The Everyway Low Back Pain Relief System, model EV-820 is indicated for over the counter use in the temporary relief of pain associated with sore and aching muscles in the low back due to strain from exercise or normal household and work activities.

Device Description

The Everyway Low Back Pain Relief System, models EV-820 is a non-invasive devices which are intended for over the counter use in temporary relief of pain associated with sore and aching muscles in the lower back due to stain from exercise or normal household and work activities. The devices contain the following main parts: TENS stimulation unit which was designed to generate 8 preprogram modes of output stimulation pulse, Support Belt, Self-adhesive pads, and Snap Cable. With the combination of the main device parts, the device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back for over the counter use without prescription in temporary relief of pain associated with sore and aching muscles in the lower back.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding acceptance criteria and study information:

This device is a TENS unit, a type of electrotherapy device. The submission explicitly states "No particular Clinical Test was conducted for Everyway Low Back Pain Relief System, model EV-820." Therefore, there is NO clinical study information, acceptance criteria, or performance data related to clinical effectiveness presented in this document for the EV-820 device.

The 510(k) summary focuses on demonstrating substantial equivalence to a legally marketed predicate device (Gemore Low Back Pain Relief System, model GM310PP (K060222)) through non-clinical testing.

Here's the breakdown based on your requested information, highlighting the lack of clinical study data:

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was conducted for the Everyway Low Back Pain Relief System, model EV-820, there are no acceptance criteria or reported device performance related to pain relief efficacy from such a study in this document.

The non-clinical tests performed were primarily for safety and engineering compliance. The acceptance criteria for these tests would typically be compliance with the respective standards, but the specific numerical criteria and detailed results are not provided in this summary.

Test Type (Non-Clinical)	Acceptance Criteria (Implied)	Reported Performance (Result)
Performance Compliance Test (ANSI/AAMI NS4)	Compliance with ANSI/AAMI NS4 standards for Transcutaneous Electrical Nerve Stimulators	Conducted by manufacturer (Implied compliance)
Usability Study (IEC 60601-1-6)	Compliance with IEC 60601-1-6 for usability engineering	Conducted by manufacturer (Implied compliance)
Electrical Compliance Test (IEC 60601-1)	Compliance with IEC 60601-1 general requirements for basic safety and essential performance	Conducted by accredited laboratory (Implied compliance)
EMC Compliance Test (IEC 60601-1-2)	Compliance with IEC 60601-1-2 for electromagnetic compatibility	Conducted by accredited laboratory (Implied compliance)
Biocompatibility Test (ISO 10993-5 & ISO 10993-10)	Compliance with ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization) for support belt and stimulation electrode	Conducted by accredited laboratory (Implied compliance)

2. Sample size used for the test set and the data provenance:

Clinical Efficacy Test Set: Not applicable, as no clinical efficacy study was conducted.
Non-Clinical Test Sets: The sample sizes for the non-clinical tests (e.g., number of devices tested for electrical compliance, number of participants for usability study, specific amounts of materials for biocompatibility) are not detailed in this summary. The data provenance would be the respective testing laboratories or the manufacturer.

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 efficacy study with expert-established ground truth was conducted. For non-clinical tests, "ground truth" is typically defined by compliance with the technical standards, which are established by expert consensus in standards bodies.

4. Adjudication method for the test set:

Not applicable, as no clinical efficacy study requiring adjudication for ground truth was conducted.

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 TENS unit for pain relief, not an AI-assisted diagnostic or interpretive system. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a TENS unit, not an algorithm or AI system.

7. The type of ground truth used:

Clinical Efficacy: Not applicable, as no clinical efficacy study was conducted.
Non-Clinical: The "ground truth" for the non-clinical tests is regulatory compliance with established international and national standards (e.g., ANSI/AAMI NS4, IEC 60601-1, IEC 60601-1-2, ISO 10993-5, ISO 10993-10).

8. The sample size for the training set:

Not applicable, as this device does not involve machine learning or AI, and therefore has no "training set."

9. How the ground truth for the training set was established:

Not applicable, as this device does not involve machine learning or AI, and therefore has no "training set" or ground truth for one.

In summary, the 510(k) submission for the Everyway Low Back Pain Relief System, model EV-820, relies entirely on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing. It explicitly states that no clinical tests were conducted for the device's effectiveness. Therefore, all questions related to clinical study design, endpoints, acceptance criteria for efficacy, and ground truth establishment for clinical performance are not applicable to the information provided in this document.

Summary

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K UD716

EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

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

OCT 1 8 2011

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 February 28, 2011.

The assigned 510(k) number is:

1. Submitter's Identifications:
  ごいで

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 Low Back Pain Relief System, model EV-820.
1. Information of the 5.10(k) Cleared Device (Predicate Device): Gemore Low Back Pain Relief System, model GM310PP(K060222).
1. Classification Information: Trade/Device Name: Everyway Low Back Pain Relief System, model EV-820, Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Nerve Stimulator Regulatory Class: II Product Code: NUH
1. Device Description:

The devices contain the following main parts: TENS stimulation unit which was designed to generate 8 preprogram modes of output stimulation pulse, Support Belt, Self-adhesive pads,

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EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

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

and Snap Cable.

: -

With the combination of the main device parts, the device can be worn on the low back part of user so as to place the stimulation pads on the treatment location of low back for over the counter use without prescription in temporary relief of pain associated with sore and aching muscles in the lower back.

6. Intended Use:

The Everyway Low Back Pain Relief System, model EV-820 is indicated for over the counter use in the temporary relief of pain associated with sore and aching muscles in the low back due to stain from exercise or normal household and work activities.

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

The Everyway Low Back Pain Relief System, model EV-820 is substantially equivalent to the Gemore Low Back Pain Relief System, model GM310PP(K060222) without any significant difference in main technological and operational feature.

1. Discussion of Non-Clinical Tests Verification Activities Performed to Determine the Safety and Performance of EV-820 are as the followings:
- 1> Performance Compliance Test according to ANSI/AAMI NS4 conducted by manufacturer
- 2> Usability Study Report according to IEC 60601-1-6 conducted by manufacturer.
- 3> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory.
- 4> EMC Compliance Test according to IEC 60601-1-2 by accredited laboratory.
- 5> Biocompatibility Test for the support belt and stimulation electrode according to ISO 10993-5 & ISO 10993-10 by accredited laboratory.
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 Low Back Pain Relief System, model EV-820.

1. Conclusions
  The Everyway Low Back Pain Relief System, model EV-820, has the same intended use and technological characteristics as the cleared device of Gemore Low Back Rain Relief System, model GM310PP(K060222). Moreover, verification and validation tests contained this submission demonstrate that the difference in the submitted model could maintain it he same safety and effectiveness as that of cleared device.

In the other words, Everyway Low Back Pain Relief System, model EV-820 is substantial equivalent with the Gemore Low Back Pain Relief System, model GM310PP(K600222).

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HU" are arranged in an arc above the eagle, and the words "& HU" are arranged in an arc below the eagle.

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

OCT 1 8 2011

Everyway Medical Instruments Co., Ltd. c/o Mr. Robert Tu President and Operator Owner 3 Fl., No. 5, Lane 155, Sec. 3 Peishen Rd., Shenkeng Hsiang Taipei Hsien 222 Taiwan

Re: K110716

Trade/Device Name: Everyway Low Back Pain Relief System (Model EV-820) Regulation Number: 21 CFR 882,5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: NUH Dated: October 4, 2011 Received: October 5, 2011

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.

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Page 2 - Mr. Robert Tu

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-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

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

Indications For Use

510(k) Number (if known):___K110716

Device Name: Everyway Low Back Pain Relief System, model EV-820.

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daryl Ellis
(Division Size 08)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110716

Page 1 of

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).