NuFACE Gel Primer

• K Number: K161654
• Device Name: NuFACE Gel Primer
• Manufacturer: Carol Cole Company
• Date Cleared: 2016-12-30 ( 198 days)
• Product Code: GYB
• Regulation Number: 882.1275

Intended Use

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

Device Description

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.

Predicate Devices

K032239

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical, chemical, and biological properties of a gel primer, not on any computational or algorithmic functions. There are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML technologies.

Therapeutic

No
The NuFACE Gel Primer is an accessory intended to improve skin conductivity for microcurrent devices, and its purpose is to reduce impedance for the proper function of the associated microcurrent device, not to provide a therapeutic effect itself.

Diagnostic

No

The device is a gel primer intended to improve skin conductivity for microcurrent devices, not to diagnose a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "clear, viscous and chloride-free formulation" and describes its physical and chemical properties, indicating it is a physical substance, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the NuFACE Gel Primer is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is to improve skin conductivity for use with a microcurrent device. This is a topical application on intact skin for a cosmetic or therapeutic purpose related to the skin itself, not for diagnosing a condition by examining samples taken from the body.
• Device Description: The description focuses on the physical and chemical properties of the gel for its function as a conductivity enhancer.
• Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
• Anatomical Site: It is applied topically on intact skin, which is not typical for IVD testing.
• Performance Studies: The performance studies focus on the physical, chemical, biological, and biocompatibility characteristics of the gel itself, not on its ability to diagnose a condition.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The NuFACE Gel Primer does not fit this definition. It is an accessory to a medical device (the microcurrent device) that facilitates its intended function on the skin.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GYB

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Topically on intact skin

Indicated Patient Age Range

Adults 18 years of age or older

Intended User / Care Setting

Home

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)

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;
2. Conductivity;
3. Biocompatibility;
4. Packaqing compatibility; and
5. Stability.
   The test results demonstrate that the NuFACE Gel Primer meets the established specifications.

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.

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.

K032239

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

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).

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Facsimile: [phone] Email: [e-mail]

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

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.

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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
• 2. biocompatibility, and
• 3. viscosity
• 4. 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) | Substantial
Equivalence
Comments |
|------------------------|-------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| 510(k) No. | K161654 | K032239 | N/A |
| Intended Use | The NuFACE Gel Primer is
intended to be used with
NuFACE microcurrent
devices to improve skin
conductivity. | Thera-Cream is a
conductive cream, which
increases skin conductivity
for electrotherapy
treatment and was
developed for use with the
Prizm brand
electrotherapy units and
the Intelligent Textiles
brand of garment
electrodes. | Equivalent to
predicate |
| Environment of
Use | Home | Home | Same as
predicate |
| Intended User | Adults 18 years of age or
older | Adults | Equivalent to
Predicate |
| Where Used | Topically on intact skin | Topically on intact skin | Same as
predicate |
| Conductive
Material | Salt (Magnesium Sulfate) | Conductive Copper Salts | Equivalent to
Predicate |
| Sterilization | Non-sterile | Non-sterile | Same as
predicate |
| Biocompatibility | Complies with ISO 10993-
1, ISO 10993-5, and ISO
10993-10 | Complies with ISO 10993-1,
ISO 10993-5, and ISO
10993-10 | Same as
predicate |
| Chemical Safety | Non-OSHA PEL | Non-OSHA PEL | Same as
predicate |
| Volume or
Weight | 2 fl. oz. and 5 fl. oz. tube | 4.2 fl. oz. tube | Equivalent to
Predicate |

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;
• 2. Conductivity;
• 3. Biocompatibility;
• 4. Packaqing compatibility; and
• 5. 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.