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510(k) Data Aggregation
(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) | < 1 μΑ | < 1 μΑ | Met (Same) |
| Output Tolerance | +/- 10% | +/- 5% | Met (Improved) |
| Pulse Width | 60 msec | 60 msec | Met (Same) |
| Frequency (Hz) | Approximately 8.3 Hz | Approximately 8.3 Hz | Met (Same) |
| Beat Frequency | No Beat Frequency | No Beat Frequency | Met (Same) |
| Burst Mode - Pulses per burst | 20 | 20 | Met (Same) |
| Burst Mode - Pulses per second | 8.3 | 8.3 | Met (Same) |
| Burst Mode - Burst duration | 2.4 s | 2.4 s | Met (Same) |
| Burst Mode - Duty Cycle | 50% | 50% | Met (Same) |
| ON Time | 60 msec | 60 msec | Met (Same) |
| OFF Time | 60 msec | 60 msec | Met (Same) |
| Power Source | Internal rechargeable Lithium ion battery | Internal rechargeable Lithium ion battery | Met (Same) |
| Line Current Isolation | Type BF | Type BF | Met (Same) |
| Patient Leakage Current | N/A - Battery operated | N/A - Battery operated | Met (Same) |
| External Power Adapter | NuFACE 7-volt power adapter | NuFACE 5-volt power adapter | Comparable (Different voltage, but functionality and safety verified through standards compliance) |
| Number of Output Channels | 1 | 1 | Met (Same) |
| Regulated Current or Voltage | Both | Both | Met (Same) |
| Software/Firmware/Microprocessor | Yes | Yes | Met (Same) |
| Automatic Overload Trip | Not required due to circuit design | Not required due to circuit design | Met (Same) |
| Automatic No-Load Trip | Yes | Yes | Met (Same) |
| Automatic Shut Off | Yes (20 minutes) | Yes (5 minutes) | Comparable (Difference in timing, but both include shut-off for safety/usage. Not a critical difference for equivalence) |
| Patient Override Control | Yes | Yes | Met (Same) |
| Indicator Display | On/Off, Low Battery, Voltage/Current Level | On/Off, Low Battery, Voltage/Current Level | Met (Same) |
| Compliance with Voluntary Standards | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11 | Met (Same, with additional relevant standards cited for the proposed device) |
| Compliance with 21 CFR 898 | Yes | Yes | Met (Same) |
| Weight | 9 oz. without charging base | 6 oz. | Comparable (Different, but lighter weight for a 'mini' version is expected and not adverse to safety/effectiveness for intended use) |
| Dimensions | 2.8" x 5.1" x 1.3" | 2.5" x 4.2" x 1.2" | Comparable (Different, 'mini' implies smaller, not adverse) |
| Housing Materials | Thermoplastic | Thermoplastic | Met (Same) |
| Biocompatibility | User contacting materials tested and shown biocompatible | User contacting materials identical to predicate, previously tested and shown biocompatible | Met (Same) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This document does not describe a clinical "test set" in the context of efficacy or clinical performance. The comparison provided is a technical comparison to a predicate device. Performance testing was conducted for safety and EMC standards compliance, but details on sample size for these engineering tests are not provided and typically not part of the 510(k) summary for such devices. There is no information on data provenance related to clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" establishment by medical experts is described, as this is a technical equivalence review against a predicate device and relevant safety standards, not a clinical efficacy study requiring interpretation of outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is described as there is no clinical test set requiring expert consensus.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a transcutaneous electrical nerve stimulator for cosmetic use (facial and neck toning), not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies and AI assistance comparisons are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware product for direct user application, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for this submission is effectively the established safety and performance characteristics of the legally marketed predicate device (NuFACE Trinity) and compliance with recognized safety and EMC standards. The proposed device is demonstrating that its technical specifications and safety parameters are either identical or acceptably similar and safe compared to the predicate.
8. The sample size for the training set
Not applicable. This document does not describe a machine learning or AI algorithm that would require a training set.
9. How the ground truth for the training set was established
Not applicable.
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