Everyway Facial MENS by EVERYWAY MEDICAL INSTRUMENTS CO., LTD.

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.

AI/ML Overview

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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 2, 2015

Everyway Medical Instruments Co., Ltd. Robert Tu 3FL., No 5, Lane 155, Section 3 Peishen Rd. Shen Keng Hsiang, Taipei Hsien Taiwan, 222, ROC

Re: K142794

Trade/Device Name: Everyway Facial MENS, model MT-200 Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II Product Code: NFO Dated: May 1, 2015 Received: May 4, 2015

Dear Mr. Tu:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours.

Felipe Aquel - S

Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K142794

Device Name

Everyway Facial MENS, model: MT-200

Indications for Use (Describe)

The Everyway Facial MENS, model: MT-200 is intended for facial stimulation and indicated for over-the-counter cosmetic use.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

|X | Over-The-Counter Use (21 CFR 801 Subpart C)

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3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being prepared in accordance with the requirements of SMDA 1990 and 21 CFR 807.92 at June 15, 2011.

The assigned 510(k) number is: K142794 .

1. Submitter's Identifications:
  Establishment: EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Registration Number: 9616877 Operations: Manufacturer

Owner/Operator:EVERYWAY MEDICAL INSTRUMENT CO., LTD. Address : 3Fl., No. 5, Lane 155, Sec. 3, Peishen Rd., Shenkeng Hsiang, Taipei Hsien 222, Taiwan Contact Person: Robert Tu Phone : 886-2-2662-0038 Fax No: 886-2-2664-5566 e-mail : tu922@ms35.hinet.net

1. Name of the Device: Everyway Facial MENS/ Model: MT-200.
1. Information of the 510(k) Cleared Device (Predicate Device): K072260: NuFace® Facial Toning Device.
1. Classification Information: Trade/Device Name: Everyway Facial MENS/ Model: MT-200. Requlation Number: 21 CFR 882.5890 Classification Name: Stimulator, Nerve, Transcutaneous For Pain Relief. Regulatory Class: II Product Code: NFO
1. Device Description:

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3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

6. Intended Use:

The Everyway Facial MENS, model: MT-200 is intended for facial stimulation and indicated for over-the-counter cosmetic use.

7. Comparison to the 510(k) Cleared Device (Predicate Device):

The following features are completely identical among the predicate device and our device
Features	510(K) Proposed Model	New Model
Model Name	NuFaceR Facial Toning Device	Everyway Facial MENS, model MT-200
510(K) No.	K072260	K142794
Prescription or OTC	OTC	OTC
FDA product code	NFO	NFO
Indication for Use	intended for facial stimulation and indicatedfor over-the-counter cosmetic use.	intended for facial stimulation and indicatedfor over-the-counter cosmetic use.
Electrode Used	Dual contact probes consist ofchrome-plated spheres with diameter 30mm.Note: Surface is 28.3cm²/ Per contactprobe	Dual contact probes consist of stainlesssteel hemispheres with diameter 25mm.Note: Surface is 9.8cm²/ Per contactprobe

8. Significant output characteristics comparison table:

Parameter		Predicate Device	New Device
510(K) Number		K072260	K142794
Device Name and Model		NuFaceR Facial Toning Device	MT-200Facial MENS
Manufacturer		Carol Cole	Everyway
Power Source(s)		9 Vx1	9 Vx1
- Method of Line current Isolation		Type BF	Type BF
- Patient Leakage Current		---	---
- Normal condition (uA)		Under 0.1	Under 0.1
- single Fault condition (uA)		Under 0.5	Under 0.5
Average DC current through electrodes whendevice is on but no pulses are being applied (uA)		Not applicable	Not applicable
Number of Output Modes		1 (8~10Hz)	3 (8Hz, 9Hz, 10Hz)
Number of OutputChannels:	Synchronous orAlternating?	Alternating	Alternating
	Method of ChannelIsolation	Output Coil	Output Coil
Regulated Current or Regulated Voltage?		0-400uA	0-3mA (load 4kΩ)
Software/Firmware/Microprocessor control?		Yes	Yes
Automatic Overload Trip?		Yes	Yes
Automatic No-Load Trip?		Yes	Yes
Automatic Shut Off?		Yes	Yes
User Override control?		Yes	Yes
Indicator Display:	On/Off Status?	Yes	Yes
	Low Battery?	Yes	Yes
	Voltage/CurrentLevel?	Yes	Yes
Timer Range (Minutes)		Continuous	20, 40 minutes and Continuous
Compliance with Voluntary Standards?		IEC 60601-2-10	IEC 60601-2-10
Compliance with 21 CFR 898?		Yes	Yes
Weight (g) including battery		817 g	115 g
Dimensions (mm.) [W x H x D]		63.5X177.8X25.4 mm	65X95X23.5
Housing Materials and construction		ABS	ABS

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3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

For the device output features, we also provided the comparison for the output characteristics as the following table:

Parameter		Predicate Device	New Device
Mode or Program Name		NuFace® Facial Toning Device	MT-200Facial MENS
Waveform (e.g., pulsed monophasic, biphasic)		Biphasic	Biphasic
Shape (e.g., rectangular, spike, rectifiedsinusoidal)		Rectangular	Rectangular
Maximum Output Voltage (volts)(+/- 20 %)		0.336V @500Ω1.14V @2KΩ5.68V @10KΩ	1.78V @500Ω6.64V @2KΩ16.2V @10KΩ
Maximum Output Current (mA)(+/-_20 %)		0.672mA @500Ω0.57mA @2KΩ0.568mA @10KΩ	3.56mA @500Ω3.32mA @2KΩ1.62mA @10KΩ
Duration of primary phase (mSec)		~108mS	~99-125mS (Burst)
Pulse Duration (mSec)		~54mS	~49-63mS
Frequency (Hz) [or Rate (pps)]		8~10Hz	8Hz, 9Hz, 10Hz
Formultiphasicwaveformsonly:	Symmetrical phases?	Yes	Yes
	Phase Duration (include units),(Stage range, if applicable),	pulsed monophasicPositive:~54mS	pulsed monophasicPositive:~49-63mS
	(both phases, if asymmetrical)	Negative: ~54mS	Negative: ~49--63mS
Maximum Charge(Microcoulombs per pulse) (ifzero, state method of achieving zero net chargefor net charge/pulse)		2.87uC	19.64uC (8Hz/500Ω)
Maximum Phase Charge(uC)		25.86uC	157.12uC (8Hz/500Ω)
Maximum Current Density		0.017mA/cm²	0.26mA/cm² (8Hz/500Ω)
Maximum Average Current		0.48mA	2.52mA (8Hz/500Ω)
Maximum Average Power Density		0.057mW/cm²	1.33mW/cm² (8Hz/10kΩ)
	Pulse per burst	No burst mode	8~10 pulses
Burst Mode	Burst per second	No burst mode	~1
(i.e. pulse trains)	Burst duration	No burst mode	~1S
	Duty Cycle	No burst mode	0.25
On Time (Second)		Constant	Constant
Off Time(second)		Constant	None
Additional Features(specify, if applicable)		NIL	NIL

1. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of the devices are as the followings:
  Compliance to applicable voluntary standards includes IEC 60601-2-10, as well as IEC 60601-1, and IEC 60601-1-2 requirement. In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA software guidance.

Discussion: The Compliance to applicable voluntary standards as above mentioned indicates that the new device in this submission used the same standards as that of predicate device. Therefore; we consider that the compliance of standards included in our submission is adequate for the determination of substantial equivalence.

1. Discussion of Clinical Test Validation Activities Performed to Determine the Effectiveness of Device are as the followings:
  No particular Clinical Test was conducted for Everyway Facial MENS, model MT-200.
1. Summary for the technology comparison.
  Basically the Everyway Facial MENS, model MT-200 has the similar technological characteristics with the predicate device in the product design, material, energy source type, main program mode and the main output waveform...etc. There exists some difference in the detailed output parameters (mainly in the output intensity and electrode sizes). 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.

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3F1., No. 5, Lane 155, Sec. 3,Peishen Rd, Shen Keng Hsiang, Taipei Hsien, Taiwan,

12. Conclusions

The Everyway Facial MENS, model MT-200 has the same intended use and the similar technological characteristics as the cleared devices. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted models could maintain the same safety and effectiveness as that of cleared device.

In the other words, those engineering difference do not: (1) affect the intended use or (2) alter the fundamental scientific technology of the device.

Regulation Number and Section

§ 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).