(114 days)
Not Found
Unknown
The device description mentions a "propriety signal processing algorithm" used to process surface electromyography signals and control the device in CVC mode. While this could potentially involve ML, the summary does not provide enough detail to confirm the use of AI/ML. The other modes (CAC and CIC) are described based on postural cues, sensor shoe measurements, and joint motion, which do not explicitly indicate AI/ML.
Yes
The device is described as a "gait training device intended to temporarily help improve ambulation" for individuals with specific medical conditions like spinal cord injury, post stroke paresis, and progressive neuromuscular diseases. Its use in medical facilities under trained medical supervision for therapeutic purposes clearly indicates it is a therapeutic device.
No
Explanation: The device is described as a gait training device intended to temporarily help improve ambulation. It provides assistive torque and is used for rehabilitation and training, not for identifying the presence or absence of a disease or condition. While it uses biofeedback and records surface electromyography signals, these are used to control the device and assist training, not for diagnostic purposes.
No
The device description clearly states it is a battery-powered lower extremity exoskeleton, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The HAL for Medical Use (Lower Limb Type) is an exoskeleton designed for gait training. It provides physical assistance and biofeedback based on surface electromyography signals. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to temporarily help improve ambulation through gait training in individuals with specific neurological conditions. This is a therapeutic and rehabilitative function, not a diagnostic one.
- Device Description: The description details the mechanical and electrical components of the exoskeleton, the modes of operation, and the use of surface electrodes to record bioelectrical signals. It does not mention any components or processes related to analyzing bodily fluids or tissues.
Therefore, the HAL for Medical Use (Lower Limb Type) falls under the category of a therapeutic or rehabilitative medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
HAL for Medical Use (Lower Limb Type) orthotically fits to the lower limbs and trunk;
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.
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);
-
post stroke paresis
-
paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL
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 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) for each of the 3 configuration types (doubleleg, right-leg, and left-leg) 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 ioint (e.g., hip or knee) using surface 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 leg 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 reqular 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; hip and knee joints
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical facilities while under trained medical supervision 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 summary lists conformance with several recognized standards:
- AAMI/ANSI ES60601-1:2005/(R)2012 and A1:2012
- IEC 60601-1-2:2014
- IEC 60601-1-6:2010 and IEC62366:2014
- IEC 62133:2012, IEC 60335-1:2010, IEC 60335-2-29:2010 and ANSI/UL 1012:2010
- . IEC 62304:2015
Bench testing was conducted for performance verification and validation. Results showed that the device met pre-defined design and performance acceptance criteria, supporting its safety and effectiveness.
Specific tests and results:
- Stopper Strength Test: Evaluated durability of the mechanical stopper. Conformance was maintained after 100 cycles, indicating the stopper endures mechanical force.
- Consecutive Landing Test: Tested durability of mechanical and electrical systems against repeated impacts during walking. All 3 samples withstood 3,000,000 cycles of landing impact with no issues, proving sufficient durability for an assumed maximum of 1,000,000 steps.
- Effective Output Test:
- A. Effective torque test: Verified that the actuator met specifications for effective output torque.
- B. Maximum angle velocity test: Verified that the angular velocity was within a range tolerable by the human knee joint.
- Results showed both objectives were met.
- Driving Parts Performance Test: Measured actual torque output against intended output by control algorithm. Results showed actual torque output fell within criteria, meeting expected performance.
- Joint angle measurement: Tested accuracy of joint angle sensing. Accuracy met specification.
- Body trunk absolute angle measurement: Tested accuracy of body trunk absolute angle sensing. Measurement could sufficiently detect stable posture in forward/backward directions, ensuring safety and effectiveness.
- Plantar load measurement: Tested accuracy of plantar load measurement. Measurement could sufficiently detect planting and lifting of the sole to determine leg phase, ensuring safety and effectiveness.
- Surface Electromyography Bioelectrical signal measurement performance: Tested accuracy of surface electromyography bioelectrical signal measurement, including input impedance, common-mode rejection ratio, and frequency characteristics. Accuracy for all measurements met specifications.
- Ankle Durability Test: Tested durability of ankle parts against repeated twisting impacts. All 3 samples withstood 300,000 impacts with no issues, indicating sufficient durability.
Clinical Performance Data
Group a: spinal cord injury
Study Type: Literature search and data held by the manufacturer. Studies were mostly non-comparative and non-randomized, with subjects acting as their own control for chronic SCI patients where spontaneous recovery is unlikely.
Sample Size: Ranges from 8 to 55 across 6 assessed studies for effectiveness and 8 for safety.
Key Results: Meaningful improvements in walking ability (10MWT speed and 6MWT distance).
- 10MWT speed difference: 0.22 m/s to 0.25 m/s gain.
- 6MWT distance difference: 22.75 m to 93.2 m gain.
- Safety: No SAEs reported; all adverse events were minor incidents.
Group b: stroke
Study Type: Literature search and manufacturer's data. Studies categorized by post-stroke stages. Some studies had control groups (parallel or cross-over design), others did not (subjects acted as their own control for chronic cases).
Sample Size: Ranges from 8 to 53 across 14 assessed studies for effectiveness and 4 for safety.
Key Results: Overall, findings suggest HAL therapy is effective for improving ambulatory function in stroke.
- Chronic stage: 10MWT speed differences varied (e.g., 0.04 m/s to 0.21 m/s gain). 6MWT distance differences varied (e.g., 48.53 m gain).
- Acute/subacute stages: Studies with control groups (HAL vs. conventional physical therapy) showed significant improvements in the HAL group that were not seen in the control group.
- Safety: No adverse events typical of the disease reported. No SAEs reported.
Group c: progressive neuromuscular disease
Study Type: 1 literature item (case report), 1 investigator-initiated randomized controlled crossover clinical study (approved by the Ministry of Health, Labour and Welfare of Japan, ID'd as I22), and Post-Market Surveillance data.
Sample Size: Case report (3 patients), clinical study (24 subjects), Post-Market Surveillance (207 patients as of November 2019).
Key Results:
- Literature (case report): Improvement in 10MWT speed, Timed Up and Go test, and 6MWT distance in all 3 subjects after HAL therapy sessions.
- Clinical Trial (I22): For the primary endpoint (2MWT), the treatment effect was -10.066+/-11.062 (mean +/- SD) (P=0.0369), confirming therapeutic efficacy.
- Post-Market Surveillance:
- Participants showed improvement in gait-related outcome measures comparing pre-post intervention of the first cycle of treatment (9 sessions), consistent with the clinical trial.
- Participants maintained physical function (approx. +20% difference from baseline) even after 1.5 years with intermittent treatment cycles, despite the progressive nature of their disease.
- Blood creatine kinase (CK) data showed a decreasing trend comparing pre-post HAL treatment measurements in 100 participants, suggesting HAL treatment does not damage muscles through overuse.
- Safety: No device-caused SAEs reported.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Spinal Cord Injury (SCI)
- 10MWT speed (m/s) and 6MWT distance (m) were used as effectiveness measures.
- Aach et al. (n=8): 10MWT speed difference: 0.22 m/s; 6MWT distance difference: 93.2 m.
- Grasmucke et al. (n=55): 10MWT speed difference: 35.23 s (reduction in time); 6MWT distance difference: 48.53 m.
- Sczesny-Kais (n=11): 10MWT speed difference: 0.25 m/s; 6MWT distance difference: 63.73 m.
- Jansen et al. (n=21): 10MWT speed difference: 28.99 s (reduction in time); 6MWT distance difference: 58.95 m.
- Jansen et al. (n=8): 10MWT speed difference: 7.39 s (reduction in time); 6MWT distance difference: 22.75 m.
- Puentes et al. (n=12): Gains in 10MWT speed in all acute and chronic patients.
Stroke
- 10MWT speed (m/s) and 6MWT distance (m) were used as effectiveness measures. MCID (Minimally Clinically Important Difference) values were mentioned for some studies.
- Kawamoto et al. (n=16): 10MWT speed differences: 0.04 m/s (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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 2, 2020
Cyberdyne Inc. Yohei Suzuki Head of Production Department 2-2-1 Gakuen-Minami Tsukuba. Ibaraki 305-0818 Japan
Re: K201559
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: June 1, 2020 Received: June 10, 2020
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. 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 probibitions 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Heather Dean, PhD Assistant Director, Acute Injury Devices DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201559
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;
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.
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);
-
post stroke paresis
-
paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL
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: K201559
5.1 Applicant Information
| Date Prepared: | June 4, 2020 |
|---|---|
| Company Name and | |
| Address: | CYBERDYNE Inc. |
| 2-2-1, Gakuen-Minami, | |
| Tsukuba, Ibaraki 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 Legally Marketed Predicate Device
| 510(k) Number: | K171909 |
|---|---|
| Primary Predicate | Primary |
| Applicant: | CYBERDYNE Inc. |
| Device Name: | HAL for Medical Use (Lower Limb Type) |
| Regulation Number: | 21 CFR 890.3480 |
| Product Code: | PHL, HCC |
| Device Class: | II |
5.4 Device Description
HAL for Medical Use (Lower Limb Type) is a battery powered 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
4
different leg lengths and 2 different hip widths) for each of the 3 configuration types (doubleleg, right-leg, and left-leg) 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 ioint (e.g., hip or knee) using surface 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 leg 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 reqular 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;
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 reqular physiotherapy.
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);
-
post stroke paresis
-
parapleqia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease,
5
distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dvstrophy)
who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
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 60601-1-2:2014
- IEC 60601-1-6:2010 and IEC62366:2014 ●
- IEC 62133:2012, IEC 60335-1:2010, IEC 60335-2-29:2010 and ANSI/UL 1012:2010 ●
- . IEC 62304:2015
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 | ||
| Test the durability of the mechanical and electrical systems of HAL against | ||
| repeated impacts with the ground that occur while walking. Confirm whether | ||
| missing parts, cracks/chips of the exterior, loosening of screws, abnormal | ||
| noises, looseness, operational malfunctions, and | ||
| loosening/detachment/deformation of the connectors do not occur after 5- | ||
| years worth (service life of HAL) of consecutive impacts and vibrations. | ||
| 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
Clinical performance data were collected for each of the disease groups through literature search and data held by the manufacturer.
6 items were assessed for effectiveness and 8 were assessed for safety. Results related to effectiveness of the treatment is summarized in the table below in the form of a pre-post comparison of gait function. Measurements were conducting without wearing HAL.
| FDA-ID | Title | Authors | n | 10MWT speed | 6MWT distance | ||||
|---|---|---|---|---|---|---|---|---|---|
| Pre | Post | Difference | Pre | Post | Difference | ||||
| 11 | Voluntary driven exoskeleton | Aach et al. | 8 | $0.28 +- 0.28 m/s$ | $0.50 +- 0.34 m/s$ | $0.22 m/s$ | $70.1 +- 130 m$ | $163.3 +- 160.6 m$ | $93.2 m$ |
| 13 | Against the odds: what to | Grasmucke et al. | 55 | $70.45 +- 61.50 s$ | $35.22 +- 30.80 s$ | $35.23 s$ | $97.81 +- 95.80 m$ | $146.34 +- 118.13 m$ | $48.53 m$ |
| 17 | HAL exoskeleton training | Sczesny-Kais | 11 | $0.25 +- 0.05 m/s$ | $0.5 +- 0.07 m/s$ | $0.25 m/s$ | $86 +- 20.86 m$ | $149.73 +- 20.32 m$ | $63.73 m$ |
| 18 | Hybrid Assistive Limb Exos | Jansen et al. | 21 | $61.17 +- 44.27 s$ | $32.18 +- 25.53 s$ | $28.99 s$ | $90.81 +- 110.18 m$ | $149.76 +- 144.28 m$ | $58.95 m$ |
| 19 | Functional Outcome of Neu | Jansen et al. | 8 | $28.61 +- 6.9 s$ | $21.22 +- 6.6 s$ | $7.39 s$ | $126.75 +- 19.25 m$ | $149.5 +- 9.41 m$ | $22.75 m$ |
| $34.28 +- 18.2 s$ | $34.61 +- 17.3 s$ | $-0.33 s$ | $200 +- 117.42 m$ | $209.5 +- 123.5 m$ | $9.5 m$ | ||||
| 110 | Reshaping of Gait Coordina | Puentes et al. | 12 | Only described as figure | |||||
| Gains in 10MWT speed in all acute and chronic patients | - | - | - |
While most of these studies do not have a control, the study populations were mostly chronic SCI where it is widely accepted that spontaneous recovery no longer occurs. The subjects from these studies may be considered their own control, and any changes seen should be attributed to the treatment with the device. From these results we conclude that treatment with the device results in meaningful improvements for SCI patients in terms of walking ability.
14 items were assessed for effectiveness and 4 were assessed for safety. Results related to the effectiveness of the treatment is summarized in the table below in the form of a pre-post comparison of gait function. Measurements were conducting without wearing HAL. The
8
tables are categorized by post stroke stages of the patient in order to explain the influence of spontaneous recovery.
Overall, the findings from these studies suggest that HAL therapy is an effective method for improving ambulatory function in stroke.
| FDA-ID Title | Authors | n | 10MWT speed | MCID | 6MWT distance | MCID | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pre | Post | Difference | P-value | Pre | Post | Difference | P-value | ||||||
| 0.41 +- 0.26 m/s | 0.45 +- 0.24 m/s | 0.04 m/s | CPT 0.49 +- 0.21 m/s | ||||||||||
| CPT -> HAL 0.64 +- 0.29 m/s | 0.56 +- 0.23 m/s | ||||||||||||
| 0.80 +- 0.26 m/s | 0.60 +- 0.22 m/s | ||||||||||||
| 0.73 +- 0.3 m/s | not sig. comparing | ||||||||||||
| the two groups | for chronic stage | 169.33 +- 81.87 m | |||||||||||
| 242.50 +- 132.15 m | 190.38 +- 87.98 m | ||||||||||||
| 243.06 +- 102.62 m | 203.25 +- 86.53 m | ||||||||||||
| 236.78 +- 115.03 m | not sig. comparing | ||||||||||||
| the two groups | Tang 2012 | ||||||||||||
| 34.4m |
Three studies (14, 119, 120) do not have a legitimate control, but because the study populations are chronic, the subjects were not expected to make any gains from natural recovery based on historical prognoses, making them their own control. The other two studies (115, 118) included a control group, with 115 having a parallel design and 118 having a cross-over design.
Although the overall results from the cross-over study (118) did not show significant differences between the HAL group and control group, when comparing both groups in the first treatment period as in a parallel design, significant treatment effect was seen only in the HAL group. All the other studies show additional improvement effects with HAL treatment.
| 10MWT speed (*6 minute walking test speed) | 6MWT distance (*2MWT distance) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-ID | Title | Authors | n | Pre | Post | Difference | P-value | MCID | Pre | Post | Difference | P-value | MCID | ||
| I5 | Gait training early after stro | Nilsson et al. | 8 | 111.5 s | 30 s | 81.5 s | N/A | Perera et al. | |||||||
| I12 | Locomotion improvement | Watanabe et al. | 22 | HAL group | 0.61 $\pm$ 0.43 m/s | 0.85 $\pm$ 0.43 m/s | 0.24 m/s | 1 item of literature was assessed for both effectiveness and safety. Results from a clinical trial and post market survey were also assessed for both effectiveness and safety. |
Literature for this group is limited due to the rare nature of the diseases and only one published study was assessed. 133 is a case report of 3 patients with Limb Girdle Muscular Dystrophy. No numerical results were reported, but the figures indicate that the 10MWT speed, Timed Up and Go test, and 6MWT distance showed an improvement in all subjects at the end of the 24 sessions of HAL therapy. The improvements in 10MWT speed and Timed Up and Go test remained at the 6 week follow up as well, though the 6MWT distance did not.
Since the literature is limited, performance needs to be further evaluated for this group using data qenerated or held by the manufacturer.
An investigator-initiated randomized controlled crossover clinical study approved by the Ministry of Health. Labour and Welfare of Japan was conducted for this patient population. and the results were used to gain medical device approval in Japan. The study, ID'd as I22, compared HAL therapy to a conventional gait training program as the control in an AB/BA crossover protocol, where each group received 9 sessions of each treatment in 4 weeks separated by a 1 week washout period. A total of 24 subjects completed the protocol, and inclusion criteria was patients who have ambulatory dysfunction due to one of the 8 rare progressive neuromuscular disorders for this group c.
For the primary endpoint, the 2MWT, the treatment effect was -10.066±11.062 (mean ± SD, hereinafter the same) (P=0.0369), which confirmed the therapeutic efficacy of HAL.
Furthermore, after the device's approval in Japan, data from Post-Market Surveillance have been collected over four years. Though certain aspects of control over adherence to the protocol used by 123 had to be ceded due to the nature of real world data, patients received 9 sessions of HAL therapy for each cycle, and the data was organized accordingly. As of November 2019 a total of 207 patients have participated in the PMS. Results support previous findings from the clinical trial that the device can maintain or even improve physical functions of patients with progressive neuromuscular disease. Overall, there were three main findings related to effectiveness and safety:
10
-
Participants showed improvement in gait related outcome measures comparing pre-post intervention of the first cycle of treatment (9 sessions). The results are in line with the results obtained in the clinical trial, which the design of the survey was based on.
-
Even after 1.5 years from the measurement of baseline, with intermittent treatment cycles participants showed about +20% difference from the baseline function, despite the progressive nature of their disease.
-
Blood creatine kinase data was collected from a total of 100 participants and results show a decreasing trend when comparing pre-post HAL treatment measurements. The lack of rise in CK levels suggests that HAL treatment does not damage the muscles through overuse.
5.8 Comparisons
5.8.1 Comparison of Intended Use/Indications for Use
| Indications for Use | |
|---|---|
| Subject Device | Predicate Device |
| HAL for Medical Use (Lower Limb Type) | HAL for Medical Use (Lower Limb Type) |
| (K171909) | |
| HAL for Medical Use (Lower Limb Type) | |
| orthotically fits to the lower limbs and trunk; | |
| 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. | 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. | |
| 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); - post stroke paresis
- paraplegia due to progressive
neuromuscular diseases (spinal muscular
atrophy, spinal and bulbar muscular
atrophy, amyotrophic lateral sclerosis,
Charcot-Marie-Tooth disease, distal
muscular dystrophy, inclusion body
myositis, congenital myopathy, muscular
dystrophy)
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 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. |
| In preparation for HAL gait training, the
controller can be used while the exoskeleton
is not donned to provide biofeedback training | HAL is intended to be used inside medical
facilities while under trained medical |
| 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. | supervision in accordance with the user
assessment and training certification program |
11
5.8.2 Similarities and Differences of Intended Use/Indications for Use (IFU)
The subject device expands upon the Indication for Use of the predicate device with the addition of these two patient populations. The stroke population and rare progressive neuromuscular diseases, namely Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, Spinal and Bulbar Muscular Atrophy, Charcot-Marie-Tooth Disease, Muscular Dystrophy, Distal Myopathy, Congenital Myopathy and Inclusion Body Myositis.
The inclusion of individuals with post stroke paresis is not uncommon among the devices in the 21 CFR 890.3480 regulation. Individuals with progressive neuromuscular diseases is a new population not found in the indications of any marketed device. Moreover there are not many medical services available for this population, with the exception of several pharmaceuticals.
The new additions to the target patient population raise different questions of safety and effectiveness, but the additional clinical evidence presented show that the device is both safe and effective for these populations.
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Limitations | • Healthy bone density.
• Skeleton does not suffer from any
fractures.
• In general good health.
• Candidates of the device should
have the following characteristics:
• i. Hip width and leg segment lengths
are within the range of adjustability
• ii. Weight is within the range of 40 -
100 kg (89 - 220 lbs)
• iii. Height is within the range of 150-
190 cm (60 ~ 74 in), with allowance
for exceptions as long as the leg
segment length is within the range
of adjustability
Judgment of whether this device is | • Healthy bone density.
• Skeleton does not suffer from any
fractures.
• In general good health.
• Candidates of the device should
have the following characteristics:
• i. Hip width and leg segment
lengths are within the range of
adjustability
• ii. Weight is within the range of 40
- 100 kg (89 - 220 lbs)
• iii. Height is within the range of
150- 190 cm (60 ~ 74 in), with
allowance for exceptions as long
as the leg segment length is within
the range of adjustability
Judgment of whether this device is |
| | | |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| | suitable for a person with an unusual
body shape (such as deformation of
the leg) shall be made after
comprehensive consideration of leg
length, hip width, positions of cuffs
and belts, sizes of sensor shoes, and
fit of the joint positions and frame to
the person's body.
• Physical and cognitive ability to use
a treadmill, walker, or parallel
bars. Use does not need to be
independent of clinical support.
• Ability to communicate pain and
need to cease session, verbally or
nonverbally.
• Ability to acknowledge
communication from the therapist,
verbally or nonverbally. | suitable for a person with an
unusual body shape (such as
deformation of the leg) shall be
made after comprehensive
consideration of leg length, hip
width, positions of cuffs and belts,
sizes of sensor shoes, and fit of the
joint positions and frame to the
person's body. |
| Contraindications | • Persons whose body dimensions
such as weight, upper leg length,
lower leg length and hip width, are
not suitable for this device.
• Persons who have severe
deformations of their body parts.*
• Persons whom physicians have
judged unsuitable for the
implementation of therapeutic
exercise such as standing and
walking treatment.
• Persons who cannot have
electrodes affixed to any part of
their body due to a skin disease or
any other reason.
• Severe spasticity (Ashworth4)
• Unstable spine or unhealed limbs or
pelvic fractures.
• Heterotopic ossification.
• Significant contractures.
• Psychiatric or cognitive situations
that may interfere with proper
operation of the device. | • Persons whose body dimensions
such as weight, upper leg length,
lower leg length and hip width, are
not suitable for this device.
• Persons who have severe
deformations of their body parts.*
• Persons whom physicians have
judged unsuitable for the
implementation of therapeutic
exercise such as standing and
walking treatment.
• Persons who cannot have
electrodes affixed to any part of
their body due to a skin disease or
any other reason.
• Severe spasticity (Ashworth4)
• Unstable spine or unhealed limbs
or pelvic fractures.
• Heterotopic ossification.
• Significant contractures.
• Psychiatric or cognitive situations
that may interfere with proper
operation of the device.
• Pregnant women. |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| | inability to follow directions.
• Pregnant women.
• History of severe neurological
injuries other than SCI, stroke,
spinal muscular atrophy, spinal and
bulbar muscular atrophy,
amyotrophic lateral sclerosis,
Charcot-Marie-Tooth disease, distal
muscular dystrophy, inclusion body
myositis, congenital myopathy or
muscular dystrophy (MS, CP, TBI,
subarachnoid hemorrhage, etc.)
• Persons with severe concurrent
medical diseases: infections,
circulatory, heart or lung, pressure
sores
• Persons with colostomy
• Persons with poor skin integrity in
areas in contact with the device
• Persons with decreased standing
tolerance due to orthostatic
hypotension
• Persons with strict range of motion
(ROM) restrictions that cannot
tolerate the entire ROM of HAL, or
that would prevent a patient from
achieving a normal, reciprocal gait
pattern
• Persons with unresolved deep vein
thrombosis
• Persons with uncontrolled
Autonomic Dysreflexia
• Persons with uncontrolled
hypertension or hypotension
• Persons with lower limb prosthesis
• Persons who require ventilators
• Persons with epilepsy | injuries other than SCI (MS, CP,
ALS, TBI, etc.)
• Persons with severe concurrent
medical diseases: infections,
circulatory, heart or lung, pressure
sores
• Persons with colostomy
• Persons with poor skin integrity in
areas in contact with the device
• Persons with decreased standing
tolerance due to orthostatic
hypotension
• Persons with strict range of motion
(ROM) restrictions that cannot
tolerate the entire ROM of HAL, or
that would prevent a patient from
achieving a normal, reciprocal gait
pattern
• Persons with unresolved deep
vein thrombosis
• Persons with uncontrolled
Autonomic Dysreflexia
• Persons with uncontrolled
hypertension or hypotension
• Persons with lower limb prosthesis
• Persons who require ventilators
• Persons with epilepsy |
| Patient Height | Same | 150-190 cm |
| Patient Weight | Same | 40-100 kg |
| Intended
Environment | Same | • Flat surface of
training/rehabilitation facility (indoor
only)
• Must be used in combination with |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| Intended Users | Same | Body Weight Support systems
Medical professionals that have
completed designated training
program to use the device |
| Hardware and
Main
Components | Same | The system consists of three major
components:
• Controller
• Main unit
• Sensor shoes |
| Device Variations | • Double leg configuration and Single
leg configurations (right and left
configurations)
• Same
• Same | • Double leg configuration
• 8 different size variations: 4
different leg lengths, 2 different
waist widths
• Sensor shoes are available in
different sizes of 23, 24, 25, 26, 27,
28, 29, 30 cm |
| Device Lifetime | Same | 5 Years |
| Power Sources | Same | • Lithium ion battery |
| Range of Motion | Same | • Hips: 120° flexion to -20° extension
• Knee: 120° flexion to -6° extension |
| Method of
Control | Same | • 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 |
| Modes of
Operation | Same | • CVC (Cybernic Voluntary Control)
• CAC (Cybernic Autonomous
Control)
• CIC (Cybernic Impedance Control)
*Can be selected for each joint
(right/left hip/knee joints) |
| Main risk
(mitigation) | Same | Drive patient's joints past their ROM
(mechanical stoppers) |
| Safety Features | Same | • 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 |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| Fall Prevention
Measures | Same | not initiate incorrect task changes
BWS systems |
| Bench Testing | Same | • Durability of mechanical stopper: applicant test
• Durability of ankle part
Consecutive Landing: applicant test
• Effective output: applicant test
• Software testing: Verification, validation & hazard analysis |
| Operating
Temperature | Same | • 50° to 86° F (10° to 30° C) |
| Performance
Standards | • Same
• Electromagnetic Compatibility: IEC 60601-1-2 Edition 4.0, 2014
• Same
• Same
• Same | • 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 |
| Training | Same
(training material has been updated to address new indications and description of additional configurations) | • 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. |
| Clinical Studies |
• There are 6 studies conducted on spinal cord injury subjects, that include the 2 studies listed in K171909, used for assessment of effectiveness. There are 8 studies that were used for assessment of safety.
• All studies were non-comparative and non-randomized. One study with an ID of I9 had 2 groups with | • 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 studies and statistical analysis has been performed for results on effectiveness.
• The studies were both non-comparative and non-randomized |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| | • different treatment frequencies.
• Subjects were mostly chronic SCI patients with the same range of lesion as the studies in K171909.
• The sample size range of the studies are the same, 8 ~ 55.
• Results on effectiveness of 3 of the newly added studies are consistent with the findings from K171909. The 4th newly added study, I9, showed that gains made from treatment with the HAL device were maintained for a year with continued treatment at the same treatment frequency as during the intervention, as well as with continued treatment at a much lower frequency.
• Results on safety is the same, that there were no SAEs reported, and all adverse events were minor incidents. Adverse events that occurred with use of other devices is unlikely to occur with the use of the HAL because falls are mitigated with a mandatory combined use with a BWS system, use on patients with low bone density is labeled as a limitation, and a swollen ankle has never been reported in our global market experience. It is assumed that the sensor shoes, which is an essential component of the HAL, protects the ankle from making physical contact with the rigid parts of the device.
• Long term use of the device has been tested, and the result supports long term effects of treatment even with decreased treatment frequency. | • 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, 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. |
| |
• There are 14 studies conducted on stroke subjects used for assessment of effectiveness. Of these, 5 were studies for patients of over 6 months | |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| | post stroke and 7 were for patients
of less than 6 months post stroke.
The remaining 2 studies monitored
weekly 10MWT results during
conventional physical
therapy/rehabilitation after stroke,
and started the intervention with HAL
when the walk speeds stopped
showing improvements.
There are 4 studies that were used
for assessment of safety.
• Some studies were comparative with
a control group receiving
conventional physical therapy.
• The sample size range of the studies
are 8 ~ 53.
• The effectiveness is primarily
measured by the 10MWT and
6MWT, all measured without
wearing the HAL device. Overall, the
results suggest a statistically
significant improvement in gait
related outcome measures. Results
from studies that could not rule out
the effects of spontaneous recovery
early after the onset of stroke still
trended toward improvement of gait
related outcome measures, and the
studies that addressed spontaneous
recovery, either through intervention
timing or with a control group,
suggest that the treatment with the
device show statistically and
clinically significant improvements in
gait related outcome measures while
conventional physical therapy does
not.
• The safety of the device is primarily
measured by SAE and AE
occurrences. Results on safety
suggest that there are no adverse
events typical of the disease. No
SAEs are reported.
• Though limited, there are some
studies that support either lasting or
long term effects. | |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| |
• There are 3 studies (1 literature, 1
clinical trial and 1 post market
survey) conducted on patients with
diseases belonging in the group. All
3 studies account for both safety and
effectiveness.
• The sample size range of the studies
are 3 ~ 207.
• The effectiveness is primarily
measured by the 10MWT and
2MWT, all measured without
wearing the HAL device. Results
suggest that treatment with the HAL
device shows improvement in gait
related outcome measures despite
the progressive nature of the
diseases. Since the literature and
clinical trial have such small sample
sizes, the findings from the post
market survey bears significant
weight and are quickly summarized
below:
- Participants showed improvement
in gait related outcome measures
comparing pre-post intervention of
the first cycle of treatment (9
sessions). - Even after 1.5 years from the
measurement of baseline, with
intermittent treatment cycles
participants showed about +20%
difference from the baseline function,
despite the progressive nature of
their disease. - Blood creatine kinase data was
collected from a total of 100
participants and results show a
decreasing trend when comparing
pre-post HAL treatment
measurements. The lack of rise in
CK levels suggests that HAL
treatment does not damage the | |
| Device | Subject Device
(HAL for Medical Use) | Predicate Device
(HAL for Medical Use K171909) |
| | • The safety of the device is primarily
measured by SAE occurrences. No
device caused SAEs are reported.
• Long term effects are evident from
post market survey results. | |
| Special Controls | Same | Conforms with special controls per
21 CFR 890.3480, as applicable |
5.8.3 Comparison of Characteristics
12
13
14
15
16
17
18
19
5.8.4 Similarities and Differences of Non-clinical Performance Data
The subject device is an expansion of the predicate device, so the characteristics that they share are many and exactly the same.
The contraindications were adjusted slightly to reflect the addition of stroke and progressive neuromuscular diseases in the indication, as well as to reflect the exclusionary criteria from the studies used to show safety and effectiveness for these new populations.
The subject device adds two single-leg configurations; right and left leg configurations. Each of these additional configurations come with all of the size/shape variations of the double leg device, as well as the different Sensor Shoe sizes. The difference between the single-leg versions and the double-leg version is simple. One of the legs, from the hip joint down has been removed from the main unit, and it is replaced by a long cord that attaches to one of the sensor shoes. The sensor shoe still provides floor reaction force sensor readings, but no assistance is provided for the side with no device leg.
Though different questions about safety may seem like to arise due to the difference in configurations, the non-clinical performance testing also applies to the new single-leg versions. Safety is therefore not compromised.
5.8.5 Similarities and Differences of Clinical Performance Data
In addition to the clinical studies presented for the predicate device that demonstrated safety and efficacy for spinal cord injury, the additional studies presented for the subject device increases the robustness of evidence supporting safety and efficacy.
Stroke is a new indication. Safety and effectiveness for this population is supported by many
20
clinical studies, although the significance level of the changes in outcome measures that show effectiveness vary among the studies.
The most representative finding comes from a comparative clinical study for 16 post stroke subjects (8 with HAL and 8 with conventional gait rehabilitation). All subjects were new stroke survivors who underwent conventional rehabilitation until their gait function ceased to improve, showing the end of natural recovery as well as the limits of the effects of conventional rehabilitation. This timing was determined through monitoring of weekly measurements of the 10 meter walk speed. Once gait function ceased to improve from conventional rehabilitation, subjects started the comparative intervention, and results after a 5 week treatment program (5 sessions per week) were compared to show significant differences between the two groups. The group that used the HAL showed great additional improvement (greater than the MCID) whereas the group that continued conventional qait rehabilitation did not show much change. The results of the control group indirectly proves that the criteria used to identify the "end" of natural recovery & rehabilitation was valid, which in turn suggests that the treatment with HAL provides additional improvements for patients in this population.
Patients with progressive neuromuscular disease are not the typical population to use this type of medical device. However a GCP clinical trial and post market survey in Japan shows temporary effects for this population. Although the speed of disease progression greatly depends on the type of disease and the progression phase, as a group, treatment with the HAL helped patients maintain their physical function (distance walked in 2 minutes) above the baseline level before starting treatment for over 1.5 years. Also noteworthy was the finding that CK (Creatine Kinase) levels did not elevate after treatment and instead showed a slight tendency to decrease, which suggests that treatment with HAL does not lead to overuse or excessively burden the muscles when used for patients in this population.
5.9 Conclusions
Based on the information above with comparisons of intended use, indications for use, and technological characteristics, the new differences that raise different questions of safety and effectiveness were addressed, and we believe that the subject device is as safe and effective as, and therefore substantially equivalent to, the identified predicate device.