(206 days)
Not Found
No
The description details basic electronic controls, Bluetooth connectivity for pre-programmed profiles, and standard safety/performance testing. There is no mention of AI or ML algorithms for data analysis, decision-making, or adaptive functionality.
No.
The intended use explicitly states "for over-the-counter cosmetic use," which distinguishes it from therapeutic devices that are intended to treat or cure medical conditions.
No
Explanation: The "Intended Use / Indications for Use" states that the device is "intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use," which explicitly indicates it's for cosmetic purposes, not for diagnosing medical conditions.
No
The device description clearly outlines physical hardware components including the main body, attachment head, charging cradle, power adaptor, and battery, which are essential for its function of delivering microcurrent. While it includes software for pairing with a smart device and selecting treatment profiles, it is not solely software.
Based on the provided information, the NuFACE® Trinity Plus Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "facial and neck stimulation" for "over-the-counter cosmetic use." This indicates a non-diagnostic, aesthetic purpose.
- Device Description: The description focuses on delivering microcurrent to the skin for aesthetic purposes. There is no mention of analyzing biological samples (like blood, urine, or tissue) or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on sample analysis.
Therefore, the NuFACE® Trinity Plus Device falls under the category of a cosmetic or aesthetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NuFACE® Trinity Plus Device is intended for facial and neck stimulation and is indicated for over-the counter cosmetic use.
Product codes (comma separated list FDA assigned to the subject device)
NFO
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face and Neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter cosmetic 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)
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
Conclusions from Biocompatibility Evaluation:
Main Body / Attachment Head / Charging Cradle: ABS Thermoplastic and Chromium were found to be biocompatible.
Wall-mount Power Adaptor: ABS Thermoplastic was found to be biocompatible.
Gel Primer: Accessory to device, biocompatible, 510K cleared (K161654).
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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.
4
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 Energy
Output | Microcurrent | Microcurrent | Same |
| Energy Delivery | Microcurrent is delivered via
dual chrome-plated spheres
(optimized for contact with the
skin) | Microcurrent is delivered via
dual chrome-plated spheres
(optimized for contact with the
skin) | Same |
| Energy Flow | Microcurrent continuously
alternates between the positive
and negative spheres | Microcurrent continuously
alternates between the positive
and negative spheres | Same |
| Energy Output | User adjustable | User adjustable | Same |
| Microcurrent Boost | Yes, Temporary, User
controllable | 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 |
| | | | |
| Special
Requirements | Conductive Gel Primer | Conductive Gel Primer | Same |
| Wireless
Technology | Bluetooth Low Energy (BLE) | None | Different |
| Output Frequency | Variable | Fixed | Different |
| Basic Unit | | | |
| Characteristics | | | |
| Power Source | Internal Rechargeable Lithium
Ion Battery | Internal Rechargeable Lithium
Ion Battery | Same |
| a. Method of Line
Current Isolation | Type BF | Type BF | Same |
| b. Patient Leakage
Current | | | --- |
| 1). Normal
Condition | N/A - Battery operated | N/A - Battery operated | Same |
| 2). Single Fault
Condition | N/A - Battery operated | N/A - Battery operated | Same |
| External Power
Adaptor | NuFACE 5-volt power adaptor | NuFACE 7-volt power adaptor | Similar |
| Number of Output
Channels | 1 | 1 | Same |
| a. Synchronous or
Alternating | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| b. Method of
Channel Isolation | N/A - 1 Output channel | N/A - 1 Output channel | Same |
| Regulated Current
or Regulated
Voltage | Both | Both | Same |
| Software/Firmware/
Microprocessor
control | Yes | Yes | Same |
| Automatic Overload
Trip | Not required due to circuit
design | Not required due to circuit
design | Same |
| Automatic No-Load
trip | Yes | Yes | Same |
| Automatic Shut Off | Yes | Yes | Same |
| Patient Override
Control | Yes | Yes | Same |
| Indicator Display | | | --- |
| a. ON/OFF Status | Yes | Yes | Same |
| b. Low Battery | Yes | Yes | Same |
| c. Voltage Current
Level | 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 of
Device (inch)
[WxLxD] | 2.6" x 5.20" x 1.6" | 2.8" x 5.1" x 1.3" | Similar |
| Housing Materials
and Construction | Thermoplastic | Thermoplastic | Same |
| Output
Specifications | | | |
| Maximum Output
Current 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)] (on
time 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®
5
CONFIDENTIAL NūFACE®
6
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:
7
| Material | Where Used | Nature of body
contact | Conclusion |
|----------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ABS
Thermoplastic | Enclosures (housings) for
the subject device main
body, the attachment head
and the charging cradle. | Surface device, intact
skin, limited (