Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.

Device Description

The Everyway OTC EMS, model EV-805 is a dual channel powered muscle stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance by applying an electrical current to electrodes, which are attached on the user's skin.

The device measures 101mm(H)x 68mm(W)x21.5mm(D). 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 output pulses that is discharged through the two adhesive electrode placed on the patient's skin for treatment and muscle training.

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. User then follow the instruction for use to get appropriate stimulation treatment and/or training on the healthy muscles.

AI/ML Overview

This document describes the 510(k) premarket notification for the Everyway OTC EMS, Model EV-805, a powered muscle stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K102926: Gemore Muscle Conditioner/Model GM320PE).

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The core of the acceptance criteria for this device, as presented in the document, is demonstrating substantial equivalence to a predicate device. This is achieved through a comparison of key parameters, with "Substantial Equivalence (SE)" being the reported performance. The table below summarizes the comparison:

Parameter	Acceptance Criteria (Predicate Device)	Reported Device Performance (Everyway OTC EMS, Model EV-805)	Substantial Equivalency
Product Code	NGX	NGX	Identical
Prescription (Rx) or OTC	OTC	OTC	Identical
Indication for Use (IFU)	Intended to stimulate healthy muscles in order to improve or facilitate muscle performance. May be considered a technique of muscle training. (Includes additional contraindications related to injured/ailing muscles).	Intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.	SE*
Waveform	Biphasic	Biphasic	Identical
Shape	Rectangular	Rectangular	Identical
Maximum Output Voltage (volts) (+/-20%)	7.5V @500Ω18.0V @2KΩ23V @10KΩ	7.66V @500Ω8.2V @2KΩ8.2V @10KΩ	SE*
Maximum Output Current (mA) (+/-20%)	15.0mA @500Ω9.0mA @2KΩ2.3mA @10KΩ	15.3mA @500Ω4.1mA @2KΩ0.82mA @10KΩ	SE*
Duration of primary phase (usec)	200-300us (single phase)	210us (single phase)	SE*
Pulse Duration (usec)	600us	420us	SE*
Frequency (Hz) [or Rate (pps)]	2~99Hz	2~99Hz	Identical
For multiphasic waveforms only: Symmetrical phases?	Yes	Yes	Identical
Maximum Charge (Microcoulombs per pulse)	22.5uC	15.75uC	SE*
Maximum Phase Charge (uC)	22.5uC	15.75uC	SE*
Maximum Current Density	0.0716mA/cm2	0.0624mA/cm2	SE*
Maximum Average Current	4.455 mA	3.119mA	SE*
Maximum Average Power Density	2.685mW/cm2	2.34mW/cm2	SE*
Pulse per burst	No burst mode	No burst mode	Identical
Burst Mode (i.e. pulse trains)	No burst mode	No burst mode	Identical
Burst duration	No burst mode	No burst mode	Identical
Duty Cycle	No burst mode	No burst mode	Identical
On Time (Second)	0s, 5s, 6s, All time	0s, 5s, 6s, All time	Identical
Off Time (second)	0s, 1s, 5s, 10s	0s, 1s, 5s, 10s	Identical

*SE = Substantially equivalent

The document states that "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 OTC EMS, Model EV-805 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."

2. Sample Size Used for the Test Set and Data Provenance

The presented document does not describe a test set with a sample size in the context of clinical performance evaluation for this device. The submission relies entirely on non-clinical tests (compliance to standards) and a comparison to a predicate device to establish substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

As there was no clinical performance test set, there were no experts used to establish ground truth in this context. The determination of substantial equivalence is based on engineering and performance criteria compared to the predicate through non-clinical testing.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical specifications, not on evaluating the improvement of human readers with or without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

N/A. This device is a powered muscle stimulator, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is evaluated based on its electrical output characteristics and compliance with safety standards.

7. Type of Ground Truth Used

The "ground truth" implicitly used for this submission is the established safety and effectiveness of the legally marketed predicate device (K102926), and compliance with recognized national and international safety standards. The assessment is that the new device's technical specifications and non-clinical test results are comparable or fall within acceptable limits of the predicate.

8. Sample Size for the Training Set

The document does not mention a training set. This type of device (powered muscle stimulator) typically does not involve machine learning algorithms or AI that would require a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set.

Summary

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Everyway Medical Instrument Co., Ltd. Paul Hung Official Correspondent 3FL., No. 5, Lane 155, Section 3, Peishen Rd. Shenkeng District, New Taipei City, Taiwan 222 R.O.C.

Re: K162744

Trade/Device Name: Everyway OTC EMS, Model EV-805 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: Class II Product Code: NGX Dated: June 27, 2017 Received: July 3, 2017

Dear Paul Hung:

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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" (21 CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely,

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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3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, 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: K162744.

1. Submitter's Identifications: Establishment: EVERYWAYMEDICALINSTRUMENTSCO.,LTD. Address: 3Fl., No. 5, Lane 155, Sec. 3, Beishen Rd., Shenkeng Dist, New Taipei City 222, Taiwan Registration Number: 9616877 Operations: Manufacturer
  Owner/Operator: EVERYWAY MEDICALINSTRUMENTSCO.,LTD. Address : 3FI., No. 5, Lane 155, Sec. 3, Beishen Rd., Shenkeng Dist., New Taipei City 222, Taiwan Contact Person: Robert Tu Phone:886-2-2662-0038 FaxNo.:886-2-2664-5566 e-mail : robert@everyway-medical.com
1. Name of the Device: Everyway OTC EMS, Model EV-805
1. Information of the 510(k) Cleared Device (Predicate Device): K102926: Gemore Muscle Conditioner/Model GM320PE
1. ClassificationInformation:

Trade/Device Name: Everywav OTC EMS. model: EV-805 Requlation Number: 21 CFR 890.5850 Regulation Name: Powered Muscle Stimulator Regulatory Class: II Product Code: NGX

5. Device Description:

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3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan.

With the combination of the main device parts as above mentioned , the device can be used as recommended in manual for muscle stimulation and indicated for over-the-counter (OTC) use to improve or facilitate muscle performance

1. Intended Use:
  Everyway OTC EMS is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The various types of muscle work that Everyway OTC EMS can impose on the stimulated muscles are able to improve or facilitate muscle performance. Everyway OTC EMS may therefore be considered a technique of muscle training.
1. Comparison to the 510(k) Cleared Device (Predicate Device): The following features are completely identical among the predicate device and our devices.

Parameter	New Device	Predicate Device	Substantive Equivalency
Mode or Program Name or 510k	EV-805 OTC EMS	K102926	--
Product Code	NGX	NGX	Identical
Prescription (Rx) or OTC	ОТС	ОТС	Identical
Indication for use (IFU)	Everyway OTC EMS is intended tostimulate healthy muscles in order toimprove or facilitate muscleperformance. The various types ofmuscle work that Everyway OTCEMS can impose on the stimulatedmuscles are able to improve orfacilitate muscle performance.Everyway OTC EMS may thereforebe considered a technique ofmuscle training.	The Gemore muscle conditioner,model GM310PE/GM320PE/GM330PE/GM340PE/GM350PE areintended to stimulate healthy musclesin order to improve or facilitate muscleperformance.The Gemore muscle conditioner,model GM310PE/GM320PE/GM330PE/GM340PE/GM350PE arenot intended to be used in conjunctionwith therapy or treatment of medicaldiseases or medical conditions of anykind. None of the Gemore muscleconditioned training programs aredesigned for injured or ailing muscleand it's use on such muscle incontraindicated. The Gemore muscleconditioner, modelGM310PE/GM320PE/GM330PE/GM340PE/GM350PEelectrically impulse triggering actionspotentials on motoneurones of motornerves (excitations). The excitationsmotoneurones are transmitted to themuscle fibers via the motor endplatewhere they generate mechanicalmuscle fiber response that correspondto muscle work. Depending on theparameters of the electrical impulses(pulse frequency, duration ofcontraction, duration of rest, totalsession duration), different type ofmuscle work can be imposed on thestimulated muscles. The various typesof muscle work that Gemore muscleconditioner can impose on thestimulated muscles are able toimprove or facilitate muscleperformance. The Gemore muscleconditioner, modelGM310PE/GM320PE/GM330PE/GM340PE/GM350PE maytherefore be considered a technique ofmuscle training.	SE*
Waveform (e.g., pulsed monophasic),	Biphasic	Biphasic	Identical
Shape (e.g., rectangular, spike,rectified sinusoidal)	Rectangular	Rectangular	Identical
Maximum Output Voltage (volts)(+/-20%)	7.66V @500Ω8.2V @2KΩ8.2V @10KΩ	7.5V @500Ω18.0V @2KΩ23V @10KΩ	SE*
Maximum Output Current (mA)(+/-20%)	15.3mA @500Ω4.1mA @2KΩ0.82mA @10KΩ	15.0mA @500Ω9.0mA @2KΩ2.3mA @10KΩ	SE*
Duration of primary phase (usec)	210us (single phase)	200-300us (single phase)	SE*
Pulse Duration (usec)	420us	600us	SE*
Frequency (Hz) [or Rate (pps)]	2~99Hz	2~99Hz	Identical
For multiphasicwaveforms only:	Symmetricalphases?	Yes	Yes	Identical
Maximum Charge(Microcoulombsper pulse) (if zero, state method ofachieving zero net charge for net	15.75uC	22.5uC	SE*
Maximum Phase Charge(uC)	15.75uC	22.5uC	SE*
Maximum Current Density	0.0624mA/cm2	0.0716mA/cm2	SE*
Maximum Average Current	3.119mA	4.455 mA	SE*
Maximum Average Power Density	2.34mW/cm2	2.685mW/cm2	SE*
Pulse per burst	No burst mode	No burst mode	Identical
Burst Mode(i.e. pulse trains)	Burst per	No burst mode	No burst mode	Identical
Bust duration	No burst mode	No burst mode	Identical
Duty Cycle	No burst mode	No burst mode	Identical
On Time (Second)	0s, 5s, 6s, All time	0s, 5s, 6s, All time	Identical
Off Time(second)	0s, 1s, 5s, 10s	0s, 1s, 5s, 10s	Identical

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3FL. No. 5. Lane 155. Sec. 3.Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan

SE*= Substantially equivalent to the predicate. Please see section 10 for more information.

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, IEC60601-1-11 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.

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3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan.

According to the device features, the testing for the following standards were considered required for the device:

The International Standard IEC 60601-2-10: 2012; Medical Electrical equipment Part 2-10: Particular requirement for the safety of nerve and muscle stimulators.
The International Standard ANSI/AAMI ES 60601-1: 2005 Safety of medical device; Electrical equipment - General safety.
The International Standard IEC 60601-1-2: 2014; Medical Electrical equipment Safety -Electromagnetic Compatibility.
International Standard ISO 10993-1: 2009; Biological evaluation of medical devices -Part 1: Guidance on selection of tests.
International standard ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
International standard EN/ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and delayed-type hypersensitivity
The International Standard IEC 60601-1-11: 2010 collateral standard: requirement for medical electrical equipment and medical electrical system used in the home healthcare environment.

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. DiscussionofClinicalTestValidationActivitiesPerformedtoDeterminetheEffectivenessof Deviceare as the followings:
  No particular Clinical Test was conducted for Everyway OTC EMS, Model EV-805.

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3FI., No. 5, Lane 155, Sec. 3,Beishen Rd., Shenkeng Dist., New Taipei City, Taiwan.

10. Summary for the technology comparison.

Basically the Everyway OTC EMS, Model EV-805 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 OTC EMS, Model EV-805 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.

11. Conclusions

The Everyway OTC EMS, Model EV-805 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

N/A