K Number

Device Name

Indego

Manufacturer

Parker Hannifin Corporation

Date Cleared

2017-09-08

(123 days)

Product Code

PHL

Regulation Number

890.3480

Intended Use

The Indego® orthotically fits to the lower limbs and the trunk; the device is intended to enable individuals with spinal cord injury at levels T3 to L5 to perform ambulatory functions with supervision of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.

Device Description

Parker Hannifin's Indego® device is a wearable powered exoskeleton that actively assists individuals to stand and walk; these are patients with walking impairments resulting from lower extremity weakness or paralysis. The Indego consists of snap-together components weighing 26 pounds total. The hip component houses a rechargeable battery pack, central processor, and Bluetooth radio, while each upper leg component houses two motors as well as embedded sensors and controllers. On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation. The Indego controls are self-contained, with forearm crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to achieve the actions of transitioning from sitting to standing, standing to walking, stop walking, and return from standing to sitting. The untethered, free roaming design of the device will allow it to be utilized in multiple indoor and outdoor locations in either a rehabilitation setting with a certified Indego Specialist or a personal setting with a trained support person.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152416, K161443

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "on-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt." This describes a control system based on sensor input and pre-programmed logic, not AI/ML. There is no mention of learning, adaptation, or complex pattern recognition characteristic of AI/ML. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".

Therapeutic

Yes.
The device is intended to enable individuals with spinal cord injury to perform ambulatory functions, which is a therapeutic purpose.

Diagnostic

The Indego device is a wearable powered exoskeleton designed to assist individuals with spinal cord injury to perform ambulatory functions. Its purpose is to enable movement and provide support, not to diagnose a medical condition.

SaMD (Software as a Medical Device)

The device description explicitly states that the Indego® is a wearable powered exoskeleton consisting of snap-together components including a battery pack, central processor, Bluetooth radio, motors, embedded sensors, and controllers. This indicates it is a hardware device with integrated software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, the Indego® device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens from the human body. The Indego® is a wearable powered exoskeleton that physically assists individuals with spinal cord injuries to stand and walk. It does not analyze any biological samples.
The intended use is for physical assistance and rehabilitation. The description clearly states its purpose is to enable ambulatory functions and assist with standing and walking.
The device description focuses on mechanical and electronic components. It details motors, sensors, processors, and battery technology, all related to physical movement assistance.
The performance studies measure physical outcomes. The key metrics are walking speed, functional independence in gait, and walking index scores, all related to physical performance, not diagnostic results from biological samples.

Therefore, the Indego® is a medical device, but it falls under a different category than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

PHL

Device Description

On-board microprocessors receive signals from integrated sensors which provide information on the user's posture and tilt. This allows the device to function in a manner similar to the Segway personal mobility device, which is controlled by the user's tilt. A user similarly controls of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). The technology of the design links the low weight and low profile to advanced battery technology (smaller size), motors (smaller and more powerful), and micro controllers (state-of-the art). Visual cues from the LED lights on the hip and vibratory feedback inform both the patient and therapist or trained support person of the status and mode of operation.

The Indego controls are self-contained, with forearm crutches or a walker used solely for stability. Users can perform sit-to-stand and stand-to-sit transitions and walk along even or uneven terrain up to about five degree (5°) grades. Taller torso "wings" are provided to support users who may need additional trunk support while walking. A physical therapist can configure, operate, and monitor the device during therapy and training to make adjustments as needed. This is achieved through the support of a wireless application that will run on mobile/wifi connected smart devices such as an iPod or iPhone. The patient and physical therapist will be able to work in concert to achieve the actions of transitioning from sitting to standing, standing to walking, stop walking, and return from standing to sitting. The untethered, free roaming design of the device will allow it to be utilized in multiple indoor and outdoor locations in either a rehabilitation setting with a certified Indego Specialist or a personal setting with a trained support person.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

lower limbs and the trunk

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Rehabilitation institutions under the supervision of a specially trained companion/therapist (Indego Specialist), or in a personal setting with a trained support person.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Rehabilitation Use Data
Clinical Indego usage data from 98 subjects in over 1,600 sessions has been gathered and analyzed. Sixty-three of these patients were SCI T6 or higher and completed 823 sessions. The remaining 35 individuals had injury levels of T7 or lower and completed 828 sessions. There are three sources for the reported clinical data; the Pilot Study, the Multi-Site Clinical Trial and postmarket clinical data.

Pilot Study:

Study Type: Pilot study
Sample Size: 16 SCI subjects
Key Results:
- All 16 subjects successfully learned to use the Indego within five 90-minute sessions.
- Most participants were able to ambulate over five-degree ramps in addition to a variety of inside and outside surfaces.
- An average walking speed of 0.34 m/s was accomplished in the 10 Meter Walk Test.
- All subjects were able to complete the 6 Minute Walk Test.
- Two minor adverse events (bruising, skin redness) and no serious adverse events reported.

Multi-Site Clinical Trial:

Study Type: Multi-site clinical study
Sample Size: 45 persons with SCI (T3 to L2)
Key Results:
- The average speed for the indoor 10 Meter Walk Test (10 MWT) at the end of the study for subjects with injury levels T3-T6 was 0.35 ± 0.10 m/s and 0.38 ± 0.08 m/s for participants T7 and lower SCI.
- Both the lower and higher injury level groups had an average Functional Independence Measure Gait (FIM) Score of 4 for the 10 MWT (minimal contact assistance).
- 100% of T3-T6 subjects and 92% of T7 and lower SCI subjects completed the 600 MWT.
- Timed Up and Go (TUG) test showed both T3-T6 and T7 and lower injury level groups performed activities with an average FIM score of 4.
- Walking Index for Spinal Cord Injury (WISCI) Scores: Both T3-T6 and T7 and lower injury level groups had an average WISCI score of 7 ± 1.1 and ± 1.8, respectively, indicating similar assistance needed (walking with rolling walker/forearm crutches and physical assistance of 1 person).
- 46 trial-related Adverse Events (20 device-related, minor instances like bruising, redness, abrasion, swelling, rolled ankle) and 0 Serious Adverse Events.
- Study concluded Indego is safe and effective for its intended use.

Postmarket Clinical Data:

Study Type: Postmarket clinical data analysis from clinical partners.
Sample Size: 37 patients (C2 to T6 SCI) in 313 Indego therapy sessions.
Key Results:
- All 37 subjects had blood pressure readings within functional limits and no falls were reported.
- 19 of 37 individuals were able to walk outside.
- 62.5% of the 16 subjects with T3-T6 SCI walked outside.
- 9 of 16 subjects with T3-T6 SCI had a reported FIM score of 4 or higher (Minimal Assistance).
- Two reported safety issues: one instance of "sit to therapist knee" (no injury) and one instance of lateral loss of balance (therapist assisted, no injury).
- Combined data shows comparable outcomes between higher and lower SCI groups, no additional safety concerns for T6 and above.

Personal Use Data
Personal Use Training Program Study:

Study Type: Research study to evaluate adequacy and success of training program.
Sample Size: Four subjects (T8 A, T10 C, T10 A) and their support persons.
Key Results:
- Users and support persons successfully completed a 40-hour Personal Use Training Program.
- Users practiced activities of daily living and walking on various indoor/outdoor surfaces.
- All user and support person teams passed competencies.
- Users reported adequate training and confidence.
- Seven minor Adverse Events (skin redness, swollen knee, skin lesions, bruising, involuntary bowel movement); all resolved. No Serious Adverse Events.

Postmarket Personal Use Data:

Study Type: Questionnaire to existing personal users.
Sample Size: 5 trained Indego personal users worldwide.
Key Results:
- All five users indicated training translated well to home and community use.
- Teams reported using Indego for activities of daily living and walking on various surfaces.
- One instance of a fall noted (user lost balance when crutch slipped, no injuries). No other falls, AEs, or SAEs reported.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Average walking speed in 10 Meter Walk Test (10 MWT): 0.34 m/s (Pilot Study); 0.35 ± 0.10 m/s (T3-T6) and 0.38 ± 0.08 m/s (T7 and lower SCI) (Multi-Site Trial).
Functional Independence Measure Gait (FIM) Score: Average of 4 (Minimal contact assistance) (Multi-Site Trial for both T3-T6 and T7 and lower SCI). FIM score of 4 or higher required for personal use competencies.
Walking Index for Spinal Cord Injury (WISCI) Scores: Average of 7 ± 1.1 and ± 1.8 for T3-T6 and T7 and lower SCI respectively.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152416, K161443

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 890.3480 Powered lower extremity exoskeleton.

(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).

Summary

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 8, 2017

Parker Hannifin Corporation % Audrey Swearingen Director Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Rd, Bldg 1, Suite 300 Austin, Texas 78746

Re: K171334 Trade/Device Name: Indego® Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: August 8, 2017 Received: August 11, 2017

Dear Ms. Swearingen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K171334

Device Name Indego®

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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Indego®

K171334

1. Submission Sponsor

Parker Hannifin Corporation Human Motion and Control 1390 E. Highland Road Macedonia, Ohio, 44056 USA Phone number: 216.896.2044 Contact: Achilleas Dorotheou Title: VPBD/Head, Human Motion and Control

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Rd., Building 1, Suite 300 Austin, TX 78746 Cell Phone: 512.818.3811 Office Phone: 512.327.9997 Fax: 512.327.9998 Contact: Audrey Swearingen, Director Regulatory Affairs Email: project.management@emergogroup.com

3. Date Prepared

September 8, 2017

4. Device Identification

Trade/Proprietary Name: Indego® Common/Usual Name: Powered Exoskeleton Classification Name: Powered lower extremity exoskeleton

Regulation Number: 890.3480 Product Code: PHL Device Class: Class II Classification Panel: Neurology

5. Legally Marketed Predicate Devices

Primary Predicate: K152416, Indego®, Parker Hannifin Corporation

K161443, Ekso™, Ekso Bionics

6. Device Description

7. Indication for Use Statement

also intended to enable individuals with spinal cord injury at levels C7 to L5 to perform ambulatory functions in rehabilitation in accordance with the user assessment and training certification program. The Indego is not intended for sports or stair climbing.

8. Substantial Equivalence Discussion

The Indego clinical data supporting these expanded indication and personal) and substantial equivalence to the predicate devices comes from five sources; a 16-subject Pilot Study, a 45subject Multi-Site Trial, postmarket clinical data (37 subject Personal Use Training Program Study and postmarket personal use data (5 subjects). A comparison of this data to that of the predicate device, which demonstrates that Indego Specialists are successfully working with SCI C7 to L5 ASIA A, B, C or D, can be found in Table 5A below.

| Summary of Ekso Data (taken directly from K143690

clearance letter dated April 1, 2016)	Summary of Indego Data
Study 1:
44 subjects total C1-L2 ASIA A, B, C, D Total sessions: ~1188	Study 1: (Pilot Study)
16 completed subjects total C5-L1 ASIA A, B, C Total sessions: 80
Study 2:
12 subjects total C7-L1 ASIA A, B Total sessions: ~288	Study 2: (Multi-Site Trial)
45 completed subjects total T3-L3 ASIA A, B, C Total sessions: 1215
	Postmarket clinical data:
37 subjects total C2-T6 ASIA A, B, C, D Total sessions: 313
	Study 3: (Personal Use Training Program Study)
4 personal user and support person teams T8-T10 ASIA A and C 40 hours of training per team
	Postmarket personal use data
5 personal user and support person teams worldwide (none of whom participated in Study 3) T4 - L1 ASIA A and C 40 hours of training per team 1 additional user (SCI T12 A) and support person have begun the Indego Personal Use Training Program and have so far completed approximately 30 hours of training
TOTAL SCI SUBJECTS:
56	TOTAL SCI SUBJECTS:
107
TOTAL SESSIONS:
1476	TOTAL SESSIONS:
1608
SCI LEVEL:
C1-L2	SCI LEVEL:
C2-L3
ASIA RANGE:
A, B, C, D	ASIA RANGE:
A, B, C, D
	Personal Use Training Hours:
390
	Combined months of Indego Personal Use in home & community settings with trained support person:
390

Table 5B below compares the subject Indego to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices found in Table 5B provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

Manufacturer	Parker Hannifin Corporation	Parker Hannifin Corporation	Ekso Bionics	Significant Differences
Trade Name	Indego®	Indego®	Ekso™
510(k) Number	TBD	K152416	K161443	N/A
Product Code	PHL	PHL	PHL	Same
Regulation Number	890.3480	890.3480	890.3480	Same
Regulation Name	Powered Exoskeleton	Powered Exoskeleton	Powered Exoskeleton	Same
Indications for Use	The Indego® orthotically fits
to the lower limbs and the
trunk; the device is intended
to enable individuals with
spinal cord injury at levels
T3 to L5 to perform
ambulatory functions with
supervision of a specially
trained companion in
accordance with the user
assessment and training
certification program. The
device is also intended to
enable individuals with
spinal cord injury at levels
C7 to L5 to perform
ambulatory functions in
rehabilitation institutions in
accordance with the user
assessment and training
certification program. The
Indego is not intended for
sports or stair climbing.	The Indego® orthotically fits
to the lower limbs and the
trunk; the device is intended
to enable individuals with
spinal cord injury at levels
T7 to L5 to perform
ambulatory functions with
supervision of a specially
trained companion in
accordance with the user
assessment and training
certification program. The
device is also intended to
enable individuals with
spinal cord injury at levels
T4 to T6 to perform
ambulatory functions in
rehabilitation institutions in
accordance with the user
assessment and training
certification program. The
Indego is not intended for
sports or stair climbing.	The Ekso™ (version 1.1) and
Ekso GT™ (version 1.2) are
intended to perform
ambulatory functions in
rehabilitation
institutions under the
supervision of a trained
physical therapist for the
following population:
• Individuals with hemiplegia
due to stroke (upper
extremity motor function of
at least 4/5 in at least one
arm)
• Individuals with spinal cord
injuries at levels T4 to L5
(upper extremity motor
function of at least 4/5 in
both arms)
• Individuals with spinal cord
injuries at levels of C7 to T3
(ASIA D with upper extremity
motor function of at least 4/5
in both arms).
The therapist must complete
a training program prior to
use of the device. The devices
are not intended for sports or
stair climbing	Comparable.
The intended use of enabling
individuals with SCI to perform
ambulatory functions under
supervision are the same among the
subject and predicate devices. The
expanded indications of use in
additional SCI levels are shared with
the Ekso device. Parker Hannifin
does not include the ASIA D
limitation because the Indego® has
been used successfully with these
higher injury levels without respect
to ASIA level. Parker Hannifin
placed the responsibility for
evaluating patients' upper
extremity motor function on the
prescribing physician and requires
the patient to exhibit sufficient
upper body strength to use forearm
crutches, front wheeled walker, or
platform walker stability aid. The
expanded indications for use of the
Indego are supported by the clinical
study data provided and clinical
training protocol tested and utilized
and do not raise any new questions
for safety and effectiveness.
Manufacturer	Parker Hannifin Corporation	Parker Hannifin Corporation	Ekso Bionics	Significant Differences
Trade Name	Indego®	Indego®	Ekso™	Significant Differences
Body Coverage	Worn over legs and around
hips and lower torso	Worn over legs and around
hips and lower torso	Worn over legs and upper
body with rigid torso	Same as the Indego predicate;
Similar to the Ekso - the
components of the Indego are
worn around the legs and torso
with the control unit integrated
into the hip piece. Ekso has
separate backpack control units.
Size of Components	Modular Small, Medium and
Large upper leg, lower leg
and hip components;
control unit integrated in
hip unit	Modular Small, Medium and
Large upper leg, lower leg
and hip components;
control unit integrated in
hip unit	Adjustable upper leg, lower
leg and hip width; control
unit integrated into rigid
torso piece	Same as the Indego predicate;
Similar to the Ekso - all three units
have upper leg, lower leg and hip
component. Ekso has rigid torso
piece.
Mobility Aid	Walker, cane or crutches	Walker, cane or crutches	Walker, cane or crutches	Same
Ability of User Mobility	Sit, stand, walk and turn	Sit, stand, walk and turn	Sit, stand, walk and turn	Same
Walking Speed	~2 km/hr	~2 km/hr	~2 km/hr	Same
Type of Surface	Smooth, grass, cement,
carpet, transitions,
thresholds	Smooth, grass, cement,
carpet, transitions,
thresholds	Smooth, cement, carpet	Same as the Indego predicate;
Similar to the Ekso - Indego
provides more ground clearance
than Ekso.
Control Method	Uses postural cues to trigger
all transitions	Uses postural cues to trigger
all transitions	Handheld interface for PT;
weight shift to initiate steps	Same as the Indego predicate;
Similar to the Ekso - movement is
activated by user.
Range of Motion	Hip: 110° flexion to 30°
extension
Knees: 110° flexion to 10°
extension	Hip: 110° flexion to 30°
extension
Knees: 110° flexion to 10°
extension	Hips: 135° flexion to 20°
extension
Knees: 130° flexion to 0°
extension
Ankles: 10° flexion to 10°
extension	Same as the Indego predicate;
Similar to the Ekso
Manufacturer	Parker Hannifin Corporation	Parker Hannifin Corporation	Ekso Bionics	Significant Differences
Trade Name	Indego®	Indego®	Ekso ™
Rechargeable Battery	Rechargeable lithium ion.
33.3 V, 36A peak current,
12A continuous current.
159Wh fully charged; 1.5
hours of continuous walking
fully charged	Rechargeable lithium ion.
33.3 V, 36A peak current,
12A continuous current.
159Wh fully charged; 1.5
hours of continuous walking
fully charged	Rechargeable lithium ion
batteries 48.1V, 30A peak
current, 1 hour of
continuous usage per
charge	Same as the Indego predicate;
Similar to the Ekso
Battery Charge Time	Maximum of 4 hours	Maximum of 4 hours	1 hour	Same as the Indego predicate;
Similar to the Ekso
Training and
Certification Program
(Clinical Use)	Yes; a thorough training
program that provides
certification is required for
clinicians before using
Indego with patients	Yes; a thorough training
program that provides
certification is required for
clinicians before using
Indego with patients	Yes	Same as the Indego predicate;
similar to the Ekso - the subject
Indego will require clinicians to
pass the same strict
competencies as the predicate
Indego before being cleared to
work with patients in the device.
Training and
Certification Program
(Personal Use)	Yes; a comprehensive
training program requires
personal users to achieve
Minimal Assist or less (FIM
Score of 4 or higher) for all
Indego skills including
donning and doffing,
walking inside and outside
and walking over ramps
with their support persons
before being cleared to use
Indego in the home and
community	Yes; a comprehensive
training program requires
personal users to achieve
Minimal Assist or less (FIM
Score of 4 or higher) for all
Indego skills including
donning and doffing,
walking inside and outside
and walking over ramps
with their support persons
before being cleared to use
Indego in the home and
community	No	Same as the Indego predicate;
different from the Ekso - identical
to the predicate Indego, the
subject Indego will require that
personal users in the expanded
indications for use population
pass the same set of strict
competencies with the same
assistance requirement of
Minimal Assist or less (FIM score
of 4 or higher) from their support
persons. The Ekso is not currently
approved for use outside the
rehabilitation setting.
User Feedback	Provides vibratory feedback
and LED indicators on top of
hip unit, visible to wearer	Provides vibratory feedback
and LED indicators on top of
hip unit, visible to wearer	Provides visual feedback on
the handheld controller and
auditory feedback	Same as the Indego predicate;
Similar to the Ekso
Manufacturer	Parker Hannifin Corporation	Parker Hannifin Corporation	Ekso Bionics	Significant Differences
Trade Name	Indego®	Indego®	Ekso ™
Fall Detection and
Mitigation	Detects forward, backward
and sideways falling as it is
happening; the device
makes adjustments during
the course of the fall to
position the user for
minimal risk of injury	Detects forward, backward
and sideways falling as it is
happening; the device
makes adjustments during
the course of the fall to
position the user for
minimal risk of injury	None	Same as the Indego predicate;
Different to the Ekso - Indego
methods help reduce risk of
injury to the user.
Failsafe Feature	In the event of power
failure knees become locked
and hips free (similar to
typical passive leg braces)	In the event of power
failure knees become locked
and hips free (similar to
typical passive leg braces)	In the event of power
failure knees become locked
and hips free (similar to
typical passive leg braces)	Same
Electrical Safety Testing	Passed ANSI/AAMI ES60601-
1:2005/(R)2012	Passed ANSI/AAMI
ES60601-1:2005/(R)2012	IEC 60601-1:2005 with US
deviations	Same
Electromagnetic
Compatibility Testing	Passed IEC 60601-1-2:2007	Passed IEC 60601-1-2:2007	Passed IEC 60601-1-2:2007	Same

9. Non-Clinical Performance Data

As part of demonstrating safety and effectiveness of the Indego device and in showing substantial equivalence to the predicate devices, Parker Hannifin completed a number of tests. The Indego device meets all requirements for design characteristics, non-clinical performance testing, and electrical safety/EMC testing to confirm that the output meets the design inputs and specifications for the device.

. Maximum Torque Testing: verify the maximum continuous and peak torques that are applied at the knees and hips measured in Nm against defined specifications: PASS
. Cleaning Chemical Compatibility Testing: verify the integrity of the structural plastics with no significant degradation over five (5) year time period through routine cleaning of the device: PASS
. Component Life Cycle Testing: verification that the device meets the requirements for the major mechanical subsystems to perform safely during the expected use between routine servicing in simulated normal use: PASS
. Durability Testing: verify the device meets the factor of safety designated by the IEC 60601-1 requirements for any mechanical hazards that require the support system maintaining structural integrity and does not decrease over simulated lifetime of use of the device: PASS
. Battery Life Cycle Testing: testing performed for the batteries being cycled through normal use including measuring the full charge amount, capacity of battery, and cycle life over defined periods according to the specification for the battery: PASS
. Storage and Transport Testing: to support that the device is protected and not damaged during normal, routine shipping according to ISTA standards for drop, compression, and vibration: PASS
. Software verification and validation testing per FDA Guidance and IEC 62304: conformance of software development life cycle for the Indego Software System and compliance to the requirements of the FDA guidance document for software contained in a medical device.
. Electrical safety testing per ANSI/AAMI ES60601-1: PASS
. Electromagnetic compatibility testing per IEC 60601-1-2: PASS

10. Clinical Performance Data

10.1 Rehabilitation Use Data

Clinical Indego usage data from 98 subjects in over 1,600 sessions has been gathered and analyzed. Sixtythree of these patients were SCI T6 or higher and completed 823 sessions. The remaining 35 individuals had injury levels of T7 or lower and completed 828 sessions. There are three sources for the reported clinical data; the Pilot Study, the Multi-Site Clinical Trial and postmarket clinical data.

10.1.1 Pilot Study

A 2014 pilot study involving 16 SCI subjects evaluated proficiency and ease of learning to use the

Indego in a clinical setting. The study was Investigational Review Board (IRB) approved and performed in compliance with Good Clinical Practices (GCP). Informed consent was obtained from each subject prior to participation. The injury levels of the subjects enrolled ranged from C5 to L1 with 10 subjects having T7 and lower injury level, 3 with T3-T6 SCI and 3 with T2 and higher SCI.

The primary objectives of the pilot study were to:

. Evaluate the ease of learning to use the Indego
. Measure proficiency using standard mobility outcomes including the 10 Meter Walk Test (10 MWT) and 6 Minute Walk Test (6 MWT).

All 16 subjects successfully learned to use the Indego within five 90 minute sessions. In addition to all participants managing a variety of inside and outside surfaces, most were also able to ambulate over five degree ramps. An average walking speed of 0.34 m/s was accomplished in the 10 Meter Walk Test and all subjects were able to complete the 6 Minute Walk Test. Two minor adverse events were reported; one instance of bruising that was resolved in 4 days and one case of grade 1 skin redness that cleared up in 2 days. No serious adverse events were reported.

10.1.2 Multi-Site Clinical Trial

A multi-site clinical study conducted in 2015 assessed the mobility of 45 persons with SCI ranging from levels T3 to L2 while using Indego. The study was performed in compliance with GCP, the protocol was IRB approved and subjects were consented before participating.

The study objectives were defined as the following:

. Demonstrate that the Indego device is both safe and effective for the intended use for patients with SCI who are non-ambulatory or poorly ambulatory to stand up and walk under a variety of conditions.
. Demonstrate that the average walking speed for persons with SCI using the Indego device with stability aid will be equal to or greater than 0.31 m/s for indoor surfaces.

A total of 45 subjects completed all required 27 study sessions which included introduction, evaluation, training with the device, assessments and various outcome measurements. Twenty four of the 27 sessions included walking in the Indego. The statistical plan was descriptive in nature to test the hypothesis that the Indego system will consistently enable legged mobility for the intended population of non-ambulatory or poorly ambulatory patients. Interviews and assessments were conducted throughout the study and outcome measurements were recorded at the beginning, mid and end points.

The key outcomes measurements for the clinical study are summarized as follows:

. The average speed for the indoor 10 Meter Walk Test (10 MWT) at the end of the study for subjects with injury levels T3-T6 was 0.35 ± 0.10 m/s and 0.38 ± 0.08 m/s for participants T7 and lower SCI. Both the lower and higher injury level groups had an average Functional Independence Measure Gait (FIM) Score of 4 for the 10 MWT corresponding to minimal

contact assistance where the Indego Specialist would have only provided occasional balance support to the user. Subjects were also asked to attempt a 600 Meter Walk Test (600 MWT) at the end of the study. One hundred percent of the participants with injury levels T3-T6 were able to complete the test and 92% of the T7 and lower SCI group were able to do the same.

. The Timed Up and Go (TUG) test measured the ability of the subjects to stand up, walk 3 meters, turn, walk 3 meters back, turn and sit down. Both the T3-T6 and T7 and lower injury level groups were able to perform these activities with an average FIM score of 4, i.e. minimal contact from the Indego Specialist, in a comparable amount of time.
. Walking Index for Spinal Cord Injury (WISCI) Scores, which measure the amount of assistance an individual with SCI needs to ambulate, were also recorded for all subjects. At the end of the study, both the T3-T6 and T7 and lower injury level groups had an average WISCI score of 7 ± 1.1 and ± 1.8, respectively, indicating that both groups required about the same amount of assistance using the Indego. A WISCI score of 7 corresponds to walking in the Indego with a rolling walker or forearm crutches and physical assistance of 1 person.

Out of over 1,200 total study sessions completed, there were 46 trial-related Adverse Events (AE) and 0 (zero) Serious Adverse Events (SAE). Of the 46 trial-related AE's, 20 were known to be device related. These 20 included minor instances of bruising, redness, abrasion, and swelling, as well as one instance of a rolled ankle. The causes of these events were all determined to improper fitting or improper padding except for one case of minor abrasion which was related to a padding malfunction.

The study concluded that the Indego device is safe and effective for its intended use and the outcomes of the trial met the stated objectives.

10.1.3 Postmarket Clinical Data

Several of Parker Hannifin's clinical partners were asked to provide Indego usage data for individuals with SCI levels T6 and above. Shepherd Center, Sheltering Arms Physical Rehabilitation Centers and Craig Hospital contributed data for a total of 37 patients in 313 Indego therapy sessions with injury levels ranging from C2 to T6. Twenty four of the 37 C2 to T6 SCI patients have AIS A or B injury.

All 37 subjects had blood pressure readings within functional limits during their sessions and no falls were reported. Of these 37 individuals, 19 were able to walk outside, and some even did so in their first Indego session. Sixteen of these 37 patients had SCI from T3-T6 and 62.5% of this injury level group walked outside. Nine of the 16 subjects with T3-T6 SCI had a reported FIM score of 4 or higher, corresponding to Minimal Assistance, for using Indego. There were two reported safety issues in the postmarket clinical data. One instance of "sit to therapist knee" was noted where a patient stopped for a rest break after walking approximately 75 feet and triggered a stand to sit transition after an accidentally leaning backwards. The patient was able to sit onto the therapist's knee and no injury occurred. Another subject experienced a lateral loss of balance. The therapist was able to help with patient catch their balance and return to a standing position. The session then resumed without incident.

The combined data from the 16-subject pilot study and the 45-subject multi-site clinical trial shows

comparable outcomes between higher and lower level of SCI groups. Neither of these studies identified any additional safety concerns for using the Indego in injury level groups above T6. The submitted postmarket clinical data also demonstrates the success that individuals with injury levels T6 and above can achieve while using Indego.

10.2 Personal Use Data

10.2.1 Personal Use Training Program Study

Four subjects with injury levels T8 A, T10 C, T10 A and their support persons successfully completed a 2015 research study designed specifically to evaluate the adequacy and success of the Indego Personal Use Training Program. Users and their support persons completed a 40-hour Personal Use Training Program within a rehabilitation setting. Training included users and their support persons walking with Indego over both indoor surfaces and outdoor surfaces (e.g. grass, ramps, sidewalks). Users were also required to use Indego in an apartment setting to practice activities of daily living (e.g. washing dishes, cooking and folding laundry). All user and support person teams were required to pass competencies similar to those required for current Indego Personal users. At the completion of this study, subjects were asked to rate their Indego training. They responded that they felt the Personal Use Training Program was adequate and they were confident in their ability to use the Indego with their support person. Seven minor Adverse Events were reported in the course of this study including skin redness, a swollen knee, skin lesions, bruising and an involuntary bowel movement. All Adverse Events were resolved by the end of the study and no Serious Adverse Events occurred.

10.2.2 Postmarket Personal Use Data

There are currently 5 trained Indego personal users worldwide. One of these individuals is a European user with an injury level of T4 A. The other 4 are from the United States and have injury levels of T7 A, T7 C, L1 C and T10 C. All five personal users were contacted and asked to complete a questionnaire about their Indego training. All five users indicated that their training translated well to using the Indego in their homes and communities with their support persons. These teams have all reported using the Indego in their home for activities of daily living in addition to walking over various indoor and outdoor surfaces following their completed training. One instance of a fall has been noted by a personal user and support person team. It was reported that one of the user's forearm crutches slipped out of their hand and as their support person was bending down to retrieve it, the user lost their balance and fell. No injuries occurred. No other falls, Adverse Events or Serious Adverse Events have been reported.

Thoracic SCI patients with injuries ranging from T2 to T12 have sensory innervation and full muscle strength bilaterally in their upper extremities. So, the neurological level of injury for these individuals is determined only by the most caudal level of intact sensation and not by muscle preservation. The literature [1], [2] shows that patients with spinal cord injury levels ranging from T2 to T9 can achieve similar levels of function post SCI, and the clinical data provided for Indego is further support.

Because there is much variation in functionality post SCI among different injury levels, clinical presentation is important in determining if a patient is appropriate for Indego. Therefore, the current comprehensive clinical evaluation will continue to be required for all new users of the Indego.

All Indego user and support person teams must pass strict competencies to be cleared for home and community use of the device. These requirements include passage of competency skills with Minimal Assist or less, corresponding to a Functional Independence Measure (FIM) score of 4 or higher, and these specifications will not be relaxed for the inclusion of the expanded indications for use population. This will ensure that there are no additional risks and no increased burden of assistance on the trained support person for users with T3 and lower SCI. There are currently five trained and approved personal users. In a previous research study, four personal users and support persons completed the Indego Personal Use Training Program for the purpose of assessing its efficacy. In addition to all 9 of the individuals who have already successfully completed and passed the Indego Personal Use Training Program, 75 of the 98 patients in the combined Indego clinical data achieved the personal use competency requirement of a FIM score of 4 or higher. There were 39 clinical subjects with injury levels T3-T6 and of these 39, 32 required only Minimal Assist or less (FIM score of 4 or higher).

Personal users have reported using the Indego in their homes for activities of daily living as well as walking over a variety of outdoor surfaces including sidewalks, grass and ramps after completing the Indego Personal Use Training Program in the clinic. Of the 98 subjects represented in the combined clinical data, 80 have walked outside in the Indego.

The Indego 522 Postmarket Surveillance Study (PS160003) which monitors the effectiveness of the rehabilitation and personal use training programs and safety of using the device in the home and clinic is in progress. Any new Indego user and support person teams who purchase a device for home use from the expanded indications for use population will be enrolled and monitored as part of this study. The first Indego 6-Month Interim Postmarket Surveillance Study report was submitted on time to the FDA and deemed adequate by the agency.

11. Statement of Substantial Equivalence

By definition, a device is substantially equivalent to a predicate device has the same intended use and the same technological characteristics as the previously cleared predicate device. Alternatively, the device may have the same intended use but different technological characteristics and it can be demonstrated that the new device is substantially equivalent and does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).

Based on the data, the subject Indego is determined to be substantially equivalent to the previously cleared Indego and Ekso predicate devices.

12. References

[1] Lee, B.A., Leiby, B.E. and Marino, R.J. (2016) Neurological and functional recovery after thoracic spinal cord injury. The Journal of Spinal Cord Medicine.

[2] McKinely, W. (2015) Functional Outcomes per Level of Spinal Cord Injury. Medscape.