(109 days)
Not Found
No
The description focuses on mechanical assistance and sensor-based timing of that assistance, with adjustable parameters set by a therapist. There is no mention of algorithms that learn or adapt based on data.
Yes
The device is intended to assist ambulatory functions in rehabilitation for people with hemiplegia/hemiparesis due to stroke, which directly addresses a medical condition to improve health.
No.
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation, not to diagnose medical conditions.
No
The device description explicitly states it is a "lightweight, wearable, battery-powered soft orthotic exosuit" and details mechanical and electrical components, including motors, cables, load cells, and sensors. This indicates it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the ReWalk ReStore is not an In Vitro Diagnostic (IVD) device.
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.
- ReWalk ReStore Function: The ReWalk ReStore is a wearable, battery-powered soft orthotic exosuit. Its purpose is to provide mechanical assistance to the ankle joint during walking for individuals with hemiplegia/hemiparesis due to stroke. It directly interacts with the patient's body to aid in physical rehabilitation.
- No Specimen Analysis: The device description and intended use clearly indicate that the ReWalk ReStore does not analyze any biological specimens. It uses sensors to detect gait events and applies mechanical forces to assist movement.
Therefore, the ReWalk ReStore falls under the category of a medical device used for physical rehabilitation and assistance, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.
Product codes (comma separated list FDA assigned to the subject device)
PHL
Device Description
The ReWalk ReStore™ ("ReStore™") device is a lightweight, wearable, battery-powered soft orthotic exosuit is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
The ReStore™ device is designed to provide plantarflexion (PF) and dorsiflexion (DF) assistance to the paretic ankle during walking by transferring mechanical forces from two motors mounted on a Waistpack through Bowden cables to attachment points worn on the calf and insole. Through a set of gears, the motors actuate the Bowden cables to provide plantarflexion and dorsiflexion forces. Forces are transferred through the Bowden cables by pulling an inner cable within an outer sheath. The distal end of the outer sheath is fixed at an attachment point worn on the Calf Wrap, and the distal end of the inner cable is fixed at an attachment point worn on an insole made of flexible plastic that is worn within the shoe on the paretic foot. The relative motion that occurs between these two points when the inner cable is moved results in torques being applied across the ankle joint. The placement of the attachment points anterior and posterior to the ankle joint result in corresponding torques to provide assistance during dorsiflexion and plantarflexion, respectively. Load cells attached to the cables provide force feedback allowing control of the level of assistance provided to the patient. Sensors attached to the shoes are used to detect gait events during walking to inform timing of the assistance from the ReStore™ device. Specifically, inertial measurement units (IMUs) are attached to shoes on both legs to provide signals corresponding to events within the gait cycle, such as heel-strike or toe-off, in order to determine the appropriate timing of assistance from ReStore™.
The ReStore™ is designed to provide adjustable levels of assistance to the patient's paretic leg. It does not constrain or provide assistance to the patient's non-paretic leg. The device enables the therapist to individually modify the level of assistance provided during plantarand dorsiflexion as appropriate for each individual patient. The timing of assistance is based on data collected from the motion sensors on both the paretic and non-paretic feet, which determines the patient's orientation within their gait cycle.
Plantarflexion assistance occurs during the late stance and toe-off portion of the paretic leg gait cycle. This level of assistance targets a desired cable force, which can be adjusted from 0% to 25% of the patient's body weight. Dorsiflexion assistance occurs during the swing and heel-strike phase of the paretic gait cycle. This level of assistance targets a desired cable travel, which can be adjusted from 0 cm to 5 cm. Plantarflexion and dorsiflexion assistance levels are determined by the therapist based on visual evaluation of the patient's gait symmetry, the therapeutic goals of the walking session or the ability of the patient to achieve consistent ground clearance or heel-strike landing patterns with their paretic foot. The ReStore™ device includes apparel-like components, mechanical components, electrical components, cables, sensors and a handheld controller.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle joint
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained therapist / rehabilitation institutions
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)
Three IRB-Approved protocols have been conducted in individuals with hemiplegia / hemiparesis resulting from Stroke: one 44-subject multi-site clinical trial and two engineering studies.
44-Subject Multisite Clinical Trial:
- Sample Size: 44 subjects enrolled; 36 subjects completed all 7 study visits.
- Study Type: Multi-site clinical trial, 7 study visits with the ReStore™ device over approximately 4 weeks.
- Data Source: Conducted across 5 study sites, IRB-approved, and conducted in accordance with principles of Good Clinical Practice (GCP).
- Key Results:
- Safety: Zero device-related serious adverse events and zero device-related falls. Initial adverse events (13.5% of study visits) were reduced to 1.3% after mandatory re-training on donning and fitting techniques.
- Walking Speed: Majority of subjects increased walking speed.
- With ReStore™ device: 31 subjects (86.1%) increased comfortable walking speed, 29 subjects (80.6%) increased maximal walking speed.
- Independent of ReStore™ device: 23 subjects (63.9%) increased comfortable walking speed, 28 subjects (77.7%) increased maximal walking speed.
- Walking Distance: Average walking distance during 2-minute walk test increased by 47.9 ft. in Assist mode compared to Slack mode.
- Duration of Use: Average duration of walking in Assist mode increased by 12.4% between Visit 2 and Visit 6.
Engineering Studies:
- Sample Size: 35 unique participants enrolled (10 participants in both studies).
- Study Type: Two ongoing protocols for development and testing of ReStore™ and similar prototypes.
- Data Source: Wyss Institute for Biologically Inspired Engineering at Harvard University (Cambridge, MA). IRB approved, conducted according to GCP.
- Key Results: 472 study visits conducted since 2014. Low frequency and severity of device-related adverse events. Zero device-related serious adverse events and zero device-related falls.
Clinical Validation Study (substudy of Engineering Protocols):
- Sample Size: 9 participants.
- Study Type: Validation substudy.
- Data Source: Conducted under the Engineering Protocols.
- Key Results: One device-related adverse event, resolved without intervention. Zero device-related serious adverse events and zero device-related falls.
Overall Summary of Clinical Performance:
- Total Subjects: 79 individuals with hemiparesis / hemiplegia from stroke.
- Total Study Visits: 740 combined visits.
- Conclusion: All three studies demonstrated that the ReStore™ is safe and well tolerated by individuals post-stroke and is appropriate for use during ambulatory functions in rehabilitation settings under the supervision of a trained therapist.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Percentage of subjects increasing walking speed, average increase in walking distance.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 890.3480 Powered lower extremity exoskeleton.
(a)
Identification. A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
i.e., cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
e.g., indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
e.g., EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
e.g., level of supervision or assistance, and environment of use (e.g., indoors and/or outdoors) including obstacles and terrain).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 3, 2019
ReWalk Robotics Ltd. Ofir Koren General Manager, VP R&D and Regulatory Affairs 3 Hetnufa St., POB Box- 161 Yokneam, 2069203 Israel
Re: K190337
Trade/Device Name: ReWalk Restore Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL Dated: March 4, 2019 Received: March 5, 2019
Dear Ofir Koren:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/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 Advice (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,
Vivek Pinto, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation 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) K190337
Device Name ReWalk Restore
Indications for Use (Describe)
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for ReWalk Robotics. The logo has the word "ReWalk" in a combination of gray and yellow. Below the word "ReWalk" is the word "Robotics" in gray with a series of horizontal lines to the left of the word.
ReStore™ 510(k) Summary
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Image /page/4/Picture/0 description: The image shows the ReWalk Robotics logo. The logo features the word "ReWalk" in a bold, stylized font, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller, gray font with lines to the left of the word. The logo is clean and modern, reflecting the company's focus on innovative robotic solutions.
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92
1. Submission Sponsor
ReWalk Robotics Ltd. 3 Hatnufa St. Yokneam, Israel 2069203. POB: 161 Establishment Registration: 3007615665
2. Submission Correspondent
Ofir Koren, General Manager, VP R&D and Regulatory Affairs
Phone: (+972) 54-52-25-792 Fax: (+972) 4-95-90-125 E-mail: Ofir@rewalk.com
3. Date Prepared:
June 3, 2019
4. Device Identification
| Name of Device: | ReWalk ReStore™ |
|---|---|
| Classification Name: | Powered Exoskeleton |
| Regulation: | 21 CFR §890.3480 |
| Regulatory Class: | Class II |
| Product Classification Code: | PHL |
| Classification panel: | Neurology |
ട്. Legally Marketed Predicate Device
| Predicate Manufacturer: | Parker Hannifin Corporation |
|---|---|
| Predicate Trade Name: | Indego® |
| Predicate 510(k): | K173530 |
6. Device Description
The ReWalk ReStore™ ("ReStore™") device is a lightweight, wearable, battery-powered soft orthotic exosuit is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
The ReStore™ device is designed to provide plantarflexion (PF) and dorsiflexion (DF) assistance to the paretic ankle during walking by transferring mechanical forces from two motors mounted on a Waistpack through Bowden cables to attachment points worn on the calf and insole. Through a set of gears, the motors actuate the Bowden cables to provide plantarflexion and dorsiflexion forces. Forces are transferred through the Bowden cables by pulling an inner cable within an outer sheath. The distal end of the outer sheath is fixed at an attachment point worn on the Calf Wrap, and the distal end of the inner cable is fixed at an attachment point worn on an insole made of flexible plastic that is worn within the shoe on the paretic foot. The relative motion that occurs between these two points when the inner cable is moved results in torques being applied across the ankle joint. The
5
Image /page/5/Picture/0 description: The image contains the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller font size and gray color. There are also some gray lines below the word "ReWalk".
placement of the attachment points anterior and posterior to the ankle joint result in corresponding torques to provide assistance during dorsiflexion and plantarflexion, respectively. Load cells attached to the cables provide force feedback allowing control of the level of assistance provided to the patient. Sensors attached to the shoes are used to detect gait events during walking to inform timing of the assistance from the ReStore™ device. Specifically, inertial measurement units (IMUs) are attached to shoes on both legs to provide signals corresponding to events within the gait cycle, such as heel-strike or toeoff, in order to determine the appropriate timing of assistance from ReStore™.
The ReStore™ is designed to provide adjustable levels of assistance to the patient's paretic leg. It does not constrain or provide assistance to the patient's non-paretic leg. The device enables the therapist to individually modify the level of assistance provided during plantarand dorsiflexion as appropriate for each individual patient. The timing of assistance is based on data collected from the motion sensors on both the paretic and non-paretic feet, which determines the patient's orientation within their gait cycle.
Plantarflexion assistance occurs during the late stance and toe-off portion of the paretic leg gait cycle. This level of assistance targets a desired cable force, which can be adjusted from 0% to 25% of the patient's body weight. Dorsiflexion assistance occurs during the swing and heel-strike phase of the paretic gait cycle. This level of assistance targets a desired cable travel, which can be adjusted from 0 cm to 5 cm. Plantarflexion and dorsiflexion assistance levels are determined by the therapist based on visual evaluation of the patient's gait symmetry, the therapeutic goals of the walking session or the ability of the patient to achieve consistent ground clearance or heel-strike landing patterns with their paretic foot. The ReStore™ device includes apparel-like components, mechanical components, electrical components, cables, sensors and a handheld controller.
| Mode Name | Mode Description |
|---|---|
| Assist Mode | |
| (dynamic ankle | |
| assistance) | A mode in which the cables provide assistance for ankle plantar and dorsiflexion during forward walking on level ground (treadmill or over ground). The level of assistance provided by the device can be adjusted by the therapist. |
| Slack Mode | |
| (no assistance) | A mode in which the cables are positioned so as to not provide any resistance to movement by the subject during his/her full range of movement. |
| Brace Mode | |
| (fixed ankle | |
| position) | A mode in which the cables are retracted in a configuration that restricts the ankle movement in the plantar and/or dorsiflexion directions to maintain ankle position. |
Table 1: (System Modes)
During treadmill walking with ReStore™ in Slack Mode, no assistance is provided by ReStore. Patients should be evaluated for their baseline treadmill walking ability, and overhead harnessing, body weight support, or the integrated ReStore™ Support Handle should be used for safety if determined appropriate by the therapist.
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Image /page/6/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo has the word "ReWalk" in large letters, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in smaller letters. There are also some gray lines below the word "ReWalk".
7. Intended Use / Indication for Use
The ReWalk ReStore is intended to be used to assist ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/ hemiparesis due to stroke who can ambulate at least 1.5m (5ft) with no more than minimal to moderate levels of assistance. The trained therapist must successfully complete a training program prior to operating the device. The device is not intended for sports or stair climbing.
8. Substantial Equivalence Discussion
The following table compares the ReStore™ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance. The comparison of the devices in Table 2 below provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new or different questions of safety or effectiveness based on the similarities to the predicate device.
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Image /page/7/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo has the word "ReWalk" in large letters, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in smaller letters. There are also some gray lines below the word "ReWalk".
| Table 2: (Substantial Equivalence Discussion) | |||
|---|---|---|---|
| Characteristic | Parker Hannifin Corporation | ||
| Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification | |
| 510(k) number | K173530 | K190337 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Regulation No. | 890.3480 | 890.3480 | Same |
| Indication for Use | The Indego® orthotically fits to the | ||
| lower limbs and trunk. The device is | |||
| intended to enable individuals with | |||
| spinal cord injury at levels T3 to L5 | |||
| to perform ambulatory functions with | |||
| supervision of a specially trained | |||
| companion in accordance with the | |||
| user assessment and training | |||
| certification program. The device is | |||
| also intended to enable individuals | |||
| with spinal cord injury at levels C7 to | |||
| L5 to perform ambulatory functions | |||
| in rehabilitation institutions in | |||
| accordance with the user assessment | |||
| and training certification program. | |||
| Finally, the Indego® is also intended | |||
| to enable individuals with hemiplegia | |||
| (with motor function of 4/5 in least | |||
| one upper extremity) due to | |||
| cerebrovascular accident (CVA) to | |||
| perform ambulatory functions in | |||
| rehabilitation institutions in | |||
| accordance with the user assessment | |||
| and training certification program. | |||
| The Indego is not intended for sports | |||
| or stair climbing. | The ReWalk ReStore is intended to be used to | ||
| assist ambulatory functions in rehabilitation | |||
| institutions under the supervision of a trained | |||
| therapist for people with hemiplegia/ | |||
| hemiparesis due to stroke who can ambulate at | |||
| least 1.5m (5ft) with no more than minimal to | |||
| moderate levels of assistance. The trained | |||
| therapist must successfully complete a training | |||
| program prior to operating the device. The | |||
| device is not intended for sports or stair | |||
| climbing. | Comparable - | ||
| The intended use of enabling individuals to perform | |||
| ambulatory functions in rehabilitation institutions is | |||
| the same. | |||
| Indego® has broader indications, namely for | |||
| individuals with spinal cord injury in addition to | |||
| individuals with hemiplegia (with motor function of | |||
| 4/5 in least one upper extremity) due to | |||
| cerebrovascular accident (CVA). | |||
| The ReStore™ indications are a subset of these | |||
| indications (individuals with hemiplegia due to | |||
| stroke). | |||
| This difference does not raise any new or different | |||
| questions of safety or effectiveness, as is | |||
| demonstrated by clinical data. | |||
| Characteristic | Parker Hannifin Corporation | ||
| Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification | |
| Patient Population | Individuals with hemiplegia (with | ||
| motor function of 4/5 in at least one | |||
| upper extremity) due to | |||
| cerebrovascular accident (CVA) | Individuals with hemiplegia / hemiparesis due | ||
| to stroke | Similar – | ||
| Both devices are indicated for use by individuals | |||
| with hemiplegia (hemiparesis which is subset of | |||
| Hemiplegia is also included in ReStore™). |
ReStore™ does not require use of upper extremity
mobility aids. Indego® inherently requires use of
mobility aides like crutches for support, and thus
requires motor function of 4/5 in at least one upper
extremity.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Device
construction and
materials | The Indego® device is composed of
rigid frame and textile strapping
providing body weight support to the
patient | ReStore™ device is composed of textile frame
and strapping worn by patient | Different –
ReStore™ provides the ankle joint with assistance
without supporting the patient, while the Indego®
provides assistance within a rigid body supporting
frame.
Both frames enable transfer of mechanical forces
from motors and gears (based on data obtained
from sensors) to the wearer.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Body Coverage | Worn over legs and around hips and
lower torso | Worn over legs and around lower torso | Similar –
ReStore™ provides assistance to paretic ankle
joint, while Indego® provides assistance to knee
and hip joints, thus the difference in body coverage.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Size of
Components | Modular small, medium and large
upper leg, lower leg and hip
components and control unit
integrated into hip unit | Modular small, medium, large and extra-large
paretic leg component, control unit
(waistpack) integrated into adjustable waist
belt | Similar -
Both devices utilize similar component sizes.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Mobility Aid | Walker, cane or crutches | Walker, cane, crutches, harness or overhead
support | Similar -
Mobility aides are required for use of Indego®. Use
of mobility aides for ReStore™ is per therapist
discretion.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Ability of User
Mobility | Sit, stand, walk and turn | Sit, stand, walk and turn | Same |
| Walking Speed | ~2 km/hr. | Up to 5km/hr. | Different -
Both devices utilize upper limit for walking speed.
The ReStore™ maximum supported speed is
higher, however the gait algorithm provides
consistent force and timing profiles to support
wearer's natural walking speed.
This difference does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Type of Surface | Smooth, grass, cement, carpet,
transitions, thresholds | In the clinical trial ReStore™ was tested under
the following conditions:
Treadmill: Assist Mode
Level Indoor Floor: All modes (Assist, Brace,
and Slack mode) | Different -
ReStore™ can be used on treadmills as well.
The device can be used on indoor only, on surfaces
including carpeting and hard floors or even
surfaces.
This difference does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Control Method | Uses postural cues and user motion to
trigger all transitions | Uses patient gait motion to trigger assistance | Similar -
Both devices are activated by user motion.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Patient
height/weight | 61" to 75" (155 to 191 cm)
Up to 250 lbs. (113kg) | 56" to 75.5" (142 to 192cm)
Up to 264 lbs. (120kg) | Similar -
Both devices support similar range of height/weight
of patient.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Range of Motion | Hip: 110° flexion to 30° extension
Knee: 110° flexion to 10° extension | Axial forces applied to the ankle joint
corresponding to wearer's ankle joint range of
motion | Similar -
Both devices utilize assistance to the patient gait
cycle by allowing movement within the joint's
range of motion.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Use environment | Rehabilitation institutions | Rehabilitation institutions | Same |
| Device weight | 26 lbs. (11.6 kg) | 11 lbs. (5 kg) | Different -
ReStore™ weighs less than the Indego® device.
The relatively low weight of the ReStore™
minimally affects the patient's balance.
This difference does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by clinical data. |
| Rechargeable
Battery | Rechargeable lithium ion.
33.3 V, 36A peak current, 12A
continuous current.
159Wh fully charged; 1.5 hours of
continuous walking fully charged | Two off-the-shelf rechargeable lithium ion
batteries: 15.0 VDC x 2
(total voltage = 30 VDC)
3.2 AH, 48Wh. Minimum 2 hours continuous
walking fully charged | Similar -
Both devices utilize the same battery technology
and provide similar use duration. |
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Battery Charge
Time | Maximum of 4 hours | Maximum of 2 hours | Similar -
Charge time difference between the devices does
not raise questions of safety and effectiveness |
| Training and
Certification
Program
(Clinical Use) | A thorough training program that
provides certification is required for
clinicians before using Indego® with
patients | A thorough training program providing
certification is required for clinicians before
using ReStore™ with patients | Same |
| Expected Useable
Life | 5 years with proper servicing | 3 years with proper servicing | Similar -
Expected useable life difference between the
devices does not raise questions of safety and
effectiveness |
| User Feedback | Provides vibratory feedback and LED
indicators on top of hip unit, visible
to wearer | Provides audible feedback to therapist and
wearer in addition to visual feedback via
Handheld Device and LED indicators on
Waistpack unit visible to therapist. | Similar -
Both devices provide visual feedback to the
therapist, audible or vibratory feedback to the
wearer.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by usability and clinical data. |
| Fall Detection and
Mitigation | Detects forward, backward and
sideways falling as it occurs. The
device makes adjustments during the
course of the fall to position the user
for minimal risk of injury or allow
the user to attempt unassisted
recovery | Therapist support handle on Waistbelt for
therapist to provide support in case of patient
loss of balance. In addition, non-paretic leg is
unconstrained and free to move at all times to
allow the user to attempt unassisted recovery. | Different -
ReStore™ usage is accompanied by a therapist
which when observes the patient loss of balance
can support the patient using the Therapist support
handle.
This difference does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by usability and clinical data. |
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Failsafe Feature | In the event of power failure knees become locked and hips free (similar to typical passive leg braces) | In the event of most error statuses, ReStore™ defaults to brace mode and holds the cables with the ankle in a neutral position (similar to typical passive ankle foot orthoses).
In the event of sudden, unexpected power failure, Bowden cables loosen and ankle joint can move freely | Similar -Similar to the predicate device, the ReStore™ defaults to a fixed position at the relevant joint during most error conditions. In the specific event of an unexpected power failure, this controlled cable movement is not possible, so the system instead releases the cables to allow the patient full range of motion for recovery.
Minor differences between failsafe features are considered within ReWalk's risk management and mitigations have been demonstrated by usability and clinical data. The ReStore™ Waist Belt is designed with an integrated support handle, and a precaution regarding the use of overhead harnessing with patients requiring significant assistance or support from the Physical Therapist to ambulate short distances is intended to mitigate this risk and ensure safe and appropriate use of ReStore™. |
| Operating
Temperature | 32° to 104°F (0° to 40° C) | 41° to 86°F (+5° to 30°C) | Similar -
ReStore™ fits operating conditions expected in its use environment (indoors). |
| Operating
Humidity | 30% - 75% relative humidity | 15% to 90% non-condensing | Similar -
ReStore™ fits a wider range humidity conditions |
| Electrical Safety
Testing | Passed ANSI/AAMI
ES60601-1:2005/(R)2012 | Passed ANSI/AAMI
ES60601-1:05+A1:12:C1:09+A2:10 | Same |
| Electromagnetic
Compatibility
Testing | Passed IEC 60601-1-2:2014 | Passed IEC 60601-1-2:2014 | Same |
| Handheld Device | Handheld Device is used for
controlling and configuring through
BT communication | Handheld Device is used for controlling and
configuring through BT communication | Same |
| Wireless
communication | Bluetooth Low Energy using 2.4
GHz industrial, scientific, and
medical radio band | Bluetooth Low Energy using 2.4 GHz
industrial, scientific, and medical radio band | Same |
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
| Drive
mechanisms | Batteries, motors, gears, frame and
strapping | Batteries, motors, gears, strapping and
Bowden cables | Similar -
Operating principle is performed by cables or
structure applying appropriate force to achieve joint
rotation.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by usability and clinical data. |
| Alignment
(between user and
device) | Alignment of hip, knee and ankle
joints with strap mechanism attached
to device frame | Alignment of user to device with soft shell
calf strap and attachment points within the
shoe | Similar -
Alignment between user and device achieved by
straps preventing sliding or misalignment of wearer
and maintaining tightness.
ReStore™ straps are attached to a soft structure and
Indego® straps to a rigid structure.
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by usability and clinical data. |
| Mechanical user
interface | Device attached to user with
strapping mechanism | Device attached to user with strapping
mechanism | Same |
| Assistance
method | Motors/gears moving rigid frame to
rotates/moves hip and knee joints | Motors/gears pulling Bowden cables to
rotate/move paretic ankle joint | Similar -
Both devices use mechanical assistance to facilitate
joint rotation. ReStore™ delivers assistance to the
ankle joint while the Indego® delivers assistance to
the knee and hip joints (ankle is supported by
AFO).
This similarity does not raise any new or different
questions of safety or effectiveness, as is
demonstrated by usability and clinical data. |
Table 2: (Substantial Equivalence Discussion)
ReStore™ Traditional 510(k) Section 005 510(k) Summary
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Image /page/8/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is in large, bold letters, with "Re" in gray and "Walk" in yellow. Below "ReWalk" is the word "Robotics" in smaller, gray letters with a series of gray lines to the left of the word.
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Image /page/9/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is in large, bold letters, with "Re" in gray and "Walk" in yellow. Below "ReWalk" is the word "Robotics" in smaller, gray letters with a series of gray lines to the left of the word.
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Image /page/10/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is written in a bold, sans-serif font, with the "Re" in gray and the "Walk" in yellow. Below the word "ReWalk" is the word "Robotics" in a smaller, sans-serif font. The word "Robotics" is also in gray, and there are several horizontal lines to the left of the word.
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Image /page/11/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in gray, with a series of horizontal lines above it, giving the impression of a road or path.
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Image /page/12/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is in large, bold letters, with "Re" in gray and "Walk" in yellow. Below "ReWalk" is the word "Robotics" in smaller, gray letters with a series of horizontal lines to the left of the word.
ReStore™ Traditional 510(k) Section 005 510(k) Summary Page 10 of 18 Rev 03
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Image /page/13/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a bold, two-tone color scheme, with "Re" in gray and "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller, sans-serif font, with a gradient effect that fades from dark gray to light gray.
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Image /page/14/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in gray, with a series of horizontal lines above it, giving the impression of a road or path.
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
|------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | None | Calf Wrap Liner:
Surface device - contact with intact skin (calf)
for limited time duration ≤ 24 hours).In
compliance with ISO 10993-1, 5 and 10 | Different -
ReStore™ device utilizes Calf Wrap liner applied
directly on skin of wearer's paretic leg calf.
This difference does not raise any new or different
questions of safety and effectiveness, as
demonstrated by a 3rd party Biocompatibility
testing & risk assessment." |
| System modes | Sit, Stand and Walk | Assist, Slack and Brace | Different-
Differences reflect that Restore™ is intended for a
subset of the Indego® population, i.e., stroke
patients only. |
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Image /page/15/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in gray, with a series of horizontal lines above it, giving the impression of a road or path.
| Characteristic | Parker Hannifin Corporation
Indego® | ReWalk Robotics Ltd. ReStore™ | SE Justification |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinical study
general
information | 30 subjects
Multisite (7) clinical trial
Duration: approx. 2 weeks
Number of visits: 5 | 44 subjects
Multisite (5) clinical trial
Duration: approx. 4 weeks.
Number of visits: 7 | Similar -
Both studies apply to acute, sub-acute and chronic
as well as mild, moderate and severe stroke
populations. Both studies have same primary
outcome - safety measure, and similar secondary/
exploratory outcome measures concerning how
well each device supports ambulatory functions. |
| | Primary endpoint:
Assess the safety of the device during
gait rehabilitation activities in post-
stroke individuals undergoing
physical therapy. | Primary endpoint:
Assess device safety during gait rehabilitation
activities in post-stroke individuals
undergoing physical therapy. | |
| | Secondary endpoints:
- Functional ambulation category;
- Gait Speed, as measured via 10
meter walk test - Spasticity of bilateral upper and
lower extremities as measured
with Modified Ashworth Scale
(MAS) - Pain measured with Face, Legs,
Activity, Cry, Consolability
Scale (FLACC) | Secondary endpoints: - Device reliability
- Device safety for Physical Therapist. | |
| | | Exploratory endpoints - 10m walk assessments.
- Temporal/spatial measures of gait
- 2 minute walk tests in 3 modes.
- Subject satisfaction
- Physical Therapist satisfaction | |
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Image /page/16/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors. Below "ReWalk" is the word "Robotics" in gray with horizontal lines to the left of the word.
9. Non-Clinical Performance data
Comprehensive bench testing has been performed on the ReStore™ device to confirm that it meets design inputs and specifications for the device, to demonstrate substantial equivalence to the predicate device and to demonstrate safety and effectiveness. These tests include nonIclinical performance testing, EMC/EMI testing, biocompatibility testing and electrical safety testing.
The test results show that the ReStore™ device meets all design requirements and is in compliance to all applicable standards and regulations including special controls in 21CFR890.3480.
These tests include the following:
| Test | Test description | Result |
|---|---|---|
| Mechanical performance | Evaluate mechanical components ability to withstand applied loads (static and cyclic) throughout device lifecycle while ensuring system accuracy and precision performance is maintained during operation and post-fatigue | PASS |
| Mechanical analysis | Evaluate adequate safety margin between clinically expected loads and failure loads on system load-bearing components throughout device lifecycle | PASS |
| Battery performance and safety testing | Evaluate battery performance and safety under maximum load conditions, charging time and high current safety disconnection | PASS |
| Apparel performance | Evaluate apparel component ability to withstand applied loads static and cyclic (Durability) and cleanability throughout device lifecycle | PASS |
| Motion performance simulation and testing | Motion performance simulation and testing to evaluate frequency response motion latency and accuracy of the device. | PASS |
| Weight distribution and center of mass analysis | Evaluate Center of Mass of the Restore™ waist pack and related implications on the Restore™ patient | PASS |
| Wireless performance and coexistence using FDA guidance AAMI TIR 69 | Evaluate wireless technology, service quality, security, and electromagnetic compatibility (EMC) | PASS |
| Environmental using ASTM D4169 ASTM D4332 | Environmental testing conformance to standards, accompanied by certificate | PASS |
| Usability using FDA guidance and IEC 62366-1 | Demonstrate that when used after training by intended users in the appropriate use environment, the device can be used safely and effectively without producing failure pattern that could result in negative | PASS |
Table 3: (Non-clinical Performance Data)
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Image /page/17/Picture/0 description: The image is a logo for ReWalk Robotics. The word "ReWalk" is written in a combination of gray and yellow. The word "Robotics" is written in gray below the word "ReWalk" with a series of gray lines to the left of the word.
| Test | Test description | Result |
|---|---|---|
| clinical impact, injury to patients and | ||
| users or device damage | ||
| Software verification and | ||
| validation using FDA Guidances | ||
| IEC 62304 and AAMI TIR 57 | The device meets design and | |
| cybersecurity requirements | PASS | |
| Electrical safety using | ||
| ANSI AAMI ES 60601-1 | Conformance to electrical safety | |
| standards, accompanied by certificate | PASS | |
| Electromagnetic compatibility | ||
| using IEC 60601-1-2 | Conformance to electromagnetic | |
| compatibility standards, accompanied | ||
| by certificate | PASS | |
| Biocompatibility using | ||
| FDA guidance, | ||
| ISO 10993-1/5 and 10 | GLP, Conformance to biocompatibility | |
| standards | PASS |
10. Clinical Performance Data
Three IRB-Approved protocols have been conducted in individuals with hemiplegia / hemiparesis resulting from Stroke. These studies consist of one 44 subject multi-site clinical trial and two engineering studies. The primary endpoint for the multi-site clinical trial was to demonstrate the safety of the ReStore™ device when used during gait training activities for individuals with hemiparesis / hemiplegia resulting from Stroke under the supervision of a trained therapist in rehabilitation institutions. Additionally, two engineering studies are ongoing at the Wyss Institute at Harvard University to develop and evaluate exosuit designs. The ReStore™ clinical validation testing was also conducted under the second engineering protocol.
10.1 44- Subject Multisite Clinical Trial
44 subjects were enrolled in a multi-site clinical trial conducted across 5 study sites. Participation consisted of 7 study visits with the ReStore™ device. All 44 subjects completed at least one study visit with the ReStore™ device, and 36 subjects completed all 7 study visits. This study was IRB-approved and conducted in accordance with principles of Good Clinical Practice (GCP). The primary endpoint for this study was to demonstrate the safety of the ReStore™ device when used during activities of gait training in rehabilitation institutions, as well as exploratory endpoints to demonstrate substantial equivalence with respect to efficacy when compared to the predicate device.
Safety was evaluated on the basis of frequency and severity of device-related adverse events, including serious adverse events and falls. There were zero device-related serious adverse events and zero device-related falls in this study. During the initial phase of the study, adverse events were reported in 13.5% of study visits. The majority of these adverse events were minor in severity and did not require intervention or follow up. The cause was determined to be related to improper donning and fitting techniques and a mandatory re-training was conducted for all study sites. Following the retraining, just one (1) device-related adverse event was reported in the remaining 75 study visits, reducing the frequency to 1.3% of study visits.
Several measures were used to evaluate subjects' walking in the study. Walking speed was measured using 10m walk tests at comfortable and maximal walking speeds, and assessments were performed during walking with and without the ReStore™ device. Additionally, subjects' 2-minute walk distances were measured in all three operational modes of the ReStore™ device: Slack (no assistance), Brace (fixed ankle position), and Assist (dynamic ankle assistance).
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Image /page/18/Picture/0 description: The image is a logo for ReWalk Robotics. The logo features the word "ReWalk" in a combination of gray and yellow colors. Below the word "ReWalk" is the word "Robotics" in gray. The logo is simple and modern.
All subjects were able to complete some or all of the walking assessments in the ReStore™ device on their first study visit. The average duration of walking in Assist mode during gait training visits increased by 12.4% between Visit 2 (the first gait training visit) and Visit 6 (the last gait training visit). Of the 36 subjects who completed all 7 study visits, the majority of subjects increased walking speed from Visit 1 to Visit 7. During walking with the ReStore™ device, 31 subjects (86.1%) increased comfortable walking speed and 29 subjects (80.6%) increased maximal walking speed. During walking assessments independent of the ReStore™ device, 23 subjects (63.9%) increased comfortable walking speed and 28 subjects (77.7%) increased maximal walking speed. Average walking distance during the 2-minute walk test increased by 47.9 ft. during walking with assistance from the ReStore™ device (Assist mode) compared to walking without assistance from the ReStore™ device (slack mode).
10.2 Engineering studies
Two ongoing protocols are being conducted at the Wyss Institute for Biologically Inspired Engineering at Harvard University (Cambridge, MA). These studies involve the development and testing of the ReStore™ device and other similar prototypes. Both studies are IRB approved and are being conducted according to principles of Good Clinical Practice (GCP). 35 unique participants have been enrolled in these two studies (10 participants are enrolled in both studies), and a total of 472 study visits have been conducted since the first study began enrolling in 2014. Device-related adverse events have been reported with low frequency and low severity. There are zero device-related serious adverse events and zero device-related falls reported in either study.
10.3 Clinical Validation Study
Nine (9) participants were enrolled in a ReStore™ validation substudy conducted under the Engineering Protocols above. The purpose of this study was to validate the ReStore™ design as well as to assess the safety and the use of the ReStore™ device during common activities of Physical Therapy. One device-related adverse event was encountered in this substudy which was resolved on its own without intervention or complications. There were zero device-related serious adverse events and zero device related falls reported in this substudy.
Summary of Clinical Performance Data 10.4
A total of 79 individuals with hemiparesis / hemiplegia resulting from stroke have completed a combined 740 study visits with the ReStore™ device or a similar prototype. All three studies have demonstrated that the ReStore™ is safe and well tolerated by individuals post-stroke and is appropriate for use during ambulatory functions in rehabilitation settings under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
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Image /page/19/Picture/0 description: The image shows the logo for ReWalk Robotics. The logo features the word "ReWalk" in a bold, sans-serif font, with the "Re" in gray and the "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller, gray font with a series of horizontal lines to the left of the word.
| Table 4: Summary of IRB-Approved ReStore™ Studies | |
|---|---|
| Trial | Number of
Subjects | Number of Sessions
per Subject | Total Sessions |
|----------------------------------------|-----------------------|-----------------------------------|----------------|
| 44-Subject Multisite Clinical
Trial | 44 | 7 | 268 |
| Clinical Validation Study¹ | 9 | 1 | 9 |
| Engineering Studies (1 & 2) | 35 | Variable | 472 |
| Total | 79 | Variable | 740 |
' Clinical Validation Testing was conducted as a subset of Engineering Study 2 (Wyss Study IRB161845) so totals from this study do not contribute to overall totals.
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Image /page/20/Picture/0 description: The image shows the logo for ReWalk Robotics. The word "ReWalk" is in a bold, sans-serif font, with "Re" in gray and "Walk" in yellow. Below "ReWalk" is the word "Robotics" in a smaller, gray, sans-serif font. There are also some gray lines to the left of the word "Robotics".
11. Statement of Substantial Equivalence
The ReStore™ and the predicate legally marketed device (Indego®) have the same intended use and similar indications for use (a subset of the predicate indications). In addition, both devices have similar technological characteristics. Finally, clinical and non-clinical performance data are similar as well.
The differences in the above mentioned characteristics do not raise any new or different questions of safety or effectiveness, thus the ReStore™ is substantially equivalent to its predicate device.