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 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.

AI/ML Overview

The provided document, K083721 for Zenieva Hydrogel Wound Dressing, does not contain the kind of detailed study information typically associated with AI/ML-based medical devices or comparative effectiveness studies involving human readers.

This submission is for a hydrogel wound dressing, a Class I non-exempt device. The context indicates it's a modification to an already cleared device, and the primary assessment is for substantial equivalence to a predicate device. The information provided heavily emphasizes the physical and chemical properties remaining unchanged.

Therefore, most of the requested information regarding acceptance criteria derived from a study, sample sizes, expert ground truth, MRMC studies, or standalone algorithm performance, as would apply to a diagnostic or AI-powered device, is not applicable or available in this document.

Here is a breakdown based on the information provided, highlighting where the requested details are absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Substantial Equivalence	No change in chemical composition	"The modification to Zenieva does not change the chemical composition"	Directly stated.
	No change in intended indications for use	"This intended use is identical to the intended use previously cleared for Zenieva."	Directly stated.
	No change in physical properties	"The modification to Zenieva does not change... physical properties"	Directly stated.
	No change in claims	"The modification to Zenieva does not change... claims"	Directly stated.
Safety & Efficacy	Product remains safe	"Tests and performance data are satisfactory and indicate the product remains safe."	General statement. No specific metrics or thresholds provided.
	Product remains effective	"Tests and performance data are satisfactory and indicate the product remains... effective."	General statement. No specific metrics or thresholds provided.
Performance Data	Satisfactory change related to modification	"The modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product."	General statement. "Satisfactory" is the acceptance, but no detailed performance metrics are given.

2. Sample size used for the test set and the data provenance:

Not Applicable/Not Provided. This document describes a modification to a hydrogel wound dressing, not a diagnostic device involving a test set of data. The "performance testing" mentioned is likely related to the physical or chemical properties of the dressing itself (e.g., pH, viscosity, stability), not clinical data from patients in the manner of an AI/ML or diagnostic study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable/Not Provided. Ground truth as understood for diagnostic or AI/ML devices is not relevant for this type of product and submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Applicable/Not Provided. Adjudication methods are specific to studies involving expert review of cases, which is not described here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This is a hydrogel wound dressing, not an AI/ML device. An MRMC study is not relevant.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This is a hydrogel wound dressing, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable. The "ground truth" for this submission revolves around the chemical composition and physical properties of the dressing aligning with its predicate and previously cleared version, and confirming no compromise to safety or efficacy. This is assessed via "Performance testing for Zenieva" which implies laboratory tests, not clinical "ground truth" for diagnosis.

8. The sample size for the training set:

Not Applicable/Not Provided. This device does not involve a training set as it's not an AI/ML algorithm.

9. How the ground truth for the training set was established:

Not Applicable/Not Provided. As above, no training set or relevant ground truth for such a set.

Summary of the Study (as described in the document):

The "study" described in the 510(k) summary is rather a verification process for a modification to an existing Class I device (Zenieva Hydrogel Wound Dressing, previously cleared under K082865).

Objective: To demonstrate that the modified Zenieva product remains substantially equivalent to its predicate device despite a change (the nature of which is not explicitly detailed but implied to be minor as it doesn't affect core properties).
Methodology: "Performance testing for Zenieva was conducted and assessed." This testing was then "compared to the approved device." The specific tests are not enumerated, but given the product type, they would likely involve:
- Stability testing (shelf life, environmental resilience)
- Chemical characterization (to confirm unchanged composition)
- pH, viscosity, spreadability (physical properties relevant to hydrogels)
- Biocompatibility (if any new materials were introduced, though the document states "modification to Zenieva does not change the chemical composition").
Conclusion: The tests indicated that "the modification was determined to be a satisfactory change with no compromise in the safety or efficacy of the product." The product's "ingredients and performance characteristics have remained unchanged."

In essence, this is a regulatory submission for a minor change to a non-AI medical device, focusing on bench testing and comparison to established parameters rather than a clinical study with patient data and expert review.

Summary

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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: (770) 886-3417 (770) 886 3917 Fax:

Contact for the Application

Company:

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

Contact Name:	Sandra R. Kircus
Phone:	(919) 281 4080
Fax:	(919) 281 4077
Email:	sandra.kircus@gorbec.com

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

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 (800) 638-2041 or (240) 276-3150 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:

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)

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.