ELETONE CREAM

K092297 · Ferndale Pharma Group, Inc. · FRO · Oct 9, 2009 · SU

Device Facts

• Record ID: K092297
• Device Name: ELETONE CREAM
• Applicant: Ferndale Pharma Group, Inc.
• Product Code: FRO · SU
• Decision Date: Oct 9, 2009
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, radiation dermatitis and allergic contact dermatitis. The product, when applied topically to the affected areas, forms a protective barrier that helps keep the skin moist, which has a beneficial effect on the healing process.

Device Story

Eletone® Cream is a semi-viscous topical emulsion supplied in 100g plastic tubes. Applied topically by patients under healthcare professional supervision to affected skin areas; forms a protective barrier to maintain skin moisture; supports healing process. Used for management of symptoms associated with dermatoses. No complex processing or software involved.

Clinical Evidence

No clinical data provided. Substantial equivalence based on identical composition and function to predicate device.

Technological Characteristics

Semi-viscous emulsion/cream formulation. Non-sterile. Supplied in 100g plastic tubes. Topical application. No electronic, software, or mechanical components.

Indications for Use

Indicated for patients requiring management and relief of burning, itching, and redness associated with dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis. Use is under the supervision of a healthcare professional.

Predicate Devices

• Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367)
• MimyXTM Cream (K041342)
• Locobase® Wound and Skin Emulsion (K060272)

Submission Summary (Full Text)

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510(k) premarket notification: Eletone® Cream Ferndale Laboratories, Inc.

K092297
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# 510 (k) SUMMARY

# I. ADMINISTRATIVE

#### Submitter:

Ferndale Laboratories, Inc. 780 W. 8 Mile Rd Ferndale, Michigan 48220 [phone]

Contact Person: Richard A. Hamer

Date of Preparation: July28, 2009

# II. DEVICE NAME

Proprietary Name: Eletone® Cream

Common Name: Wound Dressing

Classification Name: Dressing, Wound and Burn, Hydrogel w/Drug and/or Biologic

#### III. PREDICATE DEVICES

Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmaceuticals, Ltd.

MimyXTM Cream (K041342) Stiefel Laboratories, Inc.

Locobase® Wound and Skin Emulsion (Eletone® Cream) (K060272) Ferndale Laboratories, Inc.

## IV. DEVICE DESCRIPTION

Eletone® Cream is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 100g plastic tubes.

#### V. INTENDED USE

Under the supervision of a healthcare professional, the product is intended for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, radiation dermatitis and allergic contact dermatitis.

OCT - W LUUY

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510(k) premarket notification: Eletone® Cream Ferndale Laboratories, Inc.

K092297
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The product, when applied topically to the affected areas, forms a protective barrier that helps keep the skin moist, which has a beneficial effect on the healing process.

# VI. COMPARISON TO PREDICATE DEVICES

Eletone® Cream is identical in composition and function to Locobase® Wound and Skin Emulsion (K060272). Its intended use is identical to other legally marketed wound dressing products, such as Sinclair (Atopiclair™) Wound and Skin Emulsion, Sinclair Pharmaceuticals, Ltd. (K024367), MimyXTM Cream, Stiefel Laboratories, Inc. (K041342). All referenced products are non-sterile emulsions that are applied topically to manage and relieve symptoms of various dermatoses.

# VII. CONCLUSION

Functional and performance testing has been conducted to assess the safety and efficacy of Eletone® Cream. Based on the information provided herein, we conclude that the device is substantially equivalent to the above-mentioned predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

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

Ferndale Pharma Group, Inc. % Mr. Richard A. Hamer VP, Regulatory/Clinical Affairs Quality Assurance 780 West Eight Mile Road Ferndale, Michigan 48220

OCT - 9 2009

Re: K092297

Trade/Device Name: Eletone® Cream Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2009 Received: October 2, 2009

Dear Mr. Hamer:

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. Ilsting 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 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

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## Page 2 - Mr. Richard A. Hamer

device-related 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://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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

index.html.

Sincerely yours,

Mark N. Melkerson
Director
Division of Surgical Orthopaedics

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

Enclosure

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# Indications for Use

510(k) Number: K092297

Device Name: Eletone® Cream

Indications For Use: Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis, and radiation dermatitis (post-radiation treatment).

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Kron

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(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092297