(147 days)
Not Found
No
The summary describes a topical emulsion for skin conditions and does not mention any AI or ML components.
Yes
The device is intended to manage and relieve symptoms (burning, itching, pain) associated with various dermatoses and aid the healing process, which are therapeutic claims.
No
The device description clearly states it is for "managing and relieving" symptoms, and it is a "semi-viscous emulsion intended for topical application." It also mentions it is a "Prescription (requires a physician diagnosis of disease state) for use," implying that a diagnosis has already been made by a physician, and Nivatopic is a treatment, not a diagnostic tool.
No
The device description explicitly states it is a "semi-viscous emulsion intended for topical application," indicating it is a physical substance, not software.
Based on the provided information, Nivatopic™ Plus is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to manage and relieve symptoms of various dermatoses (skin conditions) by topical application. This is a therapeutic or symptomatic relief purpose, not a diagnostic one.
- Device Description: It's described as a "semi-viscous emulsion intended for topical application." This is a topical cream/lotion, not a device used to examine samples outside the body.
- Lack of Diagnostic Activity: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease.
- Anatomical Site: The anatomical site is the skin, and the application is topical. IVDs typically interact with internal biological samples.
In summary, Nivatopic™ Plus is a topical medical device intended for the management of skin conditions, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Rx: Nivatopic™ Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Nivatopic™ Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Product codes
FRO
Device Description
Nivatopic Plus is a non-sterile, steroid free, semi-viscous emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription (requires a physician diagnosis of disease state)
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)
Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory.
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
N/A
0
K132329
C 2 0 2013
510(k) Application
Nivatopic™ Plus
510(k) SUMMARY
(in accordance with 21 CFR 807.87(b) and 21 CFR 807.92)
Nivatopic™ Plus
- Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Akesis 248 Latitude Lane, Suite 104 Lake Wylie, SC 29710
Phone: (803) 831-7657 (803) 831-1494 Fax: Email:lara.noah@akesis.com
Contact Person: Lara Noah, Associate Director, Global Regulatory Affairs
Date Prepared: July 22, 2013
2. Name of Device and Name/Address of Sponsor
Nivatopic™ Plus
NivaGen Pharmaceuticals, Inc. 3100 Fite Circle #208 Sacramento, CA-95827
Common or Usual Name
Dressing, Wound & Burn, Hydrogel w/drug and/or biologic
Classification Name
Device Review Panel Product Code FRO Unclassified Reason Submission Type 510(k)
Unclassified General & Plastic Surgery Pre-Amendment
- Substantial Equivalent Devices: 3.
Nivatopic Plus is substantially equivalent to the currently marketed devices, Hylatopic Plus™ Cream, cleared under 510(K) # K110727, and distributed by PreCision Dermatology,
1
510(k) Application
Inc. and HPR™ Plus Emollient Foam, cleared under 510(K) # K113774, and distributed by PruGen, IP Holdings Inc.
The safety evaluation meets the requirements as set forth by USP and ISO. The indications of use, device description and performance testing described above and in this 510(K).
-
Device Description: 4.
Nivatopic Plus is a non-sterile, steroid free, semi-viscous emulsion intended for topical application applied 3 times per day or as needed. It is presented as a Prescription (requires a physician diagnosis of disease state) for use. -
ഗ് Intended Use Indications for Use:
Nivatopic™ Plus
Rx Use: Nivatopic Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Nivatopic Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
-
Summary of the Technological Characteristics of the Device Compared to the Predicate Device(s): 6.
All products referenced are non-sterile emulsions that are applied topically to relieve the symptoms of various dermatoses. -
- Conclusions:
Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory.
- Conclusions:
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
NivaGen Pharmaceuticals Incorporated % Dr. Loren Gelber Akesis, LLC 248 Latitude Lane, Suite 104 Lake Wylie, South Carolina 29710
Re: K132329
Trade/Device Name: Nivatopic™ Plus Regulatory Class: Unclassified Product Code: FRO Dated: October 10, 2013 Received: October 31, 2013
Dear Dr. Gelber:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
December 20, 2013
3
Page 2 - Ms. Loren Gelber
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Joshua @ Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Application
Nivatopic™ Plus
Indication for Use
Device Name: Nivatopic™ Plus
510(k) Number (if known):
Indications for Use:
Rx: Nivatopic™ Plus is indicated to manage and relieve the burning, itching, and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Nivatopic™ Plus also helps relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.
Prescription Use: X
AND/OR
Over-the-Counter Use: _
(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 CDRH, Office of Device Evaluation (ODE)
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Jiyoung Dar