IMPRUV A.I. CREAM WOUND AND SKIN EMULSION

K041342 · Stiefel Laboratories, Inc. · MGQ · Jul 19, 2005 · SU

Device Facts

• Record ID: K041342
• Device Name: IMPRUV A.I. CREAM WOUND AND SKIN EMULSION
• Applicant: Stiefel Laboratories, Inc.
• Product Code: MGQ · SU
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The prescription product requires a physician to diagnose the disease state and is indicated for the management and relief of the burning and itching associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The OTC product is indicated for general symptoms such as burning and itching associated with many common types of skin irritation. The formulation forms a protective barrier which helps to keep the wound moist, which is beneficial to the healing process.

Device Story

MimyX Cream is a non-sterile, semi-viscous topical emulsion. It functions as a physical barrier to maintain a moist wound and skin environment, facilitating the healing process. It is intended for both prescription use (under physician supervision for specific dermatoses) and over-the-counter use (for general skin irritation and minor burns). Patients or caregivers apply the cream to affected areas three times daily or as needed. By providing a protective, hydrating layer, the device relieves symptoms of burning and itching associated with various skin conditions.

Clinical Evidence

Functional and performance testing was conducted to assess safety and efficacy; results were reported as satisfactory. No specific clinical study data or metrics provided.

Technological Characteristics

Non-sterile, semi-viscous topical emulsion. Functions as a physical barrier to maintain a moist environment. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for management and relief of burning and itching associated with dermatoses (atopic dermatitis, allergic contact dermatitis, radiation dermatitis) in patients requiring prescription diagnosis, and for general skin irritation/minor burns (including sunburn) in OTC users.

Predicate Devices

• Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) (K964240)
• Sinclair Wound and Skin Emulsion (K024367)

Submission Summary (Full Text)

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Stiefel Laboratories, Inc.

# Summary of the safety and efficacy

| 1. | Submitter of the Application: | Stiefel Laboratories, Inc.<br>255 Alhambra Circle, Suite 1000<br>Coral Gables, FL 33134 |
|----|-------------------------------|-----------------------------------------------------------------------------------------|
| | Contact Person: | Mary Jane Carr<br>Route 145<br>Oak Hill, New York 12460 |
| | | Phone: [phone] extension 8784<br>Fax: [phone] |
| 2. | Proprietary Name: | MimyX™ Cream |
| | Common/Usual Name: | Dressing, Wound & Burn, Hydr<br>w/Drug or Biologic |
| | Classification Name: | Dressing, Wound & Burn, Hydr<br>w/Drug or Biologic |

#### 3. Substantially Equivalent Devices:

Stiefel Laboratories, Inc. believes that MimyX Cream is substantially equivalent to the currently marketed devices, Biafine® Wound Dressing Emulsion (Radiodermatitis Emulsion) cleared under K964240 and Sinclair Wound and Skin Emulsion cleared under K024367.

### 4. Device Description:

MimyX™ Cream is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for both Prescription (requires a physician diagnosis of disease state) and Over-the-Counter (OTC) use.

### న. Intended Use of the Device:

The prescription product requires a physician to diagnose the disease state and is indicated for the management and relief of the burning and itching associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. The OTC product is indicated for general symptoms such as burning and itching associated with many common types of skin irritation. The formulation forms a protective barrier which helps to keep the wound moist, which is beneficial to the healing process.

### 6. Summary of the Technological Characteristics of the Device Compared to the Predicate Device(s):

All products referenced are non-sterile emulsions that are applied topically to relieve the symptoms of various dermatoses.

### 7. Conclusions:

Functional and performance testing has been conducted to assess the safety and efficacy of MimyX1M Cream and results are satisfactory.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol is a stylized representation of a human figure embracing a bird. The text is arranged in a circular fashion around the symbol.

Public Health Service

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Jane Carr Assistant Director, Regulatory. Affairs . Stiefel Laboratories, Inc. Route 145 Oak Hill, New York 12460

Re: K041342

Trade/Device Name: MimyXTM Cream Regulatory Class: Unclassified Product Code: MGQ Dated: June 3, 2005 Received: June 6, 2005

Dear Ms. Carr:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Mary Jane Carr

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will and w you'll ough finding of substantial equivalence of your device to a legally prematics notification: "Thesults in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please its you desire specific as not any and [phone]. Also, please note the regulation entitled, Connect the Office of Course to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

## 510(k) Number (if known): K041342

Device Name:

MimyXTM Cream

Indications for Use:

## FOR TOPICAL DERMATOLOGICAL USE ONLY

## Description Rx Product:

Under the supervision of a healthcare professional, MimyX Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis and allergic contact dermatitis. MimyX Cream helps to relieve dry waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

### Directions for Use (Rx and OTC):

Apply MimyX Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover MimyX Cream with a dressing of choice.

## Description OTC Product:

MimyX Cream helps to nourish skin and relieve the burning and itching associated with many common types of skin irritation. MimyX Cream may also be used to soothe minor burns, including sunburn.

Over-The-Counter Use __ XX Prescription Use XX AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Eunice Carter

Jision Sign-Off) Division of General, Restorative and Neurological Devices

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