(113 days)
The NuFACE Mini Device is intended for facial and neck stimulation and is indicated for over-the-counter use.
The NuFACE® Mini Device is an over- the- counter facial and neck toning device. The chrome plated dual spheres of the NuFACE® Mini are designed to gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face and neck. The NuFACE® Mini electrodes are designed for optimal contact with the face.
The NuFACE® Mini microcurrent continually alternates between the positive electrodes and allows the user to adjust settings.
The NuFACE® Mini Device measures approximately 2.5" W x 4.2" D. Its outer case is injection mold thermoplastic resin. The device comes with an external Power Supply to recharge the lithium ion battery of the device when not in use. The external Power Supply is a pre- approved wall adapter. All charging circuitry is contained within the device itself.
This document is a 510(k) Premarket Notification for the NuFACE Mini Device. It aims to demonstrate substantial equivalence to a predicate device, the NuFACE Trinity Device, rather than proving the device meets specific performance acceptance criteria through clinical studies. Therefore, much of the requested information regarding study design, sample sizes, expert ground truth establishment, and comparative effectiveness studies is not present in this type of submission.
However, based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
Since this filing is for substantial equivalence, the "acceptance criteria" are primarily established by the characteristics and performance of the predicate device (NuFACE Trinity). The reported device performance for the NuFACE Mini is presented as a comparison to the predicate.
| Characteristic | Acceptance Criteria (Predicate: NuFACE Trinity) | Reported Device Performance (NuFACE Mini) | Met/Comparable |
|---|---|---|---|
| Regulatory | |||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Met (Same) |
| Regulation Name | Transcutaneous electrical nerve stimulator for pain relief | Transcutaneous electrical nerve stimulator for pain relief | Met (Same) |
| Regulatory Class | Class II | Class II | Met (Same) |
| Product Code | NFO | NFO | Met (Same) |
| Intended Use | Facial and neck stimulation for over-the-counter cosmetic use | Facial and neck stimulation for over-the-counter cosmetic use | Met (Same) |
| Indications for Use | Over-the-Counter Cosmetic Use | Over-the-Counter Cosmetic Use | Met (Same) |
| Anatomic Sites | Face and Neck | Face and Neck | Met (Same) |
| Technological Characteristics | |||
| Form Factor (General) | Handheld, dual spherical electrodes, microcurrent | Handheld, dual spherical electrodes, microcurrent | Comparable (Same general design principles) |
| Waveform | Pulsed Biphasic | Pulsed Biphasic | Met (Same) |
| Shape | Modulated Square | Modulated Square | Met (Same) |
| Max Output Voltage | 28 VDC | 28 VDC | Met (Same) |
| Max Output Current | $400 \mu A$ at 500 Ω | $348 \mu A$ at 500 Ω | Comparable (Slightly lower, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Max Output Current Density | 0.419 mA/cm² | 0.452 mA/cm² | Comparable (Slightly higher, but within expected range for similar devices/intended use, and not clinically significant for this type of equivalence claim) |
| Output Current (not stimulating) |
§ 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).