ITRAC CERVICAL TRACTION SYSTEM

K131983 · Pivotal Health Solutions · ITH · Sep 10, 2014 · Physical Medicine

Device Facts

• Record ID: K131983
• Device Name: ITRAC CERVICAL TRACTION SYSTEM
• Applicant: Pivotal Health Solutions
• Product Code: ITH · Physical Medicine
• Decision Date: Sep 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5900
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

The iTrac c2i is a powered cervical traction system used in clinical settings by physicians to treat cervicogenic pain. The device consists of a chair, electric lift column, pneumatic cylinders, air compressor, and a head halter/fulcrum strap system. The clinician prescribes treatment time, traction force, and fulcrum force. Software controls the pneumatic regulators to deliver these forces via a pulley system. The device includes a patient-operated stop switch that vents pneumatic pressure to immediately relieve force. The system provides a conservative treatment alternative by temporarily positioning the cervical spine into extension. The output is the application of controlled mechanical traction forces to the patient's cervical spine, which may help alleviate pain symptoms associated with altered posture or reduced lordosis.

Clinical Evidence

Bench testing only. Performance testing verified that traction forces and angles met specifications and were equivalent to the predicate. Safety features (software limits, pressure relief valves, patient stop switch) were validated. Electrical and EMC safety were confirmed via IEC 60601-1 and IEC 60601-1-2 testing. Biocompatibility of patient-contact materials was verified per ISO 10993.

Technological Characteristics

Powered traction system; electromechanical lift column; pneumatic force generation (compressor, cylinders, electro-pneumatic regulators). Materials tested per ISO 10993. Electrical safety: Class I, Type B; IEC 60601-1, IEC 60601-1-2 compliant. Connectivity: standard network connection (limited to device interface). Software: PC-based, controls force/time/speed, includes hard-coded safety limits.

Indications for Use

Indicated for patients with cervicogenic pain symptoms of mechanical origin related to reduced cervical lordosis/extension and altered posture. Contraindications include pathological lesions or congenital deformities of the vertebral column, neoplasms/spinal tumors, spina bifida, pars defects, rheumatoid arthritis, spinal cord compression, malignancy, spondylolisthesis (Grade 2+), connective tissue disease (e.g., scleroderma), post-surgical patients requiring tissue healing, pregnancy, structural disease (tumors/infection), joint instability, hypermobility, spinal fracture, osteoporosis, severe cardiovascular/vascular/respiratory disease, and acute sprains/strains/inflammation.

Regulatory Classification

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.

Predicate Devices

• CTBox Cervical/Lumbar Traction System (K063353)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### 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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## 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: [phone] Fax: [phone]

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

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

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

| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
|-----------------------|-----------------------------------------------------------------------------------------------|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Treatment<br>Position | Seated | Seated or Supine | Same (Seated) | The iTrac is intended<br>for use with patients in<br>seated position.<br>Incorporating the chair<br>and other accessories<br>as part of the device<br>assures the same<br>level of design and<br>manufacturing quality<br>has been applied. |
| Lift Mechanism | Electromechanical | Electric | The iTrac uses a<br>fixed chair with an<br>electromechanical<br>lift column to<br>elevate the<br>traction section to<br>the required<br>height for each<br>patient. | Same as above. |
| Traction force | The min. and max.<br>traction force= 0-20lbs<br>(traction force) /0-40<br>lbs.(Fulcrum force) | Cervical traction: 40lbs<br>Lumbar traction: 80<br>lbs | iTrac's traction<br>force limit is within<br>the cervical limits<br>of the predicate<br>device. | The iTrac's force limits<br>are designed<br>specifically for cervical<br>traction therapy, which<br>provides additional<br>safety to the patient. |
| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
| System Control | Computer-controlled<br>traction system with<br>operational software<br>residing on computer | None. | .<br>Difference - iTrac<br>software resides<br>on a computer.<br>The iTrac uses<br>operational<br>software to control<br>traction force,<br>speed, and time | The iTrac software<br>residing on a<br>computer creates no<br>additional safety and<br>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<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operational<br>Components | Air compressor and<br>Pneumatic cylinders,<br>software controlled<br>pneumatic regulator,<br>pulley assembly | Eccentric Drive Motor,<br>pulley assembly | Same - Both<br>operational<br>components<br>generate a linear<br>force conveyed<br>through a pulley<br>system to provide<br>therapeutic forces<br>on the patient. | Both devices provide a<br>linear force conveyed<br>though a pulley system<br>to provide a therapeutic<br>pulling force on the<br>patient's body. |
| | | | Difference - iTrac<br>uses compressed<br>air and pneumatic<br>components to<br>generate force.<br>CT Box generates<br>force via<br>suspended<br>weights and/or<br>ratcheting<br>winches, then<br>creates a additive<br>or delta force of 1<br>to 7 additional<br>pounds by use of<br>an eccentric drive<br>motor. The CTBox<br>is a metal box that<br>houses a simple<br>gear motor that<br>revolves rope<br>hook-ups that will<br>slightly and<br>constantly increase<br>and decrease the<br>transverse and/or | The iTrac utilizes<br>compressed air to<br>create the traction<br>force. This creates no<br>additional safety and<br>effectiveness issues,<br>and eliminates the<br>potential for EMC<br>safety issues by<br>eliminate the need for<br>the electric motor used<br>by the predicate. |
| Traction Speed | Stepless, Continuous,<br>Adjustable | Continuous and<br>Adjustable | Same, except the<br>iTrac provides<br>stepless traction | The iTrac uses<br>stepless traction,<br>which provides for<br>fluid motion, which<br>provides better<br>comfort and safety for<br>the patient. |
| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
| Force display | Actual Force / Preset<br>Force | Analog weight scale | The iTrac offers a<br>digital force<br>display, while the<br>predicate does<br>not. | The iTrac provides<br>additional safety to the<br>patient through<br>accurate display of the<br>force display. |
| Treatment time | 5-15 min | 15-20 minutes. | Treatment time<br>limits are within<br>the time limits of<br>the cleared<br>predicate | Treatment time is<br>limited to the required<br>time for cervical<br>treatments, providing<br>added protection to<br>the patient. |
| Therapy Mode | Continuous | Continuous force,<br>Intermittent traction | iTrac and cleared<br>predicate both<br>offer continuous<br>therapy mode. | Intermittent mode is<br>not required for the<br>iTrac's Intended Use. |
| Safety system | Multiple protections<br>including patient<br>safety switch, manual<br>release, unit stop<br>button, compressor<br>regulator, magnetic<br>safety release,<br>pressure release<br>valve, backup flow<br>control, feedback<br>gauges. | Manual Release,<br>Hand held on/off<br>switch This provides<br>release ONLY from<br>the delta or additive 1<br>to 7 pound force - the<br>primary force remains<br>in effect until released<br>by the operator. | ITrac's patient<br>stop switch<br>releases all<br>forces/ the CTBox<br>releases only the<br>7 pound delta<br>force. | iTrac provides<br>additional safety<br>controls to protect the<br>patient. |
| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
| Power supply | 110-120V (60Hz)<br>220-240V (50Hz) | 115V (60Hz) | Same | |
| Allowable<br>Voltage<br>Fluctuation | Max±10% | UNK | Different - the<br>Allowable voltage<br>fluctuation is not<br>known for the<br>predicate device. | The iTrac has been<br>verified to have<br>Max±10% of voltage<br>fluctuation through<br>NRTL testing |
| Casing leakage<br>of electricity | < 100 Microamps | UNK | Different - The<br>leakage current<br>specification is<br>unknown for the<br>predicate device. | The iTrac has been<br>verified to have <100<br>microamps leakage<br>current through NRTL<br>testing |
| Ground<br>resistance | < 0.1 Ohm | UNK | Different - The<br>ground resistance<br>specification is<br>unknown for the<br>predicate device. | The iTrac has been<br>verified to have <0.1<br>ohm resistance<br>through NRTL testing |

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

| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
|----------------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electric<br>Classification<br>and Type | Class I / Type B | UNK | Different - The<br>electric<br>classification and<br>type specification<br>is unknown for the<br>predicate device. | Type BF is for devices<br>that have conductive<br>contact with the<br>patient, or having<br>medium or long term<br>contact with the<br>/patient. When applied<br>parts are not<br>conductive, Type B is<br>the appropriate<br>protection. The iTrac<br>has been verified to<br>have Class I/Type B<br>electric classification<br>through NRTL testing |
| Electrical<br>Compliance<br>Testing | IEC 60601-1, IEC<br>60601-1-2 by<br>Accredited Test<br>Laboratory | The motor, power cord<br>and on-off hand held<br>switch meets all UL<br>safety standards | Same | |
| EMC Compliance<br>Testing | IEC 60601-1-2 by<br>Accredited Test<br>Laboratory | The motor, power cord<br>and on-off hand held<br>switch meets all UL<br>safety standards | Same | |

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Image /page/14/Picture/0 description: The image is a logo for Pivotal Health Solutions. The logo features a stylized figure in blue and green, with the word "Pivotal" in a dark green sans-serif font. Below "Pivotal" is the phrase "Health Solutions" in a smaller, lighter green font. The logo is clean and professional, suggesting a focus on health and well-being.

| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
|-----------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | All patient contact<br>components tested for<br>biocompatibility to ISO<br>10993 standard by<br>Accredited Test<br>Laboratory | Use of materials which<br>have been previously<br>use previously cleared<br>medical devices. | Same | |
| Additional<br>components | The iTrac system<br>includes the iTrac<br>device and necessary<br>accessories to<br>function as a ready to<br>use traction device. | The CT Box provides<br>the motorized<br>mechanism for<br>cervical and lumbar<br>traction. The CT Box<br>may be connected to<br>the Traction L-Frame<br>for additional<br>connection to<br>accessories: Head<br>halter, Pelvic support<br>belt, cords, pulleys,<br>and ratchets., | Difference - the<br>iTrac is a ready to<br>use traction<br>device. | The iTrac comes with<br>all the required<br>accessories to<br>function as a ready to<br>use traction device. |
| | iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
| Contraindications | • Patients with<br>pathological lesions<br>or congenital<br>deformities of the<br>vertebral column<br>that disrupt the<br>integrity and stability<br>of the vertebral and<br>ligament structures. | 1. Patients with notable<br>posterior spurring of their<br>cervical vertebra. | Similar | The iTrac provides<br>additional contraindications<br>for the following conditions: |
| | • Neoplasm, spinal<br>tumors; both<br>metastasis and<br>primary. | 2. Patients with large posterior<br>disc bulges or herniations. | | • Patients with<br>pathological lesions<br>or congenital<br>deformities of the<br>vertebral column<br>that disrupt the<br>integrity and stability<br>of the vertebral and<br>ligament structures. |
| | • Spina bifida or pars<br>defect. | 3. Patients with cervical spinal<br>stenosis. | | • Neoplasm, spinal<br>tumors; both<br>metastasis and<br>primary. |
| | • Rheumatoid arthritis | 4. Patients with structural<br>disease secondary to tumor or<br>infection. | | • Spina bifida or pars<br>defect. |
| | • Spinal cord<br>compression | 5. Patients with cervical<br>vascular compromise. | | • Rheumatoid arthritis |
| | • Malignancy | 6. Patients with acute sprain,<br>strain and/or inflammation of<br>the cervical joints. | | • Spinal cord<br>compression |
| | • Patients with<br>notable posterior<br>spurring of their<br>cervical vertebra | 7. Patients with cervical joint<br>instability. | | • Malignancy |
| | • Patients with<br>spondylolisthesis<br>Grade 2 or greater | 8. Patients with internal spinal<br>fixation hardware. | | • Patients with<br>spondylolisthesis<br>Grade 2 or greater |
| | • Patients with<br>connective tissue<br>disease; i.e.<br>Scleroderma | 9. Patients with severe<br>osteoporosis or vertebral<br>fractures. | | • Patients with<br>connective tissue<br>disease; i.e.<br>Scleroderma |
| | • Post-surgical<br>patients who have<br>had spinal surgery<br>and healing of<br>tissue is still<br>required. (The<br>period of time post | | | • Post-surgical<br>patients who have<br>had spinal surgery<br>and healing of<br>tissue is still<br>required. (The<br>period of time post<br>spinal surgery will<br>very between 6 |
| | CTBox | | | |
| iTrac™ c2i cervical | Cervical/Lumbar | Similarities/ | | |
| Traction System | Traction System | Differences | Analysis | |
| spinal surgery will<br>very between 6<br>months to a year) | | | months to a year) | |
| • Pregnancy | | | • Pregnancy | |
| • Patients with any<br>other conditions that<br>may be made worse<br>by distraction of the<br>spine | | | • Patients with any<br>other conditions that<br>may be made worse<br>by distraction of the<br>spine | |
| • Patients with<br>structural disease<br>due to tumors or<br>infection<br>(e.g.,osteomyelitis,<br>spinal caries, and<br>ankylosing<br>spondylitis). | | | • Stop traction if there<br>is an increase in<br>radiated pain to the<br>extremities<br>(radicular pain). | |
| • Patients with joint<br>instability,<br>hypermobility or<br>spinal fracture. | | | • Patients with severe<br>cardiovascular<br>disease, vascular<br>compromise, aortic<br>aneurysm or severe<br>respiratory disease. | |
| • Patients with<br>osteoporosis. | | | • Patients where<br>movement is<br>contraindicated. | |
| • Patients with severe<br>cardiovascular<br>disease, vascular<br>compromise, aortic<br>aneurysm or severe<br>respiratory disease. | | | | |
| • Patients where<br>movement is<br>contraindicated. | | | | |
| • Patients with acute<br>sprains, strains or<br>inflammation that<br>could be aggravated<br>by traction | | | | |

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

| iTrac™ c2i cervical<br>Traction System | CTBox<br>Cervical/Lumbar<br>Traction System | Similarities/<br>Differences | Analysis |
|-----------------------------------------------------------------------------------------------------------|---------------------------------------------|------------------------------|----------|
| • Stop traction if there<br>is an increase in<br>radiated pain to the<br>extremities<br>(radicular pain). | | | |
| • Patients with large<br>posterior disc<br>bulges or<br>herniations. | | | |
| • Patients with<br>cervical spinal<br>stenosis. | | | |
| • Patients with<br>cervical vascular<br>compromise. | | | |
| • Patients with acute<br>sprain, strain and/or<br>inflammation of the<br>cervical joints. | | | |
| • Patients with internal<br>spinal fixation<br>hardware. | | | |

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