(174 days)
No
The document describes a "proprietary signal processing algorithm" for processing surface electromyography signals, but it does not mention AI, ML, deep learning, or any related terms. The control modes are described as based on signal processing, postural cues, and sensor measurements, not learned patterns.
Yes
The device is intended to temporarily help improve ambulation for individuals with spinal cord injury and is used in conjunction with physiotherapy, indicating a therapeutic purpose.
No
HAL for Medical Use (Lower Limb Type) is described as a gait training device intended to improve ambulation, not to diagnose a condition. While it uses bioelectrical signals, these are for controlling the device and providing biofeedback training, not for diagnostic purposes.
No
The device description clearly states that HAL is a "battery powered bi-lateral lower extremity exoskeleton" comprised of a "controller, a main unit, and sensor shoes," and weighs approximately 14 kg. This indicates it is a physical hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The HAL device is an exoskeleton that provides physical assistance and gait training. It uses surface electromyography (sEMG) signals, but these signals are used to control the device's movement and provide biofeedback, not to diagnose or monitor a medical condition through analysis of a biological specimen.
- Intended Use: The intended use is for gait training and temporary improvement of ambulation in individuals with spinal cord injuries. This is a therapeutic and rehabilitative purpose, not an in vitro diagnostic purpose.
- Device Description: The description focuses on the mechanical and control aspects of the exoskeleton, the use of sEMG for control and biofeedback, and the different operating modes. It does not describe any components or processes related to analyzing biological specimens.
- Performance Studies: The performance studies evaluate improvements in functional mobility and gait parameters (like walking speed and distance), which are outcomes of physical training, not diagnostic measurements.
- Predicate and Reference Devices: The predicate and reference devices listed (ReWalk and Physiological Monitoring & Biofeedback Training Device) are also not IVDs. ReWalk is another exoskeleton, and the biofeedback device is used for monitoring physiological signals, not for in vitro diagnosis.
In summary, the HAL device is a therapeutic and rehabilitative medical device used for gait training, not a device that performs diagnostic tests on biological samples.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
PHL, HCC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower limbs and trunk
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Medical professionals that have completed designated training program to use the device
The device is intended to be used only in medical facilities for HAL gait training.
Must be used under the supervision of a trained medical professional in accordance with the user assessment and training certification program
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)
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.
Stopper Strength Test
Objective(s): To evaluate the durability of the mechanical stopper of the actuator that limits the maximum angle and verify that it endures the mechanical force that can be applied by the patient
Results: Conformance with acceptance criteria was maintained after 100 cycles. The mechanical stopper is expected to endure the impact in the joints.
Consecutive Landing Test
Results: All 3 samples withstood 3,000,000 [cycles] of landing impact, and there were no missing parts, cracks/chips of the exterior, loosening of screws, abnormal noises, looseness, operational malfunctions, and loosening/detachment/deformation of the connectors. The assumed maximum steps of HAL is 1,000,000[cycles] so it is sufficiently durable.
Effective Output Test
Objective(s): This test consists of two tests, each with different objectives below:
A. Effective torque test: To verify that the actuator meets specifications for effective output torque by measuring the effective output torque to the input (electrical current).
B. Maximum angle velocity test: To verify that the maximum angular velocity, generated when maximum torque is output, is within the range of that tolerable by the human knee joint.
Results:
A. Effective torque output test: The output was verified to meet the specification. It was also within the range required by risk management.
B. Maximum angular velocity test: The angular velocity was verified to be within a range that the human body can tolerate.
Driving Parts Performance Test
Objective: To Measure the actual torque output against the torque output intended by the control algorithm, and confirm that it meets the performance criteria.
Results: The test results show that the actual torque output compared to the torque output intended by the control algorithm falls within the criteria range, and the performance of the driving parts meets the expected results.
Joint angle measurement
Objective: To test the accuracy of joint angle sensing.
Results: Accuracy of joint angle measurement was verified to meet specification.
Body trunk absolute angle measurement
Objective: To test the accuracy of body trunk absolute angle sensing.
Results: The measurement results show that the body trunk absolute angle measurement of the device can sufficiently detect the stable posture in the forward/backward directions of the patient, thus ensuring the safety and effectiveness of the device.
Plantar load measurement
Objective: To test the accuracy of plantar load measurement.
Results: The measurement results show that the plantar force measurement of the device can sufficiently detect the planting and lifting of the sole, to enable the device to determine what phase (swing/support) each leg is in, thus ensuring the safety and effectiveness of the device.
Surface Electromyography Bioelectrical signal measurment performance
Objective: To test the accuracy of surface electromyography bioelectrical signal measurement performance. The tests included an assessment of input impedance, common-mode rejection ratio, and frequency characteristics.
Results: Accuracy for all measurements were verified to meet specifications.
Ankle Durability Test
Objective: Test the durability of the mechanical systems of the ankle parts against repeated impacts in a twisting direction, simulating impacts applied to the parts during a turning movement. Confirm whether missing parts, cracks/chips of the exterior, loosening of screws, abnormal noises, looseness do not occur after 5-years worth (service life of HAL) of consecutive impacts.
Results: All 3 samples withstood 300,000 [times] of impact, and there were no missing parts, cracks/chips of the exterior, loosening of screws, abnormal noises, looseness. The ankle part of the device is sufficiently durable.
Clinical Performance Data
DE-01 Clinical Study Summary (Pilot Study)
Site: BG University Hospital Bergmannsheil Patient Population: Chronic spinal cord injury (97.2 +/- 88.4 months since injury)
Objective: To determine whether locomotor training with the exoskeleton HAL® is safe to use and can increase functional mobility in chronic paraplegic patients after SCI.
Inclusion Criteria: traumatic SCI with chronic incomplete paraplegia or complete paraplegia after lesions of the conus medullaris/ cauda equine with zones of partial preservation (ZPP). patients must present motor functions of hip and knee extensor and flexor muscle groups in order to be able to trigger the exoskeleton.
Exclusion 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 Protocol: Study method: Interventional, Basic Design: Single arm, Randomization: Non-randomized, Blinding: Open (no blinding), Control: Uncontrolled
Method: During this study, the patients underwent a BWSTT (Body Weight Supported Treadmill Training) five times per week using the HAL. The treadmill system (Woodway USA, Inc., Waukesha, WI, USA) includes a body weight support system with a harness. During treatments, the velocity of the treadmill was set individually between comfortable and maximum speed tolerated by the patients. Approximately 50% of each patient's body weight needed to be supported by the harness system, individually reduced during the following sessions as tolerated without substantial knee buckling or toe drag.
Intervention: 90 days (5 times/week)
Sample size (N): 8
Results: Significant improvements have been especially shown in the functional abilities without the HAL for over ground walking obtained in the 6MWT and the 10MWT. While the TUG-Test was not significant after Bonferroni correction (a = 0.00625), the results show a trend toward improvement, and an increase in the WISCI II score of three patients is also promising.
Adverse Events: No serious/severe adverse events occurred/observed. Two cases of mild adverse events were observed. In both cases, skin redness due to electrodes was observed but patients recovered naturally shortly after electrodes were removed.
Manuscripts: The Spine Journal, titled "Voluntary driven exoskeleton as a new tool for rehabilitation in chronic spinal cord Injury -A pilot study"
DE-02 Clinical Study Summary
Site: BG University Hospital Bergmannsheil
Patient Population: Chronic spinal cord injury (6.85 +/- 5.12 years since injury), SCI C2-L5, ASIA D, C, and ASIA A with Zones of Partial Preservation
Objective: To examine functional outcomes as a function of age and lesion level in patients with chronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partial preservation (ZPP) by using the HAL as a temporary training tool.
Inclusion Criteria: SCI with chronic incomplete paraplegia or tetraplegia at any spinal cord lesion level (ASIA C/D) or chronic complete paraplegia (ASIAA) at lesion levels T11 or lower, AND 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.
Exclusion Criteria: 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 Protocol: Study method: Interventional, Basic Design: Single arm, Randomization: Non-randomized, Blinding: Open (no blinding), Control: Uncontrolled
Method: During this study, the patients underwent a BWSTT (Body Weight Supported Treadmill Training) five times per week using the HAL. 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. A 10-m walk test (10MWT) without the HAL was performed before and after each session in addition to regular physiotherapy. 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 (N): 55
Results: Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (= 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. 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. 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 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.
Adverse 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.”
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
DE-01 Clinical Study Summary
| Endpoint | n | Average Improvement | Paired T-test | Wilcoxon Signed-Rank Test | 95% Cl |
|---|---|---|---|---|---|
| 10MWT (speed) | 8 | 0.23 +/- 0.14 m/s | P = 0.0025 | P |
§ 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).
0
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
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
510(k) Number: K171909
5.1 Applicant Information
| Date Prepared: | December 15, 2017 |
|---|---|
| Company Name and | |
| Address: | CYBERDYNE Inc. |
| 2-2-1, Gakuen-Minami, | |
| Tsukuba-Shi, Ibaraki-Ken 305-0818 Japan | |
| Contact Person: | Mr. Yohei Suzuki |
| Head of Production Department | |
| Phone: +81-29-869-8453 | |
| FAX: +81-29-869-8443 | |
| Email: suzuki_yohei@cyberdyne.jp |
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) |
| Biofeedback Device (secondary) | |
| Regulation Number: | 21 CFR 890.3480 (primary) |
| 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.
5
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 | |
| Test | |
| To evaluate the durability of the mechanical stopper of the actuator that | |
| limits the maximum angle and verify that it endures the mechanical force | |
| that can be applied by the patient | |
| Conformance with acceptance criteria was maintained after 100 cycles. The | |
| mechanical stopper is expected to endure the impact in the joints. | |
| Consecutive | |
| Landing Test | |
| All 3 samples withstood 3,000,000 [cycles] of landing impact, and there | |
| were no missing parts, cracks/chips of the exterior, loosening of screws, | |
| abnormal noises, looseness, operational malfunctions, and | |
| loosening/detachment/deformation of the connectors. The assumed | |
| maximum steps of HAL is 1,000,000[cycles] so it is sufficiently durable. | |
| Effective Output | |
| Test | |
| This test consists of two tests, each with different objectives below: | |
| A. Effective torque test: To verify that the actuator meets specifications for | |
| effective output torque by measuring the effective output torque to the input | |
| (electrical current). | |
| B. Maximum angle velocity test: To verify that the maximum angular | |
| velocity, generated when maximum torque is output, is within the range of | |
| that tolerable by the human knee joint. | |
| A. Effective torque output test: The output was verified to meet the | |
| specification. It was also within the range required by risk management. | |
| B. Maximum angular velocity test: The angular velocity was verified to be | |
| within a range that the human body can tolerate. | |
| Driving Parts | |
| Performance Test | |
| To Measure the actual torque output against the torque output intended by | |
| the control algorithm, and confirm that it meets the performance criteria. | |
| The test results show that the actual torque output compared to the torque | |
| output intended by the control algorithm falls within the criteria range, and | |
| the performance of the driving parts meets the expected results. | |
| Joint angle | |
| measurement | |
| To test the accuracy of joint angle sensing. | |
| Accuracy of joint angle measurement was verified to meet specification. | |
| Body trunk | |
| absolute angle | |
| measurement | |
| To test the accuracy of body trunk absolute angle sensing. | |
| The measurement results show that the body trunk absolute angle | |
| measurement of the device can sufficiently detect the stable posture in the | |
| forward/backward directions of the patient, thus ensuring the safety and | |
| effectiveness of the device. | |
| Plantar load | |
| measurement | |
| To test the accuracy of plantar load measurement. |
The measurement results show that the plantar force measurement of the
device can sufficiently detect the planting and lifting of the sole, to enable
the device to determine what phase (swing/support) each leg is in, thus
ensuring the safety and effectiveness of the device. |
| Surface
Electromyography
Bioelectrical signal
measurment
performance |
To test the accuracy of surface electromyography bioelectrical signal
measurement performance. The tests included an assessment of input
impedance, common-mode rejection ratio, and frequency characteristics.
Accuracy for all measurements were verified to meet specifications. |
| Ankle Durability | |
| Test | Test the durability of the mechanical systems of the ankle parts against
repeated impacts in a twisting direction, simulating impacts applied to the
parts during a turning movement. Confirm whether missing parts,
cracks/chips of the exterior, loosening of screws, abnormal noises,
looseness do not occur after 5-years worth (service life of HAL) of
consecutive impacts. |
| |
All 3 samples withstood 300,000 [times] of impact, and there were no
missing parts, cracks/chips of the exterior, loosening of screws, abnormal
noises, looseness. The ankle part of the device is sufficiently durable. |
6
7
5.7 Clinical Performance Data
[Pilot Study]
| Site | BG University Hospital Bergmannsheil |
|---|---|
| Patient | |
| 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 |
| and can increase functional mobility in chronic paraplegic patients after SCI. | |
| Inclusion | |
| Criteria | traumatic SCI with chronic incomplete paraplegia or complete paraplegia after |
| lesions of the conus medullaris/ cauda equine with zones of partial preservation | |
| (ZPP). patients must present motor functions of hip and knee extensor and flexor | |
| muscle groups in order to be able to trigger the exoskeleton. | |
| Exclusion | |
| 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 | |
| Protocol | |
| Study method: Interventional | |
| Basic Design: Single arm | |
| Randomization: Non-randomized | |
| Blinding: Open (no blinding) | |
| Control: Uncontrolled |
During this study, the patients underwent a BWSTT (Body Weight Supported
Treadmill Training) five times per week using the HAL.
The treadmill system (Woodway USA, Inc., Waukesha, WI, USA) includes a body
weight support system with a harness. During treatments, the velocity of the treadmill
was set individually between comfortable and maximum speed tolerated by the
patients. Approximately 50% of each patient's body weight needed to be supported
by the harness system, individually reduced during the following sessions as
tolerated without substantial knee buckling or toe drag. |
8
| | The patients underwent a 90-day period of HAL training (five per week), including a
mean number of sessions of 51.7565.6. The training was performed on a treadmill
with individually adjustable body weight support and speed, recording walking speed,
time, and distance. It included a 10-m walk test (10MWT) before and after each
session and regular physiotherapy that lasted approximately 90 minutes. The training
was supervised by a physiotherapist and a medical doctor. | | | | | |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----|------------------------|-------------------|---------------------------------|-----------------|
| Intervention | 90 days (5 times/week) | | | | | |
| Sample size
(N) | 8 | | | | | |
| Results | Significant improvements have been especially shown in the functional abilities
without the HAL for over ground walking obtained in the 6MWT and the 10MWT.
While the TUG-Test was not significant after Bonferronni correction (a = 0.00625),
the results show a trend toward improvement, and an increase in the WISCI II score
of three patients is also promising.
| | | | | |
| | Endpoint | n | Average
Improvement | Paired T-
test | Wilcoxon
Signed-Rank
Test | 95% Cl |
| | 10MWT
(speed) | 8 | 0.23±0.14 m/s | P = 0.0025 | P
| Site | BG University Hospital Bergmannsheil |
|---|---|
| Patient | |
| Population | Chronic spinal cord injury ( $6.85\pm5.12$ years since injury), SCI C2-L5, ASIA D, C, and |
| ASIA A with Zones of Partial Preservation | |
| Objective | To examine functional outcomes as a function of age and lesion level in patients with |
| chronic incomplete SCI (iSCI) or chronic complete SCI (cSCI) with zones of partial | |
| preservation (ZPP) by using the HAL as a temporary training tool. | |
| Inclusion | |
| Criteria | • SCI with chronic incomplete paraplegia or tetraplegia at any spinal cord lesion |
| level (ASIA C/D) or chronic complete paraplegia (ASIAA) at lesion levels T11 or | |
| lower, AND | |
| Exclusion | |
| 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 | |
| Protocol | |
| Study method: Interventional | |
| Basic Design: Single arm | |
| Randomization: Non-randomized | |
| Blinding: Open (no blinding) | |
| Control: Uncontrolled |
During this study, the patients underwent a BWSTT (Body Weight Supported Treadmill Training) five times per week using the HAL.
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.
A 10-m walk test (10MWT) without the HAL was performed before and after each session in addition to regular physiotherapy.
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
(N) | 55 |
| Results | Overall, a time reduction of 47% in the 10MWT, self-selected speed (10MWTsss) (
| Endpoint | n | Pre-
(measurement
without HAL) | Post- (measurement
without HAL) | p |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|------------------------------------|--------|
| 10MWT
(speed) | 55 | $70.45\pm61.50$ s | $35.22\pm30.80$ s | 1 year since trauma) SCI patients with injuries ranging from C2-L5, ASIA D, C, B and ASIA A with Zones of Partial Preservation.
12
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
(HAL for Medical Use) | Predicate Device
(ReWalk K131798) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | | |
| Body
Coverage | • Worn over legs and around hips
and lower torso. | • Worn over legs and around hips
and lower torso |
| Patient
Height | 150-190 cm | 160-190 cm |
| Patient
Weight | 40-100 kg | Maximum 100 kg |
| Intended
Environment | • Flat surface of medical facilities
(indoor only)
• Must be used in combination
with BWS systems. | • Home use (includes outdoor)
• Used with canes (device
component) |
| Intended
Users | Medical professionals that have
completed designated training
program to use the device | Those that have completed
designated training program
(includes medical professionals and
nonprofessionals like companions or
family members) |
| Hardware
and
Main
Components | The system consists of three
major components:
• Controller
• Main unit
• Sensor shoes | The system consists of three major
components:
• Remote control communicator
• Exoskeleton
• Backpack |
| Device
Variations | • 8 different size/shape variations:
4 leg lengths, 2 waist widths.
• Sensor shoes are available in
sizes of 23, 24, 25, 26, 27, 28,
29, 30 cm | • The predicate comes in 2 different
purpose variations: R
(rehabilitation) and P (personal).
• The R type has 5 variations for
different pelvic band widths. The R
type has only one pelvic band
width. |
| Device | 5 Years | 5 Years |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(ReWalk K131798) |
| Power
Sources | Lithium-ion battery | • Main battery: Lithium ion battery
• Auxiliary battery: Lithium polymer
battery |
| Range
of
Motion | • Hips: 120° flexion to -20°
extension
• Knee: 120° flexion to -6°
extension | • Hips: 104° flexion to -34° extension
• Knee: 112° flexion to 2° extension |
| Method
of
Control | • Surface electromyography
Bioelectrical signals at knee and
hip extensor and flexor muscles
(CVC mode), Attached controller
used by medical professional,
Postural and Shoe sensor cues
for movement | • Remote control worn on wrist to
change modes; postural cues for
stepping |
| Modes
of
Operation | • CVC (Cybernic Voluntary
Control)
• CAC (Cybernic Autonomous
Control)
• CIC (Cybernic Impedance
Control)
Can be selected for each joint
(right/left hip/knee joints) | • SIT-TO-STAND
• STAND
• WALK
• STAND-TO-SIT
• MANUAL
• BYPASS |
| Safety
Features | • Limited joint torque and joint
velocity
• Mechanical stoppers to prevent
excessive joint flexion or
extension
• System fault for each component
throughout operation
• Task switching conditions that
will not initiate incorrect task
changes | • System fault at power up
• Main computer failure
• Incorrect operational mode
selection
• Excessive joint flexion/extension
angles
• Loss of balance while rising from a
chair
• Misstep or obstacle
• Complete loss of power
• Loss of communication between
remote and main computer |
| Fall
Prevention
Measures | BWS systems | Crutches |
| Bench
Testing | • Durability of mechanical stopper:
applicant test
• Durability of ankle part:
applicant test
• Consecutive Landing:
applicant test | • Worst Case Loading of Knee Joint:
Sponsor study
• Worst Case Loading of Hip Joint:
Sponsor study
• Structural analysis of frame: FEA
analysis |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(ReWalk K131798) |
| | • Software testing: Verification, validation & hazard analysis | validation & hazard analysis |
| Operating
Temperature | • 50° to 86° F (10° to 30° C) | • 10° to 95° F (-12° to 35° C) |
| Performance
Standards | • Electrical Safety: AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012
• Electromagnetic Compatibility: IEC 60601-1-2: 2007
• Usability: IEC 60601-1-6: 2010 and IEC 62366: 2014
• Battery Safety: IEC 62133: 2012, IEC 60335-1: 2010, IEC 60335-2-29: 2010 and ANSI/UL 1012: 2010
• Software: IEC 62304: 2015 | • Electrical Safety: IEC 60601-1: 2005
• Electromagnetic Compatibility: IEC 60601-1-2: 2007
• Battery testing: EMC/EMI certificate
• Flammability: ISO 7176-16: 2012 |
| Training | • CYBERDYNE-developed program for medical professionals
• The device is intended to be used only in medical facilities for HAL gait training.
• Must be used under the supervision of a trained medical professional in accordance with the user assessment and training certification program | • Tier based program
• Manufacturer developed program consisting of 4 tiers and 3 levels of tests for users and caregivers or companions |
| Clinical
Studies | • There are 2 studies conducted on spinal cord injury subjects. The studies cover the indications for use of the device. Both effectiveness and safety are measured in the study and statistical analysis has been performed for results on effectiveness.
• The studies were both non-comparative and non-randomized.
• 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
• The sample size of the studies are 8 and 55 subjects | • There are 3 studies reported, all conducted on spinal cord injury patients.
• All studies were non-comparative and non-randomized.
• The sample size of the studies are: 7 (6 completed measurements), 24 (20 completed measurements) and 7
• The effectiveness is primarily measured by 6 minute walk tests and 10 meter walk tests.
• The safety is primarily measured by reporting of no falls, and minor incidents that include blisters, skin tears, bruises, lesions, edema and hematoma. |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(ReWalk K131798) |
| | respectively
• The effectiveness is primarily
measured by 10 meter walk
tests, 6 minute walk tests, and
WISCI-II tests, all measured
without wearing the HAL device.
The results suggest a statistically
significant improvement in gait
related outcome measures.
• The safety of the device is
primarily measured by SAE and
AE occurrences. There were no
SAE reported. AE's included
reports of minor incidents that
included: pain due to pressure
from device parts that were
managed by adjusting a better
fit, skin irritation from electrodes
and chafed feet due to wrong
shoe size.
• Long term use of over 12 weeks
(60 treatment sessions) has not
been clinically tested. | |
| Special Controls | Complies with special controls per 21 CFR 890.3480, as applicable | Complies with special controls per 21 CFR 890.3480, as applicable |
5.9.1 Comparison of Technological Characteristics
13
14
15
5.9.2 Similarities and Differences of Technological Characteristics
Similarities are seen in patient height, weight, device lifetime, power sources, performance standards, compliance with special controls. Differences are seen in intended environment, intended users, hardware, device design, modes of operation, safety features, fall prevention measures, and bench testing.
The subject device demonstrates substantial equivalence to the predicate device by implementing mitigations to address design differences, including but not limited to: requiring a Body Weight Support (BWS) system, restricting device use to inside medical facilities, performing additional bench tests to validate exoskeleton design and control systems, and demonstrating conformance to similar recognized consensus standards (e.g., AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62133) to support the electrical safety and electromagnetic compatibility of the subject device. The clinical studies provided support a decision of substantial equivalence by demonstrating the subject device can be used as safely as the predicate device; as well as substantiating the claims made in the Indications for Use statement (see section 5.8.2 above for additional information).
16
5.10 Conclusions
Based on the above information and comparisons of intended use, indications for use, and technological characteristics, despite the differences described above for which we do not consider to raise different questions of safety and effectiveness, we believe that the subject device is as safe and effective as, and therefore substantially equivalent to, the identified predicate device.