Honda Walking Assist Device

K181294 · Honda Motor Company, Ltd. · PHL · Dec 14, 2018 · Physical Medicine

Device Facts

• Record ID: K181294
• Device Name: Honda Walking Assist Device
• Applicant: Honda Motor Company, Ltd.
• Product Code: PHL · Physical Medicine
• Decision Date: Dec 14, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.3480
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for the following population: Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person. The trained healthcare professional must successfully complete a training program prior to use of the device. The devices are not intended for sports.

Device Story

Lightweight (5.95 lbs) robotic exoskeleton worn on waist and thighs; assists hip joint flexion/extension. Inputs: hip joint angle and torque output via integrated sensors. Operation: trained healthcare professional uses mobile device software to configure assist settings and monitor performance. Output: mechanical torque transmitted to thighs via frames; visual/auditory feedback provided to user and therapist. Used in rehabilitation institutes to assist ambulatory function and stair training. Benefits: facilitates gait training for stroke patients; improves walking speed. Failsafe: motor torque disables upon power failure, allowing passive movement.

Clinical Evidence

Randomized controlled trial (NCT01994395) with 50 chronic stroke patients (25 HWA, 25 control). HWA group received 18 sessions of gait/stair training over 6-8 weeks. Primary endpoint: change in 10 Meter Walk Test (MWT) Self-selected Velocity. HWA group showed mean baseline speed 69.91 cm/s, with improvements of +8.87 cm/s (mid), +17.41 cm/s (post), and +19.16 cm/s (3-month follow-up). No falls or significant adverse events reported.

Technological Characteristics

Powered lower extremity exoskeleton; 5.95 lbs. Materials: waist/thigh frames. Sensing: angle and current sensors. Energy: 22.2V, 1Ah Li-Ion battery. Connectivity: Bluetooth for mobile device interface. Software: Major level of concern. Standards: ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, ISO 10993.

Indications for Use

Indicated for individuals with stroke, gait deficits, gait speeds ≥0.4m/s, and ability to walk ≥10m with assistance from max one person. Contraindicated for non-ambulatory individuals and sports use.

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 (Version 1.1) & Ekso GT (Version 1.2) (K161443)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square. The full name of the agency is "U.S. Food & Drug Administration".

December 14, 2018

Honda Motor Company, Ltd. % Mark DiPietro Assistant Vice President, Power Equipment Division American Honda Motor Company, Inc. 4900 Marconi Drive Alpharetta, Georgia 30005

Re: K181294

Trade/Device Name: Honda Walking Assist Device Regulation Number: 21 CFR 890.3480 Regulation Name: Powered lower extremity exoskeleton Regulatory Class: Class II Product Code: PHL Dated: November 16, 2018 Received: November 16, 2018

Dear Mark DiPietro:

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.

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

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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Vivek J. Pinto -S

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known) K181294

Device Name

Honda Walking Assist Device

#### Indications for Use (Describe)

The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function institutes under the supervision of a trained healthcare professional for the following population:

- Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the devices are not intended for sports.

| Type of Use (Select one or both, as applicable) | |
|---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the word "HONDA" in all capital letters. The text is a bold, sans-serif font and is colored red. The background is white, providing a strong contrast that makes the word easily visible.

## 510(k) Summary

## Administrative Information

| Device Name | Honda Walking Assist Device | | |
|------------------------------|-----------------------------|-------------------------------------------------------------------------------------------------------------------|--|
| | Company: | Honda Motor Company, Ltd.<br>1-4-1, Chuo, Wako-shi<br>Saitama, 351-0193<br>Japan | |
| Applicant<br>Information | Contact: | Kazushi Hamaya | |
| | Title: | Department Manager | |
| | Email: | [e-mail] | |
| | Phone Number: | [phone] | |
| Correspondent<br>Information | Company: | American Honda Motor Company, Inc.<br>4900 Marconi Drive<br>Alpharetta, Georgia 30005<br>United States of America | |
| | Contact: | Mark DiPietro | |
| | Title: | Assistant Vice President | |
| | Email: | [e-mail] | |
| | Phone Number: | [phone] | |
| Preparation<br>Date | December 11, 2018 | | |
| Device<br>Classification | Trade Name: | Honda Walking Assist Device | |
| | Common<br>Name: | Exoskeleton | |
| | Classification<br>Name: | Powered Lower Extremity<br>Exoskeleton | |
| | Product Code: | PHL | |
| | Device Class: | Class II | |
| | Regulation: | 21 CFR 890.3480 | |

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

#### Device Description

The Honda Walking Assist Device is a lightweight, robotic exoskeleton designed to help assist ambulatory function of stoke patients who meet the user assessment criteria, in rehabilitation institutes under the supervision of a trained healthcare professional. The device is worn around the user's waist and thighs, and assists with hip ioint flexion and extension. The device weighs 5.95lbs and has two motors that run on a single rechargeable battery. The device is equipped with angle and current sensors to monitor hip joint angle and torque output respectively. The assist torque is transmitted to the user's thighs via thigh frames. A trained healthcare professional, who operates the device, can change assist settings through software that runs on a mobile device.

#### Indications for Use

The Honda Walking Assist Device is a robotic exoskeleton that fits orthotically on the user's waist and thigh, outside of clothing. The device is intended to help assist ambulatory function in rehabilitation institutes under the supervision of a trained healthcare professional for the following population:

- Individuals with stroke who have gait deficits and exhibit gait speeds of at least 0.4m/s and are able to walk at least 10 meters with assistance from a maximum of one person.
The trained healthcare professional must successfully complete a training program prior to use of the device. The devices are not intended for sports.

## Comparison of Technological Characteristics to the Predicate

| Predicate<br>Device | Manufacturer | Device Name | 510(k)<br>Number |
|---------------------|-------------------------------------------------|-------------|------------------|
| Ekso Bionics®, Inc. | Ekso™ (Version 1.1) &<br>Ekso GT™ (Version 1.2) | K161443 | |

For simplicity, we will refer to the Ekso™ (Version 1.1) and Ekso GT™ (Version 1.2) devices as "Ekso." The table below highlights comparisons between the Honda Walking Assist Device and the predicate device, Ekso. These comparisons consider device intended use, indications for use, operating procedures and technological characteristics. Although there are some key differences between Ekso and the Honda

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

Walking Assist Device, these differences do not raise different questions of safety or effectiveness.

| CATEGORY | HONDA WALKING<br>ASSIST DEVICE<br>(HWA) | EKSO BIONICS®,<br>INC. - EKSO | Substantial Equivalence<br>Comments |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K181294 | K161443 | N/A |
| Product Code | PHL | PHL | [SAME] |
| Sub-Product Code | N/A | N/A | [SAME] |
| Regulation Name | Powered Lower<br>Extremity Exoskeleton | Powered Lower<br>Extremity Exoskeleton | [SAME] |
| Device Class | Class II | Class II | [SAME] |
| Regulation | 21 CFR 890.3480 | 21 CFR 890.3480 | [SAME] |
| Indications for<br>Use | The Honda Walking<br>Assist Device is a robotic<br>exoskeleton that fits<br>orthotically on the user's<br>waist and thigh, outside<br>of clothing. The device is<br>intended to help assist<br>ambulatory function in<br>rehabilitation institutes<br>under the supervision of a<br>trained healthcare<br>professional for the<br>following population:<br>• Individuals with stroke<br>who have gait deficits<br>and exhibit gait<br>speeds of at least<br>0.4m/s and are able to<br>walk at least 10<br>meters with assistance<br>from a maximum of<br>one person.<br>The trained healthcare<br>professional must<br>successfully complete a<br>training program prior to<br>use of the device. The<br>devices are not intended<br>for sports. | The Ekso™ is intended<br>to perform ambulatory<br>functions in rehabilitation<br>institutions under the<br>supervision of a trained<br>physical therapist for the<br>following population:<br>• Individuals with<br>hemiplegia due to<br>stroke (upper<br>extremity motor<br>function of at least<br>4/5 in at least one<br>arm)<br>• Individuals with<br>spinal cord injuries at<br>levels T4 to L5<br>(upper extremity<br>motor function of at<br>least 4/5 in both<br>arms)<br>• Individuals with<br>spinal cord injuries at<br>levels of C7 to T3<br>(ASIA D with upper<br>extremity motor<br>function of at least<br>4/5 in both arms)<br>The therapist must<br>complete a training<br>program prior to use of<br>the device. The devices<br>are not intended for<br>sports or stair climbing. | [SIMILAR]<br>• HWA may be used during stair<br>training in rehabilitation<br>institutes under the supervision<br>of a therapist who is within<br>physical reach of device users,<br>consistent with the user<br>assessment and training<br>certification program. Patients<br>who require more than minimal<br>contact by the therapist should<br>not use the device. HWA stair<br>training was performed during<br>clinical testing, during which no<br>falls or serious adverse events<br>were reported<br>• HWA is not intended for<br>individuals with spinal cord<br>injuries<br>• HWA users must be<br>ambulatory<br>• The above factors do not raise<br>different questions of safety<br>and effectiveness since the<br>HWA risk profile is not<br>substantially different. |
| Device Weight | 5.95 lbs (2.7 kg) | 50 lbs (23 kg) | [DIFFERENT] |
| CATEGORY | HONDA WALKING<br>ASSIST DEVICE<br>(HWA) | EKSO BIONICS®,<br>INC. - EKSO | Substantial Equivalence<br>Comments |
| | | | • Lighter HWA weight does not<br>raise different questions of<br>safety and effectiveness |
| Body Coverage | Worn around the waist &<br>thighs | Worn over legs & upper<br>body with rigid torso | [SIMILAR]<br>• HWA is not worn above the<br>waist or below the knees<br>• HWA users can wear bracing<br>(e.g. an Ankle-Foot Orthosis)<br>• Reduced HWA body coverage<br>or the use of supplementary<br>bracing does not raise different<br>questions of safety and<br>effectiveness |
| Mobility Aid | Optional (e.g., walker,<br>cane) | Walker, crutches, cane | [DIFFERENT]<br>• HWA does not require a<br>mobility aid<br>• The absence of a mobility aid<br>with HWA does not raise<br>different questions of safety<br>and effectiveness. The HWA is<br>indicated for ambulatory<br>individuals and intended to be<br>used with a trained healthcare<br>professional in a rehabilitation<br>institute. |
| Patient Population | • Individuals with stroke<br>who have gait deficits<br>and exhibit gait speeds<br>of at least 0.4m/s and<br>are able to walk at<br>least 10 meters with<br>assistance from a<br>maximum of one<br>person. | • 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<br>arms) | [DIFFERENT]<br>• HWA users must be<br>ambulatory<br>• HWA is only for stroke patients<br>• Differences were addressed in<br>the clinical study and do not<br>raise different questions of<br>safety and effectiveness |
| Device limit on<br>user's gait speed | None | ~2 km/hr | [DIFFERENT]<br>• HWA does not limit gait speed<br>• The above factor does not<br>raise different questions of<br>safety and effectiveness since<br>a trained healthcare<br>professional screens |
| CATEGORY | HONDA WALKING<br>ASSIST DEVICE<br>(HWA) | EKSO BIONICS®,<br>INC. - EKSO | Substantial Equivalence<br>Comments |
| | | | evaluates and measures HWA<br>users for the proper gait speed |
| Type of Surface<br>for Training | Smooth, cement, carpet | Smooth, cement, carpet | [SAME] |
| Device Range of<br>Motion (ROM) | • Hips: 113° flexion to 47°<br>extension | • Hips: 135° flexion to<br>20° extension<br>• Knees: 130° flexion to<br>0° extension<br>• Ankles: 10° flexion to<br>10° extension | [SIMILAR]<br>• HWA hip joint ROM is<br>comparable |
| User Height<br>Requirement | 1.4 m to 2.0 m<br>(~55 in to ~79 in) | 1.58 m to 1.88 m<br>(~62 in to ~74 in) | [SIMILAR] |
| User Weight<br>Requirement | ≤220 lbs (100 kg) | ≤220 lbs (100 kg) | [SAME] |
| Battery<br>Specifications | • Rechargeable Li-Ion<br>• 22.2 V, 1 A-h<br>• 1 hr continuous<br>operation<br>• 2 hr charge time | • Rechargeable Li-Ion<br>• 48.1 V, 30 A peak<br>current<br>• 1 hr continuous<br>operation<br>• 1 hr charge time | [SIMILAR]<br>• HWA outputs smaller voltage &<br>current values<br>• HWA requires a different<br>charge time<br>• Varied HWA battery specs do<br>not raise different questions of<br>safety and effectiveness |
| Actuator<br>Specifications | • 2 motors (2 at hip)<br>• 4 Nm max torque | • 4 motors (2 hip, 2<br>knee)<br>• ~[40 to 70] Nm max<br>torque | [DIFFERENT]<br>• HWA has two motors<br>• HWA outputs much less torque<br>• Reduced HWA motor torque<br>does not raise different<br>questions of safety and<br>effectiveness |
| Control Method | • Handheld interface for<br>physical therapist | • Handheld interface for<br>physical therapist<br>• Weight shift to initiate<br>steps | [DIFFERENT]<br>• HWA does not detect user<br>weight shift<br>• HWA does not initiate steps<br>• Different HWA control methods<br>do not raise different questions<br>of safety and effectiveness |
| Life Cycle | 3 years | 4 years | [SIMILAR]<br>• HWA has a different usable life<br>• Shorter HWA usable life does<br>not raise different questions of<br>safety and effectiveness |
| Training Program | Yes | Yes | [SAME] |
| Certification<br>Program | Yes | Yes | [SAME] |
| Device Feedback<br>to the User | Visual & auditory<br>feedback on both the<br>handheld controller &<br>device | Provides visual feedback<br>on the handheld<br>controller & auditory<br>feedback | [SAME]…