EksoNR

K200574 · Ekso Bionics, Inc. · PHL · Jun 19, 2020 · Physical Medicine

Device Facts

• Record ID: K200574
• Device Name: EksoNR
• Applicant: Ekso Bionics, Inc.
• Product Code: PHL · Physical Medicine
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The EksoNR™ is intended to perform ambulatory functions in rehabilitation institutions under the supervision of a trained physical therapist for the following populations: • Individuals with acquired brain injury, including traumatic brain injury and 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

EksoNR 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. Operated by physical therapist using handheld interface to initiate steps; patient weight shift also triggers movement. Used in rehabilitation clinics with assistive devices like walkers, crutches, or canes. Provides visual/auditory feedback to therapist. Facilitates gait ambulation for patients with acquired brain injury or spinal cord injury. Failsafe mechanism locks knees and frees hips during power loss. Benefits include assisted mobility and gait training in clinical settings.

Clinical Evidence

Two prospective, open-label, non-comparative studies (Kessler ABI, n=24; Kessler TBI, n=25). Kessler ABI study showed improvement in Motor FIM (20.4 to 54.2) and Cognitive FIM (12.2 to 23.0) scores. Kessler TBI study showed stable 10MWT (17 to 18s), 2MWT (126 to 128m), and TUG (19.3 to 21.7s) scores. No falls or adverse events reported in either study. Data supports safety and efficacy for ABI/TBI populations.

Technological Characteristics

Powered motorized orthosis; aluminum torso frame; adjustable leg/hip components. Rechargeable 48.1V lithium-ion batteries. Range of motion: Hips 135° flexion/20° extension; Knees 130° flexion/0° extension; Ankles 10° flexion/10° extension. Connectivity: Handheld controller. Standards: IEC 60601-1:2005, IEC 60601-1-2:2014, IEC 62133, IEC 61960, UN 38.3.

Indications for Use

Indicated for individuals with acquired brain injury (including stroke and TBI) with upper extremity motor function ≥4/5 in at least one arm, or spinal cord injuries (T4-L5 with ≥4/5 motor function in both arms; C7-T3 ASIA D with ≥4/5 motor function in both arms). Requires supervision by trained physical therapist.

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 (K161443)

Submission Summary (Full Text)

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June 15, 2020

Ekso Bionics, Inc. Jack Peurach CEO 1414 Harbour Way South, Suite 1201 Richmond, CA 94804

Re: K200574

Trade/Device Name: EksoNRTM Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: February 27, 2020 Received: March 5, 2020

Dear Mr. Peurach:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Heather Dean, PhD Acting Assistant Director, Acute Injury Devices DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

## 510(k) Number (if known) K200574 Device Name EksoNR™M

Indications for Use (Describe)

The EksoNR™ is intended to perform ambulatory functions in rehabilitations under the supervision of a trained physical therapist for the following populations:

- · Individuals with acquired brain injury, including traumatic brain injury and 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 devices are not intended for sports or star climbing.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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>Jack Peurach<br>CEO |
| | Tel: [phone]<br>Email: [e-mail] |
| | Ekso Bionics Tel: [phone]<br>Ekso Bionics Fax: [phone] |
| Preparation Date | February 27, 2020 |
| Device Name &<br>Classification | Trade Name: EksoNR™<br>Common Name: Exoskeleton<br>Classification Name: Powered Exoskeleton<br>Device Classification: Class II, 21 CFR 890.3480<br>Product Code: PHL |
| Legally Marketed | K161443, Ekso, Ekso Bionics, Inc. |
| Device Description | The Ekso is a powered motorized orthosis. It consists of a fitted metal brace that<br>supports the legs, feet, and torso. It is worn via straps on the body, legs, and feet.<br>Battery powered motors drive knee and hip joints. It has an integrated solid torso<br>containing the computer and power supply. It has a hand-held user interface to<br>specify settings and initiate steps. The Ekso is used with a cane, crutch, or walker. |
| Indication for Use<br>Statement | The EksoNR™ is intended to perform ambulatory functions in rehabilitation<br>institutions under the supervision of a trained physical therapist for the following<br>populations:<br>• Individuals with acquired brain injury, including traumatic brain injury and<br>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<br>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<br>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<br>devices are not intended for sports or stair climbing. |
| Substantial Equivalence<br>Discussion | This device and the previously cleared (predicate) device (K161443) are essentially the same products. |
| | Differences in Indications for Use |
| | The purpose of this 510(k) is to update the indications for use relative to the predicate device. The indications for use are identical to that of the predicate device, other than the following (changed wording is <b>bolded</b> ): |
| | Individuals with hemiplegia due to stroke (upper extremity motor function of at least 4/5 in at least one arm) |
| | has been updated to: |
| | Individuals with an acquired brain injury, including traumatic brain injury and stroke (upper extremity motor function of at least 4/5 in at least one arm) |
| | The change noted above expands the existing stroke indication to the broader acquired brain injury (ABI) population. The intended use of the device is unchanged. For the purposes of this intended use (ambulatory rehabilitation), ABI patients present similarly, are screened for device safety requirements including sufficient cognitive ability to follow instructions and safely use the device, and are treated in the same way as stroke patients (a subset of ABI). As such, gait ambulation effectiveness of the device is no different when used on the general ABI population. When used as instructed, the device is as safe to use with the general ABI population as the already cleared stroke population. |

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#### Technical Characteristics

The device is essentially unchanged from the current (predicate) device. All changes since the previous submission fall below the threshold requiring a 510(k) per the FDA's October 25, 2017, "Guidance for Industry and FDA Staff: Deciding When to Submit a 510(k) for a Change to an Existing Device". Even though there is no change, for completeness, the technical characteristics of the device are compared with the current device below.

| Comparison of Technical Characteristics | | | |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------|
| | | Current Device | |
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | Ekso GT® and EksoNR™ | Differences |
| 510(k) Number | | K161443 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Number | 890.3480 | 890.3480 | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Body Coverage | Worn over legs and upper<br>body with rigid torso | Worn over legs and upper<br>body with rigid torso | Same |
| Size of Components | Adjustable upper leg, lower<br>leg, and hip width; control unit<br>integrated into the torso | Adjustable upper leg, lower<br>leg, and hip width; control unit<br>integrated into the torso | Same |
| Mobility Aid | Walker, Crutches, Cane | Walker, Crutches, Cane | Same |
| Comparison of Technical Characteristics | | | |
| | | Current Device | |
| Manufacturer | Ekso Bionics®, Inc. | Ekso Bionics®, Inc. | |
| Trade Name | EksoNR™ | Ekso GT® and EksoNR™ | Differences |
| Ability of User 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, carpet | Smooth, cement, carpet | Same |
| Height of Patient | ~62" to 74" (1.58 m to 1.88 m) | ~62" to 74" (1.58 m to 1.88 m) | Same |
| Weight of Patient | Up to 220 lbs (100kg) | Up to 220 lbs (100kg) | Same |
| Control Method | Handheld interface for PT;<br>weight shift to initiate steps | Handheld interface for PT;<br>weight shift to initiate steps | Same |
| Range of Motion | Hips: 135° flexion to 20°<br>extension<br>Knees: 130° flexion to 0°<br>extension<br>Ankles: 10° 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 |
| Device Weight | 50 lbs (23 kg) | 50 lbs (23 kg) | Same |
| Rechargeable Battery | Rechargeable lithium ion<br>batteries 48.1V, 30A peak<br>current, 1 hour of continuous<br>usage per charge | Rechargeable lithium ion<br>batteries 48.1V, 30A peak<br>current, 1 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 |
| User Feedback | Provides visual feedback on the<br>handheld controller and<br>auditory feedback | Provides visual feedback on the<br>handheld controller and<br>auditory feedback | Same |
| Fall Detection and<br>Mitigation | None | None | Same |
| Failsafe Feature | In event of power failure-<br>knees become locked and hips<br>free (similar to typical passive<br>leg braces) | In event of power failure-<br>knees become locked and hips<br>free (similar to typical passive<br>leg braces) | Same |
| Operating Temperature | 10° to 95°F (-12° to -35° C) | 10° to 95°F (-12° to -35° C) | Same |
| Operating Humidity | Not available | Not available | Same |
| Electrical Safety Testing | IEC 60601-1:2005 with US<br>deviations | IEC 60601-1:2005 with US<br>deviations | Same |
| Electromagnetic<br>Compatibility Testing | Passed IEC 60601-1-2: 2014 | Passed IEC 60601-1-2: 2007 | Same, newer<br>version |

#### Comparison of Technical Characteristics

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## Comparison of Technical Characteristics

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#### Non-clinical Performance Summary

| Technical Area | Tests Completed |
|--------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical Safety and<br>Electromagnetic Compatibility | IEC 60601-1:2005, IEC 60601-1-2:2014, low battery testing, IEC 62133, IEC 61960 parts 7.4 and 7.5, UN 38.3, UN Manual (ST/SG/AC. 10/11/Rev.5/Amend.1), battery life cycle testing |
| Durability | Worst case loading of knee and hip joints beyond service life, worst case loading of structure beyond service life, ankle spring durability, component strength testing |
| Thermal | IEC 60601-1:2005 (ISO 7176 not required; batteries on the Ekso are mounted to the aluminum Torso frame, enclosed in an aluminum case, and not near any flammable material. The testing conducted per IEC 60601 -1 in terms of flame retardant evaluations is sufficient to support the device functionality in terms of flame retardant materials.) |
| Software | Verification, Validation, and hazard analysis |
| Bench Testing | IEC 60601-1:2005 sec. 15.3 (IP22 not required) |

#### Clinical Performance Summary

The current device utilized 5 different studies to demonstrate safety and efficacy of the current indications for use (K161443). This submission builds from those 5 studies with 2 additional clinical studies (summarized below) focusing on the specific populations added by the expanded indication for use in this submission. These studies demonstrate the device effectively enables gait ambulation and there were no reported adverse events indicating the device is safe to use with this expanded population.

| Study | Description |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Kessler ABI | Single center, open-label, non-comparative, non-randomized, prospective study of patients with acquired brain injury (only non-stroke patients included in this submission). |
| | Duration of Intervention |
| | Ambulation during a mean of 5.8 sessions (range 1 to 20) |
| | 24 subjects total used the Ekso |
| | Mean time since injury 92.2 days (range of 10 to 835 days) 6 closed TBI 1 TBI unspecified 3 non-TBI anoxic 2 non-TBI neoplasm NOS 2 non-TBI malignant neoplasm 3 non-TBI benign neoplasm of meninges 1 non-TBI non traumatic hemorrhage |
| | Results |
| | Mean Motor FIM scores pre and post-training were 20.4 and 54.2, respectively |

- Mean Cognitive FIM scores pre and post-training were 12.2 and 23.0, respectively ●
- There were no falls or other adverse events reported ●

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Kessler TBI Single center, open-label, non-comparative, non-randomized, prospective study of patients with traumatic brain injury.

Duration of Intervention

- Ambulation during a mean of 4.9 sessions (range 2 to 5) .
25 subjects total used the Ekso

- Mean time since injury 3540 days (range of 603 to 21360 days) ●
- . All were unspecified TBI

Results

- . Mean 10MWT pre and post-training were 17 and 18 seconds, respectively
- Mean 2MWT pre and post-training were 126 and 128 meters, respectively
- Mean TUG scores pre and post-training were 19.3 and 21.7, respectively
- There were no falls or other adverse events reported ●

#### Substantial Equivalence Conclusion

This device is substantially equivalent to the current devices have the same technical characteristics and the same intended uses, to facilitate gait ambulation. The supporting clinical data demonstrating the use of the product with patients with Acquired Brain Injury (ABI), including both Traumatic Brain Injury (TBI) and non-Traumatic Brain Injury (non-TBI), show that the device effectively facilitates gait ambulation in the expanded patient population. The clinical data reported no adverse events demonstrating the device is safe on this patient population when used in accordance with existing labeling.