The NuFACE Gel Primer is a clear, viscous and chloride-free formulation. The gel is to be applied to the area under an electrode to reduce the impedance of the contact interface between the electrode surface and the skin.

AI/ML Overview

The provided text is a 510(k) summary for the NuFACE Gel Primer, a medical device. This type of document is a premarket submission made to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. While it contains information about testing and compliance, it does not describe a study that uses human experts to establish ground truth or compare AI performance, as typically found in studies for AI/ML-based medical devices.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and the performed performance testing.

Acceptance Criteria and Reported Device Performance

Criteria	Reported Device Performance	Comments
Intended Use	"The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity."	Equivalent to predicate (Thera-Cream)
Environment of Use	Home	Same as predicate
Intended User	Adults 18 years of age or older	Equivalent to predicate (Adults)
Where Used	Topically on intact skin	Same as predicate
Conductive Material	Salt (Magnesium Sulfate)	Equivalent to predicate (Conductive Copper Salts)
Sterilization	Non-sterile	Same as predicate
Biocompatibility	Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10	Same as predicate (Complies with ISO 10993-1, ISO 10993-5, and ISO 10993-10)
Chemical Safety	Non-OSHA PEL	Same as predicate
Volume or Weight	2 fl. oz. and 5 fl. oz. tube	Equivalent to predicate (4.2 fl. oz. tube)
Physical, Chemical & Biological Characteristics	Meets established specifications for color, odor, appearance, pH, microbiological growth, specific gravity and viscosity.	All tests demonstrate compliance.
Conductivity	Meets established specifications.	All tests demonstrate compliance.
Packaging Compatibility	Meets established specifications.	All tests demonstrate compliance.
Stability	Meets established specifications.	All tests demonstrate compliance.

Study Details (based on available information):

Sample sized used for the test set and the data provenance: Not applicable. The document discusses device characteristics and performance testing internally, not on a "test set" of patient data for AI evaluation.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI algorithm is not relevant for this device.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: No. This is not an AI/ML device, so such a study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML algorithm.
The type of ground truth used: For the physical, chemical, and biological characteristics, the "ground truth" or reference is established specifications and industry standards. For biocompatibility, the ground truth is compliance with ISO 10993 standards and negative results for cytotoxicity, irritation, and sensitization. These are not 'ground truth' in the context of an AI study (e.g., pathology report, clinical outcome).
The sample size for the training set: Not applicable. This device does not involve a training set as it is not an AI/ML product.
How the ground truth for the training set was established: Not applicable.

Summary of the device proving it meets the acceptance criteria:

The NuFACE Gel Primer's acceptance criteria are primarily based on its physical, chemical, and biological characteristics, its performance in improving skin conductivity, and its biocompatibility. The study that proves the device meets these criteria involved a series of performance tests:

Physical, chemical and biological characteristics: The gel was tested for color, odor, appearance, pH, microbiological growth, specific gravity, and viscosity. The document states that "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
Conductivity: The gel's ability to improve skin conductivity was tested. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
Biocompatibility: This was a critical aspect, evaluated according to ISO 10993-1. Specific tests included:
- In vitro Cytotoxicity: ISO 10993-5
- Skin Sensitization: ISO 10993-10
- Skin Irritation: ISO 10993-10
  All biocompatibility testing was performed in accordance with CFR 21 Part 58 Good Laboratory Practice (GLP) and "The test results demonstrate the NuFACE Gel Primer is biocompatible when used as intended."
Packaging compatibility: Tested to ensure the gel remains stable and effective within its packaging. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."
Stability: Tested to confirm the product's integrity and performance over time. "The test results demonstrate that the NuFACE Gel Primer meets the established specifications."

The conclusion explicitly states: "Based on the results of the performance tests and the biocompatibility evaluation, NuFACE Gel Primer is substantially equivalent to the predicate device in safety." This indicates that meeting these established specifications and demonstrating biocompatibility are the primary means by which the device proves it meets its acceptance criteria for safety and effectiveness, especially in comparison to its predicate device.

Summary

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Image /page/0/Picture/1 description: The image is a 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 top half of the circle. In the center of the circle is an emblem that features three stylized human profiles facing to the right, with the profiles overlapping each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 30, 2016

Carol Cole Company Merle Kovacic Regulatory Affairs/Quality Assurance Specialist 1325 Sycamore Avenue, Suite A Vista, California 92081

Re: K161654

Trade/Device Name: NuFACE Gel Primer Regulation Number: 21 CFR 882.1275 Regulation Name: Electroconductive Media Regulatory Class: Class II Product Code: GYB Dated: December 5, 2016 Received: December 7, 2016

Dear Merle Kovacic:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education 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.

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K161654

Device Name NuFACE Gel Primer

Indications for Use (Describe)

The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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K161654 S002

SECTION 5. 510(K) SUMMARY

Date Prepared: May 28, 2016

510(k) Submitter/Owner

Carol Cole Company dba NuFACE® 1325 Sycamore Ave, Suite A Vista, CA 92081, USA

Contact Information:

Donald Ellis, Quality Assurance/ Regulatory Affairs Manager Phone: (760) 509-1264 Facsimile: (760) 650-3667 Email: DELLIS@MYNUFACE.COM

Device Names

Device Trade/ Proprietary Name:	NuFACE® Gel Primer
Device Common or Usual Name:	Electroconductive gel
Classification Name:	Media, Electroconductive
Regulation Number:	21 CFR 882.1275
Product Code:	GYB

Predicate Device

The legally marketed device to which NuFACE® claims substantial equivalence is the Prizm Medical, Inc. Thera-Cream™.

510(k) Number:	K032239
Manufacturer:	Prizm Medical, Inc.
Trade Name:	Thera-Cream
Product Code:	GYB

Device Description

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Intended Use

The NuFACE Gel Primer is intended to be used with NuFACE microcurrent devices to improve skin conductivity.

Technological Characteristics

The key technological characteristics of the NuFACE Gel Primer are:

1. conductivity
1. biocompatibility, and
1. viscosity
1. pH

The NuFACE Gel Primer is biocompatible for surface contact with intact skin, and therefore complies with:

a. ISO 10993-5 for in vitro Cytotoxicity
b. ISO 10993-10 for Skin Sensitization
c. ISO 10993-10 for Skin Irritation

The proposed device is formulated with a viscosity which permits the microcurrent device to easily glide across the skin for optimum results. It is a nonsterile topical qel applied to intact skin.

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Predicate Comparison

As shown below in Table 1, the NuFACE Gel Primer is substantially equivalent to the predicate device in safety and effectiveness.

ltems	NuFACE Gel Primer(Proposed Device)	Thera-Cream(Proposed Predicate)	SubstantialEquivalenceComments
510(k) No.	K161654	K032239	N/A
Intended Use	The NuFACE Gel Primer isintended to be used withNuFACE microcurrentdevices to improve skinconductivity.	Thera-Cream is aconductive cream, whichincreases skin conductivityfor electrotherapytreatment and wasdeveloped for use with thePrizm brandelectrotherapy units andthe Intelligent Textilesbrand of garmentelectrodes.	Equivalent topredicate
Environment ofUse	Home	Home	Same aspredicate
Intended User	Adults 18 years of age orolder	Adults	Equivalent toPredicate
Where Used	Topically on intact skin	Topically on intact skin	Same aspredicate
ConductiveMaterial	Salt (Magnesium Sulfate)	Conductive Copper Salts	Equivalent toPredicate
Sterilization	Non-sterile	Non-sterile	Same aspredicate
Biocompatibility	Complies with ISO 10993-1, ISO 10993-5, and ISO10993-10	Complies with ISO 10993-1,ISO 10993-5, and ISO10993-10	Same aspredicate
Chemical Safety	Non-OSHA PEL	Non-OSHA PEL	Same aspredicate
Volume orWeight	2 fl. oz. and 5 fl. oz. tube	4.2 fl. oz. tube	Equivalent toPredicate

Table 1 Predicate Device Comparison

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Performance Testing

The NuFACE Gel Primer was tested for the following characteristics:

1. Physical, chemical and biological characteristics including color, odor, appearance, pH, microbiological growth, specific gravity and viscosity;
1. Conductivity;
1. Biocompatibility;
1. Packaqing compatibility; and
1. Stability.

The test results demonstrate that the NuFACE Gel Primer meets the established specifications.

Biocompatibility Evaluation

The biocompatibility of the NuFACE Gel Primer was evaluated in accordance with ISO 10993-1 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process. The representative samples of the gel were tested for cytotoxicity (ISO 10993-5), skin irritation and skin sensitization (ISO 10993-10). All testing was performed in accordance with CFR 21 Part 58 Good Laboratory Practice (GLP). The test results demonstrate the NuFACE Gel Primer is biocompatible when used as intended.

Conclusion

Based on the results of the performance tests and the biocompatibility evaluation, NuFACE Gel Primer is substantially equivalent to the predicate device in safety.

Regulation Number and Section

§ 882.1275 Electroconductive media.

(a)
Identification. Electroconductive media are the conductive creams or gels used with external electrodes to reduce the impedance (resistance to alternating current) of the contact between the electrode surface and the skin.(b)
Classification. Class II (performance standards).