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K Number
K113807
Device Name
DEXERYL CREAM
Manufacturer
PIERRE FABRE MEDICAL DEVICES
Date Cleared
2012-03-07

(75 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K093544,K090585,K071483,K052643,K964240
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
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 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.

AI/ML Overview

The provided text describes a medical device, DEXERYL™ Cream, and its 510(k) submission to the FDA. It does not describe any acceptance criteria or studies involving the performance of a device or an algorithm against a test set.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided document.

The document primarily focuses on:

  • Device Name and Manufacturer: DEXERYL™ Cream by Pierre Fabre Medical Devices.
  • Predicate Devices: A list of similar creams (Tropazone, Neosalus, Tetrix, EpiCeram, Biafine) used to establish substantial equivalence.
  • Device Description: An oil-in-water emulsion designed as a skin emollient to protect and moisturize the skin.
  • Intended Use: To manage and relieve burning and itching associated with various dermatoses (atopic, allergic contact, irritant contact dermatitis) by providing a moist environment.
  • Summary of Testing Data: Mentions biocompatibility testing in conformance with ISO 10993-1 and clinical testing and extensive clinical use in Europe to demonstrate safety. However, it does not provide details of these clinical tests, such as patient numbers, endpoints, or results that could be interpreted as acceptance criteria or device performance figures.
  • FDA Clearance: The letter from the FDA confirms substantial equivalence to predicate devices and clearance for marketing.

N/A