(230 days)
The Trinity ELE Plus and Trinity ELE Plus Pro devices are intended for facial stimulation and are indicated for over-the counter cosmetic use.
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.
I regret to inform you that the provided text does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
The document is a 510(k) premarket notification for the Trinity ELE Plus and Trinity ELE Plus Pro devices. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing and proving new acceptance criteria for the subject device itself.
Here's a breakdown of what the document does include and why it doesn't answer your specific questions:
- Indications for Use: The devices are intended for "facial stimulation" and are indicated for "over-the-counter cosmetic use."
- Technological Characteristics Comparison: There are tables comparing the subject device's features (Type of Energy Output, Energy Delivery, Energy Flow, Energy Output, Microcurrent Boost, Energy Power Source, Power Accessories, Charging Method, Charging Circuitry, Power Supply Type, Special Requirements, Wireless Technology, Output Frequency) and output specifications (Waveform Type, Shape, Max Output Voltage, Max Output Current, Output Tolerance, Pulse Period, Output Frequency, Beat Frequency, Symmetrical Phases, Phase Duration, Net Charge, Max Phase Charge, Max Current Density, Max Power Density, Burst mode information, ON time, OFF time) to those of a predicate device. Many of these are listed as "Same" or "Different," with explanations for why the "Different" aspects do not affect safety and effectiveness.
- Non-Clinical Performance Data:
- Biocompatibility Evaluation: This describes the materials used and concludes they are biocompatible based on their use in other FDA-cleared devices or the predicate device.
- Safety, Performance, and Bench Testing: This section states that EMC, Wireless Coexistence, and bench testing concluded the device "meets and complies with the safety and performance of the applicable standards and bench testing requirements." However, it does not list specific acceptance criteria for these tests or provide detailed results. It also mentions electrical safety tests are "currently being conducted and will be provided to the FDA before the subject device is released to market."
- Software Verification and Validation: This states the software "meets and complies with the applicable software requirements specifications" but does not detail those specifications or acceptance criteria.
- No Animal Testing or Clinical Testing: The document explicitly states that substantial equivalence is not supported by animal or clinical testing.
Therefore, I cannot provide the requested table or answer the questions because the necessary data (specific acceptance criteria, detailed study results proving these criteria are met, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study details) is not present in the provided text. The document focuses on demonstrating that the new device is substantially equivalent to a previously cleared device, not on proving its independent performance against new, explicit acceptance criteria.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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: (760) 509-1187 | |
| Email: tpeterson@myNuFACE.com |
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 EnergyOutput | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered viadual chrome-plated precisewands (optimized for contactwith the skin) | Microcurrent is delivered viadual chrome-plated precisewands (optimized for contactwith the skin) | Same |
| Energy Flow | Microcurrent continuouslyalternates between the positive Microcurrent continuouslyalternates between the positiveand negative wands Same | ||
| Energy Output | User adjustable | User adjustable | Same |
| Microcurrent Boost | Yes, Temporary, Usercontrollable | No | Different |
| Energy PowerSource | Internal Rechargeable LithiumIon Battery | Internal Rechargeable NiMHBattery | 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 PowerAdaptor | Pre-approved wall-mountPower Adaptor | Same |
| SpecialRequirements | Requires Conductive Gel | Requires Conductive Gel | Same |
| WirelessTechnology | 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 DeviceSpecification | Predicate DeviceSpecification | Same /Different |
|---|---|---|---|
| Waveform Type | Pulsed Biphasic | Pulsed Biphasic | Same |
| Shape (e.g., rectangular, spike) | Modulated Square | Modulated Square | Same |
| Item | Subject DeviceSpecification | Predicate DeviceSpecification | Same /Different |
| Maximum Output Voltage | Trinity ELE Plus170 mV @ 500 Ω688 mV @ 2 kΩ3.4 V @ 10 kΩTrinity ELE Plus Pro208 mV @ 500 Ω840 mV @ 2 kΩ4.3 V @ 10 kΩ | 68 mV @ 500 Ω283 mV @ 2 kΩ1.31 V @ 10 kΩ | Different |
| Maximum Output Current | Trinity ELE Plus243 μA @ 500 Ω245 μA @ 2 kΩ246 μA @ 10 kΩTrinity ELE Plus Pro297 μA @ 500 Ω299 μA @ 2 kΩ301 μA @ 10 kΩ | 135 μA @ 500 Ω134 μA @ 2 kΩ133 μA @ 10 kΩ | Different |
| Output Tolerance | +/- 10% (RMS) | +/- 2% | Different |
| Pulse Period (Pulse Width) | Varies w/ Frequency(60 msec @ 8.33Hz) | 60 msec | Different |
| Output Frequency (Hz) | 0.3 — 50 Hz(Default 8.3 Hz) | 8.3 Hz | Different |
| For Interferential WaveformsOnly | |||
| 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 Plus14.78 μC @ 10K ΩTrinity ELE Plus Pro18.17 μC @ 10K Ω | 8.08 μC @ 500 Ω | Different |
| Item | Subject Device Specification | Predicate Device Specification | Same / Different |
| Maximum current density | Trinity ELE Plus0.947 mA/cm² @ 10K ΩTrinity ELE Plus Pro1.165 mA/cm² @ 10K Ω | 0.519 mA/cm² @ 500 Ω | Different |
| Maximum power density(μW/cm²) | Trinity ELE Plus2.331 mW/cm² @ 10K ΩTrinity ELE Plus Pro3.525 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(8.3 @ 8.33Hz) | 8.3 | Same |
| c. Burst duration (sec) | Varies w/ Frequency(2.4 @ 8.33Hz) | 2.4 | Same |
| d. Duty Cycle (%) | 50 | 50 | Same |
| ON time | Varies w/ Frequency(60ms @ 8.33Hz @ 50%Duty Cycle) | 60ms | Different |
| OFF time | Varies w/ Frequency(60ms @ 8.33Hz @ 50%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 |
|---|---|---|---|
| ABSThermoplastic | Enclosures (housings) forthe subject device mainbody, the attachment headand the charging cradle. | Surface device, intactskin, limited (<24h)duration. | Biocompatible. Thismaterial is used in otherFDA-cleared devices. |
| Chromium | Plated over the two precisewands that are part of theattachment head. | Surface device, intactskin, limited (<24h)duration. | Biocompatible. Materialand manufacturing processare the same as thepredicate. |
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 | |
| ABSThermoplastic | Power Adaptor main bodyenclosure. | Surface device, intactskin, limited (<24h)duration. | Biocompatible. The poweradaptor is identical to thepower adaptor of thepredicate device. |
Gel Primer:
| Material | Where Used | Nature of body contact | Conclusion |
|---|---|---|---|
| NūFACE®Gel Primer | Accessory to device. | Surface device, intact skin, limited (<24h)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®
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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.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).