WALKAIDE SYSTEM

K123972 · Innovative Neurotronics, Inc. · GZI · Apr 1, 2013 · Neurology

Device Facts

• Record ID: K123972
• Device Name: WALKAIDE SYSTEM
• Applicant: Innovative Neurotronics, Inc.
• Product Code: GZI · Neurology
• Decision Date: Apr 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

External functional electrical stimulator (FES) worn on leg below knee; detects gait cycle via tilt sensor or foot sensor. Stimulates common peroneal nerve to trigger tibialis anterior muscle for ankle dorsiflexion during swing phase. System includes patient kit for home use and clinician kit for setup via notebook/tablet PC. Features adjustable output voltage, pulse width, and ramp modulation (up/down) to assist with spasticity or toe slap. Powered by 1.5V AA battery. Healthcare providers use output to improve patient gait, prevent disuse atrophy, increase local blood flow, and maintain joint range of motion.

Clinical Evidence

Bench testing only. Performance validated against IEC 60601-2-10 requirements using V012 Performance Test Protocol. No clinical data presented.

Technological Characteristics

External neuromuscular stimulator; 1.5V AA battery powered; ABS housing; stainless steel 316/hydrogel electrodes. Constant voltage output (0-110V); biphasic waveform; 25-300µs pulse duration; 16.7-33.3 Hz frequency. Tilt/foot sensor trigger. Microprocessor controlled. Complies with IEC 60601-1 (3rd Ed) and IEC 60601-2-10.

Indications for Use

Indicated for patients with lack of ankle dorsiflexion due to upper motor neuron injury or spinal cord pathway damage. Used to improve gait via electrical stimulation of leg muscles during swing phase.

Regulatory Classification

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.

Predicate Devices

• WalkAide System (K052329)
• NESS L300 (K103343)
• ODFS PACE (K102115)

Submission Summary (Full Text)

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# 510(k) Summary for the Innovative Neurotronics, Inc. WalkAide System K123972

#### 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: [phone] Fax [phone]

Date Prepared: December 21, 2012

#### 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 |

### 3. PREDICATE DEVICES

| <b>Proprietary Name</b> | <b>510(k)</b> | <b>Product Code</b> | <b>Manufacturer</b> |
|-------------------------|---------------|---------------------|-------------------------------|
| WalkAide System | K052329 | GZI | Innovative Neurotronics, Inc. |
| NESS L300 | K103343 | GZI, IPF | Bioness Inc. |
| ODFS PACE | K102115 | GZI | Odstock Medical LTD |

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#### 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 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.

#### DEVICE DESCRIPTION ട.

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.

### 6. BASIS FOR SUBSTANTIAL EQUIVALENCE

WalkAide, Odstock and the Bioness L300 are designed to meet the applicable requirements of IEC 60601-2-10 "Particular requirements for the safety of nerve and muscle stimulators." Not all of this standard is applicable since the standard applies to line powered devices and the WalkAide is powered by one AA batteries. V012 " WalkAide Performance Test Protocol" tests to the applicable requirements of IEC 60601-2-10. When this protocol is run it validates that the WalkAide meets the applicable design requirements of IEC 60601-2-10.

There are basically three changes in Output Specification between the parent WalkAide (K052329) device and the proposed WalkAide (K123972) device: 1) output voltage, 2) output pulse width, and 3) addition of Ramp Modulation (Ramp Up and Ramp Down).

The Output Specifications of the proposed device and the parent device are substantially equivalent. The changes to the output voltage and output pulse width are equivalent to the Bioness and Odstock competitive devices and also still meet the

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applicable clauses of IEC 60601-2-10 "Particular Requirements for the Safety of Nerve and Muscle Stimulators". V012 " WalkAide Performance Test Protocol" tests to the applicable requirements of IEC 60601-2-10. The addition of Ramp Up and Ramp Down is equivalent to the ramping of the Bioness and Odstock devices.

For similarities and differences please review the following predicate comparison table:

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| FEATURE | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE<br>K052329<br>SUMMARY STATEMENT<br>The Innovative Neurotronics<br>WalkAide External Functional<br>Neuromuscular Stimulator<br>(WalkAide System) is intended to<br>address the lack of ankle<br>dorsiflexion in patients who have<br>sustained damage to upper motor<br>neurons or pathways to the spinal<br>cord. During the swing phase of<br>gait, the WalkAide System<br>electrically stimulates the<br>appropriate muscles that cause ankle<br>dorsiflexion and may thus improve<br>the patient's gait. Medical benefits<br>of Functional Electrical Stimulation<br>(FES) may include prevention/<br>retardation of disuse atrophy,<br>increased local blood flow, muscle<br>re-education, and maintained or<br>increased joint range of motion.<br>Intended Use | BIONESS L300 PLUS<br>K103343<br>SUMMARY STATEMENT<br>The NESS L300 Plus System is<br>intended to provide ankle<br>dorsiflexion and knee<br>flexion or extension in individuals<br>with foot drop and thigh muscle<br>weakness,<br>following an upper motor neuron<br>injury or disease. During gait, the<br>L300 Plus<br>System electrically stimulates<br>muscles in the affected leg to<br>provide dorsiflexion of<br>the foot and knee flexion or<br>extension, thus it may improve the<br>individual's gait. The<br>L300 Plus System may also:<br>* Facilitate Muscle re-education<br>* Prevent/retard disuse atrophy<br>* Maintain or increase joint range of<br>motion<br>* Increase local blood flow | ODSTOCK PACE<br>K102115<br>SUMMARY STATEMENT<br>The ODES® Pace is intended to<br>provide ankle dorsiflexion in<br>individuals who have a<br>dropped foot as a consequence of<br>upper motor neuron injury. By<br>detecting the swing<br>phase of gait through a foot switch<br>signal, appropriate electrical<br>stimulation of the leg and ankle<br>muscles may improve gait by<br>flexing the foot of persons who have<br>lost or impaired function. There<br>may be additional benefits from<br>FES such as muscle re-education,<br>prevention/retardation of disuse<br>atrophy, increased or maintained<br>range of joint motion and increase<br>in local blood flow. | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE PROPOSED<br>K123972<br>SUMMARY STATEMENT<br>The Innovative Neurotronics<br>WalkAide External Functional<br>Neuromuscular Stimulator<br>(WalkAide System) is intended to<br>address the lack of ankle<br>dorsiflexion in patients who have<br>sustained damage to upper motor<br>neurons or pathways to the spinal<br>cord. During the swing phase of<br>gait, the WalkAide System<br>electrically stimulates the<br>appropriate muscles that cause ankle<br>dorsiflexion and may thus improve<br>the patient's gait. Medical benefits<br>of Functional Electrical Stimulation<br>(FES) may include prevention/<br>retardation of disuse atrophy,<br>increased local blood flow, muscle<br>re-education, and maintained or<br>increased joint range of motion. | COMPARISON |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Power Source | 1.5 V AA Battery<br>(not rechargeable) | CU - Rechargeable AAA<br>Stim - Rechargeable Lilon<br>Gait Sensor – CR2430 coin<br>cell | PP3, 9V Battery | 1.5 V AA Battery<br>(not rechargeable) | Identical<br>Equivalent |
| Microprocessor Controlled | Yes | Yes | Yes | Yes | Identical |
| Indicators | | | | | |
| Unit functioning | Yes | Yes | Yes | Yes | Identical |
| Low Battery | Yes | Yes | Yes | Yes | Identical |
| Patient Device Set-up and<br>Training | Done by a clinician using a<br>Notebook/Tablet PC | All the set-up is done<br>through a PDA | All the set-up is done<br>through the unit | Done by a clinician using a<br>Notebook/Tablet PC | Identical |
| FEATURE | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE<br>K052329 | BIONESS L300 PLUS<br>K103343 | ODSTOCK PACE<br>K102115 | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE PROPOSED<br>K123972 | COMPARISON |
| Number of Output Modes | 1 | 2 | 2 | 1 | |
| Channels | 1 | 1 | 1 | 1 | Identical |
| Output Stage | | | | | |
| Type | Constant Voltage<br>(Adjustable) | Constant Current | Constant Current | Constant Voltage<br>(Adjustable) | |
| Range/Accuracy | 0 - 78 V (±5%) | 0 - 80 mA in 1mA steps | 10--100 mA ±10% into a<br>1000 ohm load<br>Approx 4% steps | 0 - 110V (±10%) | |
| Load | 1000 Ohm load | <120V<br>Max Load 5000 ohm<br>(subject to Max Voltage<br>Limitation) | 10 to 110 V (Calculated) | 1000 Ohm load | |
| Max Output Current | 115 mA peak (±5%) @<br>500 Ohm load<br>(max specification limit) | 80 mA pk @ 500 Ohm load<br>(measured) | 176 mA pk @ 500 Ohm load<br>(measured) | <206.8 mA peak @<br>500 Ohm load (max<br>specification limit) | |
| IEC 60601-2-10 | 11.0 mA rms max @ 500<br>ohm<br>(Computed based on<br>115 mA (+5%), square<br>pulse) | 13.14 mA rms max @ 500<br>ohm<br>(Computed based on 80 mA<br>square pulse) | 25.8 mA rms max @ 500<br>ohm<br>(Computed based on 176<br>mA square pulse) | 20.7 mA rms max @ 500<br>ohm<br>(Computed based on 206.8<br>mA square pulse) | |
| Specification of 50mA rms<br>Max) | 8.8 mA rms max @ 500<br>ohm (measured) | 13.1 mA rms max @ 500<br>ohm (measured) | 20.6 mA rms max @ 500<br>ohm (measured) | 14.2 mA rms max @ 500<br>ohm<br>(measured)<br>(IEC 60601-2-10<br>Specification of 50mA rms<br>Max) | Equivalent |
| | 78 mA peak (±5%),<br>1000 Ohm load<br>(max specification limit) | 80.7 mA pk @ 1000 Ohm<br>load<br>(measured) | 110 mA pk @ 1000 Ohm<br>load<br>(measured) | <121 mA peak @ 1000 Ohm<br>load<br>(max specification limit) | |
| Max Output Voltage | 78 V<br>1000 Ohm load | 80.7 Vpk @ 1K assym<br>(meas) | 108 Vpk @ 1K assym<br>(meas) | 121 V max<br>1000 Ohm load | |
| IEC 60601-2-10 | 161.4 Vp-p @ IK sym<br>(meas) | 161.4 Vp-p @ IK sym<br>(meas) | 216 Vp-p @ IK sym (meas) | (IEC 60601-2-10<br>Specification limit of 500 V<br>Peak) | Equivalent |
| Specification limit of 500 V<br>Peak) | <150 V<br>1M Ohm load | 120 pk @ IM assym (meas) | 150V pk @ 1M assym<br>(meas) | Spec limit <150 V<br>1M Ohm load | Identical |
| | | 240 Vp-p @ IM sym (meas) | 350 Vp-p @ 1M sym (meas) | 123V pk @ 1M (meas) | |
| FEATURE | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE<br>K052329 | BIONESS L300 PLUS<br>K103343 | ODSTOCK PACE<br>K102115 | INNOVATIVE<br>NEUROTRONICS, INC.<br>WALKAIDE PROPOSED<br>K123972 | COMPARISON |
| Ramp Modulations (for gait)<br>ON Ramp | No | Yes<br>0 to 2 sec in 0.1 sec steps…