ELTRAC 471 by ENRAF-NONIUS B.V. | FDA 510(k) Summary

The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: hermiated discs, bulging or protruding intervertebral discs, degenerative disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

Device Description

The Eltrac 471 traction device applies forces to the spine to alleviate pain caused by a variety of pressure on muscular or skeletal structures. It exerts defined forces on the human body to alleviate pain and utilizes computer technology for programming of different kinds of traction.

This device is intended for use by professional users only, such as qualified personnel in physiotherapy, rehabilitation and adjacent areas. The device is designed with a plastic housing that holds the motor and has a full color touch screen interface on which the professional user can enter various parameters by touch. The forces from the motor are transferred to the patient by cords and connected accessories. Sequential programming is possible for programming combinations of traction which can be stored as favorites for later use.

AI/ML Overview

The provided text describes the regulatory clearance for the "Eltrac 471 Traction device" based on substantial equivalence to a predicate device, rather than a study designed to prove the device meets specific acceptance criteria through performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and performance against those criteria are not present.

However, I can extract the information that is available regarding regulatory requirements and the non-clinical performance evaluation.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) against which the Eltrac 471 was compared. Instead, it relies on demonstrating substantial equivalence to a predicate device and adherence to recognized non-clinical standards.

The "performance" is generally described as meeting safety and functionality requirements through verification and validation tests against these standards.

Acceptance Criterion (Implicit)	Reported Device Performance (Summary)
Safety	Adheres to ISO 14971, IEC 60601-1, IEC 60601-1-2. Electronic safeguards of force and mechanical safety for maximum force limitation. Hardware mitigations protect from excessive force. Patient stop function. Remote control can decrease force but not increase it.
Basic Safety and Essential Performance	Adheres to IEC 60601-1.
Electromagnetic Compatibility (EMC)	Adheres to IEC 60601-1-2 (Electromagnetic disturbances - Requirements and tests).
Software Life Cycle Process	Adheres to IEC 62304.
Functionality	Applies forces to the spine, utilizes computer technology for programming, sequential programming possible, full color touch screen, transfers force via cords and accessories.
Technological Characteristics	Substantially equivalent to predicate device (Triton/Tru-Trac/TX/Triton DTS Traction devices) regarding electrical input, software control, motor-driven force delivery, safety/warning features. Minor differences in body positions, maximum treatment time (150 min vs 165 min), and force speed deemed not to raise new risks.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The non-clinical performance refers to "Verification and validation tests" conducted by Enraf-Nonius, B.V., but details about specific test sets, sample sizes, or data provenance (e.g., retrospective/prospective, country of origin) are absent. This is typical for submissions based on substantial equivalence for non-clinical devices where the "test set" would be the device itself subject to engineering and safety tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided. Clinical ground truth, experts, or their qualifications are not mentioned, as no clinical testing was performed or required. The "ground truth" for non-clinical tests would typically be defined by engineering specifications and standard requirements.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided. Adjudication methods are relevant for clinical studies, which were explicitly stated as "Not applicable" for this device.

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

This information is not applicable and not provided. This device is a physical therapy traction device, not an AI-assisted diagnostic or imaging device used by human readers/interpreters. No MRMC study was conducted.

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

This information is not applicable in the context of typical AI algorithm-only performance. The "device" itself, the Eltrac 471, performs its function (applying traction) independently to the extent of its programming. The "non-clinical performance" section describes tests on the device's electrical, safety, and software functionality, which could be considered a form of standalone testing for the device's inherent design.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the non-clinical performance, the "ground truth" implicitly used would be engineering specifications, design requirements, and the pass/fail criteria defined by the cited international standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, IEC 62304). This does not involve clinical "ground truth" like pathology or outcomes data, as no clinical studies were performed.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "software" component refers to control software, not a learned model.

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

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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

October 16, 2015

Enraf-Nonius B.V. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K151640

Trade/Device Name: Eltrac 471 Regulation Number: 21 CFR 890.5900 Regulation Name: Power Traction Equipment Regulatory Class: Class II Product Code: ITH Dated: September 16, 2015 Received: September 17, 2015

Dear Mark Job:

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carlos L. Pena -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) K151640

Device Name Eltrac 471

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image is a logo for ENRAF NONIUS. The logo consists of the words "ENRAF NONIUS" stacked on top of each other, with a geometric shape above the words and a solid black shape below the words. Below the logo is the text "Partner for Life".

1. Date Prepared:

2015-09-09

2. Owner:

Anne-Marie van Maurik, O.A. Manager Enraf-Nonius B.V. Vareseweg 127 3047 AT Rotterdam The Netherlands Phone: +31102030680 Email: Anne-Marie.van.Maurik@enraf-nonius.nl

3. Contact person:

Amy Fowler DuVal & Associates, P.A. 825 Nicollet Mall, Suite 1820 Minneapolis, MN 55402 United States Phone: 612-338-7170, ext. 4 Email: fowler@duvalfdalaw.com

4. Trade name:

Trade name: Common/Usual Name: Classification Name: Product code:

ELTRAC 471 Traction Device 890.5900 Powered traction equipment ITH

5. Predicate device:

The Triton/Tru-Trac/TX/Triton DTS Traction devices provide traction and mobilization of skeletal structures and skeletal muscles. They were cleared for marketing in K053223 on February 24th, 2006, under Product Code ITH

6. Device Description:

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Image /page/4/Picture/1 description: The image is a logo for ENRAF NONIUS. The logo consists of the words "ENRAF NONIUS" stacked on top of each other in a bold, sans-serif font. Above the words is a geometric shape that resembles a stylized hexagon with three horizontal lines above it. Below the words is the tagline "Partner for Life" in a smaller, italicized font.

The device has an on/off switch to power a medical power supply for 100-240V ~ 50/60Hz, and consumes a maximum of 50VA. The device has been designed for the standard US electric power sources and has a 100-240 VAC 50/60 Hz power supply.

To protect the patient from potential hazards, multiple mitigations are designed into the hardware and software. There are electronic safeguards of force and mechanical safety for maximum force limitation. Additional hardware mitigations are applied to protect the patient from excessive force. If no software is running, or if no patient stop is connected, the hardware is designed to lower the force. The patient stop must be held by the patient during therapy. The patient can press it to stop therapy immediately. If it is pressed, the force will lower to release the patient from the device. The patient stop is controlled in the hardware, and any software will be overruled if it is pressed. A remote control can be used as an option for decreasing the force delivered to the patient during treatment. As a safety feature, the remote control cannot increase the force.

7. Intended Use:

The ELTRAC 471 Traction device, with its accessories, is intended to provide relief for the management of pain and symptoms from a variety of pressures on muscular or skeletal structures. The ELTRAC 471 Traction device may be used to treat pain and symptoms associated with the following conditions: herniated discs, bulging or protruding intervertebral discs, degenerative disc disease, posterior facet syndrome, acute facet problems, radicular pain, prolapsed discs, spinal root impingement, hypomobility, degenerative joint disease, facet syndrome, compression fractures, joint pain, and discogenic pain.

8. Summary of Technological Characteristics of the Eltrac 471 compared to predicate device:

The intended uses of the Eltrac 471 and the predicate device are essentially still the same even though their indications for use statements have slightly different wording.

The technological characteristics of the Eltrac 471 and the predicate device are largely the same.

Both devices have an electrical input of 100-240V, 50/60Hz. Both devices employ software with touch-screen control to adjust settings, store treatment protocols, and provide reference information. Both devices utilize a software controlled motor to deliver force via a cord and accessories to apply traction to the patient.

Both devices are designed with safety/warning features so that cervical traction treatment decisions are made with care. In addition, treatment times

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are limited and the patient is able to stop the treatment at any time with a switch.

The Eltrac 471 contains a subset of the traction body positions that the predicate device allows (i.e., the Eltrac 471 does not add anything new or more in that regard). The Eltrac 471 allows for only Lumbar (Face up) or Cervical (Lying) traction, whereas the predicate device allows Lumbar (Face up), Lumbar (Face down) or Cervical (Lying). This difference with the Eltrac only means that the professional user cannot treat patients for face down lumbar traction. This difference is not raising any new technological characteristic with the Eltrac 471.

There are negligible differences between the Eltrac 471 and the predicate device in regards to traction force and base force. The Eltrac 471 and the predicate device are substantially equivalent in this regard.

The difference in the maximum treatment time between the Eltrac 471 to the predicate device also does not add any new or additional risks. The Eltrac 471 allows for 150 minutes total treatment time, whereas the predicate device allows 165 minutes. (For both devices, the normal treatment time will generally be around 20-30 minutes.) Further, total allowable treatment time can always be extended by the professional user using either the Eltrac 471 or the predicate device, as both allow the professional user to restart or extend a treatment time. Therefore, the difference in maximum treatment time between the Eltrac 471 and the predicate device does not add any new or additional risks to the predicate device (i.e., the Eltrac 471 is substantially equivalent to the predicate device in this regard).

The Eltrac 471 is also substantially equivalent to the predicate device in regards to force speed. The Eltrac 471 has a defined force speed, whereas the predicate device has an unknown force speed because of variables that influence the force speed, which are mostly the level of force and the elasticity of the patient. The predicate device's level of force varies because the higher the force, the more power is dissipated into heat, which results in a lower force speed (N/s). The elasticity of the patient is also a variable, through which a force set point is reached faster (i.e., higher force speed) when a patient has low elasticity compared to a patient with higher elasticity. The Eltrac 471 has a controlled force speed which is independent of the patient's elasticity; this aspect would not render the Eltrac 471 to not be substantially equivalent to the predicate device.

The Traction Force Hold Time and Traction Base Force Rest Time appear to be different, but the professional user is responsible for setting acceptable values for both the Eltrac 471 and the predicate device. When a very long Hold Time or Rest Time is set, it will become a Static Force. Both traction types are valid and can be used safely in both devices.

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Image /page/6/Picture/1 description: The image is a logo for ENRAF NONIUS. The logo consists of the words "ENRAF NONIUS" stacked on top of each other, with a geometric shape above the words and a horizontal line below the words. Below the line are the words "Partner for Life".

The differences between the Eltrac 471 and the identified predicate do not negatively affect the safety and effectiveness of the Eltrac 471 for the proposed indications for use, and most importantly, the Eltrac 471 is substantially equivalent to the predicate device despite these differences.

9. Non-clinical Performance:

Verification and validation tests were executed by Enraf-Nonius, B.V. to establish the performance and functionality of ELTRAC 471. Several standards were utilized:

-	ISO 14971	Medical Devices – Application of risk management tomedical devices
-	IEC 60601-1	Medical electrical equipment – Part 1: Generalrequirements for basic safety and essentialperformance
-	IEC 60601-1-2	Medical electrical equipment – Part 1-2: Generalrequirements for basic safety and essentialperformance – Collateral Standard: Electromagneticdisturbances - Requirements and tests
-	IEC 62304	Medical Device Software – Software Life CycleProcess

10. Clinical Performance:

Not applicable. This device does not require clinical testing for demonstration of substantial equivalence and safety/efficacy.

11. Conclusion:

The Eltrac 471 traction device has the same intended use and technological characteristics as the predicate device. The testing done according to the company's internal standards and industry technical standards demonstrate that the Eltrac 471 meets the requirements for electrical and EMC safety, and meets the same safety and efficacy level of the predicate device.

In conclusion, the Eltrac 471 traction device is substantially equivalent to the Triton/Tru-Trac/TX/Triton DTS traction device (K053223).

Enraf-Nonius B.V.

Vareseweg 127

3047 AT Rotterdam

P.O. Box 12080

3004 GB Rotterdam

The Netherlands

+31-(0)10- 203 06 00

= +31-(0)10- 203 06 99

info@enraf-nonius.nl

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).