Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details software controlling pneumatic cylinders based on clinician input and hard-coded limits, without mentioning learning or adaptive capabilities.

Therapeutic

Yes.
The device is intended to provide a conservative treatment alternative for patients with cervicogenic pain symptoms, aligning with the definition of a therapeutic device.

Diagnostic

No

The device description clearly states it is a "conservative treatment alternative" and works by "temporarily positions the cervical spine into an extension posture". It focuses on delivering forces and managing treatment sessions, not on diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly lists numerous hardware components beyond just software, including an air compressor, pneumatic cylinders, regulators, traction line, pulley system, head halter, fulcrum strap, magnetic safety release, backup flow controls, mechanical pressure relief valves, electric lift column, and a standard personal computer. The software controls these hardware components to deliver the intended therapy.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
Device Function: The iTrac c2i cervical traction system is a physical therapy device that applies mechanical force to the cervical spine. It does not analyze biological samples.
Intended Use: The intended use is to treat cervicogenic pain through mechanical traction, not to diagnose or monitor a condition through laboratory testing.

The device description clearly outlines a mechanical system for applying traction, controlled by software, and used directly on the patient's neck. This aligns with the definition of a therapeutic medical device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The iTrac c2i cervical traction system is intended for use as a conservative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Product codes (comma separated list FDA assigned to the subject device)

ITH

Device Description

The iTrac™ c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Operational software controls the exertion and release of the pulling forces, operation cycle, and treatment times prescribed by the physician. The iTrac's operational components consist of software, an air compressor, three pneumatic cylinders, two electro-pneumatic regulators, a traction line and pullev system, head halter, fulcrum strap, magnetic safety release, backup flow controls, and mechanical pressure relief valves.

All accessories necessary to provide the traction to the patient are included with the device making it a ready to use traction device. A head halter captures the patient's chin during treatment and is connected to an adjustable overhead traction bar that can be manually adjusted by the doctor to the doctor-prescribed traction angle. A fulcrum strap rests on the back of the patient's neck and may be used to provide an additional anterior force. During setup, an electric lift column allows the fulcrum/traction section to be raised or lowered by the doctor to the height doctor prescribed for each patient.

For each treatment session the Doctor commands the software to implement a specific treatment time, traction force, and fulcrum force. Utilizing a piecewise linear function calculation the software generates an output signal causing the electro-pneumatic pressure controllers to adjust pressure, delivering the doctor prescribed forces to the fulcrum and traction cylinders. For safety, limits are hard coded in the software to prevent traction and fulcrum forces from exceeding the allowable limits. The software is loaded on a standard personal computer which interfaces with the device via a standard network connection; this standard connection is limited to connection only with the iTrac.

A Patient Stop Switch provides additional protection to the patient by operating independent of software to relieve all forces when pressed. When activated, the patient stop switch triggers a relay which, in turn, triggers a solenoid-controlled pneumatic valve causing a quick stop and venting of all pneumatic pressure to the cylinders. This action immediately relieves the patient of traction forces and sends a discrete output from the relay to the I/O Module, placing the treatment session into 'Pause' within the software. As an added safety measure the software requires the patient stop switch to be pressed before the start of each treatment during the treatment start protocol to ensure its functionality.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cervical spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Clinician; Prescription Use Only

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Angle and force testing demonstrate the iTrac device specifications were met and traction forces were the same as the predicate device. The design and testing of the iTrac's safety features, which include software controls, hard-coded force limits, pressure relief valves, back-up flow controls, magnetic safety release, and patient stop switch, indicate all features met specification and demonstrate equivalent performance to the predicate.

Additionally, testing performed by accredited test laboratory to IEC standards 60601-1 and 60601-1-2 demonstrate the iTrac meets the requirements for electrical and EMC safety. Biocompatibility testing performed on the iTrac's patient contact materials by an accredited test laboratory demonstrates the materials meet the applicable requirements of ISO 10993.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K063353

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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).

Summary

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

September 10, 2014

Pivotal Health Solutions Attn: Aaron Tvedt Quality Manager 724 Oakwood Road Watertown, SD 57201

Re: K131983

Trade Name: iTrac c2i Cervical Traction System Regulation Number: 21 CFR 890.5900 Regulation Name: Powered traction equipment Regulatory Class: Class II Product Code: ITH, ILZ, IRS Dated: September 2, 2014 Received: September 8, 2014

Dear Mr. Tvedt:

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

1

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Felipe Aquel -S

for

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

Enclosure

2

Indications for Use

510(k) Number (if known) K131983

Device Name iTrac c2i Cervical Traction System

Indications for Use (Describe)

The iTrac c2i cervical traction system is intended for use as a conservative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Section 5

510(k) Summary

This 510(k) Summary has been prepared in accordance the requirements of 21 CFR 807.92.

016_iTrac 510(k) Summary Page 1 of 15

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510(k) Summary

1. Submitter's Identification:

Aaron Tvedt (Official Correspondent) Pivotal Health Solutions, Inc. 724 Oakwood Road Watertown SD, 57201 Phone: 605-753-0110 Fax: 605-882-8398

Establishment Registration Number: 3007278668

Date Prepared: September 3, 2014

2. Name of the Device:

Trade Name: iTrac c2i Cervical Traction System Common Name: Power Traction Equipment Regulation Number: 21 CFR, Section 890.5900 Regulation Name: Powered Traction Equipment Regulatory Class: II Product Code: ITH

1. Name of the 510(k) Cleared Device (Predicate Device): CTBox Cervical/Lumbar Traction System (K063353) Common Name: Power Traction Equipment Regulation Number: 21 CFR, Section 890.5900 Regulation Name: Powered Traction Equipment Regulatory Class: II Product Code: ITH (Primary), ILZ, IRS (Secondary codes)

4. Device Description:

The iTrac™ c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

Operational software controls the exertion and release of the pulling forces, operation cycle, and treatment times prescribed by the physician. The iTrac's operational

016 iTrac 510(k) Summary Page 2 of 15

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components consist of software, an air compressor, three pneumatic cylinders, two electro-pneumatic regulators, a traction line and pullev system, head halter, fulcrum strap, magnetic safety release, backup flow controls, and mechanical pressure relief valves.

All accessories necessary to provide the traction to the patient are included with the device making it a ready to use traction device. A head halter captures the patient's chin during treatment and is connected to an adjustable overhead traction bar that can be manually adjusted by the doctor to the doctor-prescribed traction angle. A fulcrum strap rests on the back of the patient's neck and may be used to provide an additional anterior force. During setup, an electric lift column allows the fulcrum/traction section to be raised or lowered by the doctor to the height doctor prescribed for each patient.

For each treatment session the Doctor commands the software to implement a specific treatment time, traction force, and fulcrum force. Utilizing a piecewise linear function calculation the software generates an output signal causing the electro-pneumatic pressure controllers to adjust pressure, delivering the doctor prescribed forces to the fulcrum and traction cylinders. For safety, limits are hard coded in the software to prevent traction and fulcrum forces from exceeding the allowable limits. The software is loaded on a standard personal computer which interfaces with the device via a standard network connection; this standard connection is limited to connection only with the iTrac.

A Patient Stop Switch provides additional protection to the patient by operating independent of software to relieve all forces when pressed. When activated, the patient stop switch triggers a relay which, in turn, triggers a solenoid-controlled pneumatic valve causing a quick stop and venting of all pneumatic pressure to the cylinders. This action immediately relieves the patient of traction forces and sends a discrete output from the relay to the I/O Module, placing the treatment session into 'Pause' within the software. As an added safety measure the software requires the patient stop switch to be pressed before the start of each treatment during the treatment start protocol to ensure its functionality.

5. Intended Use Statement:

The iTracTM c2i cervical traction system is intended for use as a conservative treatment alternative in patients presenting with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. It temporarily positions the cervical spine into an extension posture of varying degrees, as determined by a clinician. This device is for prescription use only and is not provided in a sterile condition.

6. Technological Characteristics

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The iTrac is substantially equivalent to the CTBox Cervical/Lumbar Traction System (predicate), without any significant difference in main technological and operational features. Both devices are intended for use in conjunction with traction accessories, such as belts and harnesses, to exert therapeutic pulling forces on the patient's body.

Table 5A provides a summary of the technological characteristics of the iTrac c2i in comparison to the CTBox Cervical/Lumbar Traction System.

| Table 5A: Summary of Technological Characteristics of iTrac c2i compared to CTBox Cervical/Lumbar

Traction System
	iTrac™ c2i cervical
Traction System	CTBox
Cervical/Lumbar
Traction System	Similarities/
Differences	Analysis
Intended Use	The iTrac™ c2i
cervical traction system
is intended for use as a
conservative treatment
alternative in patients
presenting with
cervicogenic pain
symptoms of
mechanical origin
related to reduced
cervical
lordosis/extension and
altered posture. It
temporarily positions
the cervical spine into
an extension posture of
varying degrees, as
determined by a
clinician. This device is
for prescription use
only and is not provided
in a sterile condition.	The "CT BoxTM"
cervical/lumbar
traction system is
intended for use as a
conservative treatment
alternative in patients
presenting with
cervicogenic
/lumbogenic pain
symptoms of
mechanical origin
related to reduced
cervical or lumbar
lordosis/extension and
altered posture. It
temporarily positions
the cervical or lumbar
spine into an
extension posture of
varying degrees, as
determined by a
clinician. This device
is for prescription use
only and is not
provided in a sterile
condition..	Same (except for
the CT Box may
be used in
patients
presenting with
lumbogenic pain
symptoms).
Treatment Area	Cervical	Cervical or Lumbar	Same (Cervical)	The iTrac's intended
treatment area is
cervical only which
allows force limits to
be set specifically and
appropriately for this
treatment area,
providing additional
protection to the
patient

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Table 5A: Summary of Technological Characteristics of iTrac c2i compared to CTBox Cervical/Lumbar
Traction System

| | iTrac™ c2i cervical
Traction System | CTBox
Cervical/Lumbar
Traction System | Similarities/
Differences | Analysis |
|-----------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment
Position | Seated | Seated or Supine | Same (Seated) | The iTrac is intended
for use with patients in
seated position.
Incorporating the chair
and other accessories
as part of the device
assures the same
level of design and
manufacturing quality
has been applied. |
| Lift Mechanism | Electromechanical | Electric | The iTrac uses a
fixed chair with an
electromechanical
lift column to
elevate the
traction section to
the required
height for each
patient. | Same as above. |
| Traction force | The min. and max.
traction force= 0-20lbs
(traction force) /0-40
lbs.(Fulcrum force) | Cervical traction: 40lbs
Lumbar traction: 80
lbs | iTrac's traction
force limit is within
the cervical limits
of the predicate
device. | The iTrac's force limits
are designed
specifically for cervical
traction therapy, which
provides additional
safety to the patient. |
| | iTrac™ c2i cervical
Traction System | CTBox
Cervical/Lumbar
Traction System | Similarities/
Differences | Analysis |
| System Control | Computer-controlled
traction system with
operational software
residing on computer | None. | .
Difference - iTrac
software resides
on a computer.
The iTrac uses
operational
software to control
traction force,
speed, and time | The iTrac software
residing on a
computer creates no
additional safety and
effectiveness issues. |

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Table 5A: Summary of Technological Characteristics of iTrac c2i compared to CTBox Cervical/Lumbar
Traction System

| | iTrac™ c2i cervical
Traction System | CTBox
Cervical/Lumbar
Traction System | Similarities/
Differences | Analysis |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operational
Components | Air compressor and
Pneumatic cylinders,
software controlled
pneumatic regulator,
pulley assembly | Eccentric Drive Motor,
pulley assembly | Same - Both
operational
components
generate a linear
force conveyed
through a pulley
system to provide
therapeutic forces
on the patient. | Both devices provide a
linear force conveyed
though a pulley system
to provide a therapeutic
pulling force on the
patient's body. |
| | | | Difference - iTrac
uses compressed
air and pneumatic
components to
generate force.
CT Box generates
force via
suspended
weights and/or
ratcheting
winches, then
creates a additive
or delta force of 1
to 7 additional
pounds by use of
an eccentric drive
motor. The CTBox
is a metal box that
houses a simple
gear motor that
revolves rope
hook-ups that will
slightly and
constantly increase
and decrease the
transverse and/or | The iTrac utilizes
compressed air to
create the traction
force. This creates no
additional safety and
effectiveness issues,
and eliminates the
potential for EMC
safety issues by
eliminate the need for
the electric motor used
by the predicate. |
| Traction Speed | Stepless, Continuous,
Adjustable | Continuous and
Adjustable | Same, except the
iTrac provides
stepless traction | The iTrac uses
stepless traction,
which provides for
fluid motion, which
provides better
comfort and safety for
the patient. |
| | iTrac™ c2i cervical
Traction System | CTBox
Cervical/Lumbar
Traction System | Similarities/
Differences | Analysis |
| Force display | Actual Force / Preset
Force | Analog weight scale | The iTrac offers a
digital force
display, while the
predicate does
not. | The iTrac provides
additional safety to the
patient through
accurate display of the
force display. |
| Treatment time | 5-15 min | 15-20 minutes. | Treatment time
limits are within
the time limits of
the cleared
predicate | Treatment time is
limited to the required
time for cervical
treatments, providing
added protection to
the patient. |
| Therapy Mode | Continuous | Continuous force,
Intermittent traction | iTrac and cleared
predicate both
offer continuous
therapy mode. | Intermittent mode is
not required for the
iTrac's Intended Use. |
| Safety system | Multiple protections
including patient
safety switch, manual
release, unit stop
button, compressor
regulator, magnetic
safety release,
pressure release
valve, backup flow
control, feedback
gauges. | Manual Release,
Hand held on/off
switch This provides
release ONLY from
the delta or additive 1
to 7 pound force - the
primary force remains
in effect until released
by the operator. | ITrac's patient
stop switch
releases all
forces/ the CTBox
releases only the
7 pound delta
force. | iTrac provides
additional safety
controls to protect the
patient. |
| | iTrac™ c2i cervical
Traction System | CTBox
Cervical/Lumbar
Traction System | Similarities/
Differences | Analysis |
| Power supply | 110-120V (60Hz)
220-240V (50Hz) | 115V (60Hz) | Same | |
| Allowable
Voltage
Fluctuation | Max±10% | UNK | Different - the
Allowable voltage
fluctuation is not
known for the
predicate device. | The iTrac has been
verified to have
Max±10% of voltage
fluctuation through
NRTL testing |
| Casing leakage
of electricity |