(123 days)
No
The document describes a functional electrical stimulator that uses electrical stimulation to address foot drop. There is no mention of AI, ML, or any related concepts in the device description, intended use, or performance studies. The device appears to be based on established electrical stimulation principles rather than adaptive or learning algorithms.
Yes
The device is described as addressing a medical condition (lack of ankle dorsiflexion due to upper motor neuron damage) by electrically stimulating muscles to improve gait and potentially provide other medical benefits such as preventing disuse atrophy and increasing blood flow.
No.
The device is described as an "External Neuromuscular Stimulator" and "functional electrical stimulator" that electrically stimulates muscles to improve gait. Its intended use is to address a lack of ankle dorsiflexion and improve gait, with benefits like prevention of disuse atrophy and muscle reeducation. This describes a therapeutic, rather than a diagnostic, function.
No
The device description explicitly states it is an "external functional electrical stimulator" and describes physical components that attach to the leg, indicating it is a hardware device with potential software control, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The WalkAide System is an external neuromuscular stimulator that applies electrical stimulation to the leg to improve gait. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to address a physical impairment (lack of ankle dorsiflexion) through electrical stimulation, not to diagnose or monitor a condition based on in vitro analysis.
The device is a therapeutic device used to improve physical function.
N/A
Intended Use / Indications for Use
The Innovative Neurotronics WalkAide External Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. Medical benefits of Functional Electrical Stimulation (FES) may include prevention of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.
Product codes (comma separated list FDA assigned to the subject device)
GZI
Device Description
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit. The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
WalkAide Patient Kit:
- WalkAide Control Module (Stimulator Unit)
- WalkAide Leg Cuff
- WalkAide Electrode Cable
- Electrodes (ordered separately)
- Foot Sensor (Optional)
WalkAide Clinician Kit:
- WalkAnalyst Software
- WalkLink (Hand Switch)
- Heel Sensor
The WalkAide Control Module houses the electronics and controls of the WalkAide system, and delivers electrical stimulation to the end-user's peroneal nerve via surface electrodes. It attaches to the Leg Cuff and provides the stimulation pulse to the electrodes, requiring a single AA battery. It is a microprocessor-controlled device and uses an EEPROM to store device, user, and configuration information. The intensity is controlled by a potentiometer. Stimulation can be triggered by a Tilt Sensor inside the control module, a Foot Sensor or Heel Sensor, or through the Hand Switch (the WalkLink). Three LEDs (green, amber, and red) provide indications such as start up, stimulation, low battery, and fault.
The WalkAide Bi-Flex Cuff is designed for single-handed application and removal. Electrodes are affixed by Velcro to the inside of the cuff and placement is marked via Red and Black Electrode Locators.
The WalkAide System uses two surface electrodes that have been cleared under 510(k) (K872976, K962332, K070807).
The Electrode Cable is a Y connector cable for connecting the electrodes with the WalkAide.
The Foot Sensor is an optional item, designed for individuals whose leg movement is limited, and uses a force sensor resistor (FSR) as the detection element.
The WalkAnalyst Software is used by trained professionals in a clinical setting to configure the WalkAide. It can be installed on a Tablet PC, notebook, or desktop PC. It performs functions such as setup configuration of the WalkAide Control Module (including management of data input from sensors), patient information management, graphical display of stimulation information and gait recordings, data analysis and optimization of stimulation parameters, and report generation. It communicates with WalkAide via a Bluetooth wireless communication device in the WalkLink.
The WalkLink (Hand Switch) is used during patient set-up and control module configuration. It allows the clinician to stimulate the patient and communicates gait recording from WalkAide to the PC via Bluetooth. It connects to the WalkAide using the WalkLink cable.
The Heel Sensor is intended for use in the clinic by the Clinician during device set-up and incorporates a force sensitive sensor (FSR).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ankle, leg, foot
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinician (orthotic specialist, physiotherapist, occupational therapist, etc.) in a clinical setting for setup; patient for home use.
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)
Study Type: Randomized trial with an unblinded, parallel group design.
Sample Size: Not explicitly stated, but the study compared the WalkAide Functional Electrical Stimulation device (WA) versus an Ankle-Foot Orthosis (AFO).
Data Source: Not explicitly stated beyond being a randomized trial.
Annotation Protocol: Not applicable.
Key Results: The study's purpose was to compare WA versus AFO in subjects with chronic stroke (at least 6 months post stroke) for gait improvement. The study data was analyzed using an intention to treat analysis with missing data points calculated using multiple imputations. The results showed the WA to be equivalent to the AFO for improvements in gait velocity, SIS composite score and safety. The WA produces physiological dorsiflexion, with motor and sensory benefits inherent in active muscle contraction, including improved gait speed and overall quality of gait for individuals post-stroke. The study demonstrates that functional improvements can be obtained in the chronic phase of stroke with appropriate intervention, and that continued recovery of function should remain a goal throughout the lifetime of a person with stroke.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the seal is a stylized image of three human profiles facing right, with flowing lines representing hair or fabric. To the right of the seal, the letters "DE" are visible, suggesting the full word "DEPARTMENT" was intended.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 8, 2014
Innovative Neurotronics, Inc. c/o Mr. Glen Neally 3600 North Capital of Texas Highway Building B. Suite 150 Austin, Texas 78746
Re: K140886
Trade Name: WalkAide System Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI Dated: May 5, 2014 Received: May 13, 2014
Dear Mr. Neally:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K140886
Device Name WalkAide System
Indications for Use (Describe)
The Innovative Neurotronics WalkAide External Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. Medical benefits of Functional Electrical Stimulation (FES) may include prevention of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary for the Innovative Neurotronics, Inc. WalkAide System
1. SPONSOR
Innovative Neurotronics, Inc. 3600 N. Capital of Texas Highway Bldg. B. Suite 150 Austin, Texas 87846
| Contact Person: Glen Neally – Director of Quality and Regulatory | |
|---|---|
| Telephone: | 1-512-721-1903 |
| Fax: | 1-512-721-1939 |
May 5, 2014 Date Prepared:
2. DEVICE NAME
| Proprietary Name: | WalkAide |
|---|---|
| Common/Usual Name: | External Neuromuscular Functional Stimulator |
| Classification Names: | External Neuromuscular Functional Stimulator |
| Classification Number: 21 CFR 882.5810 | |
| Product Code: | GZI |
-
- PREDICATE DEVICES WalkAide System- K123972
4. INTENDED USE
The Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator (WalkAide System) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of gait, the WalkAide System electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the gait in patients with chronic stroke. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/ retardation of disuse atrophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
4
5. DEVICE DESCRIPTION
The WalkAide is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, the WalkAide stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The WalkAide System consists of the WalkAide Patient Kit and the WalkAide Clinician Kit . The WalkAide Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System comprises the accessories that a clinician (i.e., orthotic specialist, physiotherapist, occupational therapist, etc.) will use to set up a patient's WalkAide.
WalkAide Patient Kit
The WalkAide Patient Kit consists of the components and accessories that the patient takes home. The WalkAide Patient Kit includes (See Fig 4.1):
- WalkAide Control Module (Stimulator Unit) ●
- WalkAide Leg Cuff ●
- WalkAide Electrode Cable ●
- Electrodes (ordered seperately) ●
- Foot Sensor (Optional) .
Image /page/4/Picture/9 description: The image shows a medical device with a gray and black design. The device has a control panel with a blue knob and two white buttons. A gray cable is connected to the device, and a tan-colored sensor with a black wire is also visible. The device appears to be used for medical monitoring or treatment.
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Image /page/5/Picture/0 description: The image shows a collection of medical devices and accessories. There is a foot sensor template with cutting guidelines and size markings. Additionally, there are two circular electrode pads with attached wires, a beige-colored adjustable strap, a device with a blue knob, and various connecting cables with red and black connectors.
WalkAide Patient Kit
WalkAide Control Module (WalkAide)
As with the parent K123972 WalkAide control module, the Innovative Neurotronics WalkAide Control Module houses the electronics and controls of the WalkAide system, and delivers electrical stimulation to the end-user's peroneal nerve via surface electrodes. The WalkAide attaches to the Leg Cuff and provides the stimulation pulse to the electrodes. The WalkAide requires a single AA battery to operate.
6
Image /page/6/Picture/0 description: The image shows a person's leg with a medical device attached to the upper part of the leg. The device is attached with a strap. The leg is shown from the thigh to the foot. The person's toes are visible.
WalkAide attached to WalkAide Cuff on a Patient's Leg
As with the K123972 WalkAide, the Innovative Neurotronics WalkAide is a microprocessor controlled device, and uses an EEPROM to store device, user, and configuration information. The intensity is controlled by the potentiometer on the top face of the WalkAide control module. The position of the potentiometer controls the appropriate stimulation intensity.
Stimulation could be triggered by three mechanisms: the Tilt Sensor inside the control module, a Foot Sensor or Heel Sensor, or through the Hand Switch (the WalkLink.) Three LEDs (green, amber, and red) provide indications such as start up, stimulation, low battery, and fault. Additional information about these indicators is provided in the User Manual in Appendix A-2.
WalkAide Bi-Flex Cuff
The WalkAide is designed for single-handed application and removal. It may take a bit of practice to develop a routine that works best for each person. The WalkAide is applied directly to the leg and can be easily worn under most clothing. The clinician will find the optimal placement of the electrodes on the initial visit. The electrode placement will be marked on
7
the inside of the cuff via Red and Black Electrode Locators and the position should not be moved by the patient.
Image /page/7/Picture/1 description: The image shows two different views of a medical device. The device appears to be a head-mounted apparatus with a gray frame and black straps. The top image shows the device from a side angle, revealing a padded interior with circular openings and a control panel with a blue knob. The bottom image shows the underside of the device, highlighting the frame's structure and the attachment points for the straps.
WalkAide Cuff
Electrodes
As with the K123972 Walk-Aide, the Innovative Neurotronics WalkAide System uses two surface electrodes. The WalkAide electrodes consist of electrodes that have been cleared under 510(k) (currently numbers K872976, K962332, K070807).
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Image /page/8/Figure/0 description: This image shows a technical drawing of an object with various dimensions and labels. On the left, a circular object labeled "1" has a diameter of 1.25 inches (32mm) and a height of 0.75 inches (19mm). The total height of the object, including the handle labeled "2", is 3.50 +/- 0.25 inches (89mm). The right side of the image shows a side view of the object with labels 1A, 1B, 1C, 2A, 2B, 2C, and 2D.
WalkAide Electrodes
Electrode Cable
This is a Y connector cable for connecting the electrodes with WalkAide. One end is connected to the connector slot on the back of the electrode, and the other two ends (black and red) are connected to respective electrodes.
Image /page/8/Figure/4 description: The image shows a Y-splitter cable with two female connectors on one end and a male connector on the other end. The two female connectors are identical and have a cylindrical shape with a hollow center. The male connector is right-angled and has a cylindrical shape with a pin in the center. The cable is white and has a smooth surface.
WalkAide Electrode Cable
9
Foot Sensor (Optional Item)
The Foot Sensor is the same as in the parent WalkAide system. No changes have been made to the foot sensor. The Foot Sensor is designed for those individuals whose leg movement is limited such that the Tilt Sensor cannot be adequately used. The Foot Sensor is based on a force sensor resistor (FSR) as the detection element. The Foot Sensor plugs into the receptacle on the side of the WalkAide control module as it did in the parent device.
Image /page/9/Picture/2 description: The image shows a line drawing of a heated insole with a cord and plug. The insole is shaped like a foot and has several layers. The cord is attached to the insole and has a plug at the end. The plug is a standard 3.5mm audio plug. The insole is likely used to keep feet warm in cold weather.
Foot Sensor
WalkAide Clinician Kit
The WalkAide Clinician Kit, which is similar to the Clinician System used in the parent WalkAide, is used by trained professionals (clinicians) in a clinical setting to configure WalkAide for an individual user. The WalkAide Clinician Kit is only used by the clinician and it is not sent with the patient.
Innovative Neurotronics uses the WalkAide Clinician System Software called the WalkAnalyst, with Notebook/Tablet PC/Desktop platform for the ease of use and better display. The Notebook/Tablet PC/Desktop is not provided by Innovative Neurotronics. The WalkAnalyst has been developed and validated according to regulatory guidance documents.
The WalkAide consists of the following components:
- WalkAnalyst Software ●
- WalkLink (Hand Switch)
- Heel Sensor
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Image /page/10/Picture/0 description: The image shows a white box with a black lanyard attached to the top. There is a black cord coming out of the bottom of the box. To the left of the box is a gray cord with a plug on the end and a tan-colored object. To the right of the box is a black cord.
Clinician Kit without WalkAnalyst Software
WalkAnalyst Software
The WalkAnalyst software has been developed exclusively for the proposed Innovative Neurotronics WalkAide. This software can be installed on a Tablet PC, notebook, or desktop PC hardware platform. The WalkAnalyst performs the following functions:
- Set up configuration of WalkAide Control Module, which includes management of data input from tilt sensor, and heel/foot sensor
- Management of patient information ●
- . Graphical display of stimulation information and gait recordings
- Analysis of data and optimization of stimulation parameters
- Report generation .
The WalkAnalyst software communicates with WalkAide via a Bluetooth wireless communication device in the WalkLink.
WalkLink (Hand Switch)
The WalkLink is only used during the patient set-up and control module configuration process. The WalkLink serves two purposes (1) the
11
Clinician can stimulate the patient at the appropriate times during the setup process (2) It communicate gait recording from WalkAide to the PC (Tablet/Notebook/Desktop) using Bluetooth (BT) wireless communication protocol. It should be noted that WalkAide itself does not have Bluetooth functionalities. WalkAide communicates with WalkLink using the WalkLink cable. WalkLink transmits the information received from WalkAide to the PC using the Bluetooth protocol.
The WalkLink contains a stimulation button and three LED indicators. The green blinking indicator shows adequate battery voltage, the red indicator indicates low battery or error, and the blue blinking indicator indicates that BT link is established.
Image /page/11/Picture/2 description: The image shows two devices, one is a slim device with a pairing button, and the other is a WalkLink device. The WalkLink device has a logo at the top and three lights, one green, one red, and one blue. The device also has an FC label and the text "Tested to comply with FCC standards".
WalkLink
WalkLink Cable
The WalkLink cable connects WalkLink with WalkAide. This cable contains standard RS232 communication lines. This is a 5 conductor stranded cable approximately 40 inches long cable.
Image /page/11/Figure/6 description: The image shows a drawing of a flexible endoscope. The endoscope is a long, thin tube with a camera and light at the end. It is used to view the inside of the body. The endoscope in the image has a curved shape. The endoscope has a connector at each end.
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WalkAide to WalkLink Cable
Heel Sensor
The heel sensor is the same patient heel sensor used in the parent WalkAide system. No changes have been made to the Heel Sensor. The design is similar to the Foot Sensor, as it incorporates a force sensitive sensor (FSR) as the detection element. The Heel Sensor is intended for use in the clinic by the Clinician during the device set-up stage.
Fig 4.10: Heel Sensor
4.5 Operations and Set-up of the WalkAide System
The operation and set-up of the WalkAide system is detailed in the Clinician Manual. The following is a summary:
The patient places the back electrode slightly posterior and distal to the head of the fibula and the front electrode on the upper 1/3 of the tibialis anterior muscle over the muscle belly. The back electrode is connected to the black lead and the front electrode to the red lead. The WalkAide is turned on by rotating the intensity control on the Control Module. The round intensity knob is moved counter-clockwise through "0" or in the direction of increasing numbers. The STIM button labeled (J) is depressed for 1 to 2 seconds to provide a test stimulus. An amber light on the top of the
13
WalkAide Control Module indicates that the unit is stimulating. If the ankle movement produced by the stimulus is too small, the intensity control is turned up or the black electrode is adjusted slightly to the rear, then application of the test stimulus is attempted again. Stimulation consists of delivering a train of biphasic current pulses to the common peroneal nerve via two surface electrodes. The goal is to produce a relatively pure dorsiflexion of the ankle with as low stimulus intensity as possible. Once the optimal electrode positions have been found, the cuff is placed over the electrodes.
The cuff is then removed with the electrodes that are affixed by Velcro to the inside of the cuff. The Clinician then positions the electrodes on the leg cuff for patient reference during future electrode replacement. The leads from the electrodes are threaded through the holes on the cuff. The black lead of the Y-connector cable is connected to the back electrode and the red to the anterior electrode. The electrodes, leads and connectors are placed in the groove or pocket of the cuff and covered with a Velcro strap. A heel sensor is placed in the patient's shoe on the affected side and is connected to the WalkAide Control Module. As with the parent Walk-Aide, the WalkAide Control Module houses the electronics and controls of the WalkAide, and delivers electrical stimulation to the patient via two surface electrodes.
The Clinician collects and analysis gait recording by using WalkAnalyst Software and according to set-up shown in Fig 4.11. After optimal parameters are selected, WalkAide is configured using the selected parameters.
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Image /page/14/Figure/0 description: The image shows a diagram of a clinician using a WalkLink device to apply manual stimulation to a patient. The patient is wearing a heel sensor in their shoe, and they are walking in a figure-eight pattern with a WalkAide device. The WalkAide is connected to the WalkLink, and a tablet PC, notebook, or desktop computer is collecting heel sensor and stimulation data for the clinician using WalkAnalyst. The diagram is labeled with the numbers 1-4, which correspond to the different steps in the process.
Fig 4.11: WalkAide Set-up Process
Once set up and configuration has been completed by the Clinician, WalkLink is disconnected from the WalkAide. WalkAide, including the accessories such as the WalkAide Cuff, Electrodes, Electrode Cable, and Foot Sensor (optional item) is provided to the patient.
WalkAide in normal operation mode will use the Tilt Sensor or optional Foot Sensor to sense the appropriate point in the patient's gait (walk) cycle to trigger stimulation. The WalkAide provides visual and audible indications for various conditions such as operational status and low battery condition.
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6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The purpose of this 510(k) is to update the submission of the Walk-Aide System (K123972) to include in the Indications For Use Summary Statement the specific population of chronic stroke patients for the specific indication of improved gait. This is the only change in this submission.
Clinical data is submitted to support the difference in indication for use. The randomized trial utilized an unblinded, parallel group design. The purpose of this study was to compare of the WalkAide Functional Electrical Stimulation device (WA) versus an Ankle-Foot Orthosis (AFO) in subjects with chronic stroke. Subjects were required to be at least 6 months post stroke. The study data was analyzed using an intention to treat analysis with missing data points calculated using multiple imputations. The clinical trial data outcomes support chronic stroke population for gait improvement.
Comparison Conclusion Table:
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| FEATURE | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE
Current Submission | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE
K123972 | COMPARISON |
|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Intended Use | SUMMARY STATEMENT
The Innovative Neurotronics
WalkAide External Functional
Neuromuscular Stimulator
(WalkAide System) is intended
to address the lack of ankle
dorsiflexion in patients who have
sustained damage to upper motor
neurons or pathways to the spinal
cord. During the swing phase of
gait, the WalkAide System
electrically stimulates the
appropriate muscles that cause
ankle dorsiflexion and may thus
improve the gait in patients with
chronic stroke. Medical benefits
of Functional Electrical
Stimulation (FES) may include
prevention/ retardation of disuse
atrophy, increased local blood
flow, muscle re-education, and
maintained or increased joint
range of motion. | SUMMARY STATEMENT
The Innovative Neurotronics
WalkAide External Functional
Neuromuscular Stimulator
(WalkAide System) is intended
to address the lack of ankle
dorsiflexion in patients who
have sustained damage to
upper motor neurons or
pathways to the spinal cord.
During the swing phase of gait,
the WalkAide System
electrically stimulates the
appropriate muscles that cause
ankle dorsiflexion and may
thus improve the patient's gait.
Medical benefits of Functional
Electrical Stimulation (FES)
may include prevention/
retardation of disuse atrophy,
increased local blood flow,
muscle re-education, and
maintained or increased joint
range of motion. | This current
submission has
included the
indication of gait
improvement for
chronic stroke
patients. |
| FEATURE | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE
Current Submission | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE
K123972 | COMPARISON |
| Power Source | 1.5 V AA Battery
(not rechargeable) | 1.5
V
AA
Battery
(not rechargeable) | Identical |
| Microprocessor Controlled | Yes | Yes | Identical |
| Indicators
Unit functioning
Low Battery | Yes
Yes | Yes
Yes | Identical |
| Patient Device Set-up and
Training | Done by a clinician using
a Notebook/Tablet PC | Done by a clinician
using a Notebook/Tablet
PC | Identical |
| Number of Output Modes | 1 | 1 | Identical |
| Channels | 1 | 1 | Identical |
| Output Stage
Type
Range/Accuracy
Load | Constant Voltage
(Adjustable)
0 - 110 V (±10%)
1000 Ohm load | Constant Voltage
(Adjustable)
0 - 110 V (±10%)
1000 Ohm load | Identical |
| Max Output Current |