(206 days)
The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
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. 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 dual spheres on the attachment head use chromium. 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.
This document is a 510(k) summary for the NuFACE® Trinity Plus Device. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. The document focuses on demonstrating that the new device is as safe and effective as the predicate, not on proving new clinical efficacy or superiority through rigorous clinical trials.
Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Machine Learning (ML) device, which typically involves performance metrics like sensitivity, specificity, accuracy, and detailed clinical study designs with human readers and ground truth, is not applicable to this document.
This FDA submission is for a physical medical device (Transcutaneous Electrical Nerve Stimulator for Pain Relief, used for cosmetic facial and neck stimulation) and primarily relies on a comparison of technological characteristics, safety data (biocompatibility, electrical safety, EMC), and software verification and validation to demonstrate substantial equivalence to a predicate device.
Here's why the AI/ML-centric questions are not applicable:
- No AI/ML Component: The document describes a device that "produces low levels of microcurrent" and has "indicator LED's," a "multifunction button," and Bluetooth Low Energy for app connectivity to select pre-programmed treatment profiles. There is no mention of an AI or ML algorithm making diagnostic or therapeutic decisions, interpreting data, or providing automated recommendations.
- Safety and Substantial Equivalence, Not Efficacy Proof: The core purpose of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a predicate device. This typically involves showing that its indications for use, technological characteristics, and safety and effectiveness profiles are similar enough that it doesn't raise new questions of safety or effectiveness. It's not a P-value seeking clinical trial to prove a new mechanism or superior efficacy.
- "Clinical Testing" was not performed: The document explicitly states under section 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." This clearly indicates that no human-subject efficacy study was conducted for this submission.
In summary, this document does not describe the kind of study (e.g., MRMC, standalone performance) that would be conducted for an AI/ML device requiring rigorous clinical performance validation against acceptance criteria based on metrics like sensitivity or specificity. The "acceptance criteria" here implicitly relate to demonstrating safety and similar performance to the predicate device through non-clinical testing.
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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
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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) 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | X |
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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
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.
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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 /Different |
|---|---|---|---|
| Anatomic Sites | Face and Neck | Face and Neck | Same |
| Type of EnergyOutput | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered viadual chrome-plated spheres(optimized for contact with theskin) | Microcurrent is delivered viadual chrome-plated spheres(optimized for contact with theskin) | Same |
| Energy Flow | Microcurrent continuouslyalternates between the positiveand negative spheres | Microcurrent continuouslyalternates between the positiveand negative spheres | Same |
| Energy Output | User adjustable | User adjustable | Same |
| Microcurrent Boost | Yes, Temporary, Usercontrollable | 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 |
| SpecialRequirements | Conductive Gel Primer | Conductive Gel Primer | Same |
| WirelessTechnology | Bluetooth Low Energy (BLE) | None | Different |
| Output Frequency | Variable | Fixed | Different |
| Basic Unit | |||
| Characteristics | |||
| Power Source | Internal Rechargeable LithiumIon Battery | Internal Rechargeable LithiumIon Battery | Same |
| a. Method of LineCurrent Isolation | Type BF | Type BF | Same |
| b. Patient LeakageCurrent | --- | ||
| 1). NormalCondition | N/A - Battery operated | N/A - Battery operated | Same |
| 2). Single FaultCondition | N/A - Battery operated | N/A - Battery operated | Same |
| External PowerAdaptor | NuFACE 5-volt power adaptor | NuFACE 7-volt power adaptor | Similar |
| Number of OutputChannels | 1 | 1 | Same |
| a. Synchronous orAlternating | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| b. Method ofChannel Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| Regulated Currentor RegulatedVoltage | Both | Both | Same |
| Software/Firmware/Microprocessorcontrol | Yes | Yes | Same |
| Automatic OverloadTrip | Not required due to circuitdesign | Not required due to circuitdesign | Same |
| Automatic No-Loadtrip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient OverrideControl | Yes | Yes | Same |
| Indicator Display | --- | ||
| a. ON/OFF Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage CurrentLevel | Yes | Yes | Same |
| Automatic Shut-off(Minutes) | Yes (20 minutes) | Yes (20 minutes) | Same |
| Weight | 8.8 oz. without charging base | 9 oz. without charging base | Similar |
| Dimensions ofDevice (inch)[WxLxD] | 2.6" x 5.20" x 1.6" | 2.8" x 5.1" x 1.3" | Similar |
| Housing Materialsand Construction | Thermoplastic | Thermoplastic | Same |
| OutputSpecifications | |||
| Maximum OutputCurrent Density | 0.78 mA/cm2 | 0.419 mA/cm2 | Different |
| Burst Mode (i.e.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(seconds) | 2.4s (@ 8.3 Hz) | 2.4s | Same |
| d. Duty Cycle [Line(b) x Line (c)] (ontime per burst) | Duty Cycle: 50%On time per burst: 20.2s | Duty Cycle: 50%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®
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CONFIDENTIAL NūFACE®
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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:
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| Material | Where Used | Nature of bodycontact | Conclusion |
|---|---|---|---|
| ABSThermoplastic | Enclosures (housings) forthe subject device mainbody, the attachment headand the charging cradle. | Surface device, intactskin, limited (<24h)duration. | Biocompatible. Thismaterial complies to ISO10993-1 "Biologicalevaluation ofmedical devices" ISO10993-5:Tests for in vitrocytotoxicity, ISO 10993-10:Tests for irritationIntracutaneous; Skinsensitization; Cytotoxicity-Elution method. |
| Chromium | Plated over the two spheresthat are part of theattachment head. | Surface device, intactskin, limited (<24h)duration. | Biocompatible. Materialand manufacturing processare the same as thepredicate. |
Wall-mount Power Adaptor:
| 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). |
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.
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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.
§ 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).