# Presentation: 334741

## CDRH Advisory Committee Meeting:Orthopedic and RehabilitationDevices Panel

- November 20, 2002
- INDEPENDENCETM
- iBOTTM 3000 Mobility System
- Independence Technology

## CDRH Review Team

- Robert J. DeLuca, MS  (Engineering)
- CAPT Marie A. Schroeder  (Clinical)
- Phyllis M. Silverman, MS  (Statistics)
- Laurel Mendelson, MS  (Patient Labeling
- 				        and Human Factors)
- Donald Witters, MS  (EMC)
- Joseph Jorgens III  (Software)
- William Defibaugh, BS  (Manufacturing)

## Presentation Overview

_**Non-Clinical**_**  **(Robert J. DeLuca)
- Introduction
- Device Description
- Qualification Testing
- Electromagnetic Compatibility
_**Clinical**_  (Marie A. Schroeder)
- Indications for Use
- Pivotal Study Summary
- Assessments and Training
- Safety & Effectiveness Analyses
- Human Factors

## Device Description

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

## Five Operating Functions

- Standard Function
- 4-Wheel Function
- Balance Function
- Stair Function
- Remote Function

## Standard Function

- Similar to conventional powered wheelchair
- Casters contact ground: provides good turning performance and mobility on firm, level surfaces
- 	(e.g., indoors, sidewalks, pavement)
- Dynamic stabilization _not_ used
- Inclines up to 5 degrees
- Obstacles up to 1/2 inch
- Maximum Speed: 1.8 – 5.7 mph
- 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.
- Dynamic stabilization is used
- Inclines up to 8 degrees
- Obstacles up to 4 inch (e.g., small curbs)
- Maximum Speed:  2.0 – 3.4 mph (depending on template)
- Range:  7.4 miles

## Balance Function

- Only one pair of drive wheels makes contact with the ground
- Provides mobility at an elevated height
- Enables eye-level conversations
- Can be turned on or off by clinician
- Can turn in confined spaces
- Uses Dynamic stabilization (I-Balance Technology)
- Inclines up to 5 degrees
- Obstacles up to 1⁄2 inch
- Maximum Speed:  2.2 – 3.2 mph
- Range:  12.4 miles

## Stair Function

- Available settings:  Assist or Solo
- Use with One or Two Stair Rails
- Uses Dynamic stabilization
- 	(I-Balance Technology)
- Tread Depth:  10-17 inches
- Riser Height:  5-8 inches

## Remote Function

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

## Battery and Battery Charger

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

## Human Factors / User Controls

- 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
- Assist Button
- Assist Handle

## Qualification Testing

- Evaluate non-clinical, system-level performance
- FDA-recognized 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

## Qualification Testing

- Static Stability
- Dynamic Stability
- Effectiveness of Brakes
- Electrical Energy Consumption and Distance Range
- Dimension, Mass, and Turning Space
- Speed, Acceleration, and Retardation
- Measurement of Seating and Wheel Dimensions
- 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
- Safety
- Programmable Drive Parameters
- Stability with Impact
- Crack Traversal
- User Control Panel
- Transporter Power
- Computer Interface
- 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
- Evaluate under normal and worst-case conditions
- 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.

## Device Dimensional Specifications

- Payload (driver + items carried):		250 lbs., maximum
- Total System Weight:			246 to 251 lbs.
- Battery Weight:				22 lbs (each)
- Overall Dimensions:
- 		- maximum configuration	41”(L) x 56”(H) x 27”(W)
- 		- minimum configuration	33”(L) x 27”(H) x 24”(W)
- 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”

## Device Dimensional Specifications

- Seat Height:
- 		-  Standard Function			22 inches
- 		-  4-Wheel Function			251⁄2 to 28 inches
- 		-  Balance Function			32 to 36 inches
- Armrest Height (relative to seat pan):	101⁄2 to 131⁄2 inches
- Footrest (distance from seat pan):		12 to 18 inches
- Wheelbase:
- 		-  Standard Function			22.0 in.
- 		-  4-Wheel Function			12.8 in.
- Caster Wheel Diameter:			6 inches, approx.
- Drive Wheel Diameter:			121⁄2 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
- 				 (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
- 				 (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
- 				 (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
- 				 (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 Function	9.3 mi.
- 	-  4-Wheel Function	7.4 mi.
- 	-  Balance Function	12.4 mi.
**Combined Battery Capacity:    **10 Amp-hours
**Battery Charge Time:**
- 	-  Full Charge	6 hours
- 	-  80% Charge	4 hours

## Device Performance Specifications

**Max Obstacle Height: **
- -  Standard Function	1⁄2 inch
- -  4-Wheel Function		4 inches
- -  Balance Function		1⁄2 inch
- -  Remote Function          	1 inch
**Maximum Surface Slope: **
- -  Standard Function	5 degrees
- -  4-Wheel Function		8 degrees
- -  Balance Function		5 degrees
- -  Remote Function          	25 degrees

**Stair (Step) Dimensions:****	**
-  -  Tread Depth	10 to 17 inches
-  -  Riser Height	5 to 8 inches
-  -  Nosing		1.0 inch, maximum
**Noise Emissions:**
- 	                       _Stationary_    _Driving       _
- Sleep Mode	45 dB       - - - -
- Standard Function	45 dB       73-81 dB
- 4-Wheel Function	45 dB       65-69 dB
- Balance Function	45 dB       65-70 dB
- Stair Function	 - - - -	66-80 dB

## Electromagnetic Compatibility (EMC)

- EMC background
- Performance testing and labeling
- Panel question