Indego(R)

K173530 · Parker-Hannifin Corporation · PHL · Jan 31, 2018 · Physical Medicine

Device Facts

• Record ID: K173530
• Device Name: Indego(R)
• Applicant: Parker-Hannifin Corporation
• Product Code: PHL · Physical Medicine
• Decision Date: Jan 31, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Wearable powered exoskeleton; assists standing/walking for patients with lower extremity weakness/paralysis. Inputs: postural/tilt signals from integrated sensors; user-initiated motion. Operation: Motion+ mode (tilt-based control, similar to Segway); Therapy+ mode (detects step initiation for assisted walking). Outputs: motorized leg movement; LED/vibratory feedback. Used in clinical/rehabilitation settings or home/community (for SCI); operated by patient with physical therapist/trained companion. Wireless mobile app (iPod/iPhone) allows therapist configuration/monitoring. Benefits: enables ambulation, sit-to-stand transitions, gait training; improves gait parameters/symmetry. Failsafe: power failure locks knees, frees hips.

Clinical Evidence

Four clinical studies (42 total subjects with CVA) evaluated safety and gait parameters. Multisite trial (n=30) showed 21/30 subjects had fewer gait deviations; 23/30 improved 10MWT speed; average steps increased 38% and walking time 18% over 6 sessions. Two pilot studies (n=3 each) and an engineering study (n=6) supported safety and gait improvement. Two trial-related AEs reported (one balance loss during turn, one knee pain); software updated to mitigate stand-to-sit transition risk.

Technological Characteristics

Modular powered exoskeleton; hip-integrated control unit with rechargeable Li-ion battery (33.3V, 159Wh). Sensing: tilt/postural sensors. Actuation: motors in upper leg components. Connectivity: Bluetooth, mobile app interface. Software: embedded microprocessors. Electrical safety: ANSI/AAMI ES60601-1; EMC: IEC 60601-1-2:2014. Sterilization: N/A (surface cleaning).

Indications for Use

Indicated for individuals with spinal cord injury (SCI) at levels T3-L5 (with supervision) or C7-L5 (in rehabilitation), and individuals with hemiplegia due to cerebrovascular accident (CVA) with upper extremity motor function of 4/5. Not for sports or stair climbing.

Regulatory Classification

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.

Special Controls

In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:

*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).

Predicate Devices

• Indego® (K152416/K171334)
• Ekso™ (K161443)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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: [phone] Office Phone: [phone] Fax: [phone] Contact: Audrey Swearingen, Director Regulatory Affairs Email: [e-mail]

### 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 |

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## 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

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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.

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| Manufacturer | Parker Hannifin<br>Corporation | Parker Hannifin<br>Corporation | Ekso Bionics | |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Indego®<br>Subject Device | Indego®<br>Primary Predicate | Ekso™<br>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<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T3 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is<br>also intended to enable<br>individuals with spinal cord<br>injury at levels C7 to L5 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. Finally, the<br>Indego® is also intended to<br>enable individuals with<br>hemiplegia (with motor<br>function of 4/5 in least one<br>upper extremity) due to | The Indego® orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T3 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is<br>also intended to enable<br>individuals with spinal cord<br>injury at levels C7 to L5 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. The Indego is not<br>intended for sports or stair<br>climbing. | The Ekso™ (version 1.1)<br>and Ekso GT™ (version 1.2)<br>are intended to perform<br>ambulatory functions in<br>rehabilitation<br>institutions under the<br>supervision of a trained<br>physical therapist for the<br>following population:<br>• Individuals with<br>hemiplegia due to stroke<br>(upper extremity motor<br>function of at least 4/5 in<br>at leastone arm)<br>• Individuals with spinal<br>cord injuries at levels T4 to<br>L5 (upper extremity motor<br>function of at least 4/5 in<br>both arms)<br>• Individuals with spinal<br>cord injuries at levels of C7<br>to T3 (ASIA D with upper<br>extremity motor function<br>of at least 4/5 in<br>both arms).<br>The therapist must<br>complete a training | Comparable.<br>The intended use of<br>enabling individuals with<br>SCI to perform ambulatory<br>functions under<br>supervision are the same<br>among the subject and<br>predicate devices. The<br>expanded indications of<br>use of the Indego in<br>individuals with hemiplegia<br>due to CVA are shared with<br>the Ekso device. The<br>expanded indications for<br>use of the Indego are also<br>supported by the clinical<br>study data provided, and<br>do not raise any new<br>questions for safety and<br>effectiveness. |
| Manufacturer | Parker Hannifin<br>Corporation | Parker Hannifin<br>Corporation | Ekso Bionics | Differences |
| Trade Name | Indego®<br>Subject Device | Indego®<br>Primary Predicate | Ekso ™<br>Secondary Predicate | Differences |
| | cerebrovascular accident<br>(CVA) to perform<br>ambulatory functions in<br>rehabilitation institutions<br>in accordance with the user<br>assessment and training<br>certification program. The<br>Indego is not intended for<br>sports or stair climbing. | | program prior to use of the<br>device. The devices are not<br>intended for sports or stair<br>climbing. | |
| Body Coverage | Worn over legs and around<br>hips and lower torso | Worn over legs and around<br>hips and lower torso | Worn over legs and upper<br>body with rigid torso | Same as the Indego<br>predicate; Similar to the<br>Ekso - the components of<br>the Indego are worn<br>around the legs and torso<br>with the control unit<br>integrated into the hip<br>piece. Ekso has separate<br>backpack control units.<br>This does not raise any new<br>safety or efficacy questions<br>as the component<br>configuration is similar. |
| Size of Components | Modular Small, Medium<br>and Large upper leg, lower<br>leg and hip components;<br>control unitintegrated in<br>hip unit | Modular Small, Medium<br>and Large upper leg, lower<br>leg and hip components;<br>control unit integrated in<br>hip unit | Adjustable upper leg, lower<br>leg and hip width; control<br>unit integrated into rigid<br>torso piece | Same as the Indego<br>predicate; Similar to the<br>Ekso - all three units have<br>upper leg, lower leg and<br>hip component. Ekso has<br>rigid torso piece. This does<br>not raise any new safety or<br>efficacy questions as the<br>components cover mostly<br>the same areas of the<br>patient. |
| Manufacturer | Parker Hannifin<br>Corporation | Parker Hannifin<br>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,<br>carpet, transitions,<br>thresholds | Smooth, grass, cement,<br>carpet, transitions,<br>thresholds | Smooth, cement, carpet | Same as the Indego<br>predicate; Similar to the<br>Ekso - Indego provides<br>more ground clearance<br>than Ekso. There are no<br>new safety or efficacy<br>concerns as the clinical<br>data supports walking over<br>a wide range of surfaces. |
| Control Method | Uses postural cues and<br>user motion to trigger all<br>transitions | Uses postural cues to<br>trigger all transitions | Handheld interface for PT;<br>weight shift to initiate<br>steps | Similar to the Indego<br>predicate and Ekso -<br>movement is activated by<br>user. The subject Indego is<br>activated by either postural<br>cues or user motion<br>depending on the profile<br>mode. No new safety or<br>efficacy questions are<br>raised. |
| Range of Motion | Hip: 110° flexion to 30°<br>extension<br>Knees: 110° flexion to 10°<br>extension | Hip: 110° flexion to 30°<br>extension<br>Knees: 110° flexion to 10°<br>extension | Hips: 135° flexion to 20°<br>extension<br>Knees: 130° flexion to 0°<br>extension<br>Ankles: 10° flexion to 10°<br>extension | Same as the Indego<br>predicate; Similar to the<br>Ekso - Does not raise new<br>safety or efficacy<br>questions as Indego's<br>clinical data supports safe<br>use of the device for<br>walking and sitting/<br>standing transitions. |
| Manufacturer | Parker Hannifin<br>Corporation | Parker Hannifin<br>Corporation | Ekso Bionics | Differences |
| Trade Name | Indego®<br>Subject Device | Indego®<br>Primary Predicate | Ekso ™<br>Secondary Predicate | |
| Rechargeable Battery | Rechargeable lithium ion.<br>33.3 V, 36A peak current,<br>12A continuous current.<br>159Wh fully charged; 1.5<br>hours of continuous<br>walking fully charged | Rechargeable lithiumion.<br>33.3 V, 36A peak current,<br>12A continuous current.<br>159Wh fully charged; 1.5<br>hours of continuous<br>walking fully charged | Rechargeable lithium ion<br>batteries 48.1V, 30A peak<br>current, 1 hour of<br>continuous usage per<br>charge | Same as the Indego<br>predicate; Similar to the<br>Ekso - All have<br>rechargeable lithium<br>batteries, but the Ekso is a<br>slightly different type. All<br>provide the power<br>necessary for use of the<br>device. |
| Battery Charge Time | Maximum of 4 hours…