(121 days)
The NuFACE® Mini Device is intended for facial stimulation and is indicated for overthe-counter cosmetic use. (21 CFR 801 Subpart C).
The NuFACE® Mini Device is a non-invasive at home, over-the-counter facial toning device. The dual spheres of the NuFACE® Mini Device are designed for optimal contact with the face and are identical in size to the predicate device. The NuFACE® Mini Device 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 NuFACE® Mini device measures 2.5" W x 4.2" L x 1.2" D. Its outer case is injection molded of thermoplastic resin. The device comes with an external Power Supply to charge the internal batteries of the device when not in use. The external Power Supply provides DC power from a pre-approved wall adapter. All charging circuitry is contained within the device itself. The microcurrent output is disabled when the device is connected to the external Power Supply.
An ascending sequence of beeps informs the customer the NuFACE® Mini is ready for use. When the user turns the device OFF, a descending tone is emitted. A single control button is used to turn the device on and off and to change the device's output intensity. A long press of the control button toggles the device between on and off.
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 the output intensity by briefly pressing the control button to step between multiple micro-current output level selections. When the device is set to the maximum output and the control button is pressed, the device sequences to the minimum output.
The NuFACE® Mini Device's acceptance criteria and the study proving it meets these criteria are described below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the NuFACE® Mini Device are based on demonstrating substantial equivalence to its predicate device, the NuFACE® Trinity device (cleared as NuFACE® Plus, K103472). This means that the NuFACE® Mini Device must have identical or nearly identical technological characteristics and performance specifications for its intended use.
Here's a comparison table summarizing the core electrical output specifications which form the primary acceptance criteria for demonstrating functional equivalence:
| Acceptance Criteria (Predicate Device Specification) | NuFACE® Mini Device Performance | Comparison Result |
|---|---|---|
| Waveform Type: Pulsed Monophasic | Pulsed Monophasic | Identical |
| Waveform Shape: Modulated Square | Modulated Square | Identical |
| Maximum Output Voltage: | ||
| - 137 mV @ 500 Ω | 222 mV @ 500 Ω | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| - 769 mV @ 2 kΩ | 781 mV @ 2 kΩ | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| - 3.82 V @ 10 kΩ | 3.90 V @ 10 kΩ | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| Maximum Output Current: | ||
| - 274 μA @ 500 Ω | 396 μA @ 500 Ω | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| - 387 μA @ 2 kΩ | 395 μA @ 2 kΩ | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| - 383μA @ 10 kΩ | 391 μA @ 10 kΩ | Different (Higher) - Note: The document states "identical to the predicate" but the values differ. |
| Output Tolerance: +/- 2% | +/- 2% | Identical |
| Pulse Width: 119 ms (Total) | ON phase: 60.4 ms, OFF phase: 60.4 ms, Total Pulse Width: 120.8 ms | Different (Slightly longer total pulse width) - Note: The document states "identical to the predicate" but the values differ. |
| Frequency: 8.40 Hz | 8.28 Hz | Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ. |
| Maximum Phase Charge: 23.6 µC @ 500 Ω | 23.7 µC @ 500 Ω | Different (Slightly higher) - Note: The document states "identical to the predicate" but the values differ. |
| Maximum Current Density: 0.512 mA/cm² @ 500 Ω | 0.514 mA/cm² @ 500 Ω | Different (Slightly higher) - Note: The document states "identical to the predicate" but the values differ. |
| Maximum Power Density: 1991 μW/cm² @ 10k Ω | 1981 μW/cm² @ 10k Ω | Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ. |
| Burst Mode: | ||
| - Pulses per burst: 20 | 20 | Identical |
| - Pulses per second: 8.40 | 8.28 | Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ. |
| - Burst duration (s): 2.40 | 2.42 | Different (Slightly longer) - Note: The document states "identical to the predicate" but the values differ. |
| - Duty Cycle (on time per burst): 20.2 | 20 | Different (Slightly lower) - Note: The document states "identical to the predicate" but the values differ. |
| ON Time: Constant | Constant | Identical |
Note on "Identical" Claims vs. Reported Values:
The summary prominently states that numerous output characteristics are "identical to the predicate." However, the detailed "Output Specifications" table provided later in the document (Section 3) shows minor numerical differences for Maximum Output Voltage, Maximum Output Current, Pulse Width, Frequency, Maximum Phase Charge, Maximum Current Density, Maximum Power Density, Pulses per second, Burst duration, and Duty Cycle. Despite these small numerical variations in the detailed table, the overall conclusion of "substantial equivalence" implies that these differences were deemed insignificant for the device's safety and effectiveness relative to the predicate by the FDA. The submission likely argues that these slight numerical differences fall within acceptable engineering tolerances or do not alter the fundamental mechanism of action or safety profile.
Additional acceptance criteria based on compliance standards are:
- Compliance with FDA's performance Standards set forth in 21 CFR §898.
- Compliance with IEC 60601-1-2:2010 for radiated and power line conducted emissions.
- Compliance with IEC 60601-1:2005 (3rd edition) for Electrical Safety.
The reported performance confirms compliance with these standards (Yes for 21 CFR 898, IEC 60601-1, IEC 60601-1-2).
2. Sample Size Used for the Test Set and Data Provenance
The study to prove the device meets acceptance criteria was based on non-clinical performance assessment. This type of assessment typically involves laboratory testing of the device's electrical and physical characteristics rather than testing on human subjects.
- No specific "test set" in the sense of patient data is mentioned.
- The provenance is laboratory testing of the device itself. Given the 510(k) submission is for a US market device, the testing would likely be performed in a controlled laboratory environment to meet US regulatory requirements.
- This was a non-clinical evaluation, not a clinical study with a test set of human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not applicable as the study was a non-clinical performance assessment focusing on device specifications and compliance with standards, not on clinical outcomes requiring expert consensus or ground truth from patient data.
- The "ground truth" here is the established specifications and safety profile of the predicate device and relevant industry standards.
4. Adjudication Method for the Test Set
- Not applicable, as there was no test set of patient cases requiring adjudication. The assessment was based on direct measurement and comparison of device specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission relies on demonstrating substantial equivalence through comparison of technical specifications and safety standards, not through a clinical evaluation involving human readers or assessment of improved human performance with AI assistance. This device is an over-the-counter cosmetic device, not a diagnostic or therapeutic AI-assisted medical device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- Not applicable. This is a standalone electrical stimulation device, not an AI algorithm. The device performance was assessed in a standalone capacity (i.e., its intrinsic electrical outputs) without any human-in-the-loop performance being a specific test metric.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical performance assessment was based on:
- Predicate Device Specifications: The established electrical output and technological characteristics of the NuFACE® Trinity device (NuFACE® Plus), which was previously cleared.
- Industry and Regulatory Standards: Compliance with relevant electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and FDA performance standards (21 CFR §898).
8. The Sample Size for the Training Set
- Not applicable. This device is an electrical stimulation device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. There was no training set for this 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).