**Memorandum**

**Date** October 24, 2002

**From** Director Regulatory Review Officer

**Subject** P020033 -- INDEPENDENCE™ IBOT™ 3000 Mobility System by
Independence Technology, L.L.C.

**To** Robert De Luca, Lead Reviewer, Biomedical and Electrical Engineer

This memorandum contains my review of P020033 for the INDEPENDENCE™
IBOT™ 3000 Mobility System.

> Marie A. Schroeder, MS, PT

**Background**

The application under review is an original premarket approval (PMA)
application that has been granted expedited review status.

Attachment 1 provides identifies the PMA volumes and page numbers for
each study report and study protocol for the pilot and pivotal studies.

The pivotal study is the only clinical trial that assessed the version
of the IBOT™ that will be marketed and that used the clinician and
patient training methods and materials that are intended for the
marketed device.

**Indications for Use**

The INDEPENDENCE™ IBOT™ 3000 Mobility System is a powered mobility
device for individuals who have mobility impairments and the use of at
least one upper extremity. The device is intended to provide indoor and
outdoor mobility in confined spaces, at an elevated height, climb curbs,
ascend/descend stairs, traverse obstacles, travel over a wide variety of
terrain and negotiate uneven/inclined surfaces.

The IBOT™ 3000 Mobility System is intended to be a prescription device.

Clinicians will require certification in order to train patients on the
IBOT™ 3000 Mobility System.

**Device Description**

The INDEPENDENCE™ IBOT™ 3000 Mobility System consists of a seating
system mounted onto a power base. The power base includes wheels (4
drive wheels mounted onto cluster and 2 caster wheels), batteries,
motors and computers. The device has 5 functions:

-   Standard (level surfaces; uses 2 caster wheels and 2 drive wheels)

-   4-Wheel (uneven surfaces; slopes ≤ 8^o^ and curb-like obstacles ≤ 4
    inches; uses 4 drive wheels)

-   Balance (dry, even, stable, level surfaces; slopes ≤ 5^o^ and
    obstacles ≤ ½ inch; uses 2 drive wheels)

-   Stair (flat, level, strong, dry stairs; stairs must be 30 inches
    wide, 5-8 inches height, 10-17 inches deep, maximum of 1 inch tread
    overhang and must have 1 or 2 handrails that extend beyond the step
    approximately 6 inches; uses 4 drive wheels)

-   Remote (for loading into vehicle; slopes ≤ 25^o^; uses 4 drive
    wheels)

There is a dynamic stability technology (I-BALANCE™ Technology) that is
active during every function except the standard function. This dynamic
stability is achieved through use of gyroscopes that sense movement and
a computer that processes the signals from the gyroscopes, subsequently
controlling the motors to move the wheels to maintain stability in the
sagittal plane only. There is no dynamic lateral stability technology.
The I-BALANCE™ Technology is active in every function except the
standard function. The IBOT™ can elevate the seat in the 4-wheel,
balance and stair functions. In the balance function, the device can
elevate the user to eye level of a standing person. The device is meant
to be used independently or with an assistant (for the stair function
only).

Device configurations that will be available in the marketed version of
this device include the following:

**[Functions]{.underline}**

**[Configuration Standard 4-Wheel Balance Stair Remote]{.underline}**

Solo X X On or Off Solo X

Stair Assist X X On or OFF Assist X

**[Speeds]{.underline}**

**[Speed Template Drive Setting 1 (mph) Drive Setting 2
(mph)]{.underline}**

Slow 1 2

Medium 2.5 4.5

Fast 4 6

Note that although the maximum speed is to be 6 mph (Fast Speed Template
with Drive Setting 2), it is possible that the wheel velocity can exceed
8 mph in the standard function (e-mail received October 15, 2002) at
which point the device determines it cannot control the stability of the
device and/or the subject and the device will go into system shutdown.

**Labeling**

Labeling was revised in accordance with two of the falls experienced
with the IBOT™ as noted on page 14-064. A number of additional revisions
should be made to improve safe and effective use of the IBOT™, e.g.,
amend *User Manual* to include contraindications in the first section
and to provide a glossary, clarify the entire process and materials
required for clinician certification as well as for patient training,
amend the clinician's manuals to clarify the deletion of the 4-wheel
assist option and to include an index for each, etc.

**Pilot Studies**

Three non-randomized pilot clinical studies were conducted with earlier
versions of the IBOT™. The following table provides a brief overview of
these pilot studies.

+------------------------------+----------+-----------+---------------+
| **Title**                    | **Study  | **Number  | **Duration of |
|                              | Du       | of        | IBOT™ Use**   |
|                              | ration** | P         |               |
|                              |          | atients** |               |
+------------------------------+----------+-----------+---------------+
| **Use of the INDEPENDENCE™   | Mar      | 10        | 3 days        |
| 3000 IBOT™ Transporter at    | ch-July, | u         | (unimpaired)  |
| Home and in the Community**  | 2001     | nimpaired |               |
|                              |          | users;    | 1 week        |
| -   Report ( page 15-125)    | (pages   |           | (expert)      |
|                              |          | 4 expert  |               |
| -   Protocol (page 16-179)   | 14-004 & | manual    |               |
|                              | 14-006)  | w         |               |
|                              |          | heelchair |               |
|                              |          | users     |               |
|                              |          | (spinal   |               |
|                              |          | cord      |               |
|                              |          | injured   |               |
|                              |          | \[SCI\])  |               |
+------------------------------+----------+-----------+---------------+
| **Preliminary Assessment of  | April    | 4 SCI     | 1 session for |
| a Prototype Advanced         | 11-12,   | males,    | at least 4    |
| Mobility Device in the Work  | 2001     | manual    | hours (after  |
| Environment of Veterans with |          | w         | training)     |
| Spinal Cord Injury**         | (page    | heelchair |               |
|                              |          | users     | Trained       |
| -   Report (page 15-147)     | 14-006)  |           | therapists    |
|                              |          | (2        | were present  |
| -   Protocol (page 16-179)   |          | pa        | at all times  |
|                              |          | raplegia, | to coach and  |
|                              |          | 2         | spot subjects |
|                              |          | tet       |               |
|                              |          | raplegia) |               |
+------------------------------+----------+-----------+---------------+
| **Controlled Environment     | March 15 | 96        | 1 visit       |
| Study for INDEPENDENCE™ 3000 | -- June  | evaluable | (             |
| Advanced Mobility System**   | 3, 1999  | subjects  | approximately |
|                              |          |           | 6 hours)      |
| -   Report (page 15-173)     | (page    |           |               |
|                              |          |           |               |
| -   Protocol (page 16-304)   | 15-173)  |           |               |
+------------------------------+----------+-----------+---------------+

**Use of the INDEPENDENCE™ IBOT™ 3000 Transporter at Home and in the
Community**

> **Study Design**
>
> Non-randomized study performed at 2 sites. The purpose was to gain
> experience with the IBOT at home and in the community using 10
> unimpaired non-wheelchair subjects and 4 expert manual wheelchair
> subjects having spinal cord injuries (SCI). The unimpaired subjects
> used the IBOT™ for 3 days during the period from March -- July, 2001.
> The expert subjects were then trained and used the IBOT™ for 1 week
> during the period from July -- September, 2001. Primary outcome
> measures for the expert subjects were the Activities of Daily Living
> Assessment (ADLA) and the Subject Specific Functional Scale (SSFS).
> Both of these assessments were conducted with the subjects is their
> own wheelchair versus the IBOT™. However, it is not clear whether
> unimpaired subjects were evaluated with these assessments using the
> IBOT™ as this is not discussed and data are not provided.
>
> **Results**
>
> The stair function was not used with the expert wheelchair (spinal
> cord injury \[SCI\]) subjects, but it is not clear whether the
> unimpaired subjects used this function.
>
> The summary of activity recorded from the data-logger indicates that
> both unimpaired subjects and expert wheelchair subjects used the
> standard, 4-wheel and balance modes.
>
> For the expert subjects, the balance function improved ability to
> reach higher levels. Otherwise, activities of daily living were
> essentially unchanged when comparing use of manual wheelchair to use
> of the IBOT™.
>
> Reportedly, subjects indicated that the greatest benefits to be the
> ability to easily drive over grass, gravel and dirt using the 4-wheel
> function and to communicate with friends and colleagues at eye-level
> and to reach higher levels. The case report forms do not prompt the
> subjects to report which device, i.e., the manual wheelchair or the
> IBOT™, was easier to use. It is not clear if this subjective
> information is documented.
>
> Device problems required visits from the service representative for 3
> expert subjects and for 4 unimpaired subjects. One device problem
> experienced by an unimpaired subject did not require a visit.
>
> Only one adverse event occurred and it was during the unimpaired user
> trial (unimpaired subjects participated from March -- July, 2001 and
> expert subjects participated from July -- September 2002). The device
> responded inappropriately on the stairs during assessment of an
> unimpaired subject. Therefore, the stair function was disabled for the
> expert users. However, clarification regarding the consequences to
> this subject was not provided. Additionally, it is not clear whether
> unimpaired subjects used the stair function, since stair data were not
> provided. Page 16-286 noted a protocol change that removed the stair
> function from the protocol text, but this was dated May 9, 2001 and
> the study was initiated in March, 2001.
>
> The sponsor clarified (E-mail dated October 23, 2002):

## *The primary learnings from this study were (pages 15-212 to 15-223):*

## *The inclusion/exclusion criteria identified successful users of the device,*

## *The assessment process identified successful users of the device,*

## *FIM (Functional Independence Measurement) scores successfully demonstrated an increase in independence when using the device.* 

## *The study also led to several changes in:*

## *Device hardware -- examples include footrest modifications, UCP quick release modifications, and armrest release modifications,* 

## *Device software - needing the ability for the clinician to turn device functions on/off,*

## *Training -- recognition that not only should subjects be taught how to operate the device, they also need to be taught how the device operates*

## *FIM Scoring -- a modification to the scoring system was needed to more accurately evaluate the device.*

**Preliminary Assessment of a Prototype Advanced Mobility Device in the
Work Environment of Veterans with Spinal Cord Injury**

> **Study Design**
>
> This was a 4 patient feasibility study. The purpose was to collect
> qualitative data on the potential for the INDEPENDENCE™ IBOT™ 3000 to
> influence the ability of veterans who use wheelchairs to work. There
> were 4 SCI (2 paraplegia, 2 tetraplegia) subjects who worked in an
> office environment. The device was used for at least 4 hours to
> balance on 2 wheels for communicating with colleagues, to climb
> stairs, to go up steep ramps and to climb curbs. Trained therapists
> were present at all times to coach and spot subjects.
>
> Note that the protocol for this study was reported to be the same
> protocol as used for the above pilot study (page 16-179, Appendix C-1)
> but the actual protocol does not discuss the VA site and data for the
> outcome measures specified in Appendix C-1 have not been provided.
>
> **Results**
>
> All 4 subjects used all functions except the remote function. Two of
> the 4 subjects believed that the IBOT™ would help them at work and all
> thought it should be made available to veterans who use wheelchairs.
> Reportedly, the subjects with tetraplegia gave higher ratings to the
> IBOT™ than the subjects with paraplegia for questions rating ease of
> getting around in the IBOT™ compared to the currently used
> wheelchairs. However, these data were not provided. Generally,
> complaints included difficulty or inability to pick up objects from
> the floor and difficulty using with office furniture and in tight
> places. No adverse events were reported, but therapists were present
> at all times to prevent injuries.
>
> The sponsor clarified (E-mail dated October 23, 2002):

## *The primary learning from this study (page 15-159) was that the seat height was too high making it difficult or impossible to pick up items from the floor.*

## *Subjects also preferred the device be lighter and smaller.* 

## *It is recognized this device characteristic (high seat height and device size) will mean the device is not appropriate to meet some people's needs.* 

## *In spite of these device limitations, subjects were unanimous in the belief the device could improve integration and work performance in the work environment.*

**Controlled Environment Study for INDEPENDENCE™ 3000 Advanced Mobility
System**

> **Study Design**
>
> This was a prospective, non-randomized, open label, single center
> evaluation which used participants as their own control.
>
> Study objectives included the following:

-   Primary

    -   To determine the extent to which the FIM is able to demonstrate
        that successful candidates will have an increase in functional
        independence with regard to locomotion when using the
        INDEPENDENCE™ 3000 AMS versus their own device.

-   Secondary

    -   To assess the inclusion criteria and assessment process in
        identification of successful users of the INDEPENDENCE™ 3000
        AMS.

    -   To use a consistent assessment process to determine the
        recommendation or non-recommendation of the device and version
        of operation.

> Ninety-eight subjects (32 skilled manual, 33 slow manual, 33 powered
> wheelchair users) were enrolled. Ninety-six evaluable subjects
> completed the study according to the protocol. Of the two
> non-evaluable subjects, one withdrew consent and one was tested
> without physician clearance. The subject who was tested without
> physician clearance had osteogenesis imperfecta (protocol required
> physician clearance for this medical condition) but had completed the
> solo testing in the 4-wheel and stair functions without incident. Page
> 15-194 (Protocol Deviations section) states that this patient was
> replaced.
>
> Inclusion criteria required the subjects to have as their primary
> mobility device, a manual wheelchair, a power wheelchair with a
> hand-operated joystick control or a scooter. Exclusion criteria
> basically were concerned with the excessive weight and size of the
> subjects, insufficient joint range of motion to sit in the
> INDEPENDENCE™ 3000 AMS, inability to use current postural supports
> with the INDEPENDENCE™ 3000 AMS, inability to tolerate 6 hours of
> sitting, impaired level of consciousness or seizures in the last 90
> days, conflict of interest and function specific cardiac, pulmonary
> and fracture risk factors.
>
> Subjects were tested in a simulated environment during a single visit.
> The standard, 4-wheel, balance and stair functions were tested.
> Outcome measures included:

-   Primary

    -   Combined total FIM score of locomotion and stair tests

    -   The percent of recommended for INDEPENDENCE™ 3000 AMS evaluable
        subjects

-   Secondary

    -   Breakdown by versions, "Assist" "Modified Solo" "Solo" of
        percent recommended for INDEPENDENCE™ 3000 AMS evaluable
        subjects

    -   Total FIM score of rough terrain (outdoors) test, 4-wheel
        function

    -   Total FIM score for balance function

**Results**

> Ninety-five of the 96 (99%) evaluable patients were identified and
> recommended as successful prospective users of the INDEPENDENCE™ 3000
> AMS based on the results of the comparison of a test drive in the
> INDEPENDENCE™ 3000 AMS versus the subject's own mobility device.
> Fifty-five (57%) of the 96 evaluable subjects were recommended for the
> Solo operation. The percent of evaluable subjects recommended for Solo
> operation were as follows:

-   96.8% of the skilled manual users

-   48.5% of the slow manual users

-   28.1% of the power users

> The remaining subjects required additional input from an assistant to
> activate particular functions of the device.
>
> Successful candidates demonstrated a highly significant increase of
> mobility independence for the standard plus stair-climbing functions
> when comparing the mean total FIM scores for the investigational
> versus the subject's own device. However, note that this was a
> combined score (i.e., standard function score plus stair climbing
> score). The 4-wheel function scores (mean total FIM score) also were
> significantly higher for the investigational device. There was a
> smaller but significant increase in mean total FIM scores for balance
> function. Power users and slow manual users experienced a greater gain
> with respect to uneven surface mobility independence than skilled
> manual users.
>
> No adverse events were reported during the trial, but an anonymous
> market research survey sent to the study participants revealed 2
> subjects reported adverse events. Of the 98 surveys, 82 were completed
> and returned. Both subjects reported back pain and one of these
> subjects also experienced seasickness.
>
> The sponsor clarified (E-mail dated October 23, 2002):

## *The primary learning from this study was:*

## *Training Program -- For some study participants the Training Program was too much for a single training session. The training materials were redesigned to be delivered in a modular fashion, which corresponds with the programmability of the product. Training could then be delivered in an all-in--one session or divided along the function modules:*

## *Standard and 4-Wheel*

## *Balance*

## *Remote*

## *Stair Climbing*

## 

## *Product Design -- As a result of the experience with the able-bodied subjects, changes were made to the stair-climbing function to improve both its safe and efficacy.*

## *Safety Cluster lock was added to prevent multiple cluster rotations if poor stair climbing technique is detected.*

## *Changes were made in the product's performance on sloped surfaces to prevent the driver from getting stuck between flights of stairs when climbing outdoor stairs.* 

**Pivotal Trial**

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

**Study Design**

Single center, prospective, balanced, open label study. Subjects served
as their own control using their own wheelchairs versus the
investigational mobility device. This consisted of a 2 subject pilot
phase followed by an 18 subject real world phase. The pilot phase was
used to refine the real world phase protocol.

**Study Duration**

This trial was conducted from February to May, 2002 (page 14-003).

**Objectives**

-   To demonstrate that people with a variety of mobility skills
    (different capabilities), using different configurations of the
    INDEPENDENCE™ IBOT™ 3000 Mobility System will be able to safely and
    effectively use the product in real world environments.

-   To demonstrate that subjects will have improvements in both
    objective and subjective measures of functional activities in a real
    world environment when using the INDEPENDENCE™ IBOT™ 3000 Mobility
    System compared to their current device.

**Hypotheses**

-   Community Driving Test scores will be higher when subjects use the
    INDEPENDENCE™ IBOT™ 3000 Mobility System versus their current
    wheelchair (manual, power or scooter) at the end of the real world
    trial period.

-   The Subject Specific Functional Scale (SSFS), a subjective rating
    form will show an improvement in functional mobility when using the
    INDEPENDENCE™ IBOT™ 3000 Mobility System versus their current
    wheelchair.

**Study Population**

Twenty-nine subjects were enrolled and 20 subjects (2 Pilot Trial
subjects and 18 Real World Trial subjects) completed the study.

-   Two of the enrolled subjects were not recommended for IBOT™ due to
    poor dexterity (patient \# 10 - diagnosis was rheumatoid arthritis)
    and vision problems (patient \# 23 -- diagnosis was head injury with
    R hemiplegia).

-   Six subjects withdrew prior to the Day 1 Training (2 voluntarily
    withdrew consent and the sponsor ended 4 subjects' participation.)

-   One subject voluntarily withdrew after the first day.

Of the 20 subjects who completed the study, the first 2 subjects
participated in the pilot phase which included only 1 week of use with
the investigational device as compared to 1 week of use with the
subjects' current mobility devices. Eighteen subjects completed the Real
World Trial which required 2 weeks of use with the investigational
device as compared to 2 weeks of use with the subjects' current mobility
devices.

**Evaluable Subjects**

Pilot Phase 2 skilled manual wheelchair users

Real World Phase 18 subjects:

-   Skilled manual wheelchair users 6 subjects

-   Slow manual wheelchair users 6 subjects

-   Power wheelchair users 6 subjects

Demographics:

> Gender Males 16 subjects
>
> Females 4 subjects

Age Mean: 43.7 years

> Range: 27-67 years
>
> Weight Mean: 165 pounds
>
> Range: 81-230 pounds
>
> Medical conditions Spinal cord injury (SCI) 13 subjects

-   Tetraplegia - 4 subjects

-   Paraplegia - 9 subjects

> SCI Tetraplegia + Amputation 1 subject

-   Right Below knee amputation

> (BKA)
>
> Amputation 2 subjects

-   BKA and

> above knee amputation
>
> (AKA) - 2 subjects
>
> Neuromuscular disease 4 subjects

-   Transverse myelopathy T10 -- 1 subject

-   Spina Bifida -- 1 subject

-   Idiopathic generalized dystonia -- 1 subject

-   Chronic progressive multiple sclerosis -- 1 subject

**Inclusion Criteria**

-   18-80 years of age

-   Willing to use a wheelchair accessible van or accessible public
    transportation during participation in the study (willing to
    transfer out of the INDEPENDENCE™ IBOT™ 3000 Mobility System and sit
    in the vehicle seat of the van and/or public bus)

-   Willing to give written, informed consent to participate in the
    study

-   Willing to sign a non-disclosure/confidentiality agreement

-   Using one of the following mobility aides:

    -   Manual wheelchair

    -   Power wheelchair with a hand-operated joystick control

    -   Scooter as their primary mobility device

-   And can be defined as:

    -   Skilled manual wheelchair user; identified as a new user who
        routinely propels faster than walking speed and is able to
        travel in a wheelie position for 10 feet

    -   Slow manual wheelchair user; identified as a person who
        self-propels at walking speed or slower and/or is unable to
        self-propel or travel in a wheelie position for 10 feet

    -   Power (including scooter) wheelchair; identified as a user who
        is using a power wheeled mobility device as either his/her
        primary means of mobility outside their home

**Exclusion Criteria**

-   Weighs \> 250 pounds

-   Unable to use a wheelchair seat between 14" and 20" wide

-   Not able to bend knees such that feet fit on standard footrests

-   Not able to bend hips enough to sit in a standard wheelchair that
    does not recline

-   Does not have sufficient function of at least 1 upper extremity to
    dial a pushbutton telephone and operate a hand-operated joystick

-   Current postural supports are not compatible/comparable with those
    on the IBOT™

-   Experienced impaired level of consciousness or seizure in the last
    90 days which did not meet the appropriate exceptions referenced in
    the advocacy statement overview for Driving Licensing of the
    1996-1998 Epilepsy Foundation of America.

-   Requires use of a tilt or recline seating system to perform
    activities of daily living

-   Requires use of tilt or recline seating systems as a mechanical
    method of pressure relief

-   Requires assisted mechanical ventilation

**Study Specific Exclusion Criteria**

-   Lives outside the geographical area of trained personnel

-   Not able to tolerate sitting for 4 hours or more without requiring
    tilt and recline to relieve pressure

-   Works (subject or family member) for a manufacturer or supplier of
    wheelchair or seating systems

-   Unable to use own cushion due to sizing or other reasons (if subject
    had prior pelvic/ thigh region decubitus ulceration); if no prior
    ulceration, subjects will be given currently marketed cushion that
    fits the IBOT ™

-   Has active pelvic/ thigh region decubitus ulceration

**Function** **Specific Exclusion Criteria**

**Solo Stair Function**

-   Cardiac risks

    -   New York Heart Association Classification

        -   Class I subjects allowed to try solo stair climbing with
            questioning and observation regarding fatigue, palpitations,
            dyspnea or anginal pain

        -   Class II or higher subjects allowed to try "assist" stair
            climbing.

-   Pulmonary risks

    -   Pulmonary Disability Classification

        -   Class III closely monitored and stair climbing halted if
            shortness of breath is noticed

        -   Class IV or higher restricted to "assist" operation and will
            not participate in solo stair climbing or solo 4-wheel
            training or testing **(Note: The sponsor clarified that the
            "assist" 4-Wheel function was not available in this pivotal
            trial and that they unintentionally forgot to revise this
            portion of the protocol and the case report form.)**

-   Fracture risks

    -   Severe osteopenia

    -   Osteogenesis imperfecta

    -   Spinal metastatic bone cancer

**Curb hopping in 4-Wheel Function**

-   Fracture risks

    -   Severe osteopenia

    -   Osteogenesis imperfecta

    -   Spinal metastatic bone cancer

**Balance Function**

-   Fracture risks

    -   Severe osteopenia

    -   Osteogenesis imperfecta

    -   Spinal metastatic bone cancer

**Methods**

For both the pilot and the real world phases, subjects assessed use of
the investigational devices (IBOT™ ), as well as their own mobility
devices, in their own environments for equal amounts of time (1 week
during the pilot phase and 2 weeks during the real world phase). With
respect to order of use, the monitored home and community use of the
investigational device occurred first for the 2 subjects in the pilot
phase and for approximately half of the real world subjects. For the
rest of the real world subjects, monitored home and community use of
their own devices occurred first.

Subjects for the pilot and the real world phases received training (2
days) prior to taking the IBOT™ home. During the period when the IBOT™
was used in the subjects' environments, they maintained daily mobility
logs that included inquiries about locations of travel, accessibility
and any problems, e.g., injuries, falls, device problems, etc. Subjects
were also called daily for downloading of the IBOT™'s event logs
(recorded on the IBOT™'s computer) via a modem connection using the
Service Interface program and a PCMCIA modem card. These computerized
logs documented events of device usage with respect to functions used
(e.g., times used and distances traveled per function) and hours without
a fault. The logs also documented frequency of various device actions
that occurred, e.g., device shutdown due to detection of loss of control
of stability, service triggers, and other device actions triggered by
detection of a potentially unsafe event. (See Table L, page 14-081 and
Table M, page 14-082)

During the period when subjects monitored the use of their own mobility
devices, they also maintained daily mobility logs that included
inquiries about locations of travel, accessibility and any adverse
events or other problems that occurred.

All subjects returned for assessments after the 2-week IBOT™ use period.
They completed a Community Driving Test and a post-experience Subject
Specific Function Scale (SSFS), first using their own mobility devices
and then using the IBOT™.

**Assessments and Training**

> **Subjects**
>
> Subject assessments and training consisted of the following:

1.  Telephone Screening

    a.  Telephone Screening Form (page 16-037)

        i.  Telephone Screening Form will be revised as the Product
            Qualification Survey for marketing to eliminate study
            specific information

2.  Mailings to Subjects

    a.  *Home Assessment /Transportation Assessment Survey* (page
        16-045)

        i.  *Home Assessment /Transportation Assessment Survey* has been
            revised for marketing to eliminate study specific
            information

    b.  Cardiac Form, Pulmonary Form and/or Fracture Risk Form (if
        needed, pages 16-041 & 16-068)

        i.  For the marketed device, these forms will be revised to
            condense these 3 forms into one form. A device description
            will be included along with the risks associated with each
            function. (E-mail dated October 22, 2002)

3.  Clinic Assessment (Prior to device delivery)

    a.  *Verification Survey* (Appendix O, page 16-064)

        i.  *Verification Survey* has been revised for marketing to
            eliminate study specific information.

    b.  *Medical Interface Manual* (page 19-001)

    c.  *Assessment Guidebook* (page 18-252)

4.  Materials delivered prior to receipt of device and final training

    a.  *User Manual* (If deemed appropriate to continue; page 18-006)

    b.  *Quick Reference Cards* (page 18-232)

5.  Clinic Training and Assessment (During device delivery and final
    training)

    a.  *Delivery Interface Manual* (page 19-072)

    b.  *Delivery Guidebook* (page 19-133)

    c.  Videos (Video Scripts - page 19-369)

> **Clinician Training**
>
> Clinician training (Fax dated September 25, 2002) consisted of the
> following:

1.  Independence Technology (IT) representative trained non-IT
    clinicians how to drive/operate the IBOT™ using the following
    materials:

    a.  Clinician

        i.  *User Manual* (page 18-006)

        ii. *Quick Reference Cards* (page 18-232)

    b.  IT representative

        i.  *Delivery Guidebook* (page 19-133)

2.  Clinician Training Program

    a.  Learned how to assess a client for the device:

        i.  Mat assessment

        ii. Calibration lab

        iii. Orientation/training of each function

        iv. Functional capacity evaluation considerations

    b.  Materials used:

        i.  *Medical Interface Manual* (page 19-001)

        ii. *Assessment Guidebook* (page 18-252)

3.  Clinician Training Program

    a.  Learned how to deliver the training to a client receiving the
        device:

        i.  Clinician presentations/driving for each module

        ii. Safe and effective driver's test considerations

        iii. Role playing

    b.  Materials used:

        i.  *Delivery Guidebook* (page 19-133)

        ii. *Delivery Interface Manual* (page 19-072)

        iii. Clinician Observation Test Video (Video Scripts - page
             19-369)

4.  Observation in the field

    a.  (IT representative observed clinicians during each process with
        a client)

**Outcome Measures**

The primary outcome measure:

-   *Community Driving Test* (15 tasks with 7-point scale, Appendix D,
    page 16-034)

The secondary outcome measure:

-   *Subject Specific Function Scale* (SSFS) (Appendix E, page 16-036)

Additional data:

-   Data Logger \[computerized accounting of device actions and usage
    (time and distance) of each of the IBOT™'s functions\]

-   Daily Mobility Activity Log (own and IBOT™ devices)

    -   Accessibility Problems

    -   Mechanical and Operational Problems

-   Subjective Evaluation of Home and Community Maneuvering

**Success** **Criteria and Timepoints**

Success was determined after the end of the IBOT™ home/community use
period (1 week for pilot trial and 2 weeks for the real world trial)
through comparison of the community driving test scores with the IBOT™
as compared to the scores obtained with the subjects' own mobility
devices. Similarly, the SSFS scores with the IBOT™ as compared to the
scores obtained with the subjects' own devices were also performed to
determine success. The non-parametric method of Wilcoxon signed-ranked
test was applied (p-value ≤ 0.05).

**Results**

> **Safety**
>
> The following discusses adverse events with respect to injury to
> subjects as well as device actions, problems and failures that could
> potentially place users at risk for injury.
>
> **Adverse Events**
>
> Bruises were experienced by 2 of the 20 subjects (10%). One of these
> patients pinched his mid-forearm between the UCP and the armrest and
> received treatment (forearm pad applied). The other patient received a
> bruise on his leg due to the device falling over but no treatment was
> required. (pages 14-061 and 14-065).
>
> Five falls were reported (2 patients fell with their own devices and 3
> patients fell with the IBOT™). Only one of these patients reported
> injury, i.e., 1 bruise was reported (also noted above). (pages 14-062
> and 14-065).
>
> Four other adverse events occurred that were not device related as
> they were experienced when using their own devices (pages 14-061 and
> 14-062).
>
> **Device Failures**
>
> Device failures may indicate potentially harmful situations,
> especially depending on where the user is when the problem occurs.
> However, none of the reported device failures resulted in injury to
> the subjects. Table X (page 14-099) summarizes the device failures and
> corrective actions for both the investigational device and the
> subjects' own mobility devices:
>
> Twelve of the 20 subjects experienced a total of 22 events that
> resulted in device replacement or one or more component replacements.
> Nine of these events occurred with the subjects' own devices and 13
> events occurred with the IBOT™.
>
> The replacements required during this study included the following:

-   [IBOT™ replacements included]{.underline}:

    -   3 Devices

        -   One patient had the IBOT™ replaced twice

        -   One other patient also had the IBOT™ replaced

    -   1 Powerbase

    -   2 Wheel assemblies

    -   3 Caster assemblies

    -   1 Seat assembly

    -   2 Modems

    -   3 Modem cables

    -   1 Modem card

    -   1 Backrest shroud

    -   1 Non-UCP armrest

    -   1 Non-UCP armrest cover

> Regarding the 3 IBOT™ device replacements noted above, the sponsor
> reports that each of these device replacements could have been handled
> as a component replacement. The sponsor replaced the device in order
> to minimize inconvenience to the subject. The problems that prompted
> these IBOT™ replacements included:

-   Bent charger port pin

-   Seat height unable to adjust

-   UCP backlight failed to function during stair training

```{=html}
<!-- -->
```
-   [Replacements to subjects' own mobility devices
    included]{.underline}:

    -   1 Spring loaded piece in wheel hub

    -   1 Bearings on casters

    -   1 Armrests

    -   1 Lever cable

    -   1 Bolt on caster

    -   3 Tires (Note: 3 events report replacement of tires but the
        number of tires is not specified)

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

    -   1 Bolt on backrest

    -   1 Bolt (not specified)

> **Data Logger Distributions**
>
> Computerized alert and failure data accumulated while subjects were
> using the investigational device (IBOT™) are provided in Tables L and
> M (pages 14-081 and 14-082 respectively). These alerts and failure
> actions may indicate occurrence of potentially harmful situations,
> especially depending on where the user is when the problem occurs.
> However, there was only 1 case in this clinical trial where a
> controller failure was associated with injury, i.e., a bruise that did
> not require medical attention.
>
> Table L provides data such as counts of various alert and failure
> situations, as well as other usage data. Table M provides a breakdown
> of the most of the data presented in Table L into 3 components, i.e.,
> data from the training days, data from the return test day, and data
> from use at home and in the community. Tables L and M are discussed in
> more detail under the *Effectiveness* section below. For the purposes
> of safety discussion, only the alert and failure data will be
> discussed in this section.
>
> Note that the sponsor identified a mistake on these tables in that
> there was 1 additional service trigger, i.e., there were a total of 17
> service trigger counts. (E-mail October 15, 2002)
>
> The alert/failure data included but were not limited to the following
> (See Tables L and M for additional data):
>
> **[Alert or Failure Action Total (count)]{.underline}**
>
> Controller Failure 5
>
> Controller Auto 4-Wheel 22
>
> Controller Alert Balance 42
>
> Controller Alert 4-Wheel 3
>
> Controller Alert Stair 80
>
> 4-Wheel Off Top of Stair 62
>
> Wheel Motor Hot 4
>
> Cluster Motor Hot 89
>
> Security Password 0
>
> Service Trigger 17
>
> The sponsor clarified (E-mail dated October 15, 2002) that none of
> above alert or failure actions were associated with an injury to a
> subject, except for one case. Subject 27 experienced lateral
> instability and fell while in the balance function. The right wheel
> struck a 5 inch curb and attempted to climb it. The controller failure
> and subsequent shutdown were triggered when the device sensed that it
> was falling. The subject received a bruise on his leg that did not
> require medical attention. It is not clear whether the shutdown
> contributed to the injury since the IBOT™ was already falling.
>
> With respect to the 5 controller failure counts, three occurred in
> relation to IBOT™ falls. In two of these cases (subjects 11 and 27),
> an event occurred which caused the device to fall. In each of these
> cases, the fall triggered the controller failure and subsequent device
> shutdown. As noted above, subject 27 received a bruise that did not
> require medical attention.
>
> The remaining fall was caused by the triggering of the controller
> failure and subsequent shutdown of the IBOT™. Subject 12 leaned so far
> forward that his center of gravity went outside of the wheelbase of
> the device. The device attempted to correct the situation by traveling
> forward (attempting to move the device under the subject). However,
> after the IBOT™ traveled approximately 10 feet, the safety check
> routine assumed the dynamic stabilization was not working and declared
> a controller failure. This triggered the device to go into total
> system shutdown to prevent continuance of an out-of-control situation.
> The device fell subsequent to the device shutdown, but the subject
> received no injuries. The sponsor noted that the IBOT™ is designed to
> respond in this fashion because it is believed that allowing the
> out-of-control situation to continue could cause injury especially if
> the device runs into something.
>
> Subject 29 experienced controller failure while attempting to climb
> stairs with an assistant. Stair climbing was attempted while in the
> balance function. The controller failure triggered device shutdown
> with the rear wheels resting on the first step. Passersby helped move
> the device (with the subject in the IBOT™) off the step and the device
> was powered up and functional.
>
> The fifth controller failure was experienced by subject 17. This
> occurred during an attempt to remove the IBOT™ from a van. The
> footrest got caught under the van seat and the IBOT™ was pitched \>35
> degrees at startup. This triggered controller failure and subsequent
> shutdown. After freeing the footrest, the device powered up and was
> functional.
>
> With respect to the other reported alerts, there was no consequence to
> the subjects, unless service alert reaches a count of 3. In such a
> case, the IBOT™ will not enter the balance function. The sponsor
> clarified that for each reported alert or failure count, the IBOT™
> responded as it was designed to do, i.e., the safeguards incorporated
> into the device's design worked correctly.
>
> Upon inquiry by FDA regarding whether a subject's medical condition
> contributed to any of the device failures or problems, the sponsor
> concluded (E-mail dated October 15, 2002) that a subject's medical
> condition could contribute to a controller failure. In two cases where
> the device fell, one in 4-wheel function (Subject 12, page 14-064) and
> one in balance function (Subject 27, page 14-065), the subjects'
> physical functioning may have contributed to the falls. For example:

-   Subject 12 had a C6-C7 spinal cord injury and a right below knee
    amputation. His large body build but poor to fair tone and muscle
    control of the trunk along with his compensation of large movements
    of his trunk to achieve a functional trunk position may have
    contributed to the IBOT™'s fall. He had been trying to cause the
    rear wheels to lift off the ground (which is not the recommended way
    to use the device) by leaning this trunk far forward. As the device
    started to travel forward to get the wheels under the subject's
    center of mass, the subject could not lean backward to attempt to
    regain control due to his medical condition which compromised his
    voluntary trunk control.

-   Subject 27 had a C6 spinal cord injury and lacked finger flexion to
    grip the joystick. This may have contributed to his fall. As he
    attempted to avoid a hazard, he turned too far to the right, struck
    a curb and fell laterally. Having better grip of the joystick may
    have prevented the fall. However, the sponsor noted that his
    joystick control under routine driving situations was consistent
    with all current power wheelchair users having a lower cervical
    spinal cord injury.

> **Effectiveness**
>
> Only the 18 Real World Trial subjects were included in the statistical
> analysis for the *Community Driving Test* and for the *Subject
> Specific Function Scale* (SSFS).
>
> **Community Driving Test**
>
> Scores ranged from 0 to 6 as follows:

-   0 Unable to perform or refuses to perform task

-   1, 2, 3 Performs task with assistance

> (Maximum, moderate or minimum exertion respectively)

-   4, 5, 6 Performs task independently

> (Maximum, moderate or minimum exertion respectively)
>
> A change from *unable to perform* (0) to any score performed with
> assistance (i.e., 1, 2, or 3) or to any score performed independently
> (i.e., 4, 5, or 6) was considered to be an improvement in
> independence. Likewise, a change from any of the scores requiring
> assistance to any score performed independently was considered to be
> an improvement in independence. Note that the *Community Driving Test*
> only tested subjects using the 1 rail technique for stair climbing
> because the stair cases used were too wide to use the 2 rail
> technique. (E-mail dated October 23, 2002 and photos, pages 14-027
> through 029)
>
> Note also that no patients used the slow speed template and 2 of the
> 20 subjects used the fast speed template. The speed templates assigned
> were as follows (page 14-058):

-   Slow 0 subjects

-   Medium 18 subjects

-   Fast 2 subjects

> The *Community Driving Test* demonstrated a highly statistically
> significant (using the total scores) difference in favor of the IBOT™
> as compared to the users' own mobility devices. (Table H, page 14-070)
> All subjects' total scores improved with the IBOT™ as compared to the
> current mobility devices.
>
> Every subject had an increase in total stair scores (Tables H and I,
> pages 14-070 and 14-071) and was a success in this trial. All but 2
> patients improved to a more independent score in all tasks with
> stairs. Only 1 subject (subject #13) scored 1 point lower for one of
> the stair tasks (*Down Interior Stair*) using the investigational
> device as compared to his/her own mobility device. This subject
> achieved an improvement in independence for all other stair tasks. The
> other subject (#26) improved by 2 points in each stair task but did
> not increase to a more independent level.
>
> The stairs scores also indicate that 10 subjects were independent on
> the stairs when tested with the IBOT™, i.e., scores were 4, 5, or 6.
> However, the *Demographic Analysis* of the study report (page 14-058)
> indicates that 12 subjects achieved *solo* status for stairs. This
> apparent discrepancy was clarified by the sponsor in an E-mail dated
> October 23, 2002. It was confirmed that 12 subjects achieved *solo*
> status for stairs (as determined with *Part B* - *Safe and Effective
> Driving Test,* page 16-078 and 16-079); however, 2 of these subjects
> (#6 and \# 11) were able to climb stairs with 2 rails only. These
> subjects also had trained assistants due to expectations that some
> stairs likely to be encountered in their environments would require
> assistance. The *Community Driving Test* only tested subjects using
> the 1 rail technique for stair climbing because the stair cases used
> were too wide to use the 2 rail technique. Therefore, subjects #6 and
> #11 were tested using the assistants for stair climbing. In summary:
>
> **Solo versus Assist Stair Climbing**

-   Twelve subjects achieved *solo* status for stair climbing.

    -   Four of these 12 *solo* subjects also had a trained assistant
        for the "assist" stair climbing due to concerns with some of the
        stairs that were anticipated to be encountered.

    -   Two of the 4 solo plus "assist" stair climbing subjects were
        cleared for solo stair climbing with 2 rails only (not for 1
        rail).

-   Eight subjects required the "assist" stair configuration. (page
    14-058)

> Standard function scores were similar to those obtained with the
> subjects' own mobility devices. While manual slow subjects showed a
> benefit with the IBOT™ in the standard mode, this would probably have
> been accomplished with any power device as noted by the sponsor.
>
> The majority of the real world subjects improved their level of
> independence in the balance task (i.e., 13 out of 18 subjects) and in
> 5 of the 6 tasks with the 4-wheel function. For the 4-wheel task,
> *Negotiate Uneven Terrain*, all of the *manual slow (MSL)* subjects
> improved their level of independence with the IBOT™, whereas none of
> the manual skilled subjects and only 1 of the power subjects improved
> to a higher level of independence in this task when using the IBOT™.
> Seven of the 11 subjects who did not experience a higher level of
> independence in this task had better scores (1 point improvement) with
> respect to level of exertion during the task when performed with the
> IBOT™. Four of these subjects scored the same with the IBOT™ as with
> their own mobility devices.
>
> Only 2 subjects scored better on an individual task with their current
> devices as compared to the IBOT™. One subject scored 1 point higher
> with the current mobility device for the *Down Interior Stair* task as
> he descended stairs in the manual wheelchair by going down the steps
> backwards and using his arms to control falling backwards onto each
> lower step. Another subject scored 1 point higher with the current
> mobility device for the *One Step Exit* task because the subject had
> deemed the exit step to be \>4 inches high and did not attempt this
> task. This subject, however, scored a 6 when using the investigational
> device for each of the other 4-Wheel tasks.
>
> Standard function was tested by 3 tasks and by one additional task
> that could be completed in standard or 4-wheel function. 4-wheel
> function was tested by 6 tasks in addition to the task that could be
> completed in standard or 4-wheel function. Stair function was tested
> by 4 tasks. However, Balance function was only tested by 1 task
> (*Retrieves Book off High Shelf*) and Remote function was not tested.
>
> **Subject Specific Function Scale**
>
> Statistical tests for increase in score and for increase in
> independence are highly statistically significant. (See pages 14-072
> through 14-076) However, as noted by the sponsor, this assessment's
> value is limited since not all patients identified the same tasks and
> since the assessment is focused on tasks that subjects are unable to
> perform or perform with difficulty with current devices, it is
> expected that scores with the current devices would be low. Regardless
> of the limitations, these data provide insight into some additional
> benefits and limitations that can be expected with the IBOT™.
>
> **Additional Effectiveness Data**
>
> **Data Logger Distributions**
>
> Data accumulated while subjects were using the investigational device
> (IBOT™) are provided in Tables L and M. (pages 14-081 and 14-082)
> Table L provides data such as the percent of the time used in each
> function, the percent of the total distance traveled for each
> function, the total times and distances for each function and overall,
> counts of various alert and failure situations, etc. Table M provides
> a breakdown of the data into 3 components, i.e., data from the
> training days, data from the return test day, and data from use at
> home and in the community. However, the data for the home and
> community use are somewhat underreported because data collected on
> training or testing days could not be separated into data from
> home/community use versus data collected during the actual training or
> testing period.
>
> While only one task was tested in the balance function with the
> Community Driving Test, data in Tables L and M provide additional data
> that presents a more complete understanding of the IBOT™'s usage in
> this function. For example, it indicates that subjects spent a total
> of 138.0 hours in the Balance function, and 94.7 of these hours were
> actually spent in the Balance function during home and community use
> (the rest of the time was experienced during training and testing).
> The median time spent in balance function was 5.4 hours.
>
> Data listings for individual subjects (E-mail dated October 15, 2002)
> indicate that 7 subjects used the Balance function for \< 2 hours
> total. One of these patients used the Balance function for 0.7 hours.
> It is not clear whether any of the time spent in the Balance function
> was during home and community use for these subjects. However, 13
> subjects used the Balance function for \> 2 hours during the real
> world trial, with 1 patient having used it for 18.4 hours.
>
> While Table M reports a total of 5.9 hours for the Remote Hour Meter,
> the patient listings (E-mail dated October 15, 2002) indicate that
> only subject #2 used this function (12% of the total time). None of
> the other subjects had any experience with the Remote function.
>
> Note that the sponsor identified a mistake on these tables in that
> there was 1 additional service trigger, i.e., there were a total of 17
> service trigger counts. (E-mail October 15, 2002)
>
> The sponsor clarified that none of counted alert or failure events
> resulted in injury to the subjects, except one fall that triggered the
> device to go into total system shutdown to prevent continuance of an
> out-of-control situation. The subject in this case received a bruise
> that did not require medical attention. In one case, the total system
> shutdown caused the subject to fall but this subject was not injured.
> However, if the device had not shutdown, the patient would likely have
> run into something which may have caused injury. The sponsor clarified
> that in each case of an alert or failure count, the IBOT™ responded as
> it was designed to do, i.e., the safeguards incorporated into the
> device's design worked correctly.
>
> **Device Failures**
>
> Table X (page 14-099) summarizes the device failures and corrective
> actions for both the investigational device and the subjects' own
> mobility devices.
>
> Twelve of the 20 subjects experienced a total of 22 events (for both
> mobility devices) that resulted in device replacement or one or more
> component replacements. Nine of these events occurred with the
> subjects' own mobility devices and 13 events occurred with the IBOT™.
> See the *Safety:* *Device Failures* section above for additional
> details.
>
> **Daily Activity Logs**
>
> Daily activity logs were maintained to collect information on specific
> daily activities, accessibility problems, and mechanical /operational
> difficulties. These data were reported for all 20 subjects (i.e.,
> pilot + real world subjects):
>
> **Accessibility Problems**
>
> A total of 165 accessibility problems were reported. Table N (page
> 14-084) reports 86 accessibility problems were experienced with the
> subject's own mobility device and 79 were experienced with the IBOT™.
> Accessibility problems were categorized and the results were reported
> as follows:

  ----------------------- ----------------------- -----------------------
  **Nature of             **Own Device**          **IBOT™**
  Accessibility Problem**                         

  Cannot access site due  38                      3
  to curbs, terrain, etc.                         

  Cannot access site due  28                      12
  to stairs                                       

  Cannot access high      13                      0
  shelves, counters, etc.                         

  Difficulty maneuvering  6                       22

  High seat heights       1                       34
  limits accessibility                            

  Battery limitation      0                       4

  Other                   5                       4
  ----------------------- ----------------------- -----------------------

> The sponsor noted that the number of accessibility problems was
> similar for both devices; the nature of problems was different for
> each device. For example, when in their own devices, subjects mainly
> experienced accessibility problems with respect to accessing a
> location. Thirty-eight subjects could not access a site due to curbs,
> terrain, etc., whereas only 3 subjects experienced problems of this
> nature when using the IBOT™. Twenty-eight subjects had problems
> accessing sites due to stairs, whereas only 12 subjects had such a
> problem using the IBOT™. Similarly, thirteen subjects experienced
> difficulties accessing high shelves, counters, etc., no subjects had
> such problems when using the IBOT™.
>
> The nature of the accessibility problems with the IBOT™ were primarily
> related to the maneuvering the device and the high seat height which
> makes it difficult to maneuver under tables. Tables O through U (pages
> 14- 085 through 091) list the comments for each accessibility problem.
>
> **Mechanical /Operational Difficulties**
>
> Table V (page 14-092) summarizes the number and category of the
> mechanical /operational difficulties for each device.

+-----------------------------------+----------------+----------------+
| > Mechanical/Operational          | IBOT™          | Own Device     |
| > Difficulty                      |                |                |
+-----------------------------------+----------------+----------------+
| Assist Handle/Backrest            | 1              | 1              |
+-----------------------------------+----------------+----------------+
| Battery                           | 18             | 3              |
+-----------------------------------+----------------+----------------+
| Brakes                            | 1              | 0              |
+-----------------------------------+----------------+----------------+
| Cluster/Wheels/Casters            | 7              | 6              |
+-----------------------------------+----------------+----------------+
| CPU Fault                         | 2              | 0              |
+-----------------------------------+----------------+----------------+
| Footrest/Armrest                  | 3              | 2              |
+-----------------------------------+----------------+----------------+
| Modem Cable                       | 3              | 0              |
+-----------------------------------+----------------+----------------+
| Seating/Seat Height               | 4              | 2              |
+-----------------------------------+----------------+----------------+
| Tires                             | 3              | 7              |
+-----------------------------------+----------------+----------------+
| User Control Panel                | 5              | 0              |
+-----------------------------------+----------------+----------------+
| User Technique                    | 11             | 2              |
+-----------------------------------+----------------+----------------+
| Other                             | 1              | 2              |
+-----------------------------------+----------------+----------------+

> Table W (pages14-094 through 097) lists each specific mechanical
> /operational difficulty. The main differences occurred for *Battery
> difficulties*, *User Control Panel* difficulties and *User Techniques*
> difficulties, with subjects reporting these difficulties more often
> with the IBOT™. However, as noted by the sponsor, manual devices do
> not have batteries or user control panels. Therefore, the rate of
> difficulties with these items would be expected to be lower than the
> rate experienced with the IBOT™, which was used by all of the
> subjects. The sponsor also points out that 6 of the 18 battery
> difficulties were for *low battery at end of day* which occurred on a
> training day when extensive use was required.
>
> **Subjective Evaluation of Home and Community Maneuvering**
>
> On the final day of participation with the IBOT™ and on the final day
> of participation with their own mobility devices, subjects answered
> the following questions:

-   How would you rate the ease of maneuvering in your own home?

-   How would you rate the ease of maneuvering in the community?

> Subjects rated these using a 4-point scale (poor, fair, good,
> excellent) for each question. The results (Table Y, page 14-100) were
> presented as follows:
>
> The IBOT™ tended to be less maneuverable in the home and more
> maneuverable in the community compared to subjects' own devices.

**Human Factors Concerns**

Having the power button next to the charging port initially raised
concern, but the sponsor clarified that the charging port is designed so
that the user cannot receive an electrical injury from inadvertently
placing a finger into the charging port. The following are remaining
human factors concerns that have the potential for causing injuries to
users:

-   Joystick

    -   Can be disabled but is re-enabled with pushing any button
        (except for the backlight button)

    -   Subject #6 experienced this problem, i.e., accidentally
        re-enabled the joystick and a person reaching across caused
        unexpected movement of the device (page 14-097)

-   Pinch points

    -   The *User Manual* describes a number of device features where a
        user can get pinched

-   User Control Panel

    -   Difficult to detach from armrest and user may get hurt or might
        not be able to remove for using remote function

-   Display

    -   Difficult to see due to glare and when operating joystick (hand
        covers the display)

-   Alarm tones and icons

    -   Tones/beeps are difficult to hear and background noise can mask
        entirely

    -   There are some situations where a tone/beeping occurs but there
        is no icon to indicate what the specific problem is, e.g., when
        an incorrect selection is made or the device is approaching the
        product operating limits

-   Horn

    -   Difficult to hear

-   Stair Mode

    -   Does not prompt user to hold onto railing, which is important to
        safe operation

**Conclusions**

The device was demonstrated to be effective as measured by the primary
outcome measure, the Community Driving Test. This assessment tool had
some limitations, e.g., it did not assess use of the remote function or
the 2-rail stair function and only one task was assessed using the
balance function.

The secondary outcome measure, the Subject Specific Function Scale
(SSFS), also demonstrated effectiveness although there were limitations
to this assessment method as noted by the sponsor:

-   The tasks were not standardized for all subjects; validity drawing
    broad conclusions is questionable.

-   Since subjects were instructed to choose tasks they had difficulty
    performing, it was anticipated that scores in their own devices
    would be low. Note however, that of the 73 total observations,
    subjects scored 24 as being able to do independently and 10 of these
    were independent with moderate or minimal exertion.

Additional data to be considered for effectiveness included activity and
problem logs (manually recorded on a daily basis for both mobility
devices) and computerized accountability logs for the IBOT™ (also
collected on a daily basis). For example, while only one task was
assessed for the balance function in the Community driving test,
observational data indicate that all subjects used the balance function
but also noted very short usage periods for some subjects. Limitations
of these data must also be considered. For instance, subjects were not
repeating identical daily tasks in the same locations for the periods of
IBOT™ use as compared to the period that they monitored use with their
own mobility devices. Therefore, some situations that presented
difficulty may not have been attempted with both mobility devices.

The only IBOT™ function that was not used (except for use by 1 subject
as noted with data logger data presented by subject; E-mail dated
10-15-02) or tested was the remote function. While subjects were deemed
to be safe users of the stair function with 1 and/or 2 rails, the 2-rail
function was not tested with the primary outcome measure. Additionally,
18 subjects used the medium speed template and only 2 subjects used the
fast speed template; none used the slow template, except 1 subject who
used it for 1 day only and then was given the medium speed template
(E-mail dated 4, 2002).

The standard function of the IBOT™ appears to provide functions similar
to subjects' own mobility devices, although when used in the indoor
environment, there were more difficulties primarily related to the
maneuvering the IBOT™ and its high seat height which makes it difficult
to maneuver under tables. The IBOT™ tended to be less maneuverable in
the home but more maneuverable in the community as compared to subjects'
own mobility devices.

Safety analysis reveals that minimal injury (two bruises) occurred
during the pivotal trial. While design features (e.g., automatic
triggering of device shutdown) having potential for a harmful
consequence were experienced, only one case (i.e., controller failure
that triggered device shutdown) caused the IBOT™ to fall. This fall did
not cause injury to the subject. Only one case of device shutdown was
associated with injury, i.e., a bruise that did not require medical
attention, however, it is not clear whether the shutdown contributed to
this adverse event since shutdown was triggered as the IBOT™ sensed that
it was falling over.

Users of the IBOT™ must have adequate physical capabilities and must be
capable of decision making, e.g., in order to determine which curbs,
obstacles and slopes are within the IBOT™'s performance capabilities. A
number of human factors concerns have been identified that may be
eliminated with design and/or labeling revisions in order to reduce risk
of injury.

The sponsor will require that clinicians receive certification prior to
being allowed to train patients and the IBOT™ will bear prescription
labeling. The sponsor revised the labeling in accordance with two of the
falls experienced with the IBOT™ as noted on page 14-064. A number of
additional labeling revisions should be made to improve safe and
effective use of the IBOT™.

Additional study limitations that should be considered for this pivotal
trial include the relatively small number of patients studied and the
short period of time (two weeks) during which the IBOT™ was studied.
Assessment and training requirements were intensive (i.e., they required
significant time and effort to read and comprehend the materials and to
conduct the assessments and training) for subjects and for clinicians,
but have been used with only 20 subjects and 9 therapists. Finally, it
is not clear whether additional risks will be demonstrated with long
term use of this device in users' homes and communities as long term
safety and effectiveness data are not available.

**ATTACHMENT 1**

+----------------------------------------------------+-----------------+
| **PMA Organization: Pilot and Pivotal Study        |                 |
| Reports and Protocols**                            |                 |
+----------------------------------------------------+-----------------+
| **Pivotal Study**                                  |                 |
+----------------------------------------------------+-----------------+
| **Study of the INDEPENDENCE™ IBOT™ 3000 Mobility   | **PMA           |
| System During Real World Use (February -- May,     | Volume-Page**   |
| 2002)**                                            |                 |
|                                                    | **/ Appendix**  |
+----------------------------------------------------+-----------------+
| -   Report                                         | 14-009          |
|                                                    |                 |
| -   Protocol                                       | Appendix A      |
|                                                    |                 |
| -   Protocol Amendment 1                           | 15-224          |
|                                                    |                 |
| -   Protocol Amendment 2                           | Appendix B      |
|                                                    |                 |
|                                                    | 15-317          |
|                                                    |                 |
|                                                    | Appendix B-1    |
|                                                    |                 |
|                                                    | 16-002          |
|                                                    |                 |
|                                                    | Appendix B-2    |
+----------------------------------------------------+-----------------+
| **Pilot Studies**                                  |                 |
+----------------------------------------------------+-----------------+
| **Title**                                          | **PMA           |
|                                                    | Volume-Page     |
|                                                    | /Appendix**     |
+----------------------------------------------------+-----------------+
| **Use of the INDEPENDENCE™ IBOT™ 3000 Transporter  | 15-125          |
| at Home and in the Community (March -- July,       |                 |
| 2001)**                                            | Appendix A-1    |
|                                                    |                 |
| -   Report                                         | 16-179          |
|                                                    |                 |
| -   Protocol                                       | Appendix C-1    |
+----------------------------------------------------+-----------------+
| **Preliminary Assessment of a Prototype Advanced   | 15-147          |
| Mobility Device in the Work Environment of         |                 |
| Veterans with Spinal Cord Injury (April 11-12,     | Appendix A-2    |
| 2001)**                                            |                 |
|                                                    | 16-179          |
| -   Report                                         |                 |
|                                                    | Appendix C-1    |
| -   Protocol                                       |                 |
+----------------------------------------------------+-----------------+
| -   Controlled Environment Study for INDEPENDENCE™ | 15-173          |
|     IBOT™ 3000 Mobility System, Integrated         |                 |
|     Clinical and Statistical Report (March 15 --   | Appendix A-3    |
|     June 3, 1999)                                  |                 |
|                                                    | 16-304          |
| -   Report                                         |                 |
|                                                    | Appendix E      |
| -   Protocol                                       |                 |
+----------------------------------------------------+-----------------+