(75 days)
Not Found
No
The device description and intended use clearly describe a topical cream with a chemical formulation, and there is no mention of AI or ML in any section of the summary.
Yes
The device is indicated to manage and relieve symptoms like burning and itching associated with various dermatoses and provides a moist environment beneficial to healing, which are therapeutic actions.
No
Explanation: The device is a cream indicated to manage and relieve symptoms of dermatoses and promote healing, functioning as a skin emollient. It does not perform any diagnostic function.
No
The device description clearly states it is a cream, which is a physical substance and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage and relieve symptoms of dermatoses by providing a moist environment to the skin. This is a topical application for therapeutic purposes, not for diagnosing a condition.
- Device Description: The description details a skin emollient cream applied to the skin. It does not involve testing samples of human origin (like blood, urine, tissue) outside of the body to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening.
The device is clearly described as a topical cream for skin treatment, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
FRO
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. DEXERYL™ 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. DEXERYL™ Cream is a prescription device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 DEXERYL™ Cream and the predicates are adequately addressed by the testing completed on the product and the clinical experience with the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K093544, K090585, K071483, K052643, K964240
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAR - 7 2012
Image /page/0/Picture/1 description: The image shows the logo for Pierre Fabre, along with the text "Pierre Fabre" below the logo. The logo is a circular design with two curved shapes inside. The text "K113807 page 1 of 2" is at the top of the image.
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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Image /page/1/Picture/0 description: The image shows a logo with the text "Pierre Fabre MEDICAL DEVICES" underneath it. The logo is a black circular design with a white swirl inside. Above the logo, there is handwritten text that appears to be "R 113807 page 292".
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.
2
2
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
3
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 (800) 638-2041 or (301) 796-7100 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
4
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