NuFace Trinity Plus Device

K201782 · Carol Cole Company Dba Nuface · NFO · Jan 22, 2021 · Neurology

Device Facts

• Record ID: K201782
• Device Name: NuFace Trinity Plus Device
• Applicant: Carol Cole Company Dba Nuface
• Product Code: NFO · Neurology
• Decision Date: Jan 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

Device Story

Hand-held device for facial/neck stimulation; delivers low-level microcurrent via dual chrome-plated spheres. User-operated; requires conductive gel primer. Features include adjustable microcurrent levels, 'BOOST' button for temporary output increase, and audible/LED feedback for treatment guidance. Powered by internal rechargeable battery via wireless charging cradle. Integrates Bluetooth Low Energy (BLE) for pairing with NuFACE® App to select pre-programmed treatment profiles. Device provides aesthetic benefit through muscle stimulation. Healthcare provider/user sees output via LED indicators and hears audible cues; output affects treatment duration and intensity. Designed for home use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1, -5, -10), electrical safety, EMC, wireless coexistence, and software verification/validation.

Technological Characteristics

ABS thermoplastic housing; dual chrome-plated spheres. Microcurrent output 0.3-50 Hz; Type BF isolation. Internal rechargeable Li-ion battery; wireless charging. BLE connectivity. Software-controlled. Biocompatibility per ISO 10993. Dimensions: 5.20" x 2.6" x 1.6".

Indications for Use

Indicated for over-the-counter cosmetic facial and neck stimulation in adults.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• NūFACE® Trinity (K181008)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 22, 2021

Carol Cole Company dba NuFACE % Bob Duffy President Bob Duffy Associates, Inc. 16405 Summer Sage Rd. Poway, California 92064

Re: K201782

Trade/Device Name: NuFace Trinity Plus Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: December 2, 2020 Received: December 3, 2020

Dear Bob Duffy:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm_identifies_combination product submissions. 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

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Assistant Director. Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K201782

Device Name

NūFACE® Trinity Plus

#### Indications for Use (Describe)

The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the counter cosmetic use.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> |
|----------------------------------------------|-----------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span></span> X |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

#### 510(k) Summary

This 510(k) Summary is being submitted in accordance with the requirements established by 21 CFR 807.92.

#### 1. 510(k) Submitter/Owner

Carol Cole Company dba NūFACE 1325 Sycamore Ave, Suite A Vista, CA 92081 (USA)

Contact Person: Tera Peterson Chief Executive Officer Phone: [phone] Email: [e-mail]

Date Prepared: January 21, 2020

# 2. Subject Device Name

| Device Trade / Proprietary Name: | NūFACE® Trinity Plus |
|----------------------------------|------------------------------------------------------------|
| Device Common or Usual Name: | NūFACE® Trinity Plus Facial and Neck Toning Device |
| Regulation Number: | 21 CFR 882.5890 |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NFO |
| FDA Panel: | 84 - Neurology |
| Class: | II |

# 3. Predicate Device

Below is information on the legally marketed predicate device to which the Carol Cole Company dba NuFACE is claiming substantial equivalence to:

| 510(k) Number: | K181008 |
|----------------------|------------------------------------------------------------|
| Manufacturer: | Carol Cole Company dba NūFACE |
| Trade Name: | NūFACE® Trinity |
| Regulation Number: | 21 CFR 882.5890 |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |
| Product Code: | NFO |
| FDA Panel: | 84 - Neurology |
| Class: | II |

#### 4. Subject Device Description

The NuFACE® Trinity Plus comprises the Trinity Plus device main body, a Trinity Plus microcurrent attachment head, a charging cradle and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The device and all associated components are reusable and provided non-sterile.

The NuFACE® Trinity Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual-plated chrome spheres for aesthetic purposes. The device provides audible feedback to inform the user to relocate the device to treat a new location on the skin. The device also includes "hum" features to guide the user during the treatment cycle.

{4}------------------------------------------------

The device is powered by one internal rechargeable, non-removable battery which is charged via a provided wireless charging cradle. The charging cradle connects to a provided wall-mount power adaptor. Microcurrent output is cut-off while the device is sitting on the charging cradle either charging the battery or when the battery is fully charged.

The enclosures of the device main body, the attachment head and the charging cradle are made from injection molded ABS thermoplastic material. The same ABS material is used in other FDA-cleared devices. The dual spheres on the attachment head use chromium. The same chromium plating material and process is used in the predicate device chrome-plated spheres.

The subject device, including the attachment head, measures 5.20" H x 2.6" W x 1.6" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D.

The device includes an 'ON/OFF' multifunction button to turn the device on and off, start and stop treatment, increase or decrease the microcurrent output level and pair with a smart device. The device also includes a "BOOST" button that temporarily increases the microcurrent output level.

The device includes indicator LED's to provide information to the user on the status of the device and the progress of the treatment.

The device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology allows the device to communicate with other devices running the NuFACE® App which allows the user to select and run pre-programmed treatment profiles.

The NuFACE® Trinity Plus provides microcurrent output at selected frequencies from 0.3 to 50 Hz.

# 5. Indications for Use

The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.

| Item | Subject Device | Predicate Device | Same /<br>Different |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------|
| Anatomic Sites | Face and Neck | Face and Neck | Same |
| Type of Energy<br>Output | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered via<br>dual chrome-plated spheres<br>(optimized for contact with the<br>skin) | Microcurrent is delivered via<br>dual chrome-plated spheres<br>(optimized for contact with the<br>skin) | Same |
| Energy Flow | Microcurrent continuously<br>alternates between the positive<br>and negative spheres | Microcurrent continuously<br>alternates between the positive<br>and negative spheres | Same |
| Energy Output | User adjustable | User adjustable | Same |
| Microcurrent Boost | Yes, Temporary, User<br>controllable | No | Different |
| Power Accessories | Device-specific charging cradle | Device-specific charging cradle | Same |
| Charging Method | Wireless charging | Contact charging | Different |
| Charging Circuitry | Internal to Device | Internal to Device | Same |
| | | | |
| Special<br>Requirements | Conductive Gel Primer | Conductive Gel Primer | Same |
| Wireless<br>Technology | Bluetooth Low Energy (BLE) | None | Different |
| Output Frequency | Variable | Fixed | Different |
| Basic Unit | | | |
| Characteristics | | | |
| Power Source | Internal Rechargeable Lithium<br>Ion Battery | Internal Rechargeable Lithium<br>Ion Battery | Same |
| a. Method of Line<br>Current Isolation | Type BF | Type BF | Same |
| b. Patient Leakage<br>Current | | | --- |
| 1). Normal<br>Condition | N/A - Battery operated | N/A - Battery operated | Same |
| 2). Single Fault<br>Condition | N/A - Battery operated | N/A - Battery operated | Same |
| External Power<br>Adaptor | NuFACE 5-volt power adaptor | NuFACE 7-volt power adaptor | Similar |
| Number of Output<br>Channels | 1 | 1 | Same |
| a. Synchronous or<br>Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| b. Method of<br>Channel Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| Regulated Current<br>or Regulated<br>Voltage | Both | Both | Same |
| Software/Firmware/<br>Microprocessor<br>control | Yes | Yes | Same |
| Automatic Overload<br>Trip | Not required due to circuit<br>design | Not required due to circuit<br>design | Same |
| Automatic No-Load<br>trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient Override<br>Control | Yes | Yes | Same |
| Indicator Display | | | --- |
| a. ON/OFF Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage Current<br>Level | Yes | Yes | Same |
| Automatic Shut-off<br>(Minutes) | Yes (20 minutes) | Yes (20 minutes) | Same |
| Weight | 8.8 oz. without charging base | 9 oz. without charging base | Similar |
| Dimensions of<br>Device (inch)<br>[WxLxD] | 2.6" x 5.20" x 1.6" | 2.8" x 5.1" x 1.3" | Similar |
| Housing Materials<br>and Construction | Thermoplastic | Thermoplastic | Same |
| Output<br>Specifications | | | |
| Maximum Output<br>Current Density | 0.78 mA/cm2 | 0.419 mA/cm2 | Different |
| Burst Mode (i.e.<br>pulse trains) | | | --- |
| a. Pulses per burst | 20 (10 positive and 10 negative) | 20 (10 positive and 10 negative) | Same |
| b. Pulses per second | 8.3 (@ 8.3 Hz) | 8.3 | Same |
| c. Burst duration<br>(seconds) | 2.4s (@ 8.3 Hz) | 2.4s | Same |
| d. Duty Cycle [Line<br>(b) x Line (c)] (on<br>time per burst) | Duty Cycle: 50%<br>On time per burst: 20.2s | Duty Cycle: 50%<br>On time per burst: 20.2s | Same? |
| On Time (seconds) | 60 ms (@8.3 Hz) | 60 ms | Same |
| Off Time (seconds) | 60 ms (@8.3 Hz) | 60 ms | Same |

# 6. Technological Characteristics

CONFIDENTIAL NūFACE®

{5}------------------------------------------------

CONFIDENTIAL NūFACE®

{6}------------------------------------------------

# 7. Non-Clinical Performance Data

# 7.1. Summary of Testing Performed

A program of design verification and validation testing and evaluation was conducted that includes the following:

- . Biocompatibility Evaluation
- . Safety, Performance and Bench Testing including EMC
- . Software Verification and Validation Testing

# 7.2. Conclusions from Biocompatibility Evaluation

A biocompatibility conclusions summary for the materials used in all patient-contacting parts is presented below.

Main Body / Attachment Head / Charging Cradle:

{7}------------------------------------------------

| Material | Where Used | Nature of body<br>contact | Conclusion |
|----------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ABS<br>Thermoplastic | Enclosures (housings) for<br>the subject device main<br>body, the attachment head<br>and the charging cradle. | Surface device, intact<br>skin, limited (<24h)<br>duration. | Biocompatible. This<br>material complies to ISO<br>10993-1 "Biological<br>evaluation of<br>medical devices" ISO<br>10993-5:<br>Tests for in vitro<br>cytotoxicity, ISO 10993-10:<br>Tests for irritation<br>Intracutaneous; Skin<br>sensitization; Cytotoxicity-<br>Elution method. |
| Chromium | Plated over the two spheres<br>that are part of the<br>attachment head. | Surface device, intact<br>skin, limited (<24h)<br>duration. | Biocompatible. Material<br>and manufacturing process<br>are the same as the<br>predicate. |

# Wall-mount Power Adaptor:

| Material | Where Used | Nature of body contact | Conclusion |
|----------------------|--------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------|
| ABS<br>Thermoplastic | Power Adaptor main body<br>enclosure | Surface device, intact<br>skin, limited (<24h)<br>duration. | Biocompatible. The power<br>adaptor is identical to the<br>power adaptor of the<br>predicate device. |

#### Gel Primer:

| Material | Where Used | Nature of body contact | Conclusion |
|-----------------------|----------------------|-------------------------------------------------------|----------------------------------------|
| NūFACE®<br>Gel Primer | Accessory to device. | Surface device, intact skin, limited (<24h) duration. | Biocompatible. 510K cleared (K161654). |

7.3. Conclusions from Safety, Performance and Bench Testing

The safety and performance testing results for EMC, Electrical Safety, Wireless Coexistence and bench testing concluded that the NuFACE® Trinity Plus device meets and complies with the safety and performance of the applicable standards and bench testing requirements.

7.4. Conclusions from Software Verification and Validation

The software verification and validation results concluded that the NuFACE® Trinity Plus device meets and complies with the applicable software requirements specifications.

# 8. Animal Testing

The substantial equivalence for the subject device will not be supported by animal testing. Therefore, no animal testing was conducted.

# 9. Clinical Testing

The substantial equivalence for the subject device will not be demonstrated by results of clinical testing. Therefore, no clinical testing was performed.

{8}------------------------------------------------

#### 10. Substantial Equivalence

The NuFACE® Trinity Plus device has the same intended use and indications for use as the predicate device. The subject device key technological characteristics are nearly identical to those of the predicate device.

The Microcurrent Boost can temporarily increase the microcurrent output to a level that exceeds that of the predicate device. However, the increased microcurrent level does not exceed that of a legally marketed reference device with the same intended use and classification, and therefore does not affect the safety and effectiveness of the subject device when used as labeled.

The wireless charging, while different from the contact charging used in the predicate device, only affects the method used to charge the subject device when not in use. Therefore, this difference does not affect the safety and effectiveness of the subject device when used as labeled.

The Bluetooth Low Energy (BLE) wireless technology only allows the subject device to communicate with other devices running the NūFACE® App which allows the user to select and run pre-programmed treatment profiles. Since the pre-programmed treatment profiles are already provided in the device software, this difference does not affect the safety and effectiveness of the subject device when used as labeled.

The new Bluetooth Low Energy (BLE) wireless connectivity introduced in the subject device design is a widely used multi-industry-proven technology that augments the overall user experience. The results of EMC and Wireless Coexistence testing provided in this premarket notification demonstrate that the new Bluetooth wireless connectivity poses low risk to the user of the subject device.

During design and development, a Risk Analysis of the subject device was used to identify potential Hazards that could occur in use of the device, or in the event of Failure Modes of device components. The risk analysis also included those risks that could potentially be introduced by the addition of the new technological characteristics described above. The Risk Analysis was used to identify risk reduction measures which have been incorporated in the subject device design and labeling. As a result, the residual risks for the NuFACE® Trinity Plus device are low.

# 11. Conclusion

The documentation and test results provided in this submission and a comparison of intended use, principle of operation, performance data, design and overall technological characteristics, demonstrates that the NuFACE® Trinity Plus device is substantially equivalent to the predicate device.