HAL for Medical Use (Lower Limb Type)

K171909 · Cyberdyne, Inc. · PHL · Dec 17, 2017 · Physical Medicine

Device Facts

• Record ID: K171909
• Device Name: HAL for Medical Use (Lower Limb Type)
• Applicant: Cyberdyne, Inc.
• Product Code: PHL · Physical Medicine
• Decision Date: Dec 17, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gat training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

Device Story

Battery-powered, bilateral lower-extremity exoskeleton; provides assistive torque at hip/knee joints for gait training. Inputs: surface electromyography (sEMG) signals from hip/knee extensor/flexor muscles (CVC mode); postural cues; sensor shoe measurements. Operation: CVC mode uses proprietary signal processing to detect sEMG for torque assistance; CAC mode uses postural/shoe data for trajectory; CIC mode compensates for motor friction. Used in medical facilities under trained professional supervision; requires Body Weight Support (BWS) system. Output: assistive torque; biofeedback visualization of sEMG signals. Clinical benefit: temporary improvement in ambulation post-intervention. Provider uses output to monitor gait training progress and adjust sensitivity/torque parameters.

Clinical Evidence

Two non-randomized, single-arm clinical studies (N=8 and N=55) in chronic SCI patients. Primary endpoints: 10MWT, 6MWT, and WISCI-II scores measured without device. Results: 10MWT speed improved by 0.23 m/s (N=8) and 0.20 m/s (N=55); 6MWT distance improved by 93.25m (N=8) and 48.53m (N=55). Improvements exceeded MCID. Adverse events: mild skin redness from electrodes; no serious device-related events.

Technological Characteristics

Battery-powered bilateral exoskeleton; 8 size variations. Materials: unspecified. Sensing: sEMG electrodes, joint angle sensors, plantar load sensors. Connectivity: standalone. Sterilization: N/A. Software: proprietary signal processing algorithm. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62133, IEC 62304, IEC 62366.

Indications for Use

Indicated for individuals with spinal cord injury (SCI) at levels C4-L5 (ASIA C, D) and T11-L5 (ASIA A with Zones of Partial Preservation, ASIA B) who possess sufficient residual hip/knee motor function to trigger/control the device. Contraindicated for patients without residual motor function, non-traumatic SCI, pressure sores, severe ROM limitations, cognitive impairment, weight >100kg, non-consolidated fractures, or severe heart insufficiency.

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

• ReWalk (K131798)

Reference Devices

• Physiological Monitoring & Biofeedback Training Device (K971708)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

December 17, 2017

CYBERDYNE Inc. Yohei Suzuki Head of Production Department 2-2-1 Gakuen-Minami Tsukuba, 305-0818 Jp

Re: K171909

Trade/Device Name: HAL for Medical Use (Lower Limb Type) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL, HCC Dated: November 29, 2017 Received: November 29, 2017

Dear Yohei Suzuki:

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

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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); 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,

# Michael J. Hoffmann -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) K171909

Device Name HAL for Medical Use (Lower Limb Type)

#### Indications for Use (Describe)

HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.

HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gat training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.

In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.

HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program

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

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|----------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary

510(k) Number: K171909

### 5.1 Applicant Information

| Date Prepared: | December 15, 2017 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address: | CYBERDYNE Inc.<br>2-2-1, Gakuen-Minami,<br>Tsukuba-Shi, Ibaraki-Ken 305-0818 Japan |
| Contact Person: | Mr. Yohei Suzuki<br>Head of Production Department<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

#### 5.2 Device Information

| Device Name: | HAL for Medical Use (Lower Limb Type) |
|-------------------------|---------------------------------------------------------------------------------|
| Common or Usual Name: | Powered Exoskeleton |
| Classification Name: | Powered Lower Extremity Exoskeleton (primary)<br>Biofeedback Device (secondary) |
| Regulation Number: | 21 CFR 890.3480 (primary)<br>21 CFR 882.5050 (secondary) |
| Device Class: | II |
| Product Code: | PHL |
| Secondary Product Code: | HCC |

#### 5.3.1 Legally Marketed Predicate Device

| 510(k) Number: | K131798 |
|--------------------|---------------------------------|
| Primary Predicate | Primary |
| Applicant: | Argo Medical Technologies, Inc. |
| Device Name: | ReWalk |
| Regulation Number: | 21 CFR 890.3480 |
| Product Code: | PHL |
| Device Class: | II |

#### 5.3.2 Legally Marketed Reference Device

| 510(k) Number: | K971708 |
|--------------------|--------------------------------------------------------|
| Applicant: | J & J Engineering Inc. |
| Device Name: | Physiological Monitoring & Biofeedback Training Device |
| Regulation Number: | 21 CFR 882.5050 |
| Product Code: | HCC |
| Device Class: | II |

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#### 5.4 Device Description

HAL for Medical Use (Lower Limb Type) is a battery powered bi-lateral lower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes. The device comes in 8 size variations (4 different leg lengths and 2 different hip widths) and weighs ~14 kg (30 lbs). The device uses legally marketed cutaneous electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals of the hip and knee extensor and flexor muscles when the device is used in Cybernic Voluntary Control (CVC) mode. This mode provides assistive torque at the corresponding joint (e.g., hip or knee) using sufface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the device to detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level. torque turner. and balance turner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (CIC) mode. CAC mode provides assistive torque leq trajectories based on postural cues and sensor shoe measurements. CIC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physician, physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.

Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before donning the device and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing.

In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.

HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the supervision of trained medical professionals who have successfully completed the HAL training program.

#### 5.5 Indications for Use

HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk; the device is intended for individuals with spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B), who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.

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HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.

In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.

HAL is intended to be used inside medical facilities while under trained medical supervision in accordance with the user assessment and training certification program.

#### 5.6 Non-Clinical Performance Data

The subject devices demonstrate conformance with the following recognized standards:

- AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012 ●
- IEC 60601-1-2:2007 ●
- IEC 60601-1-6:2013 ●
- IEC 62133:2012, IEC 60335-1:2010, IEC 60335-2-29:2010 and ANSI/UL 1012:2010 ●
- IEC 62304:2006 and IEC 62304:2015 ●
- . IEC 62366:2014

The subject device underwent bench testing as part of required performance verification and validation activities. Results show that the subject device has met pre-defined design and performance acceptance criteria. Results of all non-clinical testing support the safety and effectiveness of the subject devices.

| Testing | Objective(s) and Study Design |
|----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stopper Strength<br>Test | <Objective(s)><br>To evaluate the durability of the mechanical stopper of the actuator that<br>limits the maximum angle and verify that it endures the mechanical force<br>that can be applied by the patient |
| | <Results><br>Conformance with acceptance criteria was maintained after 100 cycles. The<br>mechanical stopper is expected to endure the impact in the joints. |
| | Consecutive<br>Landing Test |
| | <Results><br>All 3 samples withstood 3,000,000 [cycles] of landing impact, and there<br>were no missing parts, cracks/chips of the exterior, loosening of screws,<br>abnormal noises, looseness, operational malfunctions, and |
| | loosening/detachment/deformation of the connectors. The assumed<br>maximum steps of HAL is 1,000,000[cycles] so it is sufficiently durable. |
| | |
| Effective Output<br>Test | <Objective(s)><br>This test consists of two tests, each with different objectives below:<br>A. Effective torque test: To verify that the actuator meets specifications for<br>effective output torque by measuring the effective output torque to the input<br>(electrical current).<br>B. Maximum angle velocity test: To verify that the maximum angular<br>velocity, generated when maximum torque is output, is within the range of<br>that tolerable by the human knee joint. |
| | <Results><br>A. Effective torque output test: The output was verified to meet the<br>specification. It was also within the range required by risk management.<br>B. Maximum angular velocity test: The angular velocity was verified to be<br>within a range that the human body can tolerate. |
| Driving Parts<br>Performance Test | <Objective><br>To Measure the actual torque output against the torque output intended by<br>the control algorithm, and confirm that it meets the performance criteria. |
| | <Results><br>The test results show that the actual torque output compared to the torque<br>output intended by the control algorithm falls within the criteria range, and<br>the performance of the driving parts meets the expected results. |
| Joint angle<br>measurement | <Objective><br>To test the accuracy of joint angle sensing. |
| | <Results><br>Accuracy of joint angle measurement was verified to meet specification. |
| Body trunk<br>absolute angle<br>measurement | <Objective><br>To test the accuracy of body trunk absolute angle sensing. |
| | <Results><br>The measurement results show that the body trunk absolute angle<br>measurement of the device can sufficiently detect the stable posture in the<br>forward/backward directions of the patient, thus ensuring the safety and<br>effectiveness of the device. |
| Plantar load<br>measurement | <Objective><br>To test the accuracy of plantar load measurement.<br><Results><br>The measurement results show that the plantar force measurement of the<br>device can sufficiently detect the planting and lifting of the sole, to enable<br>the device to determine what phase (swing/support) each leg is in, thus<br>ensuring the safety and effectiveness of the device. |
| Surface<br>Electromyography<br>Bioelectrical signal<br>measurment<br>performance | <Objective><br>To test the accuracy of surface electromyography bioelectrical signal<br>measurement performance. The tests included an assessment of input<br>impedance, common-mode rejection ratio, and frequency characteristics.<br><Results><br>Accuracy for all measurements were verified to meet specifications. |
| Ankle Durability | <Objective> |
| Test | Test the durability of the mechanical systems of the ankle parts against<br>repeated impacts in a twisting direction, simulating impacts applied to the<br>parts during a turning movement. Confirm whether missing parts,<br>cracks/chips of the exterior, loosening of screws, abnormal noises,<br>looseness do not occur after 5-years worth (service life of HAL) of<br>consecutive impacts. |
| | <Results><br>All 3 samples withstood 300,000 [times] of impact, and there were no<br>missing parts, cracks/chips of the exterior, loosening of screws, abnormal<br>noises, looseness. The ankle part of the device is sufficiently durable. |

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## 5.7 Clinical Performance Data

<DE-01 Clinical Study Summary> [Pilot Study]

| Site | BG University Hospital Bergmannsheil |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Population | Chronic spinal cord injury $(97.2\pm88.4$ months since injury) |
| Objective | To determine whether locomotor training with the exoskeleton HAL® is safe to use<br>and can increase functional mobility in chronic paraplegic patients after SCI. |
| Inclusion<br>Criteria | traumatic SCI with chronic incomplete paraplegia or complete paraplegia after<br>lesions of the conus medullaris/ cauda equine with zones of partial preservation<br>(ZPP). patients must present motor functions of hip and knee extensor and flexor<br>muscle groups in order to be able to trigger the exoskeleton. |
| Exclusion<br>Criteria | Non traumatic SCI pressure sores severe limitation of range of motion (ROM) regarding hip and knee joints cognitive impairment body weight > 100kg non-consolidated fractures mild or severe heart insufficiency |
| Duration | June ~ September 2013 |
| Design and<br>Protocol | <Design><br>Study method: Interventional<br>Basic Design: Single arm<br>Randomization: Non-randomized<br>Blinding: Open (no blinding)<br>Control: Uncontrolled<br><br><Method><br>During this study, the patients underwent a BWSTT (Body Weight Supported<br>Treadmill Training) five times per week using the HAL.<br><br>The treadmill system (Woodway USA, Inc., Waukesha, WI, USA) includes a body<br>weight support system with a harness. During treatments, the velocity of the treadmill<br>was set individually between comfortable and maximum speed tolerated by the<br>patients. Approximately 50% of each patient's body weight needed to be supported<br>by the harness system, individually reduced during the following sessions as<br>tolerated without substantial knee buckling or toe drag. |

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| | The patients underwent a 90-day period of HAL training (five per week), including a<br>mean number of sessions of 51.7565.6. The training was performed on a treadmill<br>with individually adjustable body weight support and speed, recording walking speed,<br>time, and distance. It included a 10-m walk test (10MWT) before and after each<br>session and regular physiotherapy that lasted approximately 90 minutes. The training<br>was supervised by a physiotherapist and a medical doctor. | | | | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------------------------|-------------------|---------------------------------|-----------------|
| Intervention | 90 days (5 times/week) | | | | | |
| Sample size<br>(N) | 8 | | | | | |
| Results | Significant improvements have been especially shown in the functional abilities<br>without the HAL for over ground walking obtained in the 6MWT and the 10MWT.<br>While the TUG-Test was not significant after Bonferronni correction (a = 0.00625),<br>the results show a trend toward improvement, and an increase in the WISCI II score<br>of three patients is also promising.<br><functional measures=""></functional> | | | | | |
| | Endpoint | n | Average<br>Improvement | Paired T-<br>test | Wilcoxon<br>Signed-Rank<br>Test | 95% Cl |
| | 10MWT<br>(speed) | 8 | 0.23±0.14 m/s | P = 0.0025 | P < 0.01 | [0.13, 0.33] |
| | TUG test | 8 | 17.16±19.01 s | P = 0.0379 | P < 0.02 | [3.99, 30.33] |
| | 6MWT<br>(distance) | 8* | 93.25±39.40 m | P = 0.0003 | P < 0.01 | [65.95, 120.55] |
| | Wisci II | 8 | 1.125 | P = 0.0796 | N/A | [0.05, 2.20] |
| | *Only three patients were able to walk for 6 minutes before training, but all 8 patients<br>were able to walk for 6 minutes after the intervention. | | | | | |
| Adverse<br>Events | No serious/severe adverse events occurred/observed<br>●<br>●<br>Two cases of mild adverse events were observed. In both cases, skin redness<br>due to electrodes was observed but patients recovered naturally shortly after<br>electrodes were removed. | | | | | |
| Manuscripts | The Spine Journal, titled "Voluntary driven exoskeleton as a new tool for<br>●<br>rehabilitation in chronic spinal cord Injury -A pilot study" | | | | | |

#### <DE-02 Clinical Study Summary>

| Site | BG University Hospital Bergmannsheil |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Patient<br>Population | Chronic spinal cord injury ( $6.85\pm5.12$ years since injury), SCI C2-L5, ASIA D, C, and<br>ASIA A with Zones of Partial Preservation |
| Objective | To examine functional outcomes as a function of age and lesion level in patients with<br>chronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partial<br>preservation (ZPP) by using the HAL as a temporary training tool. |
| Inclusion<br>Criteria | • SCI with chronic incomplete paraplegia or tetraplegia at any spinal cord lesion<br>level (ASIA C/D) or chronic complete paraplegia (ASIAA) at lesion levels T11 or<br>lower, AND |
| Exclusion<br>Criteria | patients must present motor functions of hip and knee extensor and flexor muscle groups in order to be able to trigger and control the exoskeleton. Absence of residual motor functions in the lower extremities pressure sores severe limitation of range of motion (ROM) regarding hip and knee joints cognitive impairment body weight > 100kg non-consolidated fractures epilepsy severe heart insufficiency |
| Duration | January 2012~ June 2016 |
| Design and<br>Protocol | <Design><br>Study method: Interventional<br>Basic Design: Single arm<br>Randomization: Non-randomized<br>Blinding: Open (no blinding)<br>Control: Uncontrolled<br><br><Method><br>During this study, the patients underwent a BWSTT (Body Weight Supported Treadmill Training) five times per week using the HAL.<br><br>The patients underwent a 90-day period of HAL training (five per week), including a mean number of sessions of 58.78±2.37. The training was performed on a treadmill with individually adjustable body weight support and speed, recording walking speed, time, and distance.<br><br>A 10-m walk test (10MWT) without the HAL was performed before and after each session in addition to regular physiotherapy.<br><br>Training effects (e.g., 10 MWT, 6 MWT, WISCI-II) were assessed at the baseline, week 6, and week 12, without HAL assistance (i.e., exoskeleton is not worn during testing). |
| Intervention | 90 days (5 times/week) |
| Sample size<br>(N) | 55 |
| Results | Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (< 50 years = 56% vs ≥ 50 years = 37%) and an increase of 50% in the 6MinWT were documented. Age had a nonsignificant negative influence on the 10MWTsss. Despite a few nonsignificant subgroup differences, participants improved across all tests. Namely, patients with iSCI who had spastic motor behavior improved to a nonsignificant, lesser extent in the 6MinWT.<br><br>The level of assistance captured in the Walking Index for Spinal Cord Injury II (WISCI II) testing pre and post gaiting training reflects the test setup used during 10 MWT test pre and post gait training, respectively. There were instances where the amount of assistance used during the 6 MWT test differed slightly from the WISCI-II Score.<br><br>The results of the intervention were compared to the established MCID. The average 10MWT improvement was 0.20 m/s with 95% confidence inter of [0.16, 0.25], a value that is more than three times the MCID of 0.06 m/s. The average 6 MWT improvement was 48.53m with 95% confidence interval of [37.35, 59.71], a value that is also larger than the MCID of 36m. It can therefore be said that the improvements |

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seen in both the 10 MWT and the 6 MWT are clinically significant. Furthermore, the WISCI II scores showed a mean gain of 1.69 levels. At the end of the study, 24 of 55 patients (43.6%) were less dependent on walking aids.

# <Functional Measures>

| Endpoint | n | Pre-<br>(measurement<br>without HAL) | Post- (measurement<br>without HAL) | p |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------|--------|
| 10MWT<br>(speed) | 55 | $70.45\pm61.50$ s | $35.22\pm30.80$ s | <0.001 |
| 6MWT<br>(distance) | 55 | $97.81\pm95.80$ m | $146.34\pm118.13$ m | <0.001 |
| WISCI II | 55 | $9.35\pm5.12$ | $11.04\pm4.52$ | <0.001 |
| Adverse<br>Events | Five cases of mild adverse events were observed. In all cases, skin redness due to electrodes was observed but patients recovered naturally shortly after electrodes were removed. One subject had fallen from his wheelchair while at home, and suffered a femoral neck fracture. The incident was not related to the use of the device, and the subject was dropped from the study due to inability to continue. One subject had a pressure ulcer on her left ankle that developed while horseback riding. The incident was not related to the use of the device, and the treatment was suspended until the ulcer healed. | | | |
| Manuscripts | JNS Neurosurgical Focus, titled “Against the odds: what to expect in rehabilitation of chronic spinal cord injury with a neurologically controlled Hybrid Assistive Limb exoskeleton. A subgroup analysis of 55 patients according to age and lesion level.” | | | |

#### 5.8.1 Comparison of Intended Use/Indications for Use

| Indications for Use | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Subject Device | Predicate Device |
| HAL for Medical Use (Lower Limb Type) | ReWalk (K131798) |
| HAL for Medical Use (Lower Limb Type)<br>orthotically fits to the lower limbs and trunk; the<br>device is intended for individuals with spinal<br>cord injury at levels C4 to L5 (ASIA C, ASIA D)<br>and T11 to L5 (ASIA A with Zones of Partial<br>Preservation, ASIA B), who exhibit sufficient<br>residual motor and movement-related functions<br>of the hip and knee to trigger and control HAL. | The ARGO ReWalk orthotically fits to the<br>lower limbs and part of the upper body<br>and is intended to enable individuals with<br>spinal cord injury at levels T7 to L5 to<br>perform ambulatory functions with<br>supervision of a specially trained<br>companion in accordance with the user<br>assessment and training certification<br>program. The device is also intended to<br>enable individuals with spinal cord injury<br>at levels T4 to T6 to perform ambulatory |

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| HAL is a gait training device intended to<br>temporarily help improve ambulation upon<br>completion of the HAL gait training<br>intervention. HAL must be used with a Body<br>Weight Support system. HAL is not intended<br>for sports or stair climbing. HAL gait training is<br>intended to be used in conjunction with regular<br>physiotherapy. | functions in rehabilitation institutions in<br>accordance with the user assessment<br>and training certification program. The<br>ReWalk is not intended for sports or stair<br>climbing. |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| In preparation for HAL gait training, the<br>controller can be used while the exoskeleton is<br>not donned to provide biofeedback training<br>through the visualization of surface<br>electromyography bioelectrical signals<br>recorded. | |
| HAL is intended to be used inside medical<br>facilities while under trained medical<br>supervision in accordance with the user<br>assessment and training certification program | |

#### 5.8.2 Similarities and Differences of Intended Use/Indications for Use (IFU)

The subject device is intended for an expanded range of Spinal Cord Injury patients when compared to the predicate device. In addition to the training requirements, contraindication, warnings, precautions, the subject device mitigates risks of device use by:

- Limiting device use to inside medical facilities
- Requiring the use of a Body Weight Support system ●
- Requiring vital capacity and pulse oximetry testing for C5-C4 SCI patients before and ● after device use
- Requiring blood pressure and heart rate monitoring for all patients prior to standing. ● while standing, and after walking

These requirements do not raise new questions of safety and effectiveness.

In preparation for using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded at the hip and knee extensor and flexor muscles. The biofeedback training is provided in preparation to using HAL and does not raise new questions of safety or effectiveness.

HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. The effectiveness of HAL was demonstrated in two clinical studies (see section 5.7 above), the first with 8 subjects and the second with 55 subjects. All subjects were chronic ( > 1 year since trauma) SCI patients with injuries ranging from C2-L5, ASIA D, C, B and ASIA A with Zones of Partial Preservation.

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The effectiveness was measured by collecting data on 10 meter walk tests (10 MWT), 6minute walk tests (6 MWT), and WISCI-II tests, all measured without wearing the HAL device. The endpoints were collected at start of the study (week 0), midpoint (week 6) and upon completion of the study (week 12). The results suggest a statistically significant improvement in the gait related outcome measures collected. In contrast to the predicate device's IFU statement for device worn ambulation, the subject device's IFU statement for gait training required clinical data to support the effectiveness of the gait training intervention (i.e., testing of ambulation while not wearing the exoskeleton). The studies (see section 5.7 above) support the Indications for Use and a decision of substantial equivalence.

| | Subject Device<br>(HAL for Medical Use) | Predicate Device<br>(ReWalk K131798) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | | |
| Body<br>Coverage | • Worn over legs and around hips<br>and lower torso. | • Worn over legs and around hips<br>and lower torso |
| Patient<br>Height | 150-190 cm | 160-190 cm |
| Patient<br>Weight | 40-100 kg | Maximum 100 kg |
| Intended<br>Environment | • Flat surface of medical facilities<br>(indoor only)<br>• Must be used in combination<br>with BWS systems. | • Home use (includes outdoor)<br>• Used with canes (device<br>component) |
| Intended<br>Users | Medical professionals that have<br>completed designated training<br>program to use the device | Those that have completed<br>designated training program<br>(includes medical professionals and<br>nonprofessionals like companions or<br>family members) |
| Hardware<br>and<br>Main<br>Components | The system consists of three<br>major components:<br>• Controller<br>• Main unit<br>• Sensor shoes | The system consists of three major<br>components:<br>• Remote control communicator<br>• Exoskeleton<br>• Backpack |
| Device<br>Variations | • 8 different size/shape variations:<br>4 leg lengths, 2 waist wid…