(147 days)
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.
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.
The provided text describes a 510(k) application for a device called Nivatopic™ Plus, which is a non-sterile, steroid-free, semi-viscous emulsion intended for topical application to manage and relieve symptoms of various dermatoses.
However, the documentation does not contain information regarding acceptance criteria, a specific study proving device performance against acceptance criteria, or details about a clinical study involving human readers or standalone algorithm performance. The 510(k) summary only states that "Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory."
The 510(k) clearance process primarily establishes substantial equivalence to a predicate device, rather than requiring extensive clinical trials or performance metrics of the kind typically associated with AI/software devices. The predicates mentioned are other topical emulsions (Hylatopic Plus™ Cream and HPR™ Plus Emollient Foam). The safety evaluation is stated to meet USP and ISO requirements.
Therefore, I cannot populate the requested table and answer many of the questions as the information is not present in the provided text.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | "Functional and performance testing has been conducted to assess the safety and efficacy of Nivatopic™ Plus and the results are satisfactory." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified (no clinical study details are provided).
- Retrospective or prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified as no clinical study with expert ground truth establishment is described for this 510(k). The evaluation relies on substantial equivalence to predicate devices and general functional/performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not described. This device is a topical emulsion, not an AI/software device that would assist human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is a medical device (topical emulsion), not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not specified. The 510(k) process for this type of device relies on demonstrating substantial equivalence in terms of safety, technological characteristics, and intended use, often supported by bench testing and adherence to standards (USP, ISO), rather than clinical ground truth as understood in diagnostic studies.
8. The sample size for the training set
- Not applicable/Not specified, as this is a physical medical device (topical emulsion), not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable/Not specified, for the same reason as above.
In summary, the provided document is a 510(k) premarket notification for a topical dermatological product. It focuses on demonstrating substantial equivalence to already marketed predicate devices and mentions that functional and performance testing for safety and efficacy has been conducted. It does not contain the specific details about acceptance criteria, clinical study designs, ground truth establishment, or sample sizes for test/training sets that would be expected for a diagnostic or AI-based device.
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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:
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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
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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
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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
N/A