DEXERYL CREAM

K113807 · Pierre Fabre Medical Devices · FRO · Mar 7, 2012 · SU

Device Facts

• Record ID: K113807
• Device Name: DEXERYL CREAM
• Applicant: Pierre Fabre Medical Devices
• Product Code: FRO · SU
• Decision Date: Mar 7, 2012
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

DEXERYL™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYL™ Cream provides a moist environment, which is beneficial to the healing process.

Device Story

DEXERYL™ Cream is a non-sterile, oil-in-water emulsion skin emollient. It contains >50% water, glycerin, white soft paraffin, and liquid paraffin. Applied topically to the skin, it functions by providing a moist environment and emollient effect to soften and soothe skin, thereby managing burning and itching associated with various dermatoses. It is a prescription device intended for use in a clinical or home setting to support the skin healing process.

Clinical Evidence

Safety demonstrated through biocompatibility testing in conformance with ISO 10993-1 recommendations and extensive clinical use in Europe. No specific clinical trial data metrics (e.g., p-values, sensitivity) provided in the summary.

Technological Characteristics

Emulsified semi-viscous cream; oil-in-water emulsion. Ingredients: >50% water, glycerin, white soft paraffin, liquid paraffin. Biocompatibility testing performed per ISO 10993-1. Non-sterile.

Indications for Use

Indicated for patients experiencing burning and itching associated with dermatoses, including atopic dermatitis, allergic contact dermatitis, and irritant contact dermatitis.

Predicate Devices

• Tropazone Cream (K093544)
• Neosalus (K090585)
• Tetrix Cream (K071483)
• EpiCeram (K052643)
• Biafine (K964240)

Submission Summary (Full Text)

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MAR - 7 2012

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MEDICAL DEVICES

### 510(K) SUMMARY PIERRE FABRE DEXERYL™ CREAM

### SUBMITTER AND OWNER

Pierre Fabre Medical Devices Les Fontaines 29 avenue du Sidobre 81106 Castres Cedex France Attn .: M. Pascal Lefrancois

Date Prepared: 30 January 2012

## DEVICE NAME

Trade Name: Common Name: Classification Name: Regulation No .: Procode:

DEXERYL™ Cream Wound dressing Dressing, Wound, Drug Unclassified FRO

# PREDICATE DEVICES

DEXERYL™ Cream is substantially equivalent in composition and intended use to the following legally marketed devices in commercial distribution:

- . Tropazone Cream (K093544),
- Neosalus (K090585).
- Tetrix Cream (K071483),
- EpiCeram (K052643) and
- Biafine (K964240).

#### DEVICE DESCRIPTION

DEXERYLTM Cream is a clean but non-sterile skin emollient designed to provide protection and a moist environment to the skin, which is beneficial to the healing process. DEXER YL™ Cream is an oil in water emulsion, consisting of >50% water with glycerin, white soft paraffin, liquid paraffin, and other common excipients.

The device formulation therefore confers an emollient effect, softening and soothing the skin to help prevent dry skin, irritation and itching. DEXER YL™ Cream is a prescription device.

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## INTENDED USE

DEXERYL™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact . dermatitis and irritant contact dermatitis. DEXERYL™ Cream provides a moist environment, which is beneficial to the healing process.

# COMPARISON OF TECHNOLOGICAL FEATURES

DEXERYL™ Cream is similar in design, intended use, and technological characteristics to the predicate devices and existing wound dressings that have been cleared for US commercial distribution. The device is an emulsified semi-viscous cream intended for topical use, similar to the predicate devices in composition and in intended use.

# SUMMARY OF TESTING DATA

Device safety has been demonstrated through biocompatibility testing in conformance with recommendations of ISO 10993-1, and clinical testing and extensive clinical use in Europe. The minor differences in material constituents between DEXER YL™ Cream and the predicates are adequately addressed by the testing completed on the product and the clinical experience with the device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

#### Public Health Service

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

Pierre Fabre Medical Devices % The Weinberg Group, Inc. Diane Horwitz, Ph.D. 1129 Twentieth Street, Northwest Washington, District of Columbia 20036

Re: K113807

Trade/Device Name: DEXERYL™ Cream Regulatory Class: Unclassified Product Code: FRO Dated: December 22, 2011 Received: December 23, 2011

#### Dear Dr. Horwitz:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

MAR - 7 2012

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Page 2 - Diane Horwitz, Ph.D.

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/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 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,

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEXERYL™ Cream Premarket Notification

Pierre Fabre Medical Devices

# INDICATIONS FOR USE

510(k) Number (if known):

KIJ3807

Device Name: DEXERYL™ Cream

Indications for Use: .

DEXER YL™ Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. DEXERYL™ Cream provides a moist environment, which is beneficial to the healing process.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Da:l.Kurefa MXM
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113807