MODIFICATION TO ZENIEVA

K083721 · River'S Edge Pharmaceuticals, LLC · NAE · Jan 8, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K083721
• Device Name: MODIFICATION TO ZENIEVA
• Applicant: River'S Edge Pharmaceuticals, LLC
• Product Code: NAE · General, Plastic Surgery
• Decision Date: Jan 8, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4022
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Zenieva is used to manage and relieve the burning and itching experienced with various, types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Device Story

Zenieva is a non-sterile, semi-viscous oil-in-water emulsion for topical application. Formulated with cross-linked polyacrylic acid polymer, natural gum, cellulose, glyceride, squalane, lecithin, and fatty acids. Intended for prescription use to manage symptoms of dermatoses and maintain a moist skin/wound environment to support healing. Applied topically by clinician or patient as directed. Acts as a physical barrier/moisturizer to relieve burning, itching, and dryness.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing confirmed the modification did not compromise safety or efficacy compared to the predicate device.

Technological Characteristics

Non-sterile, semi-viscous oil-in-water emulsion. Ingredients: cross-linked polyacrylic acid polymer, natural gum, cellulose, glyceride, squalane, lecithin, fatty acids. Topical application. No electronic, software, or mechanical components.

Indications for Use

Indicated for patients experiencing burning and itching associated with dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis; also indicated for relief of dry waxy skin by maintaining a moist environment.

Regulatory Classification

Identification

A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• Zenieva (K082865)

Submission Summary (Full Text)

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K08372)

# 510(k) Summary

# JAN - 8 2009

## Submitter of the Application

Company:

River's Edge Pharmaceuticals, LLC 5400 Laurel Springs Pkwy Building 500 Suwanee, GA 30024

Phone: [phone] [phone] Fax:

#### Contact for the Application

Company:

Gorbec Pharmaceutical Services Inc. 2445 S. Alston Avc. Durham NC 27713

| Contact Name: | Sandra R. Kircus |
|---------------|--------------------------|
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

#### Trade Name

Zenieva

## Common name

バ

Hydrogel wound dressing

#### Device Classification

21 CFR 878.4022 "Dressing, Wound, Hydrogel" Class I Non-Exempt, NAE.

#### Substantial Equivalence / Predicate Device

River's Edge Pharmaceuticals, LLC believes the modification submitted for Zenieva is substantially equivalent to the approved device currently cleared under 510K Number K082865, approved 23 October 2008.

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## Device Description and Design

Zenieva is a non-sterile, semi-viscous emulsion intended for topical application. It is presented for prescription (requires a physician diagnosis of disease state) use. The product is formulated as an oil-in-water emulsion containing a cross-linked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

#### Intended Use of the Device

Zenieva is used to manage and relieve the burning and itching experienced with various, types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

This intended use is identical to the intended use previously cleared for Zenieva. Therefore, there is no issue with determining differences in the safety and efficacy as related to the predicate device. .

#### Technological Comparison to Device Predicate Device

The modification to Zenieva does not change the chemical composition, intended indications for use, physical properties, or claims.

#### Non-Clinical Performance Data

Performance testing for Zenieva was conducted and assessed. This data was compared to the approved device; the modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product.

#### Conclusion

The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are satisfactory and indicate the product remains safe. effective, and substantially equivalent to the predicate.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of 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.

FEB 5 - 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

River's Edge Pharmaceuticals, LLC % Gorbec Pharmaceutical Services, Inc. Sandra R. Kircus, Ph.D. Regulatory Affairs Manager 2445 South Alston Avenue Durham, North Carolina 27713

Re: K083721

Trade/Device Name: Zenieva Regulation Number: 21 CFR 878.4022 Regulation Name: Hydrogel wound dressing and burn dressing Regulatory Class: I Product Code: NAE Dated: January 8, 2009 Received: January 8, 2009

Dear Dr. Kircus:

This letter corrects our substantially equivalent letter of January 8, 2009.

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 (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 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

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Page 2 - Sandra R. Kircus, 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.

This letter will allow you to continue 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 (240) 276 - 0115 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mad A Millerson

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

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# Indications for Use

510(k) Number (if known): K083721

Device Name: Zenieva Wound Dressing

Indications For Use:

Zenieva is used to manage and relieve the burning and itching experienced with various types of dermatoses, including radiation dermatitis, atopic dermatitis, and allergic contact dermatitis. Zenieva helps relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Mark A. Milheim

Dir - M reneral, Restorative, Divis · n o and Neurological Devices

510(k) Number K083721

Prescription Use × (Part 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)