(246 days)
The Everyway Facial MENS, model: MT-200 is intended for facial stimulation and indicated for over-the-counter cosmetic use.
The Everyway Facial MENS, model MT-200 is a single channel transcutaneous electrical nerve stimulator intended for facial stimulation by applying an electrical current to electrodes, which are attached on the user's skin.
The device measures 95mm(H)x23.5mm (T). Its outer housing is made of injection molded thermoplastic resin with the output contact probes consist of chrome-plated spheres. The device is powered by a 9-Volt battery to generate microcurrent that is discharged through the two fixed smooth spherical probes.
The device is operated in such a way that turn on the intensity control knob and adjust the intended intensity or turn off the device during operation through the same control knob. While device is turned on for operation, a green LED will then illuminate indicating the device is in operation condition. User then follow the instruction for use to get appropriate stimulation treatment. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic location on the face as his intension.
The probes of Evweyway Facial MENS, model MT-200 are designed for optimal contact with the face. The MT-200 device continually alternates the positive and negative polarity between the two output spherical probes through the internal control circuit of the device and the pulse rate set by user. The MT-200 also allows user to adjust setting output amplitude from 0 to 400 microamp for a personalized comfort level. The MT-200 device requires the use of conductive derma gel provided together with the device. With the combination of the main device parts as above mentioned, the device can be used as recommended in manual for facial stimulation and indicated for over-the-counter cosmetic use.
This document is a 510(k) summary for the Everyway Facial MENS, model MT-200. It details the device, its intended use, and a comparison to a predicate device (NuFace® Facial Toning Device) to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of specific performance metrics for the device's clinical effectiveness (e.g., how much it improves facial appearance). Instead, the acceptance criteria are implicitly defined by demonstrating substantial equivalence to a legally marketed predicate device (K072260: NuFace® Facial Toning Device) through various technical and safety characteristics.
The comparison table provided in the document serves as the "reported device performance" against the implicitly accepted characteristics of the predicate device.
| Feature / Parameter | Predicate Device (NuFace® K072260) | New Device (Everyway Facial MENS MT-200) | Acceptance Criterion (Implicit) | Reported Performance (New Device) | Does it meet? |
|---|---|---|---|---|---|
| Intended Use | Facial stimulation, OTC cosmetic | Facial stimulation, OTC cosmetic | Same intended use as predicate | Same as predicate | Yes |
| FDA Product Code | NFO | NFO | Same product code | Same as predicate | Yes |
| Prescription or OTC | OTC | OTC | Same usage classification | Same as predicate | Yes |
| Waveform | Biphasic | Biphasic | Biphasic waveform | Biphasic | Yes |
| Shape | Rectangular | Rectangular | Rectangular shape | Rectangular | Yes |
| Manufacturer | Carol Cole | Everyway | Not a direct criterion, but noted for comparison | Different | N/A |
| Power Source(s) | 9 Vx1 | 9 Vx1 | Same power source type | Same as predicate | Yes |
| Output Modes | 1 (8~10Hz) | 3 (8Hz, 9Hz, 10Hz) | Comparable output modes | Similar frequency range, more discrete options | Yes (comparable) |
| Output Channels | Alternating | Alternating | Alternating channels | Alternating | Yes |
| Regulated Output | 0-400uA (Current) | 0-3mA (load 4kΩ) (Current) | Comparable output current range | Higher maximum current output | Yes (comparable after calculation) |
| Software/Firmware/Microprocessor | Yes | Yes | Presence of software/firmware/microprocessor control | Yes | Yes |
| Automatic Overload Trip? | Yes | Yes | Presence of automatic overload trip | Yes | Yes |
| Automatic No-Load Trip? | Yes | Yes | Presence of automatic no-load trip | Yes | Yes |
| Automatic Shut Off? | Yes | Yes | Presence of automatic shut-off | Yes | Yes |
| User Override control? | Yes | Yes | Presence of user override control | Yes | Yes |
| Indicator Display: On/Off Status? | Yes | Yes | Presence of On/Off status indicator | Yes | Yes |
| Indicator Display: Low Battery? | Yes | Yes | Presence of low battery indicator | Yes | Yes |
| Indicator Display: Voltage/Current Level? | Yes | Yes | Presence of voltage/current level indicator | Yes | Yes |
| Timer Range (Minutes) | Continuous | 20, 40 minutes and Continuous | Comparable or enhanced timer options | Enhanced timer options | Yes (better) |
| Compliance with Voluntary Standards? | IEC 60601-2-10 | IEC 60601-2-10, IEC 60601-1, IEC 60601-1-2 | Compliance with relevant electrical safety standards | Compliance with relevant electrical safety standards and general safety | Yes |
| Compliance with 21 CFR 898? | Yes | Yes | Compliance with 21 CFR 898 | Yes | Yes |
| Maximum Average Power Density | 0.057mW/cm² | 1.33mW/cm² (8Hz/10kΩ) | "Very close and within acceptable range" after calculation by applicant | Higher, but argued to be "very close and within acceptable range" | Yes (argued) |
| Maximum Current Density | 0.017mA/cm² | 0.26mA/cm² (8Hz/500Ω) | "Very close and within acceptable range" after calculation by applicant | Higher, but argued to be "very close and within acceptable range" | Yes (argued) |
| Electrode Used | Chrome-plated spheres, 30mm | Stainless steel hemispheres, 25mm | Comparable construction and material | Similar, but different material and size | Yes (comparable) |
Regarding the output differences (e.g., Maximum Output Voltage, Current, Charge): The summary explicitly states: "Through the detailed calculation comparison of stimulation output energy for each operation mode (in particular the output current density and power density), we found the output level in each operation mode for our Everyway Facial MENS, model MT-200 and predicate device are very close and within the acceptable range. So we believe the difference in detailed output parameters does not affect the determination of substantial equivalence." This implies that the 'acceptance criteria' for these parameters were that they be "very close and within the acceptable range" compared to the predicate, as determined by the applicant's calculations.
2. Sample size used for the test set and the data provenance
The document states: "No particular Clinical Test was conducted for Everyway Facial MENS, model MT-200." Therefore, there is no test set or related data provenance for clinical performance. The comparison is based on the technical specifications of the new device against the predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set was used and thus no ground truth established by experts.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used.
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, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable to this medical device type. There is no "algorithm only" performance for a facial stimulator. The device operates independently of human interpretation of data for its primary function.
7. The type of ground truth used
Not applicable. No clinical ground truth was established as no clinical studies were performed. The "ground truth" for substantial equivalence is derived from the established safety and effectiveness of the predicate device and the technical comparison to it.
8. The sample size for the training set
Not applicable. There is no mention of a training set for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable, as no training set was used.
§ 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).