CDRH Advisory Committee Meeting: Orthopedic and Rehabilitation Devices Panel November 20, 2002 INDEPENDENCE™ iBOT™ 3000 Mobility System Independence Technology

CDRH 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 Labeling Laurel Mendelson, MS (Patient Labeling 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 Overview Non-Clinical (Robert J. DeLuca) Introduction Introduction Device Description Device Description Qualification Testing Qualification Testing Electromagnetic Compatibility Electromagnetic Compatibility Clinical (Marie A. Schroeder) Indications for Use Indications for Use Pivotal Study Summary Pivotal Study Summary Assessments and Training Assessments and Training Safety & Effectiveness Analyses Safety & Effectiveness Analyses Human Factors Human Factors

Device Description Main Components User Seating/Support System User Seating/Support System User Control Panel User Control Panel Power Base Power Base Battery and Battery Charger Battery and Battery Charger Unique Features Dynamic Stabilization (I-Balance Technology) Dynamic Stabilization (I-Balance Technology) Multiple Operating Functions Multiple Operating Functions

Five Operating Functions Standard Function Standard Function 4-Wheel Function 4-Wheel Function Balance Function Balance Function Stair Function Stair Function Remote Function Remote Function

Standard Function Similar to conventional powered wheelchair Similar to conventional powered wheelchair Casters contact ground: provides good turning performance and mobility on firm, level surfaces Casters contact ground: provides good turning performance and mobility on firm, level surfaces (e.g., indoors, sidewalks, pavement) Dynamic stabilization not used Dynamic stabilization not used Inclines up to 5 degrees Inclines up to 5 degrees Obstacles up to 1/2 inch Obstacles up to 1/2 inch Maximum Speed: 1.8 – 5.7 mph Maximum Speed: 1.8 – 5.7 mph Range: 9.3 miles Range: 9.3 miles

4-Wheel Function Four drive wheels contact ground (casters are elevated): provides good performance and mobility on soft or loose terrain (e.g., outdoors on dirt, grass, gravel), and for traversing small curbs and obstacles. Four drive wheels contact ground (casters are elevated): provides good performance and mobility on soft or loose terrain (e.g., outdoors on dirt, grass, gravel), and for traversing small curbs and obstacles. Dynamic stabilization is used Dynamic stabilization is used Inclines up to 8 degrees Inclines 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 (depending on template) Maximum Speed: 2.0 – 3.4 mph (depending on template) Range: 7.4 miles Range: 7.4 miles

Balance Function Only one pair of drive wheels makes contact with the ground Only one pair of drive wheels makes contact with the ground Provides mobility at an elevated height Provides mobility at an elevated height Enables eye-level conversations Enables eye-level conversations Can be turned on or off by clinician Can be turned on or off by clinician Can turn in confined spaces Can turn in confined spaces Uses Dynamic stabilization (I-Balance Technology) Uses Dynamic stabilization (I-Balance Technology) Inclines up to 5 degrees Inclines up to 5 degrees Obstacles up to ½ inch Obstacles up to ½ inch Maximum Speed: 2.2 – 3.2 mph Maximum Speed: 2.2 – 3.2 mph Range: 12.4 miles Range: 12.4 miles

Stair Function Available settings: Assist or Solo Available settings: Assist or Solo Use with One or Two Stair Rails Use with One or Two Stair Rails Uses Dynamic stabilization Uses Dynamic stabilization (I-Balance Technology) Tread Depth: inches Tread Depth: inches Riser Height: 5-8 inches Riser Height: 5-8 inches

Remote Function Unoccupied (seat back is folded down) Unoccupied (seat back is folded down) Useful for moving device before/after transfers Useful for moving device before/after transfers Tethered UCP; use joystick while holding down OK button…two hands needed Tethered UCP; use joystick while holding down OK button…two hands needed Uses Dynamic stabilization (I-Balance Technology) Uses Dynamic stabilization (I-Balance Technology) Inclines up to 25 degrees Inclines up to 25 degrees Maximum Speed: 0.25 mph Maximum Speed: 0.25 mph Maximum Obstacle Height: 1 inch Maximum Obstacle Height: 1 inch

Battery and Battery Charger Nickel-Cadmium cells Nickel-Cadmium cells Capacity: 10 Amp-hours Capacity: 10 Amp-hours Time to full charge: 6 hours Time to full charge: 6 hours Time to 80% charge: 4 hours Time to 80% charge: 4 hours

Human Factors / User Controls User Control Panel (UCP): Located on right or left side User Control Panel (UCP): Located on right or left side  Joystick  LCD Display  LED status indicators  Annunciator / Horn  Command Buttons Power Button: On right side only Power Button: On right side only Assist Button Assist Button Assist Handle Assist Handle

Qualification Testing Evaluate non-clinical, system-level performance Evaluate non-clinical, system-level performance FDA-recognized standards FDA-recognized standards Voluntary industry standards Voluntary industry standards (e.g., ANSI/RESNA, ISO, IEC) - wheelchairs and scooters - electromagnetic compatibility - electrical safety - flammability - biocompatibility In-house test methods/acceptance criteria In-house test methods/acceptance criteria

Qualification Testing Static Stability Static Stability Dynamic Stability Dynamic Stability Effectiveness of Brakes Effectiveness of Brakes Electrical Energy Consumption and Distance Range Electrical Energy Consumption and Distance Range Dimension, Mass, and Turning Space Dimension, Mass, and Turning Space Speed, Acceleration, and Retardation Speed, Acceleration, and Retardation Measurement of Seating and Wheel Dimensions Measurement of Seating and Wheel Dimensions Static Impact and Fatigue Static Impact and Fatigue Climate Obstacle Climbing Ability Power and Control Systems Nomenclature and Labeling Resistance to Ignition of Upholstered Parts Electromagnetic Compatibility Stair Climbing Fault Insertion System Monitoring Environmental

Qualification Testing Electrical Standards Electrical Standards Safety Safety Programmable Drive Parameters Programmable Drive Parameters Stability with Impact Stability with Impact Crack Traversal Crack Traversal User Control Panel User Control Panel Transporter Power Transporter Power Computer Interface Computer Interface Exposure to Altitude Exposure to Altitude Transitions between Functions Enclosures Protection User Comfort and Convenience Packaging Lifetime Operation on Surfaces Joystick Mechanical Drop Test Exposure to Sunlight

Qualification Testing Evaluated range of operating functions and conditions Evaluated range of operating functions and conditions Evaluate under normal and worst-case conditions Evaluate under normal and worst-case conditions Results:The device met all of the Results:The device met all of the established pass/fail criteria. FDA is currently working with the sponsor to obtain clarification regarding electromagnetic compatibility test methods and results. FDA is currently working with the sponsor to obtain clarification regarding electromagnetic compatibility test methods and results.

Device Dimensional Specifications Payload (driver + items carried):250 lbs., maximum Payload (driver + items carried):250 lbs., maximum Total System Weight:246 to 251 lbs. Total System Weight:246 to 251 lbs. Battery Weight:22 lbs (each) Battery Weight:22 lbs (each) Overall Dimensions: Overall Dimensions: - maximum configuration41”(L) x 56”(H) x 27”(W) - minimum configuration33”(L) x 27”(H) x 24”(W) Seat Pan (6 sizes available):16”x16”, 16”x18”, 16”x20” 18”x16”, 18”x18”, 18”x20” Seat Pan (6 sizes available):16”x16”, 16”x18”, 16”x20” 18”x16”, 18”x18”, 18”x20” Back Rest (2 sizes available), W x D:16”x18”, 18”x18” Back Rest (2 sizes available), W x D:16”x18”, 18”x18”

Device Dimensional Specifications Seat Height: Seat Height: - Standard Function22 inches - 4-Wheel Function25½ to 28 inches - Balance Function32 to 36 inches Armrest Height (relative to seat pan):10½ to 13½ inches Armrest Height (relative to seat pan):10½ to 13½ inches Footrest (distance from seat pan):12 to 18 inches Footrest (distance from seat pan):12 to 18 inches Wheelbase: Wheelbase: - Standard Function22.0 in. - 4-Wheel Function12.8 in. Caster Wheel Diameter:6 inches, approx. Caster Wheel Diameter:6 inches, approx. Drive Wheel Diameter:12½ in., approx. Drive Wheel Diameter:12½ in., approx.

Device Performance Specifications Maximum Speed (approx): Forward Reverse - Standard Function (fast template) 5.7 mph 1.0 mph (mid template) 4.4 mph 1.0 mph (mid template) 4.4 mph 1.0 mph (slow template) 1.8 mph 1.0 mph (slow template) 1.8 mph 1.0 mph - 4-Wheel Function (fast template) 3.4 mph 1.5 mph (mid template) 3.4 mph 1.5 mph (mid template) 3.4 mph 1.5 mph (slow template) 2.0 mph 1.1 mph (slow template) 2.0 mph 1.1 mph - Balance Function (fast template) 3.2 mph 1.2 mph (mid template) 3.1 mph 1.2 mph (mid template) 3.1 mph 1.2 mph (slow template) 2.2 mph 1.0 mph (slow template) 2.2 mph 1.0 mph - Remote Function (fast template) 0.25 mph 0.25 mph (mid template) 0.25 mph 0.25 mph (mid template) 0.25 mph 0.25 mph (slow template) 0.25 mph 0.25 mph (slow template) 0.25 mph 0.25 mph

Device Performance Specifications Braking Distance: - Standard Function 9.5 ft. - 4-Wheel Function 5.6 ft. - Balance Function 9.5 ft. Minimum Turning Radius: - Standard Function 36 in - 4-Wheel Function 28 in - Balance Function 30 in Driving Range: - Standard Function9.3 mi. - 4-Wheel Function7.4 mi. - Balance Function12.4 mi. Combined Battery Capacity: 10 Amp-hours Battery Charge Time: - Full Charge6 hours - 80% Charge4 hours

Device Performance Specifications Max Obstacle Height: - Standard Function½ inch - 4-Wheel Function4 inches - Balance Function½ inch - Remote Function 1 inch Maximum Surface Slope: - Standard Function5 degrees - 4-Wheel Function8 degrees - Balance Function5 degrees - Remote Function 25 degrees Stair (Step) Dimensions: - Tread Depth10 to 17 inches - Riser Height5 to 8 inches - Nosing1.0 inch, maximum Noise Emissions: Stationary Driving Sleep Mode45 dB Standard Function45 dB dB 4-Wheel Function45 dB dB Balance Function45 dB dB Stair Function dB

Electromagnetic Compatibility (EMC) EMC background EMC background Performance testing and labeling Performance testing and labeling Panel question Panel question