(96 days)
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.
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.
The provided text describes a 510(k) summary for the Innovative Neurotronics, Inc. WalkAide System, which is an external functional neuromuscular stimulator. The summary focuses on demonstrating substantial equivalence to predicate devices, particularly regarding changes in output specifications (voltage, pulse width, and addition of ramp modulation).
Here's an analysis of the acceptance criteria and the "study" (which in this context refers to the technical comparison and testing described for regulatory approval):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantifiable manner as "acceptance criteria" for a study in the typical sense of clinical trials. Instead, the document frames "acceptance" as meeting applicable safety and performance standards (like IEC 60601-2-10) and being substantially equivalent to predicate devices. The "reported device performance" refers to the technical specifications and measured values of the proposed WalkAide (K123972) and a comparison to its predicate (K052329) and other competitive devices (Bioness L300 Plus, Odstock Pace).
Below is a table summarizing key electrical output criteria and the proposed device's performance, as derived from the "Predicate Comparison Table" and the "Discussion of Table 6.1 equivalent parameters" section.
| Feature | Acceptance Criteria (typically derived from standards or predicate equivalence) | Proposed WalkAide (K123972) Performance (Measured/Computed) | Comparison/Comments |
|---|---|---|---|
| Output Stage Type | Must be suitable for functional electrical stimulation, comparable to predicates (Constant Voltage or Constant Current). | Constant Voltage (Adjustable) | Identical to previous WalkAide. Predicates Bioness & Odstock are Constant Current. Considered equivalent in functionality. |
| Output Voltage Range | Safe and effective range, within the scope of predicate devices (e.g., similar to Bioness 120V or Odstock's 100±10%V @ 1000 Ohms). | 0 - 110V (±10%) at 1000 Ohms load | Within range of Bioness (120V) and Odstock Pace (100±10%V). |
| Max Output Current (500Ω) | Should not exceed limits defined by applicable standards (e.g., IEC 60601-2-10 paragraph 51.104 for rms current, and general safety). Comparable to predicate devices. |
§ 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).