ZENIEVA

K073246 · Gorbec Pharmaceutical Services, Inc. · NAE · Jul 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073246
• Device Name: ZENIEVA
• Applicant: Gorbec Pharmaceutical Services, Inc.
• Product Code: NAE · General, Plastic Surgery
• Decision Date: Jul 23, 2008
• Decision: SESE
• Submission Type: Traditional
• 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 topical dressing. It is applied by the patient or caregiver to the skin to manage dermatoses symptoms. The device functions by maintaining a moist wound and skin environment, which supports the healing process. It is formulated with crosslinked polyacrylic acid polymer, natural gum, cellulose, glyceride, squalane, lecithin, and fatty acids. The product is intended for prescription use.

Clinical Evidence

Bench testing only. Non-clinical performance data included in vitro cytotoxicity, skin sensitization, and primary skin irritation testing. Results confirmed the device is non-toxic, a non-sensitizer, and a non-irritant for surface use on breached skin. Microbial limit testing was performed to ensure acceptable bioburden levels.

Technological Characteristics

Non-sterile, oil-in-water emulsion. Ingredients: purified water, olive oil, glycerin, pentylene glycol, palm glycerides, vegetable oil, hydrogenated lecithin, squalane, betaine, palmitamide MEA, sarcosine, acetamide MEA, hydroxyethyl cellulose, sodium carbomer, carbomer, xanthan gum. Form factor: thick cream. No electronic or software 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.

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

• MimyX cream (K041342)

Submission Summary (Full Text)

{0}------------------------------------------------

# 510(k) Summary

Submitter of the Application

JUL 2 3 2008

| Name: | Gorbec Pharmaceutical Services Inc |
|-------|------------------------------------|
|-------|------------------------------------|

| Address: | 2445 S. Alston Ave<br>Durham, NC 27713 |
|----------|----------------------------------------|
|----------|----------------------------------------|

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

#### Trade Name

Zenieva

#### Common name

Hydrogel wound dressing

#### Device Classification

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

#### Substantial Equivalence / Predicate Device

Gorbec Pharmaceutical Services Inc. believes that Zenieva is substantially equivalent to the currently marketed device, MimyXTM cream, cleared under K041342.

#### 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 crosslinked polyacrylic acid polymer, natural gum, and cellulose as thickening agents. The oil composition of Zenieva is composed of glyceride, squalane, lecithin, and fatty acids.

{1}------------------------------------------------

### 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.

The indication for our proposed device is identical to the MimyXTM, 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

As indicated in the following table, Zenieva has the chemical composition, intended indications for use, physical properties, and claims as the predicate (MimyX™M cream):

| Product name | Zenieva | MimyX™ |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Ingredients | Purified water, olive oil,<br>glycerin, pentylene glycol, palm<br>glycerides, vegetable oil,<br>hydrogenated lecithin,<br>squalane, betaine, palmitamide<br>MEA, sarcosine, acetamide<br>MEA, hydroxyethyl cellulose,<br>sodium carbomer, carbomer,<br>xanthan gum | Purified water, olive oil,<br>glycerin, pentylene glycol, palm<br>glycerides, vegetable oil,<br>hydrogenated lecithin,<br>squalane, betaine, palmitamide<br>MEA, sarcosine, acetamide<br>MEA, hydroxyethyl cellulose,<br>sodium carbomer, carbomer,<br>xanthan gum |
| # of application per<br>day | 3 times per day or as needed | 3 times per day or as needed |
| Claim | Zenieva is used to manage and<br>relieve the burning and itching<br>experienced with various types<br>of dermatoses, including<br>radiation dermatitis, atopic<br>dermatitis, and allergic contact<br>dermatitis. Zenieva helps<br>relieve dry waxy skin by<br>maintaining a moist wound and<br>skin environment, which is<br>beneficial to the healing<br>process. | MimyX™ is used to manage<br>and relieve the burning and<br>itching experienced with<br>various types of dermatoses,<br>including radiation dermatitis,<br>atopic dermatitis, and allergic<br>contact dermatitis. MimyX™<br>helps relieve dry waxy skin by<br>maintaining a moist wound and<br>skin environment, which is<br>beneficial to the healing<br>process.. |
| Product Description | Water-based emulsion | Water-based emulsion |
| Physical properties | Non-sterile white to off white<br>thick cream | Non-sterile white to off white<br>thick cream |

{2}------------------------------------------------

## Non-Clinical Performance Data

Three applicable nonclinical tests were used to support substantial equivalence: in vitro cytotoxicity, skin sensitization, and primary skin irritation testing. Zenieva was tested as a "surface device" with limited contact duration (24 hours) on breached surfaces. Zenieva was shown to be non-toxic, a non-sensitizer, and a non-irritant (data in original 510(k) submission Section 15 and Appendices A-C, submitted 07 Nov 07, K073246). Acute system toxicity was also performed; however, this test was deemed not applicable, as the products are meant for topical applications, not for the purposes of injection (see original application).

The non-clinical performance data have shown no significant differences between the two products. This data supports our product's substantial equivalence to the predicate device.

### Conclusion

We have designed our product with identical ingredients and performance characteristics as the predicate, Mimyx™. Nonclinical tests showed the product was both equivalent to the predicate and a non-irritant, non-scnsitizer, and nonirritant. Release specifications have been determined such that the product's criteria are both equivalent to the predicate and meet the device specifications for which we are claiming on the labeling. We have also included microbial limit testing to ensure the product as acceptable bioburden levels throughout the shelflife of the product because the product is non-sterile. As such, we have put the appropriate measures in place to ensure the product is safe, effective and performs as well as the predicate device.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its wing, symbolizing strength and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 2 3 2008

Gorbec Pharmaceutical Services, Inc. % Sandra R. Kircus, Ph.D. Regulatory Affairs Manager 2445 South Alston Avenue Durham, North Carolina 27713

Re: K073246

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: July 1, 2008 Received: July 2, 2008

Dear Dr. Kircus:

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.

{4}------------------------------------------------

Page 2 - Sandra R. Kircus, Ph.D.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket, Surveillance at [phone]. For questions regarding the reporting of device adverse events. (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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.

Sincerely vours.

Mark M. Millman

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

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for "Corbec Pharmaceutical Services Inc." The word "Corbec" is written in large, bold, white letters against a black background. Above the letters are chemical structures. Below the word "Corbec" is the text "PHARMACEUTICAL SERVICES INC."

Gorbec Pharmaceutical Ser 2445 South Alston Avenue Durham, NC 27713 Phone: [phone] Fax: [phone]

# Indications for Use

510(k) Number (if known): K073246 Device Name: Zenieva

> 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.

Prescription Use × (Part 21 CFR 801 subpart D) AND/OR

Over-The-Counter Use (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)

(Division Sign-Off) Division of General, Restorative, and Nearological Devices

**510(k) Number** C623246