br>PADOVA, ITALY |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Dr. Giusi LoCastro<br>Regulatory Affairs |
| Phone: | [phone] |
| Fax: | [phone] |
| | MAY - 7 2010 |
| Date Summary Prepared: | May 4, 2010 |
| Device: | |
| Trade Name: | HYALO GYN® |
| Common/Classification Name: | Lubricant, Patient, Vaginal, Latex<br>Compatibile<br>Product Code NUC |
| Classification: | 21 C.F.R. § 884.5300 |
| Predicate Device: | Glycerin & Paraben Free Astroglide<br>Biofilm, Inc.<br>K072647 |
| Device Description: | HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel<br>that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid),<br>propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and<br>propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The<br>hyaluronic acid is manufactured using a bacterial fermentation process.<br>HYALO GYN is intended for use as a personal lubricant. HYALO GYN is<br>compatible with latex condoms: lubricated/non-lubricated latex, lubricated<br>polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and<br>a shelf life of 3 years.<br><br>HYALO GYN acts as a moisturizer and lubricant because of the strong<br>hydrating properties of its hyaluronic acid derivative component. The<br>carbomer and propylene glycol, combined with the hyaluronic acid<br>derivative, enable HYALO GYN to achieve its thick, viscous gel form, and<br>the mucoadhesive properties of the product allow it to adhere to the vaginal<br>mucosa, enhancing the residence time, thus hydrating and protecting this<br>tissue. |

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| K094039<br>Pg 2 of 2 | |
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| Intended Use: | Hyalo Gyn is a personal lubricant, for penile and/or vaginal application,<br>intended to moisturize and lubricate, to enhance the ease and comfort of<br>intimate sexual activity and supplement the body's natural lubrication. This<br>product is compatible with condoms: lubricated/non-lubricated latex,<br>lubricated polyurethane, lubricated natural skin. |
| Technological<br>Characteristics: | HYALO GYN is substantially equivalent to the predicate device with regard<br>to intended use and technological characteristics. Hydeal-D has been used in<br>legally marketed devices, and no new questions of safety or effectiveness are<br>presented. In addition, the other components (carbomer, propylene glycol,<br>preservatives, and water) meet the specifications defined in the United States<br>Pharmacopoeia (USP) or National Formulary (NF), where applicable. |
| Biocompatibility<br>Data | Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic. An<br>acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal<br>dose is >10 ml/kg but <20 ml/kg. A skin sensitization study provides<br>evidence for the lack of a sensitizing effect. Vaginal tolerance testing<br>demonstrated that HYALO GYN is a minimal vaginal irritant in the rabbit<br>model. |
| Performance<br>Data --<br>Nonclinical | Condom compatibility testing demonstrates that HYALO GYN is compatible<br>with latex, polyurethane, and natural skin condoms. No macroscopic signs<br>and no statistically significant differences were observed in tensile strength,<br>elongation at break, and breaking force between treated and non-treated<br>groups of condoms. Stability studies conducted in accordance with the ICH<br>Q1A guidelines confirm a shelf-life of 36 months. |
| Performance<br>Data -- Clinical | A pilot, open, uncontrolled clinical study was conducted in Italy to assess the<br>safety and effectiveness of HYALO GYN. A total of 80 women were<br>enrolled at a single site. They were instructed to use the test product every<br>three days for 30 days. Follow-up visits were performed on Days 7 and 21,<br>with the final visit taking place three days after the last application of test<br>product. The results obtained in this study demonstrated that the test material<br>had moisturizing effects on the vaginal mucosa. Safety was considered to be<br>excellent as demonstrated by the absence of adverse events and the<br>investigator's overall assessment of tolerability score (98.7%). There were no<br>alterations of the vaginal ecosystem. |
| Conclusions | Based on the biocompatibility testing, nonclinical performance testing, and<br>the clinical data provided in this 510(k), it is concluded that HYALO GYN is<br>safe and effective as a vaginal lubricant and moisturizer, and at least as safe<br>and effective as legally marketed vaginal lubricants. Further, the lack of<br>adverse events reported over 8 years of postmarket experience with HYALO<br>GYN outside of the U.S. demonstrate the safe and effective use of this device. |

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Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

### MAY - 7 2010

Fidia Farmaceutici S.p.A % Sharon A. Segal, Ph.D. Director of Regulatory Science Morgan, Lewis & Bockius, LLP 1111 Pennsylvania Avenue, N.W. WASHINGTON DC 20004

Re: K094039 Trade Name: HY ALO GYN® Regulation Number: 21 CFR §884.5300 Regulation Name: Condom Regulatory Class: II Product Code: NUC Dated: April 7, 2010 Received: April 7, 2010

Dear Dr. Segal:

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 of medical device-related

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janine M. Morris

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

### Enclosure

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### Indications for Use

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lubricated latex, lubricated polyurethane, lubricated natural skin.

| 510(k) Number (if known): | K094039 |
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| Device Name: | HYALO GYN® |
| Indications for Use: | HYALO GYN 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 condoms: lubricated/non- |

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Prescription Use Part 21 CFR 801 Subpart D)

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Over-The-Counter Use X (21 CFR 801 Subpart C)

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K094039 |