Clinical ReviewClinical Review

bybyCAPT Marie A. CAPT Marie A.

SchroederSchroeder

OVERVIEWOVERVIEW BackgroundBackground Indications for UseIndications for Use Assessments and TrainingAssessments and Training Pivotal Trial SummaryPivotal Trial Summary

Safety AnalysesSafety Analyses Effectiveness AnalysesEffectiveness Analyses Human FactorsHuman Factors

BACKGROUND BACKGROUND

Original premarket approval (PMA) Original premarket approval (PMA) application application

Expedited reviewExpedited review

Pilot studiesPilot studies 1999 -- 1 Study1999 -- 1 Study 2001 – 2 Studies2001 – 2 Studies

BACKGROUNDBACKGROUND(continued)(continued)

Pivotal study - February to May, Pivotal study - February to May, 20022002 Assessed marketing version of the Assessed marketing version of the

iBOT™ iBOT™ Used marketing versions of the Used marketing versions of the

assessment and training methods and assessment and training methods and materialsmaterials

Indications for UseIndications for Use

The INDEPENDENCE™ iBOT™ 3000 Mobility The INDEPENDENCE™ iBOT™ 3000 Mobility System is a powered mobility device for System is a powered mobility device for individuals who have mobility impairments individuals who have mobility impairments and the use of at least one upper extremity. and the use of at least one upper extremity.

To provide indoor and outdoor mobility in To provide indoor and outdoor mobility in confined spaces, at an elevated height, to confined spaces, at an elevated height, to climb curbs, ascend/descend stairs, traverse climb curbs, ascend/descend stairs, traverse obstacles, travel over a wide variety of obstacles, travel over a wide variety of terrain and negotiate uneven/inclined terrain and negotiate uneven/inclined surfaces. surfaces.

Indications for UseIndications for Use(continued)(continued)

Prescription device Prescription device

Clinicians require certification Clinicians require certification

PIVOTAL TRIAL SUMMARYPIVOTAL TRIAL SUMMARY

Study of the INDEPENDENCE™ IBOT™ Study of the INDEPENDENCE™ IBOT™ 3000 Mobility System During Real 3000 Mobility System During Real World UseWorld Use

ASSESSMENTS and TRAININGASSESSMENTS and TRAINING

Clinician Clinician CertificationCertification

User TrainingUser Training

CLINICIAN CERTIFICATIONCLINICIAN CERTIFICATION

1)1) Drive/operate the iBOT™ Drive/operate the iBOT™

2)2) Assess device userAssess device user

3)3) Deliver the iBOT™ training to Deliver the iBOT™ training to a usera user

4)4) Observation in the field Observation in the field

CLINICIAN CERTIFICATIONCLINICIAN CERTIFICATION(continued)(continued)

1)1) Drive/operate the Drive/operate the iBOT™ iBOT™ User ManualUser Manual Quick Reference CardsQuick Reference Cards Delivery Guidebook Delivery Guidebook Safe usage videosSafe usage videos

2)2) Assess device userAssess device user Medical Interface Manual Medical Interface Manual Assessment GuidebookAssessment Guidebook

CLINICIAN CERTIFICATIONCLINICIAN CERTIFICATION(continued)(continued)

3) 3) Deliver the iBOT™ training to a Deliver the iBOT™ training to a useruser Delivery Guidebook Delivery Guidebook Delivery Interface Manual Delivery Interface Manual Clinician Observation Test VideoClinician Observation Test Video

4)4) Observation in the field Observation in the field

USER ASSESSMENT and USER ASSESSMENT and TRAININGTRAINING

1)1)ScreeningScreening

2)2)Mailings Mailings

3)3)Clinic Assessment (Prior to Clinic Assessment (Prior to device delivery)device delivery)

4)4)Materials delivered prior to Materials delivered prior to receipt of device and final receipt of device and final trainingtraining

5) Clinic Training and Assessment 5) Clinic Training and Assessment

USER ASSESSMENT and USER ASSESSMENT and TRAININGTRAINING(continued)(continued)

1) Screening 1) Screening Telephone Screening Form/Product Telephone Screening Form/Product

Qualification SurveyQualification Survey

2) Mailings 2) Mailings Home/Transportation Assessment Survey Home/Transportation Assessment Survey Cardiac, Pulmonary and Fracture Risk FormsCardiac, Pulmonary and Fracture Risk Forms

3) Clinic Assessment (Prior to device 3) Clinic Assessment (Prior to device delivery)delivery)

Verification Survey Verification Survey Medical Interface Manual Medical Interface Manual Assessment Guidebook Assessment Guidebook

USER ASSESSMENT and USER ASSESSMENT and TRAININGTRAINING(continued)(continued)

4) Materials delivered prior to receipt 4) Materials delivered prior to receipt of deviceof device

User Manual (If deemed appropriate to User Manual (If deemed appropriate to continue)continue)

Quick Reference Cards Quick Reference Cards

5) Clinic Training and Assessment 5) Clinic Training and Assessment Delivery Interface Manual Delivery Interface Manual Delivery Guidebook Delivery Guidebook Safe Usage Videos Safe Usage Videos

STUDY RESULTSSTUDY RESULTS

Safety AnalysesSafety Analyses

Effectiveness AnalysesEffectiveness Analyses

SAFETYSAFETY ANALYSESANALYSES

ADVERSE EVENTSADVERSE EVENTS

BruisesBruises - 2 / 20 subjects (10%) - 2 / 20 subjects (10%) Pinched mid-forearm between the iBOT™ UCP Pinched mid-forearm between the iBOT™ UCP

and the armrest - received treatment (forearm and the armrest - received treatment (forearm pad applied) pad applied)

Bruised leg due to the iBOT™ falling over - no Bruised leg due to the iBOT™ falling over - no treatment required treatment required

FallsFalls – 5 / 20 subjects (25%) – 5 / 20 subjects (25%) iBOT™ …iBOT™ … ……..…….. 3 / 20 subjects (15%)3 / 20 subjects (15%) Own device …...Own device …... 2 / 20 subjects (10%)2 / 20 subjects (10%)

OtherOther – 4 / 20 subjects (20%) experienced adverse – 4 / 20 subjects (20%) experienced adverse events not related to the iBOT™events not related to the iBOT™

DEVICE FAILURESDEVICE FAILURES

Twelve of the 20 subjects experienced a total Twelve of the 20 subjects experienced a total of 22 events that resulted in device of 22 events that resulted in device replacement or one or more component replacement or one or more component replacements:replacements:

DeviceDevice # Events# EventsOwn deviceOwn device 9 events9 eventsiBOT™iBOT™ 13 events13 events

None of the above device failures resulted in None of the above device failures resulted in injury to the subjects. injury to the subjects.

iBOT™ REPLACEMENTSiBOT™ REPLACEMENTS

• 3 Total devices 3 Total devices -- One subject had the iBOT™ replaced twice-- One subject had the iBOT™ replaced twice-- One other patient also had the iBOT™ replaced-- One other patient also had the iBOT™ replaced

• 1 Powerbase 1 Powerbase • 2 Wheel assemblies 2 Wheel assemblies • 3 Caster assemblies3 Caster assemblies• 1 Seat assembly1 Seat assembly• 2 Modems 2 Modems • 3 Modem cables3 Modem cables• 1 Modem card1 Modem card• 1 Backrest shroud1 Backrest shroud• 1 Non-UCP armrest1 Non-UCP armrest• 1 Non-UCP armrest cover1 Non-UCP armrest cover

Problems Prompting Total iBOT™ Problems Prompting Total iBOT™ ReplacementReplacement

Bent charger port pinBent charger port pin

Seat height unable to adjustSeat height unable to adjust

UCP backlight failed to functionUCP backlight failed to functionduring stair trainingduring stair training

Replacements to Own Mobility Replacements to Own Mobility DevicesDevices

1 Spring loaded piece in wheel hub1 Spring loaded piece in wheel hub1 Bearings on casters1 Bearings on casters1 Armrests1 Armrests1 Lever cable1 Lever cable1 Bolt on caster1 Bolt on caster3 Tires (Note: 3 events report replacement of tires,3 Tires (Note: 3 events report replacement of tires,

but the number of tires is not specified)but the number of tires is not specified)1 Wheels (Note: 1 event reports replacement of wheels,1 Wheels (Note: 1 event reports replacement of wheels,

but the number of wheels is not specified)but the number of wheels is not specified)1 Bolt on backrest1 Bolt on backrest1 Bolt (not specified)1 Bolt (not specified)

Computerized Alert and Failure Computerized Alert and Failure Identification DataIdentification Data

Alert / FailureAlert / Failure Total (count)Total (count)Controller Failure Controller Failure 5 5Controller Auto 4-Wheel Controller Auto 4-Wheel 2222Controller Alert BalanceController Alert Balance 4242Controller Alert 4-WheelController Alert 4-Wheel 3 3Controller Alert StairController Alert Stair 80804-Wheel Off Top of Stair4-Wheel Off Top of Stair 6262Wheel Motor Hot Wheel Motor Hot 4 4Cluster Motor HotCluster Motor Hot 8989Security Password Security Password 0 0Service Trigger Service Trigger 1717

EFFECTIVENESS EFFECTIVENESS ANALYSES ANALYSES

PrimaryPrimary - Community Driving Test - Community Driving Test

SecondarySecondary - Subject Specific Function - Subject Specific Function ScaleScale

Community Driving Test Community Driving Test LimitationsLimitations

The 2-rail stair climbing technique The 2-rail stair climbing technique was not included. was not included.

Balance function was tested by 1 taskBalance function was tested by 1 task(“Retrieves book off high shelf”) (“Retrieves book off high shelf”)

Remote function was not tested. Remote function was not tested. Speed templates assigned:Speed templates assigned:

SlowSlow 0 subjects 0 subjects MediumMedium 18 subjects18 subjects FastFast 2 subjects 2 subjects

Solo versus Assist Stair Solo versus Assist Stair ClimbingClimbing

Twelve subjects achieved “soloTwelve subjects achieved “solo”” status for stair climbing.status for stair climbing. Four Four solosolo subjects also had a trained subjects also had a trained

assistant for the “assist” stair climbing.assistant for the “assist” stair climbing. Two Two solosolo plus plus assistassist subjects were subjects were

cleared for solo stair climbing with 2 cleared for solo stair climbing with 2 rails only (not for 1 rail). rails only (not for 1 rail).

Eight subjects required the “assist” Eight subjects required the “assist” stair configuration. stair configuration.

SUBJECT SPECIFIC SUBJECT SPECIFIC FUNCTION SCALEFUNCTION SCALE

Assessment limitationsAssessment limitations Not all patients identified the same Not all patients identified the same

taskstasks Assessment focused on tasks that Assessment focused on tasks that

subjects are unable to perform or subjects are unable to perform or perform with difficulty with current perform with difficulty with current devices; it is expected that scores with devices; it is expected that scores with the current devices would be low.the current devices would be low.

ADDITIONAL EFFECTIVENESS ADDITIONAL EFFECTIVENESS DATADATA

Data Logger DistributionsData Logger Distributions

Device Failures and ReplacementsDevice Failures and Replacements

Accessibility ProblemsAccessibility Problems

Mechanical /Operational DifficultiesMechanical /Operational Difficulties

Home and Community Maneuvering Home and Community Maneuvering Summary Summary

Mechanical /Operational Mechanical /Operational DifficultiesDifficulties

Mechanical/Operational Mechanical/Operational Difficulty Difficulty

iBOT™ iBOT™ Own Own Device Device

Assist Handle/Backrest Assist Handle/Backrest 11 11Battery Battery 1818 33Brakes Brakes 11 00Cluster/Wheels/Casters Cluster/Wheels/Casters 77 66CPU Fault CPU Fault 22 00Footrest/Armrest Footrest/Armrest 33 22Modem Cable Modem Cable 33 00Seating/Seat Height Seating/Seat Height 44 22Tires Tires 33 77User Control Panel User Control Panel 55 00User Technique User Technique 1111 22Other Other 11 22

HUMAN FACTORSHUMAN FACTORS

JoystickJoystick Can be disabled but is re-enabled with pushing Can be disabled but is re-enabled with pushing

any control panel button (except for the any control panel button (except for the backlight button) backlight button)

Subject accidentally re-enabled the joystick Subject accidentally re-enabled the joystick and a person reaching across caused and a person reaching across caused unexpected movement of the device.unexpected movement of the device.

Pinch pointsPinch points The The User ManualUser Manual describes a number of describes a number of

device features where a user can get pincheddevice features where a user can get pinched

HUMAN FACTORSHUMAN FACTORS User Control Panel (UCP)User Control Panel (UCP)

Difficult to detach from armrest and user Difficult to detach from armrest and user may get hurt or might not be able to may get hurt or might not be able to remove for using Remote Functionremove for using Remote Function Subject experienced this problem Subject experienced this problem

UCP Display UCP Display Difficult to see due to glare and when Difficult to see due to glare and when

operating joystick (hand covers the operating joystick (hand covers the display)display) Subject experienced this problemSubject experienced this problem

CONCLUDING REMARKSCONCLUDING REMARKS