(242 days)
The NuFACE® Mini Plus device is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use.
The NuFACE® Mini Plus (subject device) comprises the Mini Plus device itself and a wall-mount power adaptor. A tube of NuFACE® Gel Primer is provided with the device as an accessory. The Instructions for Use (IFU) are also included with the device and all its associated components are reusable and provided non-sterile.
The subject device produces low levels of microcurrent that is discharged through two chrome-plated spheres when they come in contact with and are glided over the skin being treated.
The subject device allows the user to turn on and turn off the device at any time during the treatment. Once the device is on, the user can select different microcurrent intensity levels. The device provides visual (lights), audible (beeps) and haptic (hum) feedback to guide the user during treatment. The device will shut off automatically after 20 minutes of use.
The subject device is powered by one internal rechargeable, non-removable battery which is charged via the provided wall-mount power adaptor. During battery charging the device microcurrent output is disabled to prevent accidental and/or intentional use.
The subject device is capable of pairing and connecting to compatible smart devices using Bluetooth Low Energy (BLE) technology. BLE allows the subject device to wirelessly communicate with other devices such a smart phone running the NuFACE® App. The NuFACE® App allows the user to customize treatment options.
The subject device is made from thermoplastic and metal materials already used in other FDA-cleared medical devices. The device measures 2.7" W x 3.6" L x 2.6" D.
This document is a 510(k) premarket notification for the NuFACE Mini Plus, a cosmetic device. It focuses on demonstrating substantial equivalence to a predicate device (NuFACE Mini) rather than presenting a clinical study to prove the device meets acceptance criteria for a medical diagnosis or treatment.
Therefore, many of the requested details, such as sample size for test/training sets, expert qualifications, ground truth establishment methods (for medical conditions), MRMC studies, or effect sizes for human readers, are not applicable to the information provided in this regulatory submission.
The document primarily addresses non-clinical performance data to show that the new device is as safe and effective as the predicate device, not that it meets specific diagnostic or treatment accuracy acceptance criteria as one might expect for an AI-enabled diagnostic device.
Here's a breakdown of the available information based on your request, explaining why certain points are not present:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "acceptance criteria" table in the sense of diagnostic accuracy (e.g., sensitivity, specificity, AUC) against clinical ground truth. Instead, it compares the technical specifications and safety/performance testing results of the subject device (NuFACE Mini Plus) to its predicate device (NuFACE Mini) to demonstrate substantial equivalence.
Here's a table summarizing the primary comparisons, which serve as the "performance" demonstrated for this type of device submission:
| Item | Acceptance/Comparison Point | Subject Device (NuFACE Mini Plus) Reported Performance | Predicate Device (NuFACE Mini) Performance | Meets Equivalence? |
|---|---|---|---|---|
| Intended Use | Identical Indications | Facial and neck stimulation for over-the-counter cosmetic use. | Facial and neck stimulation for over-the-counter cosmetic use. | Yes (Identical) |
| Type of Energy Output | Microcurrent | Microcurrent | Microcurrent | Yes (Same) |
| Energy Delivery | Plated dual sphere electrodes | Plated dual sphere electrodes | Plated dual sphere electrodes | Yes (Same) |
| Energy Flow | Alternating between positive/negative electrodes | Microcurrent continuously alternates between the positive and negative electrode spheres | Microcurrent continuously alternates between the positive and negative electrode spheres | Yes (Same) |
| Energy Output | User adjustable | User adjustable | User adjustable | Yes (Same) |
| Energy Power Source | Internal rechargeable battery | Internal rechargeable battery | Internal rechargeable battery | Yes (Same) |
| Battery Type | Lithium Ion | Lithium Ion | Lithium Ion | Yes (Same) |
| Charging Circuitry | Internal to Device | Internal to Device | Internal to Device | Yes (Same) |
| Power Supply Type | Pre-approved wall-mount Power Adaptor | Pre-approved wall-mount Power Adaptor | Pre-approved wall-mount Power Adaptor | Yes (Same) |
| Special Requirements | Conductive Gel Primer | Conductive Gel Primer | Conductive Gel Primer | Yes (Same) |
| Waveform Type | Pulsed Biphasic | Pulsed Biphasic | Pulsed Biphasic | Yes (Same) |
| Shape | Modulated Square | Modulated Square | Modulated Square | Yes (Same) |
| Maximum Output Voltage | 28 VDC | 28 VDC | 28 VDC | Yes (Same) |
| Maximum Output Current | 335 µA | 348 µA | Yes (Within Acceptable Range) | |
| Maximum Output Current Density | 0.435 mA/cm² | 0.452 mA/cm² | Yes (Within Acceptable Range) | |
| Microcurrent Output (Device OFF/Charging) |
§ 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).