Indego

K171334 · Parker Hannifin Corporation · PHL · Sep 8, 2017 · Physical Medicine

Device Facts

• Record ID: K171334
• Device Name: Indego
• Applicant: Parker Hannifin Corporation
• Product Code: PHL · Physical Medicine
• Decision Date: Sep 8, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K171334 · Sep 8, 2017	Indego	Parker Hannifin Corporation	Postmarket clinical data from rehabilitation centers (Shepherd Center, Sheltering Arms, Craig Hospital); Postmarket personal use data from home and community settings	The sponsor used postmarket clinical and personal use data to demonstrate the safety and effectiveness of the Indego device for an expanded patient population (SCI levels T3-T6) and to support substantial equivalence to predicate devices.	Postmarket clinical data; Personal use data; Spinal cord injury; Real-world performance

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Postmarket clinical data; Retrospective analysis of clinical usage data; Follow-up/Duration: 313 therapy sessions	37 patients with SCI levels C2 to T6; Sample Size: 37; Number of Sites: 3	Not applicable for this study	Safety (adverse events), blood pressure, ability to walk outside, FIM scores
Postmarket personal use data; Postmarket surveillance / observational	5 personal users (SCI levels T4-L1); Sample Size: 5; Number of Sites: Worldwide	Not applicable for this study	Training translation to home/community use, safety (adverse events/falls)

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. The Indego is not intended for sports or stair climbing.

Device Story

Indego is a wearable, powered lower-extremity exoskeleton assisting individuals with walking impairments (SCI) to stand and walk. System comprises modular hip, upper leg, and lower leg components; hip unit houses rechargeable battery, central processor, and Bluetooth radio. Embedded sensors and microprocessors detect user posture and tilt; device operation mimics Segway-style control, where user leans to initiate movement (e.g., walking forward). Provides visual (LED) and vibratory feedback to user and therapist. Used in rehabilitation clinics or home/community settings; requires trained support person. Patients use forearm crutches or walkers for stability. Enables sit-to-stand, stand-to-sit, and walking on even/uneven terrain (up to 5° grade). Wireless application on mobile devices allows therapist configuration and monitoring. Benefits include increased mobility and ability to perform activities of daily living.

Clinical Evidence

Evidence from 98 subjects across three sources: 16-subject pilot study, 45-subject multi-site trial, and postmarket clinical data (37 subjects). Primary endpoints included 10-meter walk test (10 MWT), 6-minute walk test (6 MWT), Timed Up and Go (TUG), and WISCI scores. Results: Mean 10 MWT speed 0.35-0.38 m/s; FIM scores of 4 (minimal assistance) achieved. 100% of T3-T6 group completed 600 MWT. No serious adverse events reported; minor events (bruising, redness) resolved. Data supports safety/efficacy for T3-L5 SCI.

Technological Characteristics

Modular exoskeleton; hip, upper leg, lower leg components. Rechargeable lithium-ion battery (33.3V, 159Wh). Actuation via motors in upper leg components. Sensors for posture/tilt detection. Connectivity via Bluetooth and mobile/Wi-Fi application. Electrical safety per ANSI/AAMI ES60601-1; EMC per IEC 60601-1-2. Software-controlled.

Indications for Use

Indicated for individuals with spinal cord injury (SCI) at levels T3 to L5 for ambulatory functions with supervision of a trained companion, and individuals with SCI at levels C7 to L5 for ambulatory functions in rehabilitation. Contraindicated 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)
• Ekso™ (K161443)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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### Indications for Use

510(k) Number (if known) K171334

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. The Indego is not intended for sports or stair climbing.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span> </span> |
|----------------------------------------------|----------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span> </span> |

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

#### 3. Date Prepared

September 8, 2017

#### 4. Device Identification

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

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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

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.

#### 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 trained support person in accordance with the user assessment and training certification program. The device is

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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.

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| Summary of Ekso Data (taken directly from K143690<br>clearance letter dated April 1, 2016) | Summary of Indego Data |
|--------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Study 1:<br>44 subjects total C1-L2 ASIA A, B, C, D Total sessions: ~1188 | Study 1: (Pilot Study)<br>16 completed subjects total C5-L1 ASIA A, B, C Total sessions: 80 |
| Study 2:<br>12 subjects total C7-L1 ASIA A, B Total sessions: ~288 | Study 2: (Multi-Site Trial)<br>45 completed subjects total T3-L3 ASIA A, B, C Total sessions: 1215 |
| | Postmarket clinical data:<br>37 subjects total C2-T6 ASIA A, B, C, D Total sessions: 313 |
| | Study 3: (Personal Use Training Program Study)<br>4 personal user and support person teams T8-T10 ASIA A and C 40 hours of training per team |
| | Postmarket personal use data<br>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:<br>56 | TOTAL SCI SUBJECTS:<br>107 |
| TOTAL SESSIONS:<br>1476 | TOTAL SESSIONS:<br>1608 |
| SCI LEVEL:<br>C1-L2 | SCI LEVEL:<br>C2-L3 |
| ASIA RANGE:<br>A, B, C, D | ASIA RANGE:<br>A, B, C, D |
| | Personal Use Training Hours:<br>390 |
| | Combined months of Indego Personal Use in home & community settings with trained support person:<br>390 |

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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.

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| 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<br>to the lower limbs and the<br>trunk; the device is intended<br>to enable individuals with<br>spinal cord injury at levels<br>T3 to L5 to perform<br>ambulatory functions with<br>supervision of a specially<br>trained companion in<br>accordance with the user<br>assessment and training<br>certification program. The<br>device is also intended to<br>enable individuals with<br>spinal cord injury at levels<br>C7 to L5 to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program. The<br>Indego is not intended for<br>sports or stair climbing. | The Indego® orthotically fits<br>to the lower limbs and the<br>trunk; the device is intended<br>to enable individuals with<br>spinal cord injury at levels<br>T7 to L5 to perform<br>ambulatory functions with<br>supervision of a specially<br>trained companion in<br>accordance with the user<br>assessment and training<br>certification program. The<br>device is also intended to<br>enable individuals with<br>spinal cord injury at levels<br>T4 to T6 to perform<br>ambulatory functions in<br>rehabilitation institutions in<br>accordance with the user<br>assessment and training<br>certification program. The<br>Indego is not intended for<br>sports or stair climbing. | The Ekso™ (version 1.1) and<br>Ekso GT™ (version 1.2) are<br>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 hemiplegia<br>due to stroke (upper<br>extremity motor function of<br>at least 4/5 in at least one<br>arm)<br>• Individuals with spinal cord<br>injuries at levels T4 to L5<br>(upper extremity motor<br>function of at least 4/5 in<br>both arms)<br>• Individuals with spinal cord<br>injuries at levels of C7 to T3<br>(ASIA D with upper extremity<br>motor function of at least 4/5<br>in both arms).<br>The therapist must complete<br>a training program prior to<br>use of the device. The devices<br>are not intended for sports or<br>stair climbing | Comparable.<br>The intended use of enabling<br>individuals with SCI to perform<br>ambulatory functions under<br>supervision are the same among the<br>subject and predicate devices. The<br>expanded indications of use in<br>additional SCI levels are shared with<br>the Ekso device. Parker Hannifin<br>does not include the ASIA D<br>limitation because the Indego® has<br>been used successfully with these<br>higher injury levels without respect<br>to ASIA level. Parker Hannifin<br>placed the responsibility for<br>evaluating patients' upper<br>extremity motor function on the<br>prescribing physician and requires<br>the patient to exhibit sufficient<br>upper body strength to use forearm<br>crutches, front wheeled walker, or<br>platform walker stability aid. The<br>expanded indications for use of the<br>Indego are supported by the clinical<br>study data provided and clinical<br>training protocol tested and utilized<br>and do not raise any new questions<br>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<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 predicate;<br>Similar to the Ekso - the<br>components of the Indego are<br>worn around the legs and torso<br>with the control unit integrated<br>into the hip piece. Ekso has<br>separate backpack control units. |
| Size of Components | Modular Small, Medium and<br>Large upper leg, lower leg<br>and hip components;<br>control unit integrated in<br>hip unit | Modular Small, Medium and<br>Large upper leg, lower leg<br>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 predicate;<br>Similar to the Ekso - all three units<br>have upper leg, lower leg and hip<br>component. Ekso has rigid torso<br>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,<br>carpet, transitions,<br>thresholds | Smooth, grass, cement,<br>carpet, transitions,<br>thresholds | Smooth, cement, carpet | Same as the Indego predicate;<br>Similar to the Ekso - Indego<br>provides more ground clearance<br>than Ekso. |
| Control Method | Uses postural cues to trigger<br>all transitions | Uses postural cues to trigger<br>all transitions | Handheld interface for PT;<br>weight shift to initiate steps | Same as the Indego predicate;<br>Similar to the Ekso - movement is<br>activated by user. |
| 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 predicate;<br>Similar to the Ekso |
| Manufacturer | Parker Hannifin Corporation | Parker Hannifin Corporation | Ekso Bionics | Significant Differences |
| Trade Name | Indego® | Indego® | Ekso ™ |…