NuFACE Gel Primer

K161654 · Carol Cole Company · GYB · Dec 30, 2016 · Neurology

Device Facts

• Record ID: K161654
• Device Name: NuFACE Gel Primer
• Applicant: Carol Cole Company
• Product Code: GYB · Neurology
• Decision Date: Dec 30, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1275
• Device Class: Class 2

Intended Use

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

Device Story

NuFACE Gel Primer is a clear, viscous, chloride-free, non-sterile topical gel; applied to intact skin under electrodes of NuFACE microcurrent devices. Function: reduces impedance at electrode-skin interface; improves skin conductivity; facilitates smooth gliding of microcurrent device across skin. Used in home environment by adult users. Output is physical interface medium; enables effective delivery of microcurrent therapy. Benefits: ensures consistent electrical contact; optimizes device performance.

Clinical Evidence

Bench testing only. No clinical data. Performance testing evaluated physical/chemical characteristics (pH, viscosity, specific gravity, microbiological growth), conductivity, packaging compatibility, and stability. Biocompatibility testing conducted per ISO 10993-1, including cytotoxicity (ISO 10993-5), skin irritation, and skin sensitization (ISO 10993-10) under GLP conditions. Results demonstrate compliance with specifications.

Technological Characteristics

Clear, viscous, chloride-free topical gel. Conductive agent: Magnesium Sulfate. Biocompatibility: ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin irritation/sensitization). Non-sterile. Formulated for specific viscosity to facilitate electrode glide. Standalone topical application.

Indications for Use

Indicated for use by adults 18 years of age or older to improve skin conductivity when using NuFACE microcurrent devices on intact skin.

Regulatory Classification

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.

Predicate Devices

• Thera-Cream (K032239)

Submission Summary (Full Text)

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