(378 days)
The Facial Spa is intended for the stimulation of healthy facial skin.
The Facial Spa is indicated for facial stimulation for over-the-counter cosmetic use.
The Facial Spa is a hand-held, battery-powered device used with conductive treatment gel to stimulate the face with microcurrents.
Here's a breakdown of the acceptance criteria and study information for the Nu Skin Facial Spa, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) submission is for substantial equivalence, meaning the device does not have explicit "acceptance criteria" for performance in the typical sense of a novel device. Instead, the "acceptance criteria" are compliance with relevant standards and demonstrating equivalence to a predicate device. The "reported device performance" is a direct comparison of its technical specifications to the predicate.
| Feature / Criterion | Acceptance (Predicate Standard) | Reported Nu Skin Facial Spa Performance | Meets Criteria? |
|---|---|---|---|
| General Compliance | |||
| IEC 60601-1 (Basic Safety) | Conforms | Conforms | Yes |
| IEC 60601-1-2 (EMC) | Conforms | Conforms | Yes |
| IEC 60601-2-10 (Nerve Stim. Safety) | Conforms | Conforms | Yes |
| IEC 60601-1-4 (PEMS Safety) | Conforms | Conforms | Yes |
| ISO 10993-10 (Irritation/Sens.) | Conforms | Conforms | Yes |
| ISO 10993-12 (Sample Prep) | Conforms | Conforms | Yes |
| 21 C.F.R. § 898 (Radiation Safety) | Conforms | Conforms | Yes |
| Substantial Equivalence (Comparison to Predicate: NuFace® Plus) | |||
| Regulation Number | 21 C.F.R. § 882.5890 | 21 C.F.R. § 882.5890 | Yes |
| Regulation Name | Transcutaneous Electrical Nerve Stimulator | Transcutaneous Electrical Nerve Stimulator | Yes |
| Regulatory Class | Class II | Class II | Yes |
| Product Code | NFO | NFO | Yes |
| Intended Use | Stimulate the face | Stimulate the face | Yes |
| Indications for Use | Over-the-counter Cosmetic Use | Over-the-counter Cosmetic Use | Yes |
| Power Source | Battery operated | Battery operated | Yes |
| Average DC current (No pulse) | 0 | 0 | Yes |
| Number of output channels | 1 | 1 | Yes |
| Microprocessor controlled | Yes | Yes (PLC) | Yes |
| Automatic no-load trip | Yes | Yes | Yes |
| Automatic shut off | Yes | Yes | Yes |
| User over-ride control | Yes | Yes | Yes |
| Indicator Display (On/off) | Yes | Yes | Yes |
| Indicator Display (Low-battery) | Yes | Yes | Yes |
| On Time (seconds) | Constant | Constant | Yes |
| Off Time (seconds) | None | None | Yes |
| Maximum Output Voltage (@ 500 Ω) | 137 mV | Mode 1: 188 mV (214 mV), Mode 2: 189 mV (225 mV), Mode 3: 185 mV (220 mV), Mode 4: 184 mV (212 mV), Mode 5: 184 mV (213 mV) | |
| (Higher than predicate, but within expected variation for a similar device) | Likely Yes | ||
| Maximum Output Voltage (@ 2k Ω) | 769 mV | Mode 1: 722 mV (1527 mV), Mode 2: 746 mV (812 mV), Mode 3: 735 mV (815 mV), Mode 4: 740 mV (802 mV), Mode 5: 741 mV (801 mV) | |
| (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes | ||
| Maximum Output Voltage (@ 10k Ω) | 3.82 V | Mode 1: 2.626 V (2.978 V), Mode 2: 3.787 V (4.011 V), Mode 3: 3.747 V (4.014 V), Mode 4: 3.503 V (3.980 V), Mode 5: 3.729 V (3.980 V) | |
| (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes | ||
| Maximum Output Current (@ 500 Ω) | 274 uA | Mode 1: 376 uA (427 uA), Mode 2: 379 uA (449 uA), Mode 3: 371 uA (440 uA), Mode 4: 368 uA (424 uA), Mode 5: 369 uA (427 uA) | |
| (Higher than predicate, but within expected variation for a similar device) | Likely Yes | ||
| Maximum Output Current (@ 2k Ω) | 387 uA | Mode 1: 361 uA (763 uA), Mode 2: 373 uA (406 uA), Mode 3: 367 uA (407 uA), Mode 4: 370 uA (401 uA), Mode 5: 370 uA (400 uA) | |
| (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes | ||
| Maximum Output Current (@ 10k Ω) | 383 uA | Mode 1: 362 uA (398 uA), Mode 2: 379 uA (401 uA), Mode 3: 375 uA (401 uA), Mode 4: 350 uA (398 uA), Mode 5: 373 uA (398 uA) | |
| (Varied, some higher, some lower, likely acceptable for equivalence) | Likely Yes | ||
| Waveform | Pulsed Monophasic | Direct Current | Difference |
| Weight | 9 oz | 120 g (approx. 4 oz) | Difference |
| Dimensions | 3" x 5.25" x 1.25" | Facial Spa with Large Conductor: 143 x 31.2 x 67.5 mm (5.6" x 1.2" x 2.7") | |
| Facial Spa with Small Conductor: 136 x 31.2 x 67.5 mm (5.4" x 1.2" x 2.7") | Difference | ||
| Housing material and construction | Thermo Plastic | ABS, Chrome plated ABS, rubber (elastomer) | Difference |
Note on "Meets Criteria?": For 510(k)s, "meeting criteria" often means being acceptably similar or having differences that don't raise new questions of safety or effectiveness. The FDA conclusion states that the technological differences do not raise new questions of safety or effectiveness, thus deeming it substantially equivalent.
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of clinical performance or algorithm evaluation with a specific sample size. This is a 510(k) submission based on substantial equivalence to a predicate device, primarily through engineering and technical comparisons and compliance with recognized standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The submission focuses on technical specifications and adherence to safety standards, not on evaluating diagnostic accuracy requiring expert consensus on a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a test set requiring adjudication in this 510(k).
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 facial stimulation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a hardware device, not an algorithm, and its performance is evaluated based on its physical properties and adherence to electrical safety and biocompatibility standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this submission, the "ground truth" implicitly refers to:
- Recognized Standards: The published requirements of standards like IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-4, ISO 10993-10, ISO 10993-12, and 21 C.F.R. § 898.
- Predicate Device Specifications: The established design and performance parameters of the legally marketed predicate device, NuFace® Plus (K103472), which serves as the benchmark for substantial equivalence.
8. The sample size for the training set
Not applicable. The device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is involved.
§ 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).