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 Description

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.

AI/ML Overview

The provided document is a 510(k) summary for a hydrogel wound dressing called "Zenieva." It details a submission for a modification to an already cleared device (K073246).

The key takeaway from the document regarding acceptance criteria and studies is that no new performance data or studies were conducted or required for this particular submission. The modification was solely a labeling change to add a contraindication. Therefore, the device is considered to meet acceptance criteria because its core composition, intended use, and technological characteristics remain unchanged from the previously cleared device.

Here's how the information requested applies to this specific submission:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
No new acceptance criteria were established or evaluated. The submission is for a labeling change to an already cleared device. The product's ingredients and performance characteristics are stated to have remained unchanged from the previously cleared predicate device (K073246).	Not Applicable (N/A). No new performance data was generated or required as the device itself was not modified.

Sample Size Used for the Test Set and Data Provenance:
- N/A. No new test set or performance study was conducted. The submission is for a labeling change to an already cleared device.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- N/A. No new ground truth establishment was required as no new performance study was conducted.
Adjudication Method for the Test Set:
- N/A. No new test set or adjudication was required.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
- No. An MRMC study was not done. The device is a hydrogel wound dressing, not an AI-assisted diagnostic tool.
Standalone (i.e. algorithm only without human-in-the loop performance) Study:
- No. This is a medical device (hydrogel wound dressing), not an algorithm.
Type of Ground Truth Used:
- N/A. No new ground truth was established for this specific submission as there were no new performance studies. The substantial equivalence for the original device would have been based on appropriate clinical or non-clinical data for a hydrogel wound dressing.
Sample Size for the Training Set:
- N/A. This is a medical device, not a machine learning algorithm requiring a training set.
How the Ground Truth for the Training Set Was Established:
- N/A. Not applicable, as there is no training set for this type of medical device.

Summary Explanation:

The 510(k) submission K082865 for "Zenieva" is a resubmission or modification of a previously cleared device (K073246). The core of this submission is a labeling change to add a contraindication for one of the ingredients. The document explicitly states:

"The proposed modification to Zenieva does not change the chemical composition, intended indications for use, physical properties, or claims."
"Research has shown that a labeling change - adding a contraindication for one of the ingredients - is necessary. This is adding safety to the product."
"The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are not applicable: research has shown that adding a contraindication statement for an ingredient is necessary. The product itself is not being modified; we are putting the appropriate measures in place to increase the product's safety."

Therefore, the device meets its acceptance criteria by demonstrating that the modification itself (labeling change) does not alter the fundamental safety and effectiveness of the device as previously established by the original clearance. No new studies were required or conducted for this specific 510(k) submission K082865 because the device's performance characteristics remain identical to the predicate device.

Summary

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K080865
p. 1 of 2

Image /page/0/Picture/1 description: The image shows the logo for "Gorbac Pharmaceutical Services Inc." The text is in a bold, sans-serif font and is white against a black background. The background has a pattern of hexagons. The text is arranged in two lines, with "Gorbac" on the top line and "Pharmaceutical Services Inc." on the bottom line.

2445 South Alston Avenue Durham. NC 27713 Phone: 919-281-4080 Fax: 919-281-4076

OCT 2 3 2008

510(k) Summary

Submitter of the Application

Name:

Gorbec Pharmaceutical Services Inc.

Address:

2445 S. Alston Ave Durham, NC 27713

Contact Person: Phone: Fax: Email:

Sandra R. Kircus (919) 281-4080 (919) 281-4077 sandra.kircus@gorbec.com

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 the modification submitted for Zenieva is substantially equivalent to the currently approved device, cleared under K073246.

Device Description and Design

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Intended Use of the Device

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

Technological Comparison to Device Predicate Device

The proposed modification to Zenieva docs not change the chemical composition, intended indications for use, physical properties, or claims. Research has shown that a labeling change - adding a contraindication for one of the ingredients - is necessary. This is adding safety to the product.

Non-Clinical Performance Data

N/A

Conclusion

The product's ingredients and performance characteristics have remained unchanged. Tests and performance data are not applicable: research has shown that adding a contraindication statement for an ingredient is necessary. The product itself is not being modified; we are putting the appropriate measures in place to increase the product's safety.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or other bird with outstretched wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2008

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

Re: K082865

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: September 26, 2008 Received: September 30, 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.

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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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N Millman

Mark N. Melkerson 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): 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 _ X

AND/OR

Over-The-Counter Use

(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 C oe of Device Evaluation (ODE)

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

510(k) Number K082865

Regulation Number and Section

§ 878.4022 Hydrogel wound dressing and burn dressing.

(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.