LOCOBASE WOUND AND SKIN EMULSION

K060272 · Ferndale Laboratories, Inc. · FRO · Jan 12, 2007 · SU

Device Facts

• Record ID: K060272
• Device Name: LOCOBASE WOUND AND SKIN EMULSION
• Applicant: Ferndale Laboratories, Inc.
• Product Code: FRO · SU
• Decision Date: Jan 12, 2007
• 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 atopic dermatiis. The product, when applied topically to the affected area, forms a protective barrier.that tells. Ins keep the skin moist, which has a beneficial effect on the healing rooces of

Device Story

Locobase® Wound and Skin Emulsion is a semi-viscous topical emulsion/cream. Applied to affected skin areas under healthcare professional supervision; forms protective barrier to maintain skin moisture; supports healing processes. Used for management of burning, itching, and redness in atopic dermatitis. Supplied in 30g and 100g tubes.

Clinical Evidence

Functional and performance testing conducted to assess safety and efficacy. No specific clinical study data or performance metrics provided in the summary.

Technological Characteristics

Semi-viscous emulsion/cream formulation; non-sterile; supplied in 30g and 100g tubes; topical application; forms protective barrier.

Indications for Use

Indicated for management and relief of burning, itching, and redness associated with atopic dermatitis in patients under the supervision of a healthcare professional.

Predicate Devices

• Biafine™ Wound Dressing Emulsion (K964240)
• Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367)
• MimyXTM Cream (K041342)

Submission Summary (Full Text)

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K060272

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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: February 3, 2006

#### II. DEVICE NAME

Proprietary Name: Locobase® Wound and Skin Emulsion

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

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

#### III. PREDICATE DEVICES

Biafine™ Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc. Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmacreut;cals, Ltd.

MimyXTM Cream (K041342) Stiefel Laboratories, Inc.

#### IV. DEVICE DESCRIPTION

Locobase® Wound and Skin Emulsion is a semi-viscous emulsion/cream formulation intended for topical application supplied non-sterile in 30 g and 100g 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 atopic dermatiis. The product, when applied topically to the affected area, forms a protective barrier.that tells. Ins keep the skin moist, which has a beneficial effect on the healing rooces of

JAN 1 2 2007

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K060073

# VI. COMPARISON TO PREDICATE DEVICES

2/2 Locobase® Wound and Skin Emulsion is similar in composition, function and intended use to other legally marketed hydrogel wound dressing products, such as Biafine™ Wound Dressing Emulsion (K964240) Medix Pharmaceuticals America, Inc., Sinclair (Atopiclair™) Wound and Skin Emulsion (K024367) Sinclair Pharmaceutcals, I.t., and MimyX™ Cream (K041342) Stiefel Laboratories, Inc. All referenced products, are nonsterile viscous emulsions/creams that are applied topically to manage and relieve symtoms of various dermatoses.

## VII. CONCLUSION

Functional and performance testing has been conducted to assess the safety and efficacy of Locobase® Wound and Skin Emulsion.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ferndale Laboratories, Inc. % Mr. Richard A. Hamer Vice President, Regulatory/Clinical Affairs and Quality Assurance 780 West Eight Mile Road Ferndale, Michigan 48220

JAN 1 2 2007

Re: K060272

Trade/Device Name: Locobase® Wound and Skin Emulsion Regulatory Class: Unclassified Product Code: FRO Dated: October 13, 2006 Received: October 16, 2006

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, 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 -- Mr. Richard A. Hamer

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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 contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

> y yours, Mark N

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060J7S

# INDICATIONS FOR USE

510(k) Number (if known): __

Device Name: Locobase® Wound and Skin Emulsion

Indications for Use:

Under the supervision of a healthcare professional, for the management and relief of burning, itching and redness associated with atopic dermatitis.

Prescription Use X (Per 21 CFR §801.109 OR

Over-the-Counter Use

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

Concurrence of CDRH, Office of Device Devaluation (ODE)

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**(Division Sign-Off)**

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Division of General, Restorative and Neurological Devices

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**510(k) Number** *[k060272*

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