CDRH Advisory Committee CDRH Advisory Committee Meeting:Meeting:Orthopedic and Orthopedic and RehabilitationRehabilitationDevices PanelDevices Panel

November 20, 2002November 20, 2002

INDEPENDENCE™INDEPENDENCE™iBOT™ 3000 Mobility iBOT™ 3000 Mobility SystemSystem

Independence TechnologyIndependence Technology

CDRH Review TeamCDRH Review Team

Robert J. DeLuca, MS (Engineering)Robert J. DeLuca, MS (Engineering) CAPT Marie A. Schroeder (Clinical)CAPT Marie A. Schroeder (Clinical) Phyllis M. Silverman, MS (Statistics)Phyllis M. Silverman, MS (Statistics) Laurel Mendelson, MS (Patient Laurel Mendelson, MS (Patient

LabelingLabeling and Human Factors)and Human Factors)

Donald Witters, MS (EMC)Donald Witters, MS (EMC) Joseph Jorgens III (Software)Joseph Jorgens III (Software) William Defibaugh, BS (Manufacturing)William Defibaugh, BS (Manufacturing)

Presentation OverviewPresentation Overview

Non-ClinicalNon-Clinical (Robert J. (Robert J. DeLuca)DeLuca)

IntroductionIntroduction Device DescriptionDevice Description Qualification TestingQualification Testing Electromagnetic Electromagnetic

CompatibilityCompatibility ClinicalClinical (Marie A. Schroeder) (Marie A. Schroeder) Indications for UseIndications for Use Pivotal Study SummaryPivotal Study Summary

Assessments and TrainingAssessments and Training Safety & Effectiveness AnalysesSafety & Effectiveness Analyses Human FactorsHuman Factors

Device DescriptionDevice Description

Main ComponentsMain Components User Seating/Support SystemUser Seating/Support System User Control PanelUser Control Panel Power BasePower Base Battery and Battery ChargerBattery and Battery Charger

Unique FeaturesUnique Features Dynamic Stabilization (I-Balance Dynamic Stabilization (I-Balance

Technology)Technology) Multiple Operating FunctionsMultiple Operating Functions

Five Operating FunctionsFive Operating Functions

Standard Standard FunctionFunction

4-Wheel Function4-Wheel Function Balance FunctionBalance Function Stair FunctionStair Function Remote FunctionRemote Function

Standard FunctionStandard Function

Similar to conventional powered Similar to conventional powered wheelchairwheelchair

Casters contact ground: provides good Casters contact ground: provides good turning performance and mobility on firm, turning performance and mobility on firm, level surfaceslevel surfaces(e.g., indoors, sidewalks, pavement)(e.g., indoors, sidewalks, pavement)

Dynamic stabilization Dynamic stabilization notnot used used Inclines up to 5 degreesInclines up to 5 degrees Obstacles up to 1/2 inchObstacles up to 1/2 inch Maximum Speed: 1.8 – 5.7 mphMaximum Speed: 1.8 – 5.7 mph Range: 9.3 milesRange: 9.3 miles

4-Wheel Function4-Wheel Function

Four drive wheels contact ground (casters Four drive wheels contact ground (casters are elevated): provides good performance are elevated): provides good performance and mobility on soft or loose terrain (e.g., and mobility on soft or loose terrain (e.g., outdoors on dirt, grass, gravel), and for outdoors on dirt, grass, gravel), and for traversing small curbs and obstacles.traversing small curbs and obstacles.

Dynamic stabilization is usedDynamic stabilization is used Inclines up to 8 degreesInclines up to 8 degrees Obstacles up to 4 inch (e.g., small curbs)Obstacles up to 4 inch (e.g., small curbs) Maximum Speed: 2.0 – 3.4 mph Maximum Speed: 2.0 – 3.4 mph

(depending on template)(depending on template) Range: 7.4 milesRange: 7.4 miles

Balance FunctionBalance Function

Only one pair of drive wheels makes contact with Only one pair of drive wheels makes contact with the groundthe ground

Provides mobility at an elevated heightProvides mobility at an elevated height Enables eye-level conversationsEnables eye-level conversations Can be turned on or off by clinicianCan be turned on or off by clinician Can turn in confined spacesCan turn in confined spaces Uses Dynamic stabilization (I-Balance Uses Dynamic stabilization (I-Balance

Technology)Technology) Inclines up to 5 degreesInclines up to 5 degrees Obstacles up to ½ inchObstacles up to ½ inch Maximum Speed: 2.2 – 3.2 mphMaximum Speed: 2.2 – 3.2 mph Range: 12.4 milesRange: 12.4 miles

Stair FunctionStair Function

Available settings: Assist or SoloAvailable settings: Assist or Solo Use with One or Two Stair RailsUse with One or Two Stair Rails Uses Dynamic stabilizationUses Dynamic stabilization

(I-Balance Technology)(I-Balance Technology) Tread Depth: 10-17 inchesTread Depth: 10-17 inches Riser Height: 5-8 inchesRiser Height: 5-8 inches

Remote FunctionRemote Function

Unoccupied (seat back is folded down)Unoccupied (seat back is folded down) Useful for moving device before/after Useful for moving device before/after

transferstransfers Tethered UCP; use joystick while holding Tethered UCP; use joystick while holding

down OK button…two hands neededdown OK button…two hands needed Uses Dynamic stabilization (I-Balance Uses Dynamic stabilization (I-Balance

Technology)Technology) Inclines up to 25 degreesInclines up to 25 degrees Maximum Speed: 0.25 mphMaximum Speed: 0.25 mph Maximum Obstacle Height: 1 inchMaximum Obstacle Height: 1 inch

Battery and Battery Battery and Battery ChargerCharger

Nickel-Cadmium cellsNickel-Cadmium cells Capacity: 10 Amp-hoursCapacity: 10 Amp-hours Time to full charge: 6 Time to full charge: 6

hourshours Time to 80% charge: 4 Time to 80% charge: 4

hourshours

Human Factors / User Human Factors / User ControlsControls

User Control Panel (UCP): User Control Panel (UCP): Located on Located on right right oror left side left side JoystickJoystick LCD DisplayLCD Display LED status indicatorsLED status indicators Annunciator / HornAnnunciator / Horn Command ButtonsCommand Buttons

Power Button: Power Button: On right side onlyOn right side only Assist ButtonAssist Button Assist HandleAssist Handle

Qualification TestingQualification Testing

Evaluate non-clinical, system-level Evaluate non-clinical, system-level performanceperformance

FDA-recognized standardsFDA-recognized standards Voluntary industry standardsVoluntary industry standards

(e.g., ANSI/RESNA, ISO, IEC)(e.g., ANSI/RESNA, ISO, IEC)- wheelchairs and scooters- wheelchairs and scooters- electromagnetic compatibility- electromagnetic compatibility- electrical safety- electrical safety- flammability- flammability- biocompatibility- biocompatibility

In-house test methods/acceptance criteriaIn-house test methods/acceptance criteria

Qualification TestingQualification Testing

Static StabilityStatic Stability Dynamic StabilityDynamic Stability Effectiveness of BrakesEffectiveness of Brakes Electrical Energy Electrical Energy

Consumption and Consumption and Distance RangeDistance Range

Dimension, Mass, and Dimension, Mass, and Turning SpaceTurning Space

Speed, Acceleration, Speed, Acceleration, and Retardationand Retardation

Measurement of Seating Measurement of Seating and Wheel Dimensionsand Wheel Dimensions

Static Impact and Static Impact and FatigueFatigue

ClimateClimate Obstacle Climbing Obstacle Climbing

AbilityAbility Power and Control Power and Control

SystemsSystems Nomenclature and Nomenclature and

LabelingLabeling Resistance to Ignition of Resistance to Ignition of

Upholstered PartsUpholstered Parts Electromagnetic Electromagnetic

CompatibilityCompatibility Stair ClimbingStair Climbing Fault InsertionFault Insertion System MonitoringSystem Monitoring EnvironmentalEnvironmental

Qualification TestingQualification Testing

Electrical StandardsElectrical Standards SafetySafety Programmable Drive Programmable Drive

ParametersParameters Stability with ImpactStability with Impact Crack TraversalCrack Traversal User Control PanelUser Control Panel Transporter PowerTransporter Power Computer InterfaceComputer Interface Exposure to AltitudeExposure to Altitude

Transitions between Transitions between FunctionsFunctions

Enclosures ProtectionEnclosures Protection User Comfort and User Comfort and

ConvenienceConvenience PackagingPackaging LifetimeLifetime Operation on SurfacesOperation on Surfaces Joystick MechanicalJoystick Mechanical Drop TestDrop Test Exposure to SunlightExposure to Sunlight

Qualification TestingQualification Testing

Evaluated range of operating functions Evaluated range of operating functions and conditionsand conditions

Evaluate under normal and worst-case Evaluate under normal and worst-case conditionsconditions

Results:Results: The device met all of theThe device met all of theestablished established pass/fail criteria.pass/fail criteria.

FDA is currently working with the FDA is currently working with the sponsor to obtain clarification sponsor to obtain clarification regarding electromagnetic compatibility regarding electromagnetic compatibility test methods and results. test methods and results.

Device Dimensional Device Dimensional SpecificationsSpecifications

Payload (driver + items carried):Payload (driver + items carried): 250 lbs., maximum250 lbs., maximum Total System Weight:Total System Weight: 246 to 251 lbs.246 to 251 lbs. Battery Weight:Battery Weight: 22 lbs (each)22 lbs (each) Overall Dimensions:Overall Dimensions:

- maximum configuration- maximum configuration 41”(L) x 56”(H) x 41”(L) x 56”(H) x 27”(W)27”(W)

- minimum configuration- minimum configuration 33”(L) x 27”(H) x 33”(L) x 27”(H) x 24”(W)24”(W)

Seat Pan (6 sizes available):Seat Pan (6 sizes available): 16”x16”, 16”x18”, 16”x16”, 16”x18”, 16”x20”16”x20” 18”x16”, 18”x18”, 18”x16”, 18”x18”, 18”x20”18”x20”

Back Rest (2 sizes available), W x D:Back Rest (2 sizes available), W x D: 16”x18”, 16”x18”, 18”x18”18”x18”

Device Dimensional Device Dimensional SpecificationsSpecifications

Seat Height:Seat Height:- Standard Function- Standard Function 22 inches22 inches- 4-Wheel Function- 4-Wheel Function 25½ to 28 inches25½ to 28 inches- Balance Function- Balance Function 32 to 36 inches32 to 36 inches

Armrest Height (relative to seat pan):Armrest Height (relative to seat pan): 10½ to 13½ inches10½ to 13½ inches Footrest (distance from seat pan):Footrest (distance from seat pan): 12 to 18 inches12 to 18 inches Wheelbase: Wheelbase:

- Standard Function- Standard Function 22.0 in.22.0 in.- 4-Wheel Function- 4-Wheel Function 12.8 in.12.8 in.

Caster Wheel Diameter:Caster Wheel Diameter: 6 inches, approx.6 inches, approx. Drive Wheel Diameter:Drive Wheel Diameter: 12½ in., approx.12½ in., approx.

Device Performance Device Performance SpecificationsSpecifications

Maximum SpeedMaximum Speed (approx):(approx): Forward Forward Reverse Reverse

- - Standard FunctionStandard Function (fast template) (fast template) 5.7 mph 5.7 mph 1.0 mph 1.0 mph (mid template)(mid template) 4.4 mph 4.4 mph 1.0 mph 1.0 mph (slow template)(slow template) 1.8 mph 1.8 mph 1.0 mph 1.0 mph

- - 4-Wheel Function4-Wheel Function (fast template) (fast template) 3.4 mph 3.4 mph 1.5 mph 1.5 mph (mid template)(mid template) 3.4 mph 3.4 mph 1.5 mph 1.5 mph (slow template)(slow template) 2.0 mph 2.0 mph 1.1 mph 1.1 mph

- - Balance FunctionBalance Function (fast template) (fast template) 3.2 mph 3.2 mph 1.2 mph 1.2 mph (mid template)(mid template) 3.1 mph 3.1 mph 1.2 mph 1.2 mph (slow template)(slow template) 2.2 mph 2.2 mph 1.0 mph 1.0 mph

- - Remote FunctionRemote Function (fast template) (fast template) 0.25 mph 0.25 mph 0.25 mph 0.25 mph (mid template)(mid template) 0.25 mph 0.25 mph 0.25 mph 0.25 mph (slow template)(slow template) 0.25 mph 0.25 mph 0.25 mph 0.25 mph

Device Performance Device Performance SpecificationsSpecifications

Braking Distance:Braking Distance:- Standard Function- Standard Function 9.5 9.5 ft.ft.- 4-Wheel Function- 4-Wheel Function 5.6 5.6 ft.ft.- Balance Function- Balance Function 9.5 9.5 ft.ft.

Minimum Turning Minimum Turning Radius:Radius:- Standard Function- Standard Function 36 in 36 in- 4-Wheel Function- 4-Wheel Function 28 in 28 in- Balance Function- Balance Function 30 in 30 in

Driving Range: Driving Range: - Standard Function- Standard Function 9.3 9.3 mi.mi.- 4-Wheel Function- 4-Wheel Function 7.4 7.4 mi.mi.- Balance Function- Balance Function 12.4 12.4 mi.mi.

Combined Battery Combined Battery Capacity: Capacity: 10 Amp-10 Amp-hourshours

Battery Charge Time:Battery Charge Time:- Full Charge- Full Charge 6 hours6 hours- 80% Charge- 80% Charge 4 4 hourshours

Device Performance Device Performance SpecificationsSpecifications

Max Obstacle Height: Max Obstacle Height: - Standard Function- Standard Function ½ inch½ inch- 4-Wheel Function- 4-Wheel Function 4 4

inchesinches- Balance Function- Balance Function ½ ½

inchinch- Remote Function - Remote Function 1 inch1 inch

Maximum Surface Maximum Surface Slope: Slope:

- Standard Function- Standard Function 5 degrees5 degrees- 4-Wheel Function- 4-Wheel Function 8 8

degreesdegrees- Balance Function- Balance Function 5 5

degreesdegrees- Remote Function - Remote Function 25 25

degreesdegrees

Stair (Step) Dimensions:Stair (Step) Dimensions:

- Tread Depth- Tread Depth 10 to 17 inches10 to 17 inches - Riser Height- Riser Height 5 to 8 inches5 to 8 inches - Nosing- Nosing 1.0 inch, maximum1.0 inch, maximum

Noise Emissions:Noise Emissions: StationaryStationary Driving Driving

Sleep ModeSleep Mode 45 dB - - - -45 dB - - - -Standard FunctionStandard Function 45 dB 45 dB

73-81 dB73-81 dB4-Wheel Function4-Wheel Function 45 dB 65-69 dB45 dB 65-69 dBBalance FunctionBalance Function 45 dB 65-70 dB 45 dB 65-70 dB Stair FunctionStair Function - - - - - - - - 66-80 dB66-80 dB

Electromagnetic Electromagnetic Compatibility (EMC)Compatibility (EMC)

EMC backgroundEMC background Performance testing and Performance testing and

labelinglabeling Panel questionPanel question