(24 days)
Not Found
No
The summary describes a topical emulsion with no mention of software, algorithms, or any technology related to AI or ML.
Yes
Zenieva is described as managing and relieving symptoms (burning and itching) and aiding the healing process, clearly indicating a therapeutic purpose.
No
The device description states that Zenieva is "presented for prescription (requires a physician diagnosis of disease state) use" and its intended use is to "manage and relieve the burning and itching experienced with various types of dermatoses." This indicates it is a treatment device, not a diagnostic one. The physician performs the diagnosis.
No
The device description explicitly states it is a "non-sterile, semi-viscous emulsion intended for topical application," indicating it is a physical product (a cream or lotion) and not software.
Based on the provided information, Zenieva is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that Zenieva is for the management and relief of symptoms experienced with various types of dermatoses (skin conditions). This is a therapeutic or symptomatic relief purpose, applied directly to the skin.
- Device Description: The description details a topical emulsion for application to the skin.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. Zenieva does not involve the analysis of such specimens.
Therefore, Zenieva is a topical medical device intended for direct application to the skin for therapeutic purposes, not an in vitro diagnostic device.
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 (comma separated list FDA assigned to the subject device)
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 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.
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 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)
N/A
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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K080865
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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
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.
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