Ekso™ (version 1.1) and Ekso GT™ (version 1.2)

K161443 · Ekso Bionics, Inc. · PHL · Jul 19, 2016 · Physical Medicine

Device Facts

• Record ID: K161443
• Device Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)
• Applicant: Ekso Bionics, Inc.
• Product Code: PHL · Physical Medicine
• Decision Date: Jul 19, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Ekso™ (version 1.1) and Ekso GT™ (version 1.2) are intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following population: • Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm) • Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms) • Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms). The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing.

Device Story

Ekso is a powered motorized orthosis; consists of fitted metal brace supporting legs, feet, and torso; worn via straps. Battery-powered motors drive hip and knee joints. Integrated torso contains computer and power supply. Operated by physical therapist using handheld interface to specify settings and initiate steps. Used in rehabilitation institutions with mobility aids (cane, crutch, or walker). Device assists patients with sit, stand, walk, and turn functions. Provides visual/auditory feedback to therapist. Failsafe: power failure locks knees and frees hips (passive brace mode). Benefits include enabling ambulatory function in clinical settings for patients with specific neurological impairments.

Clinical Evidence

Clinical evidence includes two prospective, non-randomized studies of stroke patients with hemiplegia. Study 1 (n=54) and Study 2 (n=8) evaluated safety and performance over 216 total walking sessions. 93% of patients in Study 1 and 88% in Study 2 safely performed ambulatory functions using only one arm for stability. No falls or adverse events reported. Data supports safety and effectiveness for the expanded indication.

Technological Characteristics

Powered motorized orthosis; metal brace with adjustable hip, leg, and foot components. Energy source: 48.1V rechargeable lithium-ion battery. Connectivity: handheld controller interface. Safety: IEC 60601-1:2005, IEC 60601-1-2:2007. Failsafe: passive knee lock/hip free mode. Weight: 50 lbs. Max speed: ~2 km/hr. Operating temp: 10° to 95°F.

Indications for Use

Indicated for adults >18 with hemiplegia due to stroke (UE motor function ≥4/5 in at least one arm), spinal cord injury (SCI) T4-L5 (UE motor function ≥4/5 in both arms), or SCI C7-T3 ASIA D (UE motor function ≥4/5 in both arms). 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

• Ekso (K143690)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an image of three stylized human profiles facing to the right, with a design element below them that resembles flowing water or fabric.

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

July 19, 2016

Ekso Bionics, Inc. % John J. Smith, MD, JD Regulatory Counsel Hogan Lovells U.S. L.L.P. 555 Thirteenth Street NW Washington, DC 20004

Re: K161443

Trade/Device Name: Ekso™ (version 1.1) and Ekso GTTM (version 1.2) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: Mav 25, 2016 Received: May 25, 2016

Dear Dr. Smith:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

related 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 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 at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely yours,

# Michael J. Hoffmann -A

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) K161443

Device Name

EksoTM (version 1.1) and Ekso GTTM (version 1.2)

Indications for Use (Describe)

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 one arm)

- · Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)
· Individuals with spinal cord injuries at levels of C7 to T3 (ASIA D with upper extremity motor function of at least 4/5 in both arms).

The therapist must complete a training program prior to use of the devices are not intended for sports or star 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary as required by 21 CFR 807.92(c)

| Device name | Ekso |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitters name &<br>contact info | Ekso Bionics® Inc.<br>1414 Harbour Way South<br>Suite 1201<br>Richmond, CA 94804 |
| | <b>Contact Details:</b><br>Thomas Looby<br>CEO<br>Tel: [phone]<br>Email: [e-mail]<br>Tel: [phone]<br>Fax: [phone] |
| Preparation Date | June 27, 2016 |
| Device Name &<br>Classification | Trade Name: Ekso™ (version 1.1) and Ekso GT™ (version 1.2)<br>Common Name: Exoskeleton<br>Classification Name: Powered Exoskeleton<br>Device Classification: Class II, 21 CFR 890.3480<br>Product Code: PHL |
| Indications for Use | 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:<br>• Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm)<br>• Individuals with spinal cord injuries at levels T4 to L5 (upper extremity motor function of at least 4/5 in both arms)<br>• 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).<br>The therapist must complete a training program prior to use of the device. The devices are not intended for sports or stair climbing. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet. Battery powered motors drive knee and hip joints. It has an integrated solid torso containing the computer and power supply. It has a hand-held user interface to specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |
| Predicate Device | Manufacturer: Ekso Bionics<br>510(k): K143690<br>Date of Clearance: 4/1/2016 |

{4}------------------------------------------------

| Manufacturer | Ekso Bionics®, Inc. | Predicate Ekso<br>Bionics®, Inc. | Differences |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | |
| 510(k) Number | TBD | K143690 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Indications for Use | The Ekso™ is intended<br>to perform ambulatory<br>functions in<br>rehabilitation<br>institutions under the<br>supervision of a trained<br>physical therapist for<br>the following<br>population:<br>Individuals with<br>hemiplegia due to<br>stroke (upper<br>extremity motor<br>function of at least 4/5<br>in at least one arm),<br>Individuals with spinal<br>cord injuries at levels<br>T4 to L5 (upper<br>extremity motor<br>function of at least 4/5<br>in both arms),<br>Individuals with spinal<br>cord injuries at levels<br>of C7 to T3 (ASIA D<br>with upper extremity<br>motor function of at<br>least 4/5 in both arms).<br>The therapist must<br>complete a training<br>program prior to use of<br>the device. The<br>devices are not<br>intended for sports or<br>stair climbing. | The Ekso™ is intended<br>to perform ambulatory<br>functions in<br>rehabilitation<br>institutions under the<br>supervision of a trained<br>physical therapist for<br>the following<br>population with upper<br>extremity motor<br>function of at least 4/5<br>in both arms:<br>Individuals with<br>hemiplegia due to<br>stroke, Individuals with<br>spinal cord injuries at<br>levels T4 to L5, and<br>Individuals with spinal<br>cord injuries at levels<br>of C7 to T3 (ASIA D).<br>The therapist must<br>complete a training<br>program prior to use of<br>the device. The Ekso<br>1.1 and 1.2 are not<br>intended for sports or<br>stair climbing. | Similar; the new<br>indication is clarified<br>to explicitly include<br>individuals with<br>hemiplegia due to<br>stroke, who have<br>upper extremity motor<br>function of at least 4/5<br>in only one arm.<br>Individuals with spinal<br>cord injury still require<br>upper extremity motor<br>function of at least 4/5<br>in both arms. |
| Body Coverage | Worn over legs and<br>upper body with rigid<br>torso | Worn over legs and<br>upper body with rigid<br>torso | Same |
| Manufacturer | Ekso Bionics®, Inc. | Predicate Ekso<br>Bionics®, Inc. | Differences |
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | |
| Size of Components | Adjustable upper leg,<br>lower leg, and hip<br>width; control unit<br>integrated into the<br>torso | Adjustable upper leg,<br>lower leg, and hip<br>width; control unit<br>integrated into the<br>torso | Same |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Ability of User<br>Mobility | Sit, stand, walk, and<br>turn | Sit, stand, walk, and<br>turn | Same |
| Walking Speed | ~2 km/hr | ~2 km/hr | Same |
| Grade of Inclination | 1.15 deg | 1.15 deg | Same |
| Type of Surface | Smooth, cement,<br>carpet | Smooth, cement,<br>carpet | Same |
| Patient Population | Adults over age of 18<br>with hemiplegia due to<br>stroke, Spinal Cord<br>Injury (SCI) from T4 to<br>L5, and SCI from C7 to<br>L5 ASIA D | Adults over age of 18<br>with hemiplegia due to<br>stroke, Spinal Cord<br>Injury (SCI) from T4 to<br>L5, and SCI from C7 to<br>L5 ASIA D | Same |
| Height of Patient | ~62″ to 74″ (1.58 m to<br>1.88 m) | ~62″ to 74″ (1.58 m to<br>1.88 m) | Same |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface for<br>PT; weight shift to<br>initiate steps | Handheld interface for<br>PT; weight shift to<br>initiate steps | Same |
| Range of Motion | Hips: 135° flexion to<br>20° extension<br>Knees: 130° flexion to<br>0° extension<br>Ankles: 10° flexion to<br>10° extension | Hips: 135° flexion to<br>20° extension<br>Knees: 130° flexion to<br>0° extension<br>Ankles: 10° flexion to<br>10° extension | Same |
| Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithium<br>ion batteries 48.1V,<br>30A peak current, 1<br>hour of continuous<br>usage per charge | Rechargeable lithium<br>ion batteries 48.1V,<br>30A peak current, 1<br>hour of continuous<br>usage per charge | Same |
| Battery Charge Time | 1 hour | 1 hour | Same |
| Expected Useable Life | 4 years | 4 years | Same |
| Training Program | Yes | Yes | Same |
| Certification Program | Yes | Yes | Same |
| Manufacturer | Ekso Bionics®, Inc. | Predicate Ekso<br>Bionics®, Inc. | Differences |
| Trade Name | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | Ekso™ (version 1.1)<br>and Ekso GT™ (version<br>1.2) | |
| User Feedback | Provides visual<br>feedback on the<br>handheld controller<br>and auditory feedback | Provides visual<br>feedback on the<br>handheld controller<br>and auditory feedback | Same |
| Fall Detection and<br>Mitigation | None | None | Same |
| Failsafe Feature | In event of power<br>failure- knees become<br>locked and hips free<br>(similar to typical<br>passive leg braces) | In event of power<br>failure- knees become<br>locked and hips free<br>(similar to typical<br>passive leg braces) | Same |
| Operating<br>Temperature | 10° to 95°F (-12° to -<br>35°C) | 10° to 95°F (-12° to -<br>35°C) | Same |
| Operating Humidity | Not available | Not available | Same |
| Electrical Safety<br>Testing | IEC 60601-1:2005 with<br>US deviations | IEC 60601-1:2005 with<br>US deviations | Same |
| Electromagnetic<br>Compatibility Testing | Passed IEC 60601-1-2:<br>2007 | Passed IEC 60601-1-2:<br>2007 | Same |

{5}------------------------------------------------

{6}------------------------------------------------

# Table 2 - Clinical Information

| Study | Description…