(77 days)
Not Found
No
The description mentions microprocessors, sensors, and controllers, but the control logic is described as being based on user posture and tilt, similar to a Segway, or responding to user-initiated motion. There is no mention of learning, adaptation, or complex pattern recognition that would typically indicate AI/ML.
Yes
The device is intended to enable individuals with spinal cord injury and hemiplegia to perform ambulatory functions, which is a therapeutic purpose. It is used in rehabilitation settings and helps improve gait parameters.
No
The Indego device is a wearable powered exoskeleton designed to assist individuals with walking impairments; it is not described as diagnosing any medical conditions.
No
The device description clearly states that the Indego is a "wearable powered exoskeleton" consisting of physical components like motors, sensors, a battery pack, and a central processor. While it utilizes software for control and operation, it is fundamentally a hardware device with integrated software.
Based on the provided text, the Indego® device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze biological samples: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Indego is a physical assistance device: The Indego is a wearable powered exoskeleton designed to physically assist individuals with walking impairments. It works by providing external support and power to the lower limbs and trunk to enable ambulation.
- The description focuses on physical function: The entire description details the device's mechanical components, how it assists with standing and walking, its operating modes, and its use in rehabilitation and personal settings. There is no mention of analyzing biological samples or providing diagnostic information based on such analysis.
Therefore, the Indego® device falls under the category of a physical rehabilitation or assistive device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 rehabilitations in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) 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.
Product codes
PHL
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.
In the original operational mode of the device, called Motion+, 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 the motions of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). Alternatively, the device can be placed in a second operating mode, referred to as Therapy+, in which the device responds to the motion of users who are able to initiate stepping on their own. When operating in Therapy+, the user walks normally while the system detects step initiation and assists the user. Therapy+ may be used only in a clinical setting under clinical supervision. The technology of the design links the 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 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. Tall hip wings and a tall torso pad 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 actions of transitioning from sitting to standing to walking, stop walking, and return from standing to sitting. The untethered, free-roaming design of the device allows it to be utilized in multiple indoor and outdoor locations within a rehabilitation or personal setting.
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
individuals with spinal cord injury at levels T3 to L5 ... with supervision of a specially trained companion; individuals with spinal cord injury at levels C7 to L5 ... in rehabilitations; individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) ... in rehabilitations.
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)
Clinical Performance Data:
- 30-Subject Multisite Clinical Trial:
- Sample Size: 30 subjects completed all six study sessions across eight clinical sites.
- Study Design: IRB approved, GCP compliant. Six study sessions (one evaluation and five Indego training sessions).
- Key Results:
- 21 of 30 subjects had fewer reported gait deviations at the end of Session 6 compared to Session 1.
- After walking in the Indego, equal step length was reported in 26 of 108 sessions that began with unequal step length.
- Average number of steps taken in the Indego increased 38% from Session 2 to Session 6.
- Average amount of time spent walking in the Indego increased 18%.
- 23 of 30 subjects who completed the study had improved 10MWT times in Session 6.
- Average FAC score across subjects was 5, with no change observed throughout the study.
- Two trial-related Adverse Events (unintended stand-to-sit transition, knee pain) and zero Serious Adverse Events.
- Single-Site Pilot Study 1:
- Sample Size: 3 subjects.
- Study Design: Used the Vanderbilt Exoskeleton (prototype of Indego). Three 2-hour sessions with ~45 minutes walking in the Indego. IRB approved.
- Key Results: Subjects learned to use the Indego within the first session and demonstrated improvement in gait parameters (Gait Speed, Asymmetry in Step Length, Stride Length). No adverse events.
- Single-Site Pilot Study 2:
- Sample Size: 3 subjects.
- Study Design: Used the Indego Exoskeleton. Four 2-hour sessions with 20-30 minutes walking in the exoskeleton. IRB approved.
- Key Results: Subjects learned to use the Indego within the first session and demonstrated improvement in gait parameters (Gait Speed, Stride Length). Two of three subjects experienced improvements. No adverse events.
- Engineering Study:
- Sample Size: 6 CVA patients.
- Study Design: Ongoing, IRB approved study at Shepherd Center.
- Key Results: One adverse event (heel discomfort) reported.
Non-Clinical Performance Data:
- Maximum Torque Testing: PASS
- Cleaning Chemical Compatibility Testing: PASS
- Component Life Cycle Testing: PASS
- Durability Testing: PASS
- Battery Life Cycle Testing: PASS
- Storage and Transport Testing: PASS
- Software verification and validation testing per FDA Guidance and IEC 62304: conformance of software development life cycle.
- Electrical safety testing per ANSI/AAMI ES60601-1: PASS
- Electromagnetic compatibility testing per IEC 60601-1-2: PASS
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Gait deviations: 21 of 30 subjects had fewer reported gait deviations.
- Equal step length: 26 of 108 sessions that began with unequal step length.
- Average number of steps: increased 38%.
- Average time walking: increased 18%.
- 10 Meter Walk Test (10MWT): 23 of 30 subjects had improved times.
- Functional Ambulation Classification (FAC) scores: Average score of 5, no change observed.
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/K171334, Indego®, Parker Hannifin Corporation
K161443, Ekso™, Ekso Bionics
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
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
January 31, 2018
Parker-Hannifin Corporation % Audrey Swearingen Director Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Bldg 1, Suite 300 Austin, Texas 78746
Re: K173530
Trade/Device Name: Indego® Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: November 14, 2017 Received: November 15, 2017
Dear Audrey 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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
2
Indications for Use
510(k) Number (if known) K173530
Device Name Indego®
Indications for Use (Describe)
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. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Indego®
K173530
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: VP/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
January 8, 2018
4. Device Identification
| Trade/Proprietary Name: | Indego® |
|---|---|
| Common/Usual Name: | Powered Exoskeleton |
| Classification Name: | Powered Exoskeleton |
| Regulation Number: | 890.3480 |
| Product Code: | PHL |
| Device Class: | Class II |
| Classification Panel: | Neurology |
4
5. Legally Marketed Predicate Devices
K152416/K171334, Indego®, Parker Hannifin Corporation
K161443, Ekso™, Ekso Bionics
6. 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.
In the original operational mode of the device, called Motion+, 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 the motions of the Indego by means of postural changes (e.g., to walk forward, the user just leans forward). Alternatively, the device can be placed in a second operating mode, referred to as Therapy+, in which the device responds to the motion of users who are able to initiate stepping on their own. When operating in Therapy+, the user walks normally while the system detects step initiation and assists the user. Therapy+ may be used only in a clinical setting under clinical supervision. The technology of the design links the 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 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. Tall hip wings and a tall torso pad 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 actions of transitioning from sitting to standing to walking, stop walking, and return from standing to sitting. The untethered, free-roaming design of the device allows it to be utilized in multiple indoor and outdoor locations within a rehabilitation or personal setting.
7. Indication for Use Statement
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 in accordance with the user assessment and training certification program. Finally, the Indego® is also intended to enable individuals with hemiplegia (with motor function
5
of 4/5 in at least one upper extremity) due to cerebrovascular accident (CVA) 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 following table comparesthe Indego to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices in Table 5A below 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.
6
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Indego®
Subject Device | Indego®
Primary Predicate | Ekso™
Secondary Predicate | Differences |
| 510(k) Number | K173530 | K152416/K171334 | 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. Finally, the
Indego® is also intended to
enable individuals with
hemiplegia (with motor
function of 4/5 in least one
upper extremity) due to | 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 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 leastone 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 | 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 of the Indego in
individuals with hemiplegia
due to CVA are shared with
the Ekso device. The
expanded indications for
use of the Indego are also
supported by the clinical
study data provided, and
do not raise any new
questions for safety and
effectiveness. |
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | Differences |
| Trade Name | Indego®
Subject Device | Indego®
Primary Predicate | Ekso ™
Secondary Predicate | Differences |
| | cerebrovascular accident
(CVA) 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. | | program prior to use of the
device. The devices are not
intended for sports or stair
climbing. | |
| 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.
This does not raise any new
safety or efficacy questions
as the component
configuration is similar. |
| Size of Components | Modular Small, Medium
and Large upper leg, lower
leg and hip components;
control unitintegrated 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. This does
not raise any new safety or
efficacy questions as the
components cover mostly
the same areas of the
patient. |
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | Differences |
| Trade Name | Indego® | Indego® | Ekso ™ | |
| | Subject Device | Primary Predicate | Secondary Predicate | |
| 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. There are no
new safety or efficacy
concerns as the clinical
data supports walking over
a wide range of surfaces. |
| Control Method | Uses postural cues and
user motion to trigger all
transitions | Uses postural cues to
trigger all transitions | Handheld interface for PT;
weight shift to initiate
steps | Similar to the Indego
predicate and Ekso -
movement is activated by
user. The subject Indego is
activated by either postural
cues or user motion
depending on the profile
mode. No new safety or
efficacy questions are
raised. |
| 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 - Does not raise new
safety or efficacy
questions as Indego's
clinical data supports safe
use of the device for
walking and sitting/
standing transitions. |
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | Differences |
| Trade Name | Indego®
Subject Device | Indego®
Primary Predicate | Ekso ™
Secondary Predicate | |
| 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 lithiumion.
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 - All have
rechargeable lithium
batteries, but the Ekso is a
slightly different type. All
provide the power
necessary for use of the
device. |
| Battery Charge Time | Maximum of 4 hours | Maximum of 4 hours | 1 hour | Same as the Indego
predicate; Similar to the
Ekso - the charge time
difference does not
present any new questions
of safety or efficacy. |
| 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 |
| 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-the Ekso is not
approved for personal use. |
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | |
| Trade Name | Indego®
Subject Device | Indego®
Primary Predicate | Ekso™
Secondary Predicate | Differences |
| 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 - the Ekso offers visual
and auditory feedback
while Indego provides
vibratory and visual cues.
This difference is
supported by clinical and
usability data. |
| 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 or
allow the user to attempt
to recover unassisted | 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 | Similar to the Indego
predicate; Different from
the Ekso - there are no
additional safety concerns
as 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; the Indego passed
the currently recognized
electrical safety standard. |
| Electromagnetic
Compatibility Testing | Passed IEC 60601-1-2:2014 | Passed IEC 60601-1-2:2014 | Passed IEC 60601-1-2:2007 | Both the subject Indego
and predicate Indego are
compatible with the latest
version of IEC 60601-1-
2:2014. Data for Ekso
indicates compatibility with
IEC 60601-1-2:2007. No |
| Manufacturer | Parker Hannifin
Corporation | Parker Hannifin
Corporation | Ekso Bionics | Differences |
| Trade Name | Indego®
Subject Device | Indego®
Primary Predicate | Ekso™
Secondary Predicate | new concerns of safety or
effectiveness. |
Table 5A – Comparison of Characteristics
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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
Four Indego clinical studies have been performed in individuals with hemiplegia resulting from CVA; two 3-subject single-site pilot studies, an engineering study, and a 30-subject multisite clinical trial. The main goal of the multisite clinical trial was to show that the Indego is a safe gait training tool for individuals with hemiplegia due to CVA. The primary objective of both pilot studies was to evaluate whether the Indego could be used to improve gait parameters in subjects recovering from CVA. Additionally, an engineering study remains open to test Indego with CVA patients.
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10.1 30-Subject Multisite Clinical Trial
Thirty subjects completed all six study sessions (one evaluation and five Indego training sessions) across eight clinical sites. The study was IRB approved, Good Clinical Practice (GCP) complaint and informed consent was received from all participants. Several measures were used to evaluate the quality of gait for each subject. Gait deviations, which assess a person's walking technique and the actual quality of their gait pattern, were recorded independent of the Indego in the Evaluation during Session 1 and both before and after ambulating in the Indego in Sessions 2-6. Twenty-one of 30 subjects had fewer reported gait deviations at the end of Session 6 compared to Session 1.
Data was collected from 150 Indego walking sessions, 108 of which began with unequal step length. After walking in the Indego, equal step length was reported in 26 of these 108 sessions that began with unequal step length. The average number of steps taken in the Indego increased 38% from Session 2 (the first Indego walking session) to Session 6 and the average amount of time spent walking in the Indego increased 18%. The 10MWT was used to capture walking speed independent of the Indego in Sessions 1 and 6. Twenty-three of the 30 subjects who completed the study had improved 10MWT times in Session 6.
Functional Ambulation Classification (FAC) scores measure the how independently an individual can walk. The scores range from 1, where assistance of more than 1 person is required, to 6, where the person can walk independently over level and non-level surfaces. FAC scoring criteria is shown in Table 20A below. The average FAC score across subjects was 5, corresponding to walking independently on level surfaces, and no change was observed throughout the course of the study.
There were two trial-related Adverse Events and zero trial-related Serious Adverse Events reported throughout the course of this study. The first adverse event occurred when the subject was attempting to turn in-place in the device. The subject flexed his/her knee to pivot which inadvertently triggered a stand-to-sit transition from the Indego. This caused the subject to lose his/her balance. The subject was stabilized by the physical therapists and assisted in descending to a seat. The subject was not injured. The adverse event was the unintended stand-to-sit transition. Following this event, Parker HMC developed a new sequence of events to initiate a stand-to-sit transition which includes the user or physical therapist deliberately pushing the power button to signal that they are ready to sit. This updated software was distributed to sites participating in the clinical trials beginning in May of 2017. No further events of this type were reported when using the updated software, and the issue is believed to be resolved. The second reported adverse event was a case of knee pain. The patient had a history of osteoarthritis and the physical therapist believed it was aggravated during training.
10.2 Single-Site Pilot Study 1
In the first pilot study the Vanderbilt Exoskeleton – a prototype of the Indego Exoskeleton – was used, as the Indego was not yet commercially hardened. The subjects' time since CVA ranged from 3 to 17 months, spanning the subacute and chronic stages of recovery. Each subject successfully learned to use the Indego within the first session and demonstrated improvement in gait parameters after with PT assistance. Each subject participated in three 2-hour sessions consisting of approximately 45 minutes spent walking in the Indego. Gait Speed, Asymmetry in Step Length, and Stride Length were analyzed. IRB approval was obtained for this study and informed consent was received from each subject. No adverse events were reported.
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10.3 Single-Site Pilot Study 2
In the second pilot study the Indego Exoskeleton was used. The since CVA ranged from 7 to 22 months, meaning all subjects were in the chronic phase of recovery and not experience any spontaneous gait recovery. Each subject successfully learned to use the Indego within the first session and demonstrated improvement in gait parameters. Each subject participated in four 2-hour sessions consist ing of 20-30 minutes walking in the exoskeleton, with time before and after the session to evaluate their gait. During these sessions, subjects used one of two different control methods for the exoskeleton, both of which proved safe and easy to use. Gait Speed and Stride Length were analyzed to determine whether the subjects were experiencing improvements in their gait parameters. Two of the three subjects experienced improvements in their gait parameters. Informed consent was obtained each subject and this study was IRB approved. There were no reported adverse events during the course of this study.
10.4 Engineering Study
Six CVA patients have completed a total of thirty sessions of experimental Indego testing at Shepherd Center (Atlanta, GA). The study is IRB approved and remains open. The study is to trial Indego in individuals with CVA and informed consent has been obtained from each participant thus far. One adverse event, an incidence of heeldiscomfort, has been reported to date.
A total of 42 individuals with CVA have completed over 200 sessions in the combined four studies described above. This is summarized in Table 5B below. All four trials have demonstrated that the Indego is safe and effective when used as a gait training intervention in individuals with hemiplegia due to CVA. No additional safety concerns have been identified.
| Trial | Number of Subjects | Number of Indego
Sessions per Subject | Total Indego Sessions |
|-------------------------------------|--------------------|------------------------------------------|-----------------------|
| 30-Subject Multisite Clinical Trial | 30 | 5 | 150 |
| Single-Site Pilot Study 1 | 3 | 3 | 9 |
| Single-Site Pilot Study 2 | 3 | 4 | 12 |
| Engineering Study | 6 | Variable | 30 |
| Total | 42 | Variable | 201 |
Table 5B – Summary of IRB Approved Indego CVA Clinical Trials
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; or the device has the same intended use and different technological characteristics but it can be demonstrated that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicat e device(s) and that the device is substantially equivalent to the predicate device.
Based on the data, the subject Indego is determined to be substantially equivalent to the previously cleared Indego and the Ekso predicate devices.