Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on microcurrent technology, user interface elements (buttons, LEDs, audible feedback), and Bluetooth connectivity for pre-programmed treatment profiles. There is no mention of adaptive algorithms, learning from user data, or any other characteristics typically associated with AI/ML.

Therapeutic

No
The device is described as intended for "facial stimulation" and indicated for "over-the-counter cosmetic use," rather than for treating a disease or condition.

Diagnostic

No

Explanation: The device is intended for "facial stimulation" and is indicated for "over-the-counter cosmetic use," not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical hardware components including a main body, attachment head, charging cradle, power adaptor, and wands, and describes their materials and dimensions. It also mentions an internal battery and physical buttons. While it includes software for pairing with a smart device, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Trinity ELE Plus and Trinity ELE Plus Pro devices are not IVD (In Vitro Diagnostic) devices.

Here's why:

Intended Use: The intended use is clearly stated as "facial stimulation" and indicated for "over-the counter cosmetic use." This is a cosmetic application, not a diagnostic one.
Device Description: The device applies microcurrent to the skin for aesthetic purposes. It does not analyze biological samples (like blood, urine, or tissue) which is a key characteristic of IVD devices.
Lack of Diagnostic Claims: There are no claims or indications that the device is used to diagnose, monitor, or treat any disease or condition based on in vitro analysis.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The Trinity ELE Plus devices do not perform this function.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

NFO

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

facial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

over-the-counter cosmic use

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Performance Data:

Biocompatibility Evaluation: Conclusions presented for all patient-contacting materials (ABS Thermoplastic, Chromium, NūFACE® Gel Primer), indicating biocompatibility and similarity to predicate materials where applicable.
Safety, Performance, and Bench Testing including EMC: Concluded that the device meets and complies with applicable standards and bench testing requirements. Electrical safety tests for ANSI AAMI 60601-1 and IEC 60601-1-11 standards are being conducted and will be provided before market release.
Software Verification and Validation Testing: Concluded that the device meets and complies with applicable software requirements specifications.

No animal testing or clinical testing was performed to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K131251

Reference Device(s)

K103472

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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).

Summary

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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®

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

5. Device Description