(247 days)
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.
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.
This submission describes Zenieva, a hydrogel wound dressing, and its substantial equivalence to the predicate device, MimyXTM cream (K041342). The provided text focuses on the device's composition, intended use, and non-clinical performance data, as well as the FDA's clearance letter.
Device Acceptance Criteria and Performance
The acceptance criteria for Zenieva are based on demonstrating substantial equivalence to the predicate device, MimyXTM cream. The study presented is a non-clinical performance evaluation, which aims to show that Zenieva performs similarly to the predicate and meets safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Zenieva) |
|---|---|---|
| Formulation | Identical chemical ingredients as predicate (MimyX™) | Zenieva's ingredients are identical to MimyX™. (Ingredients provided in the table: 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) |
| Intended Use | Identical intended use as predicate | Zenieva's intended use is identical to MimyX™: to manage and relieve burning and itching from various dermatoses (radiation, atopic, allergic contact dermatitis) and maintain a moist wound/skin environment for healing. (Claim identical to predicate) |
| Physical Properties | Identical physical properties as predicate | Zenieva's physical properties are identical to MimyX™: Non-sterile white to off-white thick cream; Water-based emulsion. |
| Application Instructions | Identical application frequency as predicate | 3 times per day or as needed, identical to MimyX™. |
| In Vitro Cytotoxicity | Non-toxic | Zenieva was shown to be non-toxic when tested as a "surface device" with limited contact (24 hours) on breached surfaces. |
| Skin Sensitization | Non-sensitizer | Zenieva was shown to be a non-sensitizer. |
| Primary Skin Irritation | Non-irritant | Zenieva was shown to be a non-irritant. |
| Acute Systemic Toxicity | Not applicable (topical use, not injection) | Test was performed but deemed not applicable, as the product is for topical application. |
| Microbial Limits | Acceptable bioburden levels throughout shelf-life (non-sterile) | Microbial limit testing was performed to ensure acceptable bioburden levels throughout the shelf-life, as the product is non-sterile. (No specific numerical results provided, but stated as a conducted and met measure). |
2. Sample Size for the Test Set and Data Provenance
The provided summary does not detail the sample sizes for the in vitro cytotoxicity, skin sensitization, and primary skin irritation tests. It states that Zenieva was tested as a "surface device" with "limited contact duration (24 hours) on breached surfaces." The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin, but it is implied to be from testing conducted by Gorbec Pharmaceutical Services Inc. to support this 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
This submission does not involve clinical studies with human assessors establishing ground truth for performance metrics in a typical sense (e.g., image interpretation). Instead, the "ground truth" for the non-clinical tests (cytotoxicity, sensitization, irritation) would be established by the results of standardized laboratory assays, interpreted by qualified laboratory personnel and toxicologists. The specific number and qualifications of experts for interpreting these non-clinical tests are not detailed in the provided document.
4. Adjudication Method for the Test Set
Not applicable. The non-clinical tests (cytotoxicity, sensitization, irritation) are typically objective laboratory assays with predefined endpoints, rather than requiring expert consensus or adjudication on subjective interpretations for a "test set" in the context of diagnostic or treatment efficacy.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission for a hydrogel wound dressing, not an AI-assisted diagnostic or treatment device that would typically involve a MRMC study. Therefore, no effect size for human readers with and without AI assistance is reported.
6. Standalone Performance Study
Yes, in a sense. The non-clinical performance tests (cytotoxicity, skin sensitization, primary skin irritation) assess the intrinsic biological safety of the device (Zenieva) in isolation, without human-in-the-loop performance influencing the assay results. The device's "performance" in this context is its safety profile.
7. Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on standardized laboratory assay results and regulatory definitions for toxicity, sensitization, and irritation. For example, a "non-toxic" finding is based on the cellular response in a cytotoxicity assay meeting predefined criteria, rather than expert consensus on a clinical outcome or pathology.
8. Sample Size for the Training Set
Not applicable. This device is a medical product (hydrogel wound dressing) and not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device submission.
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510(k) Summary
Submitter of the Application
JUL 2 3 2008
| Name: | Gorbec Pharmaceutical Services Inc |
|---|---|
| ------- | ------------------------------------ |
| Address: | 2445 S. Alston AveDurham, NC 27713 |
|---|---|
| ---------- | ---------------------------------------- |
| Contact Person: | Sandra R. Kircus |
|---|---|
| Phone: | (919) 281-4080 |
| Fax: | (919) 281-4077 |
| Email: | 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 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.
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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,glycerin, pentylene glycol, palmglycerides, vegetable oil,hydrogenated lecithin,squalane, betaine, palmitamideMEA, sarcosine, acetamideMEA, hydroxyethyl cellulose,sodium carbomer, carbomer,xanthan gum | Purified water, olive oil,glycerin, pentylene glycol, palmglycerides, vegetable oil,hydrogenated lecithin,squalane, betaine, palmitamideMEA, sarcosine, acetamideMEA, hydroxyethyl cellulose,sodium carbomer, carbomer,xanthan gum |
| # of application perday | 3 times per day or as needed | 3 times per day or as needed |
| Claim | Zenieva is used to manage andrelieve the burning and itchingexperienced with various typesof dermatoses, includingradiation dermatitis, atopicdermatitis, and allergic contactdermatitis. Zenieva helpsrelieve dry waxy skin bymaintaining a moist wound andskin environment, which isbeneficial to the healingprocess. | MimyX™ is used to manageand relieve the burning anditching experienced withvarious types of dermatoses,including radiation dermatitis,atopic dermatitis, and allergiccontact dermatitis. MimyX™helps relieve dry waxy skin bymaintaining a moist wound andskin environment, which isbeneficial to the healingprocess.. |
| Product Description | Water-based emulsion | Water-based emulsion |
| Physical properties | Non-sterile white to off whitethick cream | Non-sterile white to off whitethick cream |
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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.
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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.
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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 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
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Gorbec Pharmaceutical Ser 2445 South Alston Avenue Durham, NC 27713 Phone: 919-281-4080 Fax: 919-281-4070
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
§ 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.