The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body.

Device Description

Everyway Traction Unit, model EVER-TRAC ET-800 is a medical device constructed for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body. For this intended operation function, ET-800 is the combination of driving moter, speed reduction gear, pulley assembly, spring, force and speed control unit... etc. All of the operational parts as above mentioned are mounted on the frame of device housing. The pulling force for ET-800 is generated by the combination of induction motor and speed reduction gear. For the operation of ET-800, the single phase AC power shall be supplied from the general wall socket of house (Note: In USA, the power supply specification is single phase, 60Hz, 120V). Basically ET-800 is a microprocessor-controlled traction system in which the operational software is built inside the control unit to properly control the exertion and release of pulling force according to the setting for applying force, operation cycle, and operation time prescribed by the physician. To ensure the safety of operation, the device was designed and constructed to provide the following safety protection: <1> Manual release, <2>Auto shutdown, and <3>Safe protect. In addition, the device also provides warning alarm function for same near dangerous situations as mentioned in user's manual.

AI/ML Overview

Here's an analysis of the provided 510(k) summary, specifically addressing the requested information about acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, there are no specific quantitative acceptance criteria or detailed device performance metrics reported for the Everyway Traction Unit, model EVER-TRAC ET-800. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Acceptance Criteria (Quantitative/Qualitative)	Reported Device Performance
Not explicitly stated in terms of specific performance thresholds (e.g., force accuracy, speed range compliance)	The device passed electrical compliance and EMC compliance tests as per IEC 60601-1 and IEC 60601-1-2.
General safety features (manual release, auto shutdown, safe protect, warning alarms)	These features are designed into the device, implying they function as intended to meet safety objectives.
Substantial equivalence to predicate device (Ever Prosperous Traction System model DIGIT-TRAC 930) in technological and operational features	The document concludes that the device maintains the "same safety and effectiveness" as the predicate device, indicating that its performance in these areas is considered equivalent.

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

The provided document does not mention a "test set" in the context of clinical performance or a specific dataset used for evaluating the device's therapeutic effectiveness. The tests conducted were non-clinical:

Non-Clinical Testing: Electrical Compliance Test and EMC Compliance Test.
Sample Size: Not applicable in the context of clinical data. These tests would typically be performed on a single or a few units of the manufactured device.
Data Provenance: Not applicable for clinical data. The tests were performed by "accredited laboratory."

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

Not applicable. No clinical test set or ground truth established by experts is mentioned in the provided document. The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical safety testing.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. No clinical test set or adjudication process is mentioned.

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. The device is a powered traction unit, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. The device is a physical medical instrument, not a standalone algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable for clinical performance. For the safety and performance evaluation, the "ground truth" used would be the standards themselves (IEC 60601-1 and IEC 60601-1-2). The device's electrical and EMC characteristics were compared against the requirements of these standards.

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. The device is not an AI/ML algorithm that requires a training set.

Summary of the Study:

The provided document describes a 510(k) premarket notification for the Everyway Traction Unit, model EVER-TRAC ET-800. The study conducted to demonstrate the device meets acceptance criteria (specifically for market clearance via substantial equivalence) is not a clinical study. Instead, it relies on non-clinical verification activities:

Electrical Compliance Test: According to IEC 60601-1, performed by an accredited laboratory.
EMC Compliance Test: According to IEC 60601-1-2, performed by an accredited laboratory.

The conclusion is that these tests, along with the device's similar technological and operational features to the predicate device (Ever Prosperous Traction System model DIGIT-TRAC 930), demonstrate substantial equivalence and maintain "the same safety and effectiveness" as the cleared predicate device. No particular clinical test was conducted for this device. Therefore, the "acceptance criteria" primarily relate to compliance with specified electrical and electromagnetic compatibility standards, and the "study" is limited to these non-clinical engineering tests.

Summary

{0}------------------------------------------------

K112074
PAGE 1 OF 2

EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

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

FEB = 1 2012

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:

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 Traction Unit, model EVER-TRAC ET-800.
1. Information of the 510(k) Cleared Device (Predicate Device): Ever Prosperous Traction System model DIGIT-TRAC 930(K052453)

Classification Information: Trade/Device Name: Everyway Traction Unit, model EVER-TRAC ET-800. Regulation Number: 21 CFR Part 890.5900 Regulation Name: Powered Traction Equipment Regulatory Class: II Product Code: ITH

1. Device Description:
  Everyway Traction Unit, model EVER-TRAC ET-800 is a medical device constructed for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

For this intended operation function, ET-800 is the combination of driving moter, speed reduction gear, pulley assembly, spring, force and speed control unit... etc. All of the operational parts as above mentioned are mounted on the frame of device housing.

{1}------------------------------------------------

EVERYWAY MEDICAL INSTRUMENTS CO.,LTD.

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

The pulling force for ET-800 is generated by the combination of induction motor and speed reduction gear. For the operation of ET-800, the single phase AC power shall be supplied from the general wall socket of house (Note: In USA, the power supply specification is single phase, 60Hz, 120V).

Basically ET-800 is a microprocessor-controlled traction system in which the operational software is built inside the control unit to properly control the exertion and release of pulling force according to the setting for applying force, operation cycle, and operation time prescribed by the physician.

To ensure the safety of operation, the device was designed and constructed to provide the following safety protection: <1> Manual release, <2>Auto shutdown, and <3>Safe protect. In addition, the device also provides warning alarm function for same near dangerous situations as mentioned in user's manual.

1. Intended Use:
  The Everyway Traction System, model EVER-TRAC ET-800 is intended for medical purpose for use in conjunction with traction accessories, such as belts and harnesses , to exert therapeutic pulling forces on the patient's body
1. Comparison to the 510(k) Cleared Device (Predicate Device): The Everyway Traction Unit, model EVER-TRAC ET-800 is substantially equivalent to the Ever Prosperous Traction System model DIGIT-TRAC 930(K052453) 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 EVER-TRAC ET-800 are as the followings: 1> Electrical Compliance Test according to IEC 60601-1 by accredited laboratory. 2> EMC Compliance Test according to IEC 60601-1-2 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 Traction Unit, model EVER-TRAC ET-800.
1. Conclusions

The Everyway Traction Unit, model EVER-TRAC ET-800, has the same intended use and technological characteristics as the cleared device of Ever Prosperous Traction System model DIGIT-TRAC 930(K052453. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted model could maintain the same safety and effectiveness as that of cleared device.

In the other words, Everyway Traction Unit, model EVER-TRAC ET-800 is substantial equivalent with the Ever Prosperous Traction System model DIGIT-TRAC 930(K052453) .

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and features the department's name around the perimeter. In the center is a stylized image of an eagle.

Public Health Service

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

FEB - 1 2012

Everyway Medical Instruments Co., Ltd. % Mansour Consulting LLC Mr. Jay Mansour 845 Aronson Lake Court Roswell, Georgia 30075

Re: K112074

Trade/Device Name: Everyway Traction Unit, Model EVER-TRAC ET-800 Regulation Number: 21 CFR 890.5900 Regulation Name: Power traction equipment Regulatory Class: Class II Product Code: ITH Dated: December 30, 2011 Received: January 03, 2012

Dear Mr. Mansour:

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

{3}------------------------------------------------

Page 2 - Mr. Jay Mansour

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 (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 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,
Mark A. Millerson

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

EVERYWAY 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): _

Device Name: Everyway Traction Unit, model EVER-TRAC ET-800.

Indications For Use:

Prescription Use ブ (Part 21 CFR 801 Subpart D) OR

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)

///

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K112074

Page 1 of _ 1

Page 3 of 3

Regulation Number and Section

§ 890.5900 Power traction equipment.

(a)
Identification. Powered traction equipment consists of powered devices intended for medical purposes for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.(b)
Classification. Class II (performance standards).