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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the iTrac c2i Cervical Traction System. It focuses on demonstrating substantial equivalence to a predicate device, the CTBox Cervical/Lumbar Traction System, rather than presenting a clinical study to prove device performance against specific acceptance criteria in the manner usually seen for AI/ML-driven devices.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable or available in this type of submission. The document primarily details technical specifications and safety features compared to a predicate device.

Here's an attempt to answer the questions based on the available information, noting when information is not present in the document.

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

Since this is a substantial equivalence submission for a physical medical device (traction system), "acceptance criteria" here refers to demonstrating that the new device's technical characteristics and safety features are equivalent to or better than a legally marketed predicate device. There aren't "performance metrics" in the typical sense of accuracy, sensitivity, specificity, etc., as would be the case for AI/ML diagnostic tools.

Acceptance Criteria (Inferred from comparison to predicate)	Reported Device Performance (iTrac™ c2i Cervical Traction System)
Functional Equivalence
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. (Similar to predicate, but only for cervical).
Treatment Area	Cervical only. (Predicate treats Cervical or Lumbar).
Treatment Position	Seated. (Predicate allows Seated or Supine).
Lift Mechanism	Electromechanical. (Predicate uses electric).
Traction Force Range (Cervical)	Min. and Max. traction force = 0-20 lbs (traction force) / 0-40 lbs (fulcrum force). (Predicate's cervical traction limit is 40 lbs).
System Control	Computer-controlled traction system with operational software residing on a computer. (Predicate's control mechanism not detailed, but described as "Eccentric Drive Motor" and "gear motor that revolves rope hook-ups").
Operational Components	Air compressor and Pneumatic cylinders, software controlled pneumatic regulator, pulley assembly to generate linear force. (Predicate uses Eccentric Drive Motor, pulley assembly, and suspended weights/ratcheting winches).
Traction Speed	Stepless, Continuous, Adjustable. (Predicate is Continuous and Adjustable).
Force Display	Actual Force / Preset Force (digital). (Predicate uses Analog weight scale).
Treatment Time	5-15 min. (Predicate is 15-20 minutes).
Therapy Mode	Continuous. (Predicate offers Continuous and Intermittent).
Additional Components	The iTrac system includes the iTrac device and necessary accessories to function as a ready-to-use traction device. (Predicate provides the motorized mechanism and may be connected to a separate Traction L-Frame for accessories).
Safety Features
Safety system for force release	Multiple protections including patient safety switch (releases all forces), manual release, unit stop button, compressor regulator, magnetic safety release, pressure release valve, backup flow control, feedback gauges. (Predicate has Manual Release, Hand held on/off switch which releases only 1-7 lb delta force).
Power supply	110-120V (60Hz), 220-240V (50Hz). (Predicate is 115V (60Hz)).
Allowable Voltage Fluctuation	Max ±10%. (Predicate UNK). Verified through NRTL testing.
Casing leakage of electricity	< 100 Microamps. (Predicate UNK). Verified through NRTL testing.
Ground resistance	< 0.1 Ohm. (Predicate UNK). Verified through NRTL testing.
Electrical Classification and Type	Class I / Type B. (Predicate UNK). Verified through NRTL testing.
Electrical Compliance Testing	IEC 60601-1, IEC 60601-1-2 by Accredited Test Laboratory. (Predicate's motor, power cord, and on-off hand-held switch meets all UL safety standards).
EMC Compliance Testing	IEC 60601-1-2 by Accredited Test Laboratory. (Predicate's motor, power cord, and on-off hand-held switch meets all UL safety standards).
Biocompatibility	All patient contact components tested for biocompatibility to ISO 10993 standard by Accredited Test Laboratory. (Predicate uses materials previously cleared medical devices).
Contraindications	Detailed list of contraindications provided, similar to predicate but with additional conditions explicitly stated. (See pages 14-17 for extensive list).
Angle and Force Accuracy	"[A]ngle and force testing demonstrate the iTrac device specifications were met and traction forces were the same as the predicate device." (Specific values or ranges for "device specifications" and "same as predicate" are not explicitly tabulated beyond the general traction force limit comparison.)

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

This document does not describe a clinical test set in the sense of patient data. The testing is based on engineering verification and validation of the device's technical specifications and safety features.

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)

Not applicable. The ground truth for this type of device submission is based on engineering standards, design specifications, and comparison to a legally marketed predicate device's established safety and effectiveness.

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

Not applicable, as there is no clinical test set requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical traction device, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical traction device.

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

The "ground truth" for this submission are:

Engineering Specifications: The device's design specifications for force application, speed, and safety mechanisms.
International Standards: Compliance with electrical safety (IEC 60601-1, IEC 60601-1-2) and biocompatibility (ISO 10993).
Predicate Device Characteristics: The known, legally marketed characteristics and safety profile of the CTBox Cervical/Lumbar Traction System.

8. The sample size for the training set

Not applicable. This is a physical device, and there is no "training set" in the context of AI/ML.

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

Not applicable.

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

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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 (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

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Indications for Use

510(k) Number (if known) K131983

Device Name iTrac c2i Cervical Traction System

Indications for Use (Describe)

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: 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:

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.

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/LumbarTraction System
	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
Intended Use	The iTrac™ c2icervical traction systemis intended for use as aconservative treatmentalternative in patientspresenting withcervicogenic painsymptoms ofmechanical originrelated to reducedcervicallordosis/extension andaltered posture. Ittemporarily positionsthe cervical spine intoan extension posture ofvarying degrees, asdetermined by aclinician. This device isfor prescription useonly and is not providedin a sterile condition.	The "CT BoxTM"cervical/lumbartraction system isintended for use as aconservative treatmentalternative in patientspresenting withcervicogenic/lumbogenic painsymptoms ofmechanical originrelated to reducedcervical or lumbarlordosis/extension andaltered posture. Ittemporarily positionsthe cervical or lumbarspine into anextension posture ofvarying degrees, asdetermined by aclinician. This deviceis for prescription useonly and is notprovided in a sterilecondition..	Same (except forthe CT Box maybe used inpatientspresenting withlumbogenic painsymptoms).
Treatment Area	Cervical	Cervical or Lumbar	Same (Cervical)	The iTrac's intendedtreatment area iscervical only whichallows force limits tobe set specifically andappropriately for thistreatment area,providing additionalprotection to thepatient

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

	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
TreatmentPosition	Seated	Seated or Supine	Same (Seated)	The iTrac is intendedfor use with patients inseated position.Incorporating the chairand other accessoriesas part of the deviceassures the samelevel of design andmanufacturing qualityhas been applied.
Lift Mechanism	Electromechanical	Electric	The iTrac uses afixed chair with anelectromechanicallift column toelevate thetraction section tothe requiredheight for eachpatient.	Same as above.
Traction force	The min. and max.traction force= 0-20lbs(traction force) /0-40lbs.(Fulcrum force)	Cervical traction: 40lbsLumbar traction: 80lbs	iTrac's tractionforce limit is withinthe cervical limitsof the predicatedevice.	The iTrac's force limitsare designedspecifically for cervicaltraction therapy, whichprovides additionalsafety to the patient.
	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
System Control	Computer-controlledtraction system withoperational softwareresiding on computer	None.	.Difference - iTracsoftware resideson a computer.The iTrac usesoperationalsoftware to controltraction force,speed, and time	The iTrac softwareresiding on acomputer creates noadditional safety andeffectiveness issues.

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

	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
OperationalComponents	Air compressor andPneumatic cylinders,software controlledpneumatic regulator,pulley assembly	Eccentric Drive Motor,pulley assembly	Same - Bothoperationalcomponentsgenerate a linearforce conveyedthrough a pulleysystem to providetherapeutic forceson the patient.	Both devices provide alinear force conveyedthough a pulley systemto provide a therapeuticpulling force on thepatient's body.
			Difference - iTracuses compressedair and pneumaticcomponents togenerate force.CT Box generatesforce viasuspendedweights and/orratchetingwinches, thencreates a additiveor delta force of 1to 7 additionalpounds by use ofan eccentric drivemotor. The CTBoxis a metal box thathouses a simplegear motor thatrevolves ropehook-ups that willslightly andconstantly increaseand decrease thetransverse and/or	The iTrac utilizescompressed air tocreate the tractionforce. This creates noadditional safety andeffectiveness issues,and eliminates thepotential for EMCsafety issues byeliminate the need forthe electric motor usedby the predicate.
Traction Speed	Stepless, Continuous,Adjustable	Continuous andAdjustable	Same, except theiTrac providesstepless traction	The iTrac usesstepless traction,which provides forfluid motion, whichprovides bettercomfort and safety forthe patient.
	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
Force display	Actual Force / PresetForce	Analog weight scale	The iTrac offers adigital forcedisplay, while thepredicate doesnot.	The iTrac providesadditional safety to thepatient throughaccurate display of theforce display.
Treatment time	5-15 min	15-20 minutes.	Treatment timelimits are withinthe time limits ofthe clearedpredicate	Treatment time islimited to the requiredtime for cervicaltreatments, providingadded protection tothe patient.
Therapy Mode	Continuous	Continuous force,Intermittent traction	iTrac and clearedpredicate bothoffer continuoustherapy mode.	Intermittent mode isnot required for theiTrac's Intended Use.
Safety system	Multiple protectionsincluding patientsafety switch, manualrelease, unit stopbutton, compressorregulator, magneticsafety release,pressure releasevalve, backup flowcontrol, feedbackgauges.	Manual Release,Hand held on/offswitch This providesrelease ONLY fromthe delta or additive 1to 7 pound force - theprimary force remainsin effect until releasedby the operator.	ITrac's patientstop switchreleases allforces/ the CTBoxreleases only the7 pound deltaforce.	iTrac providesadditional safetycontrols to protect thepatient.
	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
Power supply	110-120V (60Hz)220-240V (50Hz)	115V (60Hz)	Same
AllowableVoltageFluctuation	Max±10%	UNK	Different - theAllowable voltagefluctuation is notknown for thepredicate device.	The iTrac has beenverified to haveMax±10% of voltagefluctuation throughNRTL testing
Casing leakageof electricity	< 100 Microamps	UNK	Different - Theleakage currentspecification isunknown for thepredicate device.	The iTrac has beenverified to have <100microamps leakagecurrent through NRTLtesting
Groundresistance	< 0.1 Ohm	UNK	Different - Theground resistancespecification isunknown for thepredicate device.	The iTrac has beenverified to have <0.1ohm resistancethrough NRTL testing

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

	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
ElectricClassificationand Type	Class I / Type B	UNK	Different - Theelectricclassification andtype specificationis unknown for thepredicate device.	Type BF is for devicesthat have conductivecontact with thepatient, or havingmedium or long termcontact with the/patient. When appliedparts are notconductive, Type B isthe appropriateprotection. The iTrachas been verified tohave Class I/Type Belectric classificationthrough NRTL testing
ElectricalComplianceTesting	IEC 60601-1, IEC60601-1-2 byAccredited TestLaboratory	The motor, power cordand on-off hand heldswitch meets all ULsafety standards	Same
EMC ComplianceTesting	IEC 60601-1-2 byAccredited TestLaboratory	The motor, power cordand on-off hand heldswitch meets all ULsafety standards	Same

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	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
Biocompatibility	All patient contactcomponents tested forbiocompatibility to ISO10993 standard byAccredited TestLaboratory	Use of materials whichhave been previouslyuse previously clearedmedical devices.	Same
Additionalcomponents	The iTrac systemincludes the iTracdevice and necessaryaccessories tofunction as a ready touse traction device.	The CT Box providesthe motorizedmechanism forcervical and lumbartraction. The CT Boxmay be connected tothe Traction L-Framefor additionalconnection toaccessories: Headhalter, Pelvic supportbelt, cords, pulleys,and ratchets.,	Difference - theiTrac is a ready touse tractiondevice.	The iTrac comes withall the requiredaccessories tofunction as a ready touse traction device.
	iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
Contraindications	• Patients withpathological lesionsor congenitaldeformities of thevertebral columnthat disrupt theintegrity and stabilityof the vertebral andligament structures.	1. Patients with notableposterior spurring of theircervical vertebra.	Similar	The iTrac providesadditional contraindicationsfor the following conditions:
	• Neoplasm, spinaltumors; bothmetastasis andprimary.	2. Patients with large posteriordisc bulges or herniations.		• Patients withpathological lesionsor congenitaldeformities of thevertebral columnthat disrupt theintegrity and stabilityof the vertebral andligament structures.
	• Spina bifida or parsdefect.	3. Patients with cervical spinalstenosis.		• Neoplasm, spinaltumors; bothmetastasis andprimary.
	• Rheumatoid arthritis	4. Patients with structuraldisease secondary to tumor orinfection.		• Spina bifida or parsdefect.
	• Spinal cordcompression	5. Patients with cervicalvascular compromise.		• Rheumatoid arthritis
	• Malignancy	6. Patients with acute sprain,strain and/or inflammation ofthe cervical joints.		• Spinal cordcompression
	• Patients withnotable posteriorspurring of theircervical vertebra	7. Patients with cervical jointinstability.		• Malignancy
	• Patients withspondylolisthesisGrade 2 or greater	8. Patients with internal spinalfixation hardware.		• Patients withspondylolisthesisGrade 2 or greater
	• Patients withconnective tissuedisease; i.e.Scleroderma	9. Patients with severeosteoporosis or vertebralfractures.		• Patients withconnective tissuedisease; i.e.Scleroderma
	• Post-surgicalpatients who havehad spinal surgeryand healing oftissue is stillrequired. (Theperiod of time post			• Post-surgicalpatients who havehad spinal surgeryand healing oftissue is stillrequired. (Theperiod of time postspinal surgery willvery between 6
	CTBox
iTrac™ c2i cervical	Cervical/Lumbar	Similarities/
Traction System	Traction System	Differences	Analysis
spinal surgery willvery between 6months to a year)			months to a year)
• Pregnancy			• Pregnancy
• Patients with anyother conditions thatmay be made worseby distraction of thespine			• Patients with anyother conditions thatmay be made worseby distraction of thespine
• Patients withstructural diseasedue to tumors orinfection(e.g.,osteomyelitis,spinal caries, andankylosingspondylitis).			• Stop traction if thereis an increase inradiated pain to theextremities(radicular pain).
• Patients with jointinstability,hypermobility orspinal fracture.			• Patients with severecardiovasculardisease, vascularcompromise, aorticaneurysm or severerespiratory disease.
• Patients withosteoporosis.			• Patients wheremovement iscontraindicated.
• Patients with severecardiovasculardisease, vascularcompromise, aorticaneurysm or severerespiratory disease.
• Patients wheremovement iscontraindicated.
• Patients with acutesprains, strains orinflammation thatcould be aggravatedby traction

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Image /page/16/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 serif font in green. Below "Pivotal" is the phrase "Health Solutions" in a smaller, sans-serif font, also in green. There are also three horizontal lines in gray below the figure.

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

iTrac™ c2i cervicalTraction System	CTBoxCervical/LumbarTraction System	Similarities/Differences	Analysis
• Stop traction if thereis an increase inradiated pain to theextremities(radicular pain).
• Patients with largeposterior discbulges orherniations.
• Patients withcervical spinalstenosis.
• Patients withcervical vascularcompromise.
• Patients with acutesprain, strain and/orinflammation of thecervical joints.
• Patients with internalspinal fixationhardware.

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7. Performance and Testing Summary

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.

8. Conclusion

The iTrac c2i has the same intended use and technological characteristics as the cleared predicate, CTBox Cervical/Lumbar Traction System. Moreover, verification and validation tests contained in this submission demonstrate that the difference in the submitted model maintains the same safety and effectiveness as that of the cleared device.

In other words, the iTrac c2i is substantially equivalent to the CTBox Cervical/Lumbar Traction System.

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).