TRINITY ELE

K131251 · Carol Cole Company · NFO · Oct 1, 2013 · Neurology

Device Facts

• Record ID: K131251
• Device Name: TRINITY ELE
• Applicant: Carol Cole Company
• Product Code: NFO · Neurology
• Decision Date: Oct 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C). The anatomical site for application of the Trinity ELE is the face.

Device Story

Trinity ELE is a non-invasive, handheld, battery-operated facial stimulation device for at-home, over-the-counter cosmetic use. It features dual chrome-plated spheres designed for contact with smaller facial areas. The device delivers low-level, pulsed biphasic micro-current (53 to 192 microamps) to the skin and muscles to increase facial contour and firm skin. Operation involves applying a conductive gel, turning the device on, and gliding the spheres over the face. The device provides audio cues (beeps) to signal when to relocate the device to a new treatment area and when the device is powered off. Users can adjust intensity levels via buttons. The device includes a charging cradle and internal batteries. By maintaining specific current density, the device aims to provide cosmetic skin toning benefits similar to the predicate device.

Clinical Evidence

No clinical data. Substantial equivalence is based on bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and comparative output performance testing (waveform, voltage, current, pulse width, frequency, and current density) against the predicate device.

Technological Characteristics

Non-invasive, handheld, battery-operated (4x NiMH). Case: injection-molded thermoplastic resin. Dual chrome-plated spheres. Output: pulsed biphasic, modulated square waveform. Frequency: 8.33 Hz. Current: 53-192 microamps. Connectivity: standalone with charging cradle. Sterilization: N/A. Software: microprocessor-controlled with audio/visual feedback (LEDs, beeps).

Indications for Use

Indicated for over-the-counter cosmetic facial 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

• NuFACE® Trinity (K103472)

Submission Summary (Full Text)

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K13125/

ОСТ 0 1 2013

510(k) Summarv Trinity ELE Device

Updated: October 1st. 2013

### CONTACT INFORMATION

Rand Daoud, Compliance Specialist Carol Cole Company 1325 Sycamore Ave, Suite A Vista, California 92081

Phone: [phone] x126 Facsimile: [phone] Email: [e-mail]

### DEVICE NAME

Trade Name: Trinity ELE Common Name: Facial Stimulation Device Classification Name: Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890) Product Code: NFO

### PREDICATE DEVICE

The Carol Cole Company is claiming substantial equivalence with its own device, the NuFACE® Trinity device, cleared as the NuFACE® Plus under 510(k) K103472. This Abbreviated 510(k) submission is a new design based on the manufacturer's cleared device. Both devices are for transcutaneous electrical nerve stimulation for cosmetic use.

### INDICATIONS FOR USE/INTENDED USE

The Trinity ELE is intended for facial stimulation and is indicated for over-the-counter cosmetic use. (21 CFR 801 Subpart C).

The anatomical site for application of the Trinity ELE is the face.

### TECHNOLOGICAL CHARACTERISTICS

The Trinity ELE is a non-invasive at home, over-the-counter facial stimulation device. The dual spheres of the Trinity ELE are designed for optimal contact with smaller surface areas of the face. The Trinity ELE is extremely responsive as it delivers soft wave micro-current in the millionths of an ampere and has the ability to increase facial contour and firm the skin and muscles. The Trinity ELE continually alternates between the positive and negative probes, and allows the user to adjust settings from approximately 53 to 192 microamps for a personalized comfort level.

The Trinity ELE measures 2.8" W x 6.2" L x 1.3" D. Its outer case is injection molded of thermoplastic resin. The device comes with a Charging Cradle, which measures 3.1" W x 4.0" L x 3.3" D, to charge the internal batteries of the main body when not in use. The Charging Cradle is powered by DC power from a pre-approved wall adapter Power Supply provided with the device. All charging circuitry is contained within the main body unit itself.

An ascending sequence of beeps informs the customer the Trinity ELE is ready for

#### Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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use. When the user turns off the device, a descending tone is emitted.

To promote proper use, a single audio beep informs the user to relocate the device to treat a new location on the skin. The user can also adjust output by pressing the + or - intensity buttons to increase or decrease the micro-current output.

### COMPLIANCE DATA

The Trinity ELE was tested and found to conform with the FDA's performance Standards set forth in 21 CFR §898.

The Trinity ELE was also tested and found to be in compliance with IEC 60601-1-2 for radiated and power line conducted emissions. The Trinity ELE was evaluated and found to be in compliance with IEC 60601-1 for Electrical Safety.

### SUBSTANTIAL EQUIVALENCE

The Trinity ELE has the same intended use and indications for use as the predicate device. The device also has similar technological characteristics. During design and development, a Risk Analysis of the 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 was used to identify risk reduction measures which have been incorporated in the device design and labeling.

The determination of substantial equivalence for the Trinity ELE is based on an assessment of non-clinical performance. This assessment included a comparison of the output of the Trinity ELE to that of the predicate. The output performance testing included:

- 1. Waveform type (e.g., pulsed monophasic, biphasic)
- Waveform Shape (e.g., rectangular, spike, rectified sinusoidal) 2.
- Maximum Output Voltage 3.
- 4. Maximum Output Current
- Output Tolerance 5.
- 6. Puise Width
- 7. Output Frequency
- 8. Maximum Phase Charge
- Maximum Current Density თ

10. Maximum Power Density (using smallest electrode conductive surface area)

- 11. Burst Mode (i.e., pulse trains)
- a. Pulses per burst
- b. Pulses per second
- c. Burst duration
- d. Duty Cycle
- 12. ON Time
- 13. OFF Time

The results are provided in Section 3 (Output Specifications) below. As shown in the Substantial Equivalence Comparison Table:

- 1. Waveform type is identical to the predicate
- 2. Waveform Shape is identical to the predicate
- 3. Maximum Output Voltage is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- 4. Maximum Output Current is less than the predicate due to maintaining the

#### Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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Maximum Current Density identical to the predicate

- Output Tolerance is identical to the predicate റ്റ്
- 6. Pulse Width is identical to the predicate
- Output Frequency is identical to the predicate 7.
- 8. Maximum Phase Charge is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- ഗ് Maximum Current Density is identical to the predicate
- 10. Maximum Power Density is less than the predicate due to maintaining the Maximum Current Density is identical to the predicate
- 11. Burst Mode (i.e., pulse trains)
- a. Pulses per burst is identical to the predicate
- b. Pulses per second is identical to the predicate
- Burst duration is identical to the predicate c.
- Duty Cvcle is identical to the predicate o
- 12. ON Time is identical to the predicate

13. OFF Time is identical to the predicate

The dual spheres of the Trinity ELE are smaller in size than the predicate to allow optimal contact with smaller areas of the face. To maintain the Maximum Current Density with these smaller spheres identical to the predicate with larger spheres, the output current was reduced corresponding to the reduced contact area. As a result, the Maximum Output Voltage, Maximum Output Current, Maximum Phase Charge, and Maximum Power Density were correspondingly reduced.

The results support a determination of substantial equivalence in that the smaller spheres of the Trinity ELE treat a smaller area of the face with the same Current Density as the predicate.

### Carol Cole Company Trinity ELE Device 510(k) Submission 510(k) Summary

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# Section 1: Device Descriptions

| Section 1: Device<br>Descriptions | Trinity ELE Device<br>New Device | NuFACE® Trinity<br>Predicate Device |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. 510(k) Number | K131251 | K103472 |
| 2. Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 |
| 3. Regulation Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator |
| 4. Regulatory Class | Class II | Class II |
| 5. Product Code | NFO | NFO |
| 6. Intended Use | Stimulate the face; skin toning | Stimulate the face: skin toning |
| 7. Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use |
| 8. Technological<br>Characteristics | The Trinity ELE is an over-the-counter facial<br>stimulation device. The chrome plated dual spheres<br>of the Trinity ELE are designed to gently glide over<br>the skin to deliver low-level electrical impulses to<br>strategic locations on the face. The Trinity ELE<br>probes are designed for optimal contact with smaller<br>surface areas of the face.<br><br>The Trinity ELE microcurrent continually alternates<br>between the positive and negative probes, and allows<br>the user to adjust settings from approximately 53 to<br>192 microamps for a personalized comfort level.<br><br>The Trinity ELE device measures 2.8" W x 6.2" L x<br>1.3" D. Its outer case is injection molded of<br>thermoplastic resin. The device comes with a<br>Charging Cradle, which measures 3.1" W x 4.0" L x<br>3.3" D, to charge the internal batteries of the main<br>body when not in use. The Charging Cradle is<br>powered by DC power from a pre-approved wall<br>adapter Power Supply provided with the device. All<br>charging circuitry is contained within the main body<br>unit itself.<br><br>To turn the device on, the on/off button is pressed.<br>An ascending sequence of beeps and one to five blue<br>LED lights illuminate indicating the unit is ready for<br>use. Users then follow the instructions for use. The<br>Trinity ELE requires the use of a conductive gel or<br>medium. The user can also adjust output level by<br>pressing the + or - intensity buttons to increase or<br>decrease the microcurrent output.<br><br>To promote proper use and feedback to the user, the<br>Trinity ELE beeps to cue the user to relocate the<br>device after approximately 5 seconds of treatment.<br>When the user turns off the device, a descending tone<br>is emitted. | The NuFACE® Trinity is an over-the-counter<br>facial toning device. The chrome plated dual<br>spheres of the NuFACE® Trinity are designed to<br>gently glide over the skin to deliver low-level<br>electrical impulses to strategic locations on the<br>face. The NuFACE® Trinity probes are designed<br>for optimal contact with the face.<br><br>The NuFACE® Trinity microcurrent continually<br>alternates between the positive and negative<br>probes, and allows the user to adjust settings<br>from approximately 0 to 400 microamps for a<br>personalized comfort level.<br><br>The NuFACE® Trinity device measures 2.8" W<br>x 5.1" L x 1.3" D Its outer case is injection<br>molded thermoplastic resin. The device comes<br>with a Charging Cradle, which measures 3.1" W<br>x 4.0" L x 3.3" D, to charge the internal batteries<br>of the main body when not in use. The Charging<br>Cradle is powered by DC power from a pre-<br>approved wall adapter Power Supply provided<br>with the device. All charging circuitry is<br>contained within the main body unit itself.<br><br>To turn the device on, the on/off button is<br>pressed. An ascending sequence of beeps and<br>one to five blue LED lights illuminate indicating<br>the unit is ready for use. Users then follow the<br>instructions for use. The NuFACE® Trinity<br>device requires the use of a conductive gel or<br>medium. The user can also adjust output level by<br>pressing the + or - intensity buttons to increase<br>or decrease the microcurrent output.<br><br>To promote proper use and feedback to the user,<br>the NuFACE® Trinity beeps to cue the user to<br>relocate the device after approximately 5 seconds<br>of treatment. When the user turns off the device,<br>a descending tone is emitted. |
| Section 2: Basic Unit<br>Characteristics | Trinity ELE Device<br>New Device. | NuFACE® Trinity<br>Predicate Device |
| 1. 510(k) Number | K131251 | K103472 |
| 2. Device Name, Model | Trinity ELE Device | NuFACE® Trinity |
| 3. Manufacturer | Carol Cole Company (CCC) | Carol Cole Company (CCC) |
| 4. Power Source(s) | | |
| a. Method of Line Current<br>Isolation | 4 rechargeable AA NiMH<br>batteries | 4 rechargeable AA NiMH<br>batteries |
| b. Patient Leakage Current | | |
| 1. Normal condition | N/A - Battery Operated | N/A - Battery Operated |
| 2. Single fault condition | N/A - Battery Operated | N/A - Battery Operated |
| 5. Number of Output Modules | 1 | 1 |
| 6. Number of Output Channels | 1 | 1…