(24 days)
Not Found
No
The document describes a topical emulsion and does not mention any AI or ML components or functionalities.
Yes
Zenieva manages and relieves symptoms, and aids in the healing process of various dermatoses, indicating a therapeutic purpose.
No
The device description states its purpose is to "manage and relieve the burning and itching experienced with various types of dermatoses" and to "help relieve dry waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process." These are therapeutic or management functions, not diagnostic ones. The text also mentions that it "requires a physician diagnosis of disease state," indicating that the diagnosis is presumed to be made prior to the use of the device.
No
The device description clearly states it is a "non-sterile, semi-viscous emulsion intended for topical application," indicating it is a physical product (a cream or lotion), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "manage and relieve the burning and itching experienced with various types of dermatoses." This describes a therapeutic or palliative action on the skin, not a diagnostic test performed on samples taken from the body.
- Device Description: Zenieva is a "non-sterile, semi-viscous emulsion intended for topical application." This is a topical cream or lotion, not a device designed to analyze biological samples.
- Lack of Diagnostic Activity: There is no mention of analyzing blood, urine, tissue, or any other biological sample to diagnose a condition. The product is applied directly to the skin for symptom relief and wound environment maintenance.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. Zenieva does not fit this description.
N/A
Intended Use / 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.
Product codes
NAE
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription (requires a physician diagnosis of disease state) use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.
2
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
3
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:
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)