(96 days)
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No
The summary describes a functional electrical stimulator that uses electrical stimulation based on the gait cycle, without mentioning any AI or ML components for analysis, decision-making, or adaptation.
Yes
The device is described as an external functional neuromuscular stimulator intended to improve gait and provides various medical benefits through functional electrical stimulation. These benefits, such as preventing disuse atrophy, increasing local blood flow, and muscle re-education, clearly indicate a therapeutic purpose.
No
The device is described as an "External Functional Neuromuscular Stimulator" and "functional electrical stimulator" that electrically stimulates muscles to improve gait. Its intended use is to "address the lack of ankle dorsiflexion" and provide "medical benefits of Functional Electrical Stimulation (FES)," which are therapeutic actions rather than diagnostic ones.
No
The device description explicitly states it is an "external functional electrical stimulator" and a "small device that attaches to the leg," indicating it is a hardware device that delivers electrical stimulation.
Based on the provided information, the Innovative Neurotronics WalkAide External Functional Neuromuscular Stimulator is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- WalkAide Function: The WalkAide is an external device that applies electrical stimulation to the leg to improve gait. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes a therapeutic function (addressing lack of ankle dorsiflexion) through external stimulation, not diagnostic testing of biological samples.
Therefore, the WalkAide falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
leg just below the knee, near the head of the fibula; ankle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
orthotic specialist, physiotherapist, occupational therapist, patients
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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
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: 1-512-721-1903 Fax 1-512-721-1939
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
| Proprietary Name | 510(k) | Product Code | Manufacturer |
|---|---|---|---|
| WalkAide System | K052329 | GZI | Innovative Neurotronics, Inc. |
| NESS L300 | K103343 | GZI, IPF | Bioness Inc. |
| ODFS PACE | K102115 | GZI | Odstock Medical LTD |
1
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
2
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
NEUROTRONICS, INC.
WALKAIDE
K052329
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.
Intended Use | BIONESS L300 PLUS
K103343
SUMMARY STATEMENT
The NESS L300 Plus System is
intended to provide ankle
dorsiflexion and knee
flexion or extension in individuals
with foot drop and thigh muscle
weakness,
following an upper motor neuron
injury or disease. During gait, the
L300 Plus
System electrically stimulates
muscles in the affected leg to
provide dorsiflexion of
the foot and knee flexion or
extension, thus it may improve the
individual's gait. The
L300 Plus System may also:
- Facilitate Muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint range of
motion - Increase local blood flow | ODSTOCK PACE
K102115
SUMMARY STATEMENT
The ODES® Pace is intended to
provide ankle dorsiflexion in
individuals who have a
dropped foot as a consequence of
upper motor neuron injury. By
detecting the swing
phase of gait through a foot switch
signal, appropriate electrical
stimulation of the leg and ankle
muscles may improve gait by
flexing the foot of persons who have
lost or impaired function. There
may be additional benefits from
FES such as muscle re-education,
prevention/retardation of disuse
atrophy, increased or maintained
range of joint motion and increase
in local blood flow. | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE PROPOSED
K123972
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. | COMPARISON |
|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Power Source | 1.5 V AA Battery
(not rechargeable) | CU - Rechargeable AAA
Stim - Rechargeable Lilon
Gait Sensor – CR2430 coin
cell | PP3, 9V Battery | 1.5 V AA Battery
(not rechargeable) | Identical
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
Training | Done by a clinician using a
Notebook/Tablet PC | All the set-up is done
through a PDA | All the set-up is done
through the unit | Done by a clinician using a
Notebook/Tablet PC | Identical |
| FEATURE | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE
K052329 | BIONESS L300 PLUS
K103343 | ODSTOCK PACE
K102115 | INNOVATIVE
NEUROTRONICS, INC.
WALKAIDE PROPOSED
K123972 | COMPARISON |
| Number of Output Modes | 1 | 2 | 2 | 1 | |
| Channels | 1 | 1 | 1 | 1 | Identical |
| Output Stage | | | | | |
| Type | Constant Voltage
(Adjustable) | Constant Current | Constant Current | Constant Voltage
(Adjustable) | |
| Range/Accuracy | 0 - 78 V (±5%) | 0 - 80 mA in 1mA steps | 10--100 mA ±10% into a
1000 ohm load
Approx 4% steps | 0 - 110V (±10%) | |
| Load | 1000 Ohm load |