Trinity ELE Plus and Trinity ELE Plus Pro

K201906 · Carol Cole Company Dba Nuface · NFO · Feb 24, 2021 · Neurology

Device Facts

• Record ID: K201906
• Device Name: Trinity ELE Plus and Trinity ELE Plus Pro
• Applicant: Carol Cole Company Dba Nuface
• Product Code: NFO · Neurology
• Decision Date: Feb 24, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trinity ELE Plus is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

Device Story

Hand-held device for facial stimulation; delivers low-level microcurrent via dual chrome-plated wands. User-operated; intended for over-the-counter cosmetic use. Device features multi-function button for power, treatment control, and Bluetooth pairing; includes 'BOOST' button for temporary output increase. Provides audible feedback and 'hum' features to guide treatment cycles; LED indicators show device status and treatment progress. Powered by internal rechargeable battery via wireless charging cradle. Pairs with NūFACE App via Bluetooth Low Energy (BLE) to select/run pre-programmed treatment profiles. Microcurrent output is user-adjustable (0.3–50 Hz). Benefits include aesthetic facial toning. Healthcare provider involvement is not required; device is for consumer self-use.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, biocompatibility evaluation, and software verification/validation.

Technological Characteristics

Microcurrent stimulation; pulsed biphasic waveform; modulated square shape. Materials: ABS thermoplastic enclosures, chromium-plated wands. Power: Internal rechargeable Li-ion battery, wireless charging. Connectivity: Bluetooth Low Energy (BLE). Output: 0.3–50 Hz variable frequency; user-adjustable current. Dimensions: 6.1" x 2.4" x 1.2". Standards: ANSI AAMI 60601-1, IEC 60601-1-11.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation.

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

• Trinity ELE (K131251)

Reference Devices

• NūFACE® Plus (K103472)
• NūFACE® Gel Primer (K161654)

Submission Summary (Full Text)

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February 24, 2021

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

Re: K201906

Trade/Device Name: Trinity ELE Plus and Trinity ELE Plus Pro Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NFO Dated: January 20, 2021 Received: January 25, 2021

Dear Bob Duffy:

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. 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/cfpmn/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, 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

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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

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# Indications for Use

510(k) Number (if known) K201906

Device Name

Trinity ELE Plus and Trinity ELE Plus Pro

#### Indications for Use (Describe)

The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.

| 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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### 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] |

February 23, 2021 Date Prepared:

# 2. Subiect Device Name

| | Device Trade / Proprietary Name: | Trinity ELE Plus and Trinity ELE Plus Pro |
|--|----------------------------------|------------------------------------------------------------|
| | Device Common or Usual Name: | Trinity ELE Plus Facial 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 NūFACE is claiming substantial equivalence to:

| 510(k) Number: | K131251 |
|----------------------|------------------------------------------------------------|
| Manufacturer: | Carol Cole Company dba NūFACE |
| Trade Name: | Trinity ELE |
| 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. Reference Device

Below is information on the legally marketed predicate device which the Carol Cole Company dba NūFACE is using as a reference device:

| 510(k) Number: | K103472 |
|----------------------|------------------------------------------------------------|
| Manufacturer: | Carol Cole Company dba NūFACE |
| Trade Name: | NūFACE® Plus |
| Regulation Number: | 21 CFR 882.5890 |
| Classification Name: | Transcutaneous electrical nerve stimulator for pain relief |

#### NūFACE®

Page 1 of 7

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| Product Code: | NFO |
|---------------|----------------|
| FDA Panel: | 84 - Neurology |
| Class: | II |

### 5. Device Description

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

The Trinity ELE Plus is a hand-held device that produces low levels of microcurrent which is discharged through two dual chrome-plated precise wands 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.

The subject 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 subject 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 chrome-plated precise wands on the attachment head use chromium. The same chromium material is used in the predicate device dual chrome-plated precise wands.

The subject device, including the attachment head, measures 6.1" H x 2.4" W x 1.2" D. The charging cradle measures 2.3" H x 3.0" W x 2.7" D.

The device includes an 'ON/OFF' multi-function 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 subject device is the capable of pairing with compatible smart devices using Bluetooth Low Energy (BLE) wireless communications technology. This technology 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.

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

The Trinity ELE Plus is available in two models, a Standard model and a 'Pro'' model. The Trinity ELE Plus Standard model has a maximum output current without Boost of 170 uA, and the Trinity ELE Plus Pro model has a maximum output current without Boost of 200 uA. All other aspects of the Trinity ELE Plus except those related to maximum output current, are the same between the Standard model and Pro models.

# 6. Intended Use

The Trinity ELE Plus is intended for facial stimulation and is indicated for over-the-counter cosmetic use.

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# 7. Technological Characteristics

| Item | Subject Device | Predicate Device | Same / Different |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|------------------|
| Type of Energy<br>Output | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered via<br>dual chrome-plated precise<br>wands (optimized for contact<br>with the skin) | Microcurrent is delivered via<br>dual chrome-plated precise<br>wands (optimized for contact<br>with the skin) | Same |
| Energy Flow | Microcurrent continuously<br>alternates between the positive Microcurrent continuously<br>alternates between the positive<br>and negative wands Same | | |
| Energy Output | User adjustable | User adjustable | Same |
| Microcurrent Boost | Yes, Temporary, User<br>controllable | No | Different |
| Energy Power<br>Source | Internal Rechargeable Lithium<br>Ion Battery | Internal Rechargeable NiMH<br>Battery | 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 |
| Power Supply Type | Pre-approved wall-mount Power<br>Adaptor | Pre-approved wall-mount<br>Power Adaptor | Same |
| Special<br>Requirements | Requires Conductive Gel | Requires Conductive Gel | Same |
| Wireless<br>Technology | Bluetooth Low Energy (BLE) | None | Different |
| Output Frequency | Variable | Fixed | Different |

# 8. Qutput Specifications

The Table below reflects the results of the testing performed to demonstrate substantial equivalence to the predicate.

| Item | Subject Device<br>Specification | Predicate Device<br>Specification | Same /<br>Different |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|---------------------|
| Waveform Type | Pulsed Biphasic | Pulsed Biphasic | Same |
| Shape (e.g., rectangular, spike) | Modulated Square | Modulated Square | Same |
| Item | Subject Device<br>Specification | Predicate Device<br>Specification | Same /<br>Different |
| Maximum Output Voltage | Trinity ELE Plus<br>170 mV @ 500 Ω<br>688 mV @ 2 kΩ<br>3.4 V @ 10 kΩ<br>Trinity ELE Plus Pro<br>208 mV @ 500 Ω<br>840 mV @ 2 kΩ<br>4.3 V @ 10 kΩ | 68 mV @ 500 Ω<br>283 mV @ 2 kΩ<br>1.31 V @ 10 kΩ | Different |
| Maximum Output Current | Trinity ELE Plus<br>243 μA @ 500 Ω<br>245 μA @ 2 kΩ<br>246 μA @ 10 kΩ<br>Trinity ELE Plus Pro<br>297 μA @ 500 Ω<br>299 μA @ 2 kΩ<br>301 μA @ 10 kΩ | 135 μA @ 500 Ω<br>134 μA @ 2 kΩ<br>133 μA @ 10 kΩ | Different |
| Output Tolerance | +/- 10% (RMS) | +/- 2% | Different |
| Pulse Period (Pulse Width) | Varies w/ Frequency<br>(60 msec @ 8.33Hz) | 60 msec | Different |
| Output Frequency (Hz) | 0.3 — 50 Hz<br>(Default 8.3 Hz) | 8.3 Hz | Different |
| For Interferential Waveforms<br>Only | | | |
| Beat Frequency (Hz) | No Beat Frequency | No Beat Frequency | Same |
| For Multiphasic Modes Only | | | |
| Symmetrical Phases | Not Multiphasic | Not Multiphasic | Same |
| Phase Duration | Not Determined | Not Determined | Same |
| Net Charge (µC per pulse) | N/A - Battery Operated | N/A - Battery Operated | Same |
| Maximum phase charge | Trinity ELE Plus<br>14.78 μC @ 10K Ω<br>Trinity ELE Plus Pro<br>18.17 μC @ 10K Ω | 8.08 μC @ 500 Ω | Different |
| Item | Subject Device Specification | Predicate Device Specification | Same / Different |
| Maximum current density | Trinity ELE Plus<br>0.947 mA/cm² @ 10K Ω<br><br>Trinity ELE Plus Pro<br>1.165 mA/cm² @ 10K Ω | 0.519 mA/cm² @ 500 Ω | Different |
| Maximum power density<br>(μW/cm²) | Trinity ELE Plus<br>2.331 mW/cm² @ 10K Ω<br><br>Trinity ELE Plus Pro<br>3.525 mW/cm² @ 10K Ω | 670 μW/cm² @ 500 Ω | Different |
| Burst mode information | | | |
| a. Pulses per burst | 20 | 20 | Same |
| b. Pulses per second | Varies w/ Frequency<br>(8.3 @ 8.33Hz) | 8.3 | Same |
| c. Burst duration (sec) | Varies w/ Frequency<br>(2.4 @ 8.33Hz) | 2.4 | Same |
| d. Duty Cycle (%) | 50 | 50 | Same |
| ON time | Varies w/ Frequency<br>(60ms @ 8.33Hz @ 50%<br>Duty Cycle) | 60ms | Different |
| OFF time | Varies w/ Frequency<br>(60ms @ 8.33Hz @ 50%<br>Duty Cycle) | 60ms | Different |

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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.

# 9. Non-Clinical Performance Data

9.1. Summary of Testing Performed

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

- . Biocompatibility Evaluation
# NuFACE®

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

# 9.2. Conclusions from Biocompatibility Evaluation

A biocompatibility conclusions summary for the all patient-contacting materials is presented below. These conclusions are described fully in detail in Section 15 of this premarket notification.

| Material | Where Used | Nature of body 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 is used in other<br>FDA-cleared devices. |
| Chromium | Plated over the two precise<br>wands 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. |

### Main Body / Attachment Head / Charging Cradle:

### Wall-mount Power Adaptor:

| 11 111 111 111 111 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 11 | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|
| 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)<br>duration. | Biocompatible. 510K cleared (K161654). |

9.3. Conclusions from Safety, Performance and Bench Testing

The safety and performance testing results for EMC, Wireless Coexistence and bench testing concluded that the Trinity ELE Plus device meets and complies with the safety and performance of the applicable standards and bench testing requirements. These results and conclusions are described fully in detail in Sections 17 and 18 of this premarket notification.

The electrical safety tests for compliance to the ANSI AAMI 60601-1 and IEC 60601-1-11 standards are currently being conducted and will be provided to the FDA before the subject device is released to market.

9.4. Conclusions from Software Verification and Validation

The software verification and validation results concluded that the Trinity ELE Plus device meets and complies with the applicable software requirements specifications. These results and conclusions are described fully in detail in Sections 16 of this premarket notification.

# 10. Animal Testing

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

#### NūFACE®

{9}------------------------------------------------

# 11. Clinical Testing

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

# 12. Substantial Equivalence

The Trinity ELE 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 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 Trinity ELE Plus device are low.

# 13. Overall Conclusion

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