(212 days)
Not Found
No
The summary describes a robotic exoskeleton with sensors and motors controlled by software, but there is no mention of AI or ML being used for control, adaptation, or analysis. The control appears to be based on sensor data and settings adjusted by a healthcare professional.
Yes
The device is intended to help assist ambulatory function in rehabilitation institutes for individuals with stroke who have gait deficits, which is a therapeutic purpose.
No
The device is an assistive device designed to aid ambulatory function in stroke patients. It does not diagnose medical conditions.
No
The device description clearly states it is a "robotic exoskeleton" that is "worn around the user's waist and thighs" and includes physical components like "two motors," a "rechargeable battery," "angle and current sensors," and "thigh frames." While it uses software for control, it is fundamentally a hardware device with integrated software.
Based on the provided information, the Honda Walking Assist Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This device is an external robotic exoskeleton that assists with physical movement.
- The intended use and device description clearly state its purpose is to assist ambulatory function in rehabilitation. It interacts with the user's body externally to aid in walking, not to analyze biological samples.
- There is no mention of analyzing blood, urine, tissue, or any other bodily fluid or substance.
Therefore, the Honda Walking Assist Device falls under the category of a medical device, specifically a rehabilitation device or exoskeleton, but not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PHL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
waist and thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained healthcare professional / rehabilitation institutes
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing - Study #1
Study Type: Randomized Controlled Trial
Sample Size: Fifty participants with chronic stroke and moderate gait impairments were randomized. FTST (n=25), HWA (n=25).
AUC: Not Found
MRMC: Not Found
Standalone Performance: Not Found
Key Results:
The objectives were to compare the safety and effectiveness of the Honda Walking Assist Device compared to task-specific gait training.
Fifty participants with chronic stroke and moderate gait impairments were randomized to receive functional, task-specific gait training (FTST) or over-ground gait training with the Honda Walking Assist Device (HWA), delivered in 18 sessions over 6-8 weeks. Training sessions were comprised of gait training and stair training, all performed and assessed within a rehabilitation institute under clinical supervision. The primary endpoint was the change in 10 Meter Walk Test (MWT) Self-selected Velocity (SSV) from baseline in gait speed. Adverse events were monitored/assessed, before and after every data collection session, through study completion. Both groups exhibited improvements in clinical outcomes after training and at a 3-month follow up. There were no significant adverse events during the study.
The results from the HWA group were reviewed to support the use of the device for assisting ambulation function and stair training in rehabilitation institutes. The data demonstrates the HWA device helps assist the ambulatory function of stroke patients who exhibit sufficient ambulatory function to operate the device safely and effectively under the supervision of a healthcare professional in a rehabilitation institute. The data also addresses special controls 21 CFR 890.3480(b)(6) by assessing the level of supervision needed and appropriate environment for use.
HWA RESULTS (n = 25) for 10 Meter Walking Test, Self-selected Velocity (Units: cm/s Mean (SD)):
Baseline: 69.91 (3.03)
Change from Baseline:
Mid (after 9 sessions): +8.87 (2.59)
Post (after 18 sessions): +17.41 (2.23)
3 Month Follow Up: +19.16 (4.37)
No falls or significant adverse events were reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3480 Powered lower extremity exoskeleton.
(a)
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.(b)
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).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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510(k) Summary
Administrative Information
| Device Name | Honda Walking Assist Device | ||
|---|---|---|---|
| Company: | Honda Motor Company, Ltd. | ||
| 1-4-1, Chuo, Wako-shi | |||
| Saitama, 351-0193 | |||
| Japan | |||
| Applicant | |||
| Information | Contact: | Kazushi Hamaya | |
| Title: | Department Manager | ||
| Email: | Kazushi_hamaya@hm.honda.co.jp | ||
| Phone Number: | +81 80 4900-4527 | ||
| Correspondent | |||
| Information | Company: | American Honda Motor Company, Inc. | |
| 4900 Marconi Drive | |||
| Alpharetta, Georgia 30005 | |||
| United States of America | |||
| Contact: | Mark DiPietro | ||
| Title: | Assistant Vice President | ||
| Email: | Mark_DiPietro@ahm.honda.com | ||
| Phone Number: | +1 (678) 339-2623 | ||
| Preparation | |||
| Date | December 11, 2018 | ||
| Device | |||
| Classification | Trade Name: | Honda Walking Assist Device | |
| Common | |||
| Name: | Exoskeleton | ||
| Classification | |||
| Name: | Powered Lower Extremity | ||
| 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
Device | Manufacturer | Device Name | 510(k)
Number |
|---------------------|-------------------------------------------------|-------------|------------------|
| Ekso Bionics®, Inc. | Ekso™ (Version 1.1) &
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
ASSIST DEVICE
(HWA) | EKSO BIONICS®,
INC. - EKSO | Substantial Equivalence
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
Extremity Exoskeleton | Powered Lower
Extremity Exoskeleton | [SAME] |
| Device Class | Class II | Class II | [SAME] |
| Regulation | 21 CFR 890.3480 | 21 CFR 890.3480 | [SAME] |
| 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. | The Ekso™ is intended
to perform ambulatory
functions in rehabilitation
institutions under the
supervision of a trained
physical therapist for the
following population:
• Individuals with
hemiplegia due to
stroke (upper
extremity motor
function of at least
4/5 in at least one
arm)
• Individuals with
spinal cord injuries at
levels T4 to L5
(upper extremity
motor function of at
least 4/5 in both
arms)
• Individuals with
spinal cord injuries at
levels of C7 to T3
(ASIA D with upper
extremity motor
function of at least
4/5 in both arms)
The therapist must
complete a training
program prior to use of
the device. The devices
are not intended for
sports or stair climbing. | [SIMILAR]
• HWA may be used during stair
training in rehabilitation
institutes under the supervision
of a therapist who is within
physical reach of device users,
consistent with the user
assessment and training
certification program. Patients
who require more than minimal
contact by the therapist should
not use the device. HWA stair
training was performed during
clinical testing, during which no
falls or serious adverse events
were reported
• HWA is not intended for
individuals with spinal cord
injuries
• HWA users must be
ambulatory
• The above factors do not raise
different questions of safety
and effectiveness since the
HWA risk profile is not
substantially different. |
| Device Weight | 5.95 lbs (2.7 kg) | 50 lbs (23 kg) | [DIFFERENT] |
| CATEGORY | HONDA WALKING
ASSIST DEVICE
(HWA) | EKSO BIONICS®,
INC. - EKSO | Substantial Equivalence
Comments |
| | | | • Lighter HWA weight does not
raise different questions of
safety and effectiveness |
| Body Coverage | Worn around the waist &
thighs | Worn over legs & upper
body with rigid torso | [SIMILAR]
• HWA is not worn above the
waist or below the knees
• HWA users can wear bracing
(e.g. an Ankle-Foot Orthosis)
• Reduced HWA body coverage
or the use of supplementary
bracing does not raise different
questions of safety and
effectiveness |
| Mobility Aid | Optional (e.g., walker,
cane) | Walker, crutches, cane | [DIFFERENT]
• HWA does not require a
mobility aid
• The absence of a mobility aid
with HWA does not raise
different questions of safety
and effectiveness. The HWA is
indicated for ambulatory
individuals and intended to be
used with a trained healthcare
professional in a rehabilitation
institute. |
| Patient 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. | • Individuals with
hemiplegia due to
stroke (upper
extremity motor
function of at least 4/5
in at least one arm)
• Individuals with spinal
cord injuries at levels
T4 to L5 (upper
extremity motor
function of at least 4/5
in both arms)
• Individuals with spinal
cord injuries at levels
of C7 to T3 (ASIA D
with upper extremity
motor function of at
least 4/5 in both
arms) | [DIFFERENT]
• HWA users must be
ambulatory
• HWA is only for stroke patients
• Differences were addressed in
the clinical study and do not
raise different questions of
safety and effectiveness |
| Device limit on
user's gait speed | None | ~2 km/hr | [DIFFERENT]
• HWA does not limit gait speed
• The above factor does not
raise different questions of
safety and effectiveness since
a trained healthcare
professional screens |
| CATEGORY | HONDA WALKING
ASSIST DEVICE
(HWA) | EKSO BIONICS®,
INC. - EKSO | Substantial Equivalence
Comments |
| | | | evaluates and measures HWA
users for the proper gait speed |
| Type of Surface
for Training | Smooth, cement, carpet | Smooth, cement, carpet | [SAME] |
| Device Range of
Motion (ROM) | • Hips: 113° flexion to 47°
extension | • Hips: 135° flexion to
20° extension
• Knees: 130° flexion to
0° extension
• Ankles: 10° flexion to
10° extension | [SIMILAR]
• HWA hip joint ROM is
comparable |
| User Height
Requirement | 1.4 m to 2.0 m
(~55 in to ~79 in) | 1.58 m to 1.88 m
(~62 in to ~74 in) | [SIMILAR] |
| User Weight
Requirement | ≤220 lbs (100 kg) | ≤220 lbs (100 kg) | [SAME] |
| Battery
Specifications | • Rechargeable Li-Ion
• 22.2 V, 1 A-h
• 1 hr continuous
operation
• 2 hr charge time | • Rechargeable Li-Ion
• 48.1 V, 30 A peak
current
• 1 hr continuous
operation
• 1 hr charge time | [SIMILAR]
• HWA outputs smaller voltage &
current values
• HWA requires a different
charge time
• Varied HWA battery specs do
not raise different questions of
safety and effectiveness |
| Actuator
Specifications | • 2 motors (2 at hip)
• 4 Nm max torque | • 4 motors (2 hip, 2
knee)
• ~[40 to 70] Nm max
torque | [DIFFERENT]
• HWA has two motors
• HWA outputs much less torque
• Reduced HWA motor torque
does not raise different
questions of safety and
effectiveness |
| Control Method | • Handheld interface for
physical therapist | • Handheld interface for
physical therapist
• Weight shift to initiate
steps | [DIFFERENT]
• HWA does not detect user
weight shift
• HWA does not initiate steps
• Different HWA control methods
do not raise different questions
of safety and effectiveness |
| Life Cycle | 3 years | 4 years | [SIMILAR]
• HWA has a different usable life
• Shorter HWA usable life does
not raise different questions of
safety and effectiveness |
| Training Program | Yes | Yes | [SAME] |
| Certification
Program | Yes | Yes | [SAME] |
| Device Feedback
to the User | Visual & auditory
feedback on both the
handheld controller &
device | Provides visual feedback
on the handheld
controller & auditory
feedback | [SAME] |
| Fall Detection &
Mitigation | None | None | [SAME] |
| CATEGORY | HONDA WALKING
ASSIST DEVICE
(HWA) | EKSO BIONICS®,
INC. - EKSO | Substantial Equivalence
Comments |
| Failsafe Features | Motor torque disables;
device becomes passive | In event of power failure
- knees become locked
and hips free (similar to
typical passive leg
braces) | [SIMILAR]
• HWA does not impede joint
range of motion (ROM)
• Unrestricted joint ROM does
not raise different questions of
safety and effectiveness |
| Operating
Temperature | 32 °F to 86 °F
(0 °C to 30 °C) | 10 °F to 95 °F
(-12 °C to 35 °C) | [SIMILAR]
• HWA has a different range of
operating temperature
• Reduced HWA operating
temperature does not raise
different questions of safety
and effectiveness |
| Operating
Humidity | 30% to 85% | Not Available | [SIMILAR]
• HWA probably has a similar
range of tolerable humidity
• The above factor does not
raise different questions of
safety and effectiveness |
6
7
8
Non-Clinical Performance Testing
As part of our overall R&D process, several performance tests were conducted to demonstrate device safety, effectiveness and usability. The table below gives a broad overview of our bench testing and device development criteria. Testing was conducted according to a combination of internal criteria and international technical standards. The device passed all criteria under an assumed 3-year life cycle.
| CATEGORY | DESCRIPTION |
|---|---|
| Durability | • Component & bulk system worst case loading |
| Vibration | • Component & bulk system worst case oscillations |
| Thermal | • Component & bulk system temperature & humidity cycles |
| • Component exposure to thermal shock | |
| Impact | • Component free-fall drop testing |
| Particulate | |
| Resistance | • Component exposure to dust particles |
| Disinfection | • Bulk system exposure to medical grade cleaning substances |
| Quality | |
| Management | • Bulk system development per ISO 13485 |
| Risk Management | • Bulk system development per ISO 14971 |
| Usability | • Bulk system development per IEC 60601-1-6 & IEC 62366-1 |
9
| CATEGORY | DESCRIPTION |
|---|---|
| Biocompatibility | • Component testing for In Vitro Cytotoxicity (ISO 10993-5), |
| Skin Sensitization (ISO 10993-10), Intracutaneous Reactivity | |
| (ISO 10993-10) & Acute Systemic Toxicity (ISO 10993-11) | |
| Battery Life Cycle | • Battery certification testing per IEC 62133 & IEC 60601-1-2 |
| Electromagnetic | |
| Compatibility (EMC) | • EMC certification testing per IEC 60601-1-2 |
| Electrical Safety | • Electrical safety testing per ANSI/AAMI IEC 60601-1:2005 |
| (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 | |
| & IEC 60950-1 | |
| Software & | |
| Cybersecurity | • Software verification, validation & hazard analysis per IEC |
| 62304 & FDA guidelines (MAJOR Level of Concern) | |
| Radio Frequency | |
| Wireless | |
| Technology | • Bluetooth module certification testing per EN 300 328 & EN |
| 301 489-1/-17 (FCC compliant module) |
Clinical Testing - Study #1
The table below summarizes a study of the Honda Walking Assist Device for stroke patients. The objectives were to compare the safety and effectiveness of the Honda Walking Assist Device compared to task-specific gait training.
Fifty participants with chronic stroke and moderate gait impairments were randomized to receive functional, task-specific gait training (FTST) or over-ground gait training with the Honda Walking Assist Device (HWA), delivered in 18 sessions over 6-8 weeks. Training sessions were comprised of gait training and stair training, all performed and assessed within a rehabilitation institute under clinical supervision. The primary endpoint was the change in 10 Meter Walk Test (MWT) Self-selected Velocity (SSV) from baseline in gait speed. Adverse events were monitored/assessed, before and after every data collection session, through study completion. Both groups exhibited improvements in clinical outcomes after training and at a 3-month follow up. There were no significant adverse events during the study.
The results from the HWA group were reviewed to support the use of the device for assisting ambulation function and stair training in rehabilitation institutes. The data demonstrates the HWA device helps assist the ambulatory function of stroke patients who exhibit sufficient ambulatory function to operate the device safely and effectively under the supervision of a healthcare professional in a rehabilitation institute. The data also addresses special controls 21 CFR 890.3480(b)(6) by assessing the level of supervision needed and appropriate environment for use.
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| TRIAL REGISTRATION | URL: http://www.clinicaltrials.gov
Identifier: NCT01994395 | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| TRIAL DESIGN | Randomized Controlled Trial | | |
| TRIAL SITE | The Shirley Ryan AbilityLab (Chicago, Illinois, USA) | | |
| CONDITION | Stroke | | |
| TEST GROUPS | Functional Task Specific Training (FTST) – Control | Honda Walking Assist (HWA) – Intervention | |
| INTERVENTION | 18 total training sessions
without HWA device
• 45min training sessions
• 3 sessions/week
• 6-8 weeks duration | 18 total training sessions
with HWA device
• 45min training sessions
• 3 sessions/week
• 6-8 weeks duration | |
| TOTAL
SUBJECTS
(n=50) | Groups | FTST (n=25) | HWA (n=25) |
| | Age | $62 \pm 3$ years | $60 \pm 2$ years |
| | Gender | 9 female, 16 male | 8 female, 17 male |
| | Hemiparesis | 12 right-side, 13 left-side | 13 right-side, 12 left-side |
| | Stroke Latency | $5.4 \pm 0.8$ years | $7.1 \pm 1.5$ years |
| | Initial Gait Speed | $0.65 \pm 0.02$ m/s | $0.7 \pm 0.03$ m/s |
| CLINICAL OUTCOME
ASSESSMENTS | • Pre (before study)
• Mid (after 9 sessions)
• Post (after 18 sessions)
• Follow-Up (3 months after study) | | |
| | 10 Meter Walking Test, Self-selected Velocity
Units: cm/s
Mean (SD) | | |
| HWA RESULTS
(n = 25) | Baseline: 69.91 (3.03)
Change from Baseline
Mid: +8.87 (2.59)
Post: +17.41 (2.23)
3 Month Follow Up: +19.16 (4.37) | | |
| | No falls or significant adverse events were reported | | |
Training Certification
The Honda Walking Assist Device (HWA) is an adjustable exoskeleton that allows fitting of the main waist frame and thigh frames to the user's dimensions. A mobile app, which runs on a touchscreen tablet, is provided with the device and is used by the
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physical therapist to select the user settings and dynamically adjust the amount of assistance provided by the device during set up.
To ensure appropriate utilization, therapists are required to complete a certification training prior to using the device with their patients. This 8-hour training course is divided into two 4-hour sessions. The HWA training activities will allow therapists to:
- Screen, evaluate and measure patients for HWA use ●
- Configure the HWA device and tablet accessory for patients ●
- Fit the exoskeleton to patients for proper donning and doffing ●
- Safely guard and cue patients while using the HWA ●
- Complete 2-3 practice training sessions with the exoskeleton ●
- Demonstrate competence during emergency situations ●
- Become familiar with available resources for technical support
Statement of Substantial Equivalence
Based on comparisons of technological characteristics, intended use, indications for use, bench testing and clinical evidence, we conclude that the Honda Walking Assist Device is appropriate for its intended use and is considered substantially equivalent to the identified predicate device. We believe that any differences in comparisons do not raise different questions of safety and effectiveness.