ATTACHMENT 2 '' 4
510(k) SUMMARY
5 10(k) Owner: Fidia Farmaceutici, S.p.A.
Via Ponte deli Fabbrica 3/A
35031 Abano Terme
PADOVA, ITALY
Contact: Dr. Giusi LoCastro
Regulatory Affairs
Phone: +39-049-8232906 MAY - 7 2010
Fax: + 39-049-8232398
Date Summary May 4, 201 0
Prepared:
Device: Trade Name: HYALO GYN®'
Common/Classification Name: Lubricant, Patient, Vaginal, Latex
Compatibile
Product Code NUC
Classification: 21 C.F.R. § 884.5300
Predicate Glycerin & Paraben Free Astroglide
Device: Bioflim, Inc.
K072647
Device HYALO GYN is a colorless, odorless, transparent, aqueous, hydrating gel
Description: that contains "Hydeal-D®" (a partial benzyl ester of hyaluronic acid),
propylene glycol, a carbomer, preservatives (methyl-p-hydroxybenzoate and
propyl-p-hydroxybenzoate), and sodium hydroxide (to balance the pH). The
hyaluronic acid is manufactured using a bacterial fermentation process.
HYALO GYN is intended for use as a personal lubricant. HYALO GYN is
compatible with latex condoms: lubricated/non-Iubricated latex, lubricated
polyurethane, lubricated natural skin. HYALO GYN has a pH of 5.5-6.5 and
a shelf life of 3 years.
HYALO GYN acts as a moisturizer and lubricant because of the strong
hydrating properties of its hyaluronic acid derivative component. The
carbomer and propylene glycol, combined with the hyaluronic acid
derivative, enable HYALO GYN to achieve its thick, viscous gel form, and
the mucoadhesive properties of the product allow it to adhere to the vaginal
mucosa, enhancing the residence time, thus hydrating and protecting this
tissue.
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: lubricatedlnon-lubricated latex,
lubricated polyurethane, lubricated natural skin.
Technological HYALO GYN is substantially equivalent to the predicate device with regard
Characteristics: to intended use and technological characteristics. Hydeal-D has been used in
legally marketed devices, and no new questions of safety or effectiveness are
presented. In addition, the other components (carbomer, propylene glycol,
preservatives, and water) meet the specifications defined in the United States
Pharmnacopoeia (USP) or National Forrmulary (NT), where applicable.
Biocompatibility Cytotoxicity studies demonstrate that HYALO GYN is not cytotoxic. An
Data acute intraperitoneal toxicity study on HYALO GYN indicated that the lethal
dose is >1 0 mi/kg but <20 ml/kg. A skin sensitization study provides
evidence for the lack of a sensitizing effect. Vaginal tolerance testing
demonstrated that HYALO GYN is a minima] vaginal irritant in the rabbit
model.
Performance Condom compatibility testing demonstrates that HYALO GYN is compatible
Data -- with latex, polyurethane, and natural skin condoms. No macroscopic signs
Nonclinical and no statistically significant differences were observed in tensile strength,
elongation at break, and breaking force between treated and non-treated
groups of condoms. Stability studies conducted in accordance with the ICH
QiA guidelines confirm a shelf-life of 36 months.
Performance A pilot, open, uncontr olled clinical study was conducted in Italy to assess the
Data -- Clinical safety and effectiveness of HYALO GYN. A total of 80 women were
enrolled at a single site. They were instructed to use the test product every
three days for 30 days. Follow-up visits were performed on Days 7 and 21,
with the final visit taking place three days after the last application of test
product. The results obtained in this study demonstrated that the test material
had moisturizing effects on the vaginal mucosa. Safety was considered to be
excellent as demonstrated by the absence of adverse events and the
investigator's overall assessment of tolerability score (98.7%). There were no
alterations of the vaginal ecosystem.
Conclusions Based on the biocompatibility testing, nonclinical performance testing, and
the clinical data provided in this 5 10O(k), it is concluded that HYALO GYN is
safe and effective as a vaginal lubricant and moisturizer, and at least as safe
and effective as legally marketed vaginal lubricants. Further, the lack of
adverse events reported over 8 years of postmnarket experience with HYALO
GYN outside of the U.S. demonstrate the safe and effective use of this device.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Admiinistration
10903 New H~ampshire Avenue
Documient Mail Center - W066-G609
Silver Sprin, MD 20993-0002.
MAY 72010
7
Fidia Farmaceutici S.p.A
% Sharon A. Segal, Ph.D.
Director of Regulatory Science
Morgan, Lewis & Bockius, *LLP
1111I Pennsylvania Avenue, NW
WASHINGTON DC 20004
Ike: K094039
Trade Name: HYALO GYN®
Regulation Number: 21 CFR §884.5300
Regultition Name: Conddm
Regulatory Class: 1I
Product Code: NUC
Dated: April 7, 2010
Received: April 7, 2910
Dear Dr. Segal:
We have reviewed your Section 5 10(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 mark eted 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, Ding,
and Cosmetic Act (Act) that do not require approval of a prernarket approv alapplication (PMA).
You may, therefore, maiket the device, subject to the general controls provisions of the.Act. The
general controls provisionsof the Act includerequirements for annual registration,lis1n-o
devices, goodrnanufacturing 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 misleadig.
If your device is classified (see.above) into either class II(Special'Cpntrols) otclass III (PMA), it
may be subject to additional cofitrols. Existing major regulations affecting your device can be
found in the Cdde of Federal Regulations; Title 21, Parts 800 to 898. In~addition, FDA may
publish further announcements concerning your device, in the Federal Register.
beadviedtat DAs issuance of a substantial equivalence determination does not mean
Pleae
that FDA has made a determination that your device complies with other requirenients of the Act.
or any federal statutes and regulations administered by other Federal agencies. You mustecomply
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part
*807); labeling (21 CFR Pant 801); medical device reporting (reporting of medical device-related
Page 2 -
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:/Hwww.fda. 20v/AboutFDA/CentersOffices/CDRHICDRHOffices/ucmI I15809.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.g20v/MedicalDevices/Safetv/ReportaProblem'defaiult.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
(800) 638-2041 or (301) 796-7100 or at its Internet addtess
htt2://www.fda.gov[MedicalDeviceslResourcesforYou/Industry/default.htm.
ct Dire or, Division of Reproductive,
Abominal, and Radiological Devices
ffice of Device Evaluation
Center for Devices and Radiological Health
Enclosure
Indications for Use
5 10(k) Number K094039
(if known):
Device Name: HYALb GYN®
Indications for Use: HYALO GYN is a personal lubricant, or 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/nonl-
lubricated latex, lubricated polyurethane, lubricated natural skin..
Prescription Use _____AND/OR Over-The-Counter Use X
Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS L -- CONT]N/ON ANO THER PAGE IF NEEDED
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Nme--~~
DBI1/64550482.1
