(277 days)
MyndMove and MyndMove 2.0 are electrical stimulation devices indicated for the following uses:
Functional electrical stimulation (FES)
Improvement of arm and hand function and active range of motion in patients with hemplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury.
NeuroMuscular Electrical Stimulation (NMES) for general rehabilitation for:
- · maintenance and/or increase of arm and hand range of motion,
- · prevention and/or retardation of disuse atrophy,
- · increase in local blood circulation,
- · reduction in muscle spasm, and
- · re-education of muscles.
MyndMove and MyndMove 2.0 therapies can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove 2.0 Systems.
The MyndMove and MyndMove 2.0 Systems are neuromodulation devices that deliver short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove and MyndMove 2.0 systems comprise the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software.
The Functional Electrical Stimulators in the MyndMove 2.0 are eight-channel devices with a touch screen user interface (UI). The Stimulator software allows the User to choose from a number of pre-programmed stimulation protocols, to customize the stimulation intensities for each patient, and to document the treatments provided.
Each MyndMove/MyndMove 2.0 Stimulator is connected, via an IEEE 802.11 a/b/g/n wireless radio adapter, to a cloud-based backend data management system. The primary function of the backend is to manage the various elements of the MyndMove 2.0 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols.
MyndMove and MyndMove 2.0 use surface electrical stimulation to produce muscle contractions in different combinations to achieve a wide range of reaching and grasping functions. To achieve these movements, the single use electrodes are placed in various combinations on the surface of muscles in the arm and hand.
MyndMove and MyndMove 2.0 are based on advanced functional electrical stimulation (FES) principles designed to promote neuroplasticity by influencing the efferent and afferent pathways. Proper sequencing of the muscle contractions as per the MyndMove or MyndMove 2.0 protocols achieve a wide range of functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the MyndMove/MyndMove 2,0 device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 2.0 stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contraction. In this manner, the patient gets both efferent and afferent input as they are actively attempting a movement. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.
The provided text is a 510(k) summary for the MyndMove and MyndMove 2.0 electrical stimulation devices. It aims to demonstrate substantial equivalence to previously cleared predicate devices (MyndMove K170564 and MyndMove 2.0 K212149).
The key takeaway is that no new acceptance criteria, performance studies, or clinical data were generated or required for this 510(k) submission (K233006). The submission explicitly states: "No additional non-clinical performance testing was conducted because there was no change to the hardware or software since clearances of MyndMove (K170564) and MyndMove 2.0 (K212149)."
Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" for this specific submission (K233006) refer to the previously established criteria and studies for the predicate devices. The document essentially argues that since the new submission's devices are identical in technological characteristics and therapy protocols to the cleared predicates, they inherently meet the acceptance criteria validated by the predicate studies.
However, to answer your request fully, I will extrapolate the "acceptance criteria" and "reported device performance" based on the "Substantial Equivalence Discussion" table, which compares the subject devices (MyndMove and MyndMove 2.0) to their predicates across various technical specifications. The acceptance criteria, in this context, are the specifications of the predicate devices that the subject devices are claiming to be identical to.
1. Table of Acceptance Criteria and the Reported Device Performance
Since the submission explicitly states there are no changes to the technological characteristics of MyndMove or MyndMove 2.0, the "reported device performance" for the subject devices (MyndMove and MyndMove 2.0 in K233006) is asserted to be identical to the predicate devices. The "acceptance criteria" are the specifications of the predicate devices.
| Feature / Acceptance Criteria (from Predicate Device) | Reported Device Performance (MyndMove & MyndMove 2.0 in K233006) | SE Comparison |
|---|---|---|
| Indications for Use: FES for improvement of arm/hand function and active ROM in hemiplegia (stroke) or upper limb paralysis (C3-T1 SCI). NMES for general rehabilitation (maintenance/increase ROM, prevention disuse atrophy, increase local blood circulation, reduction muscle spasm, re-education muscles). Administered by trained PT/OT professionals. | Identical to Predicate | Similar (minor wording change for NMES definition) |
| Anatomical Sites for Stimulation (Upper Limb): Extensor Digitorum, Extensor Carpi Radialis & Ulnaris, Thenar Eminence (Opponens Pollicis Brevis, Flexor Pollicis Brevis & Abductor Pollicis Brevis), Flexor Digitorum Superficialis and Profundus, Biceps, Triceps, Posterior Deltoid, Middle Deltoid, Anterior Deltoid, Pectoralis Major, 1st, 2nd, and 3rd Lumbricals, 2nd Dorsal Interosseous, Serratus Anterior, Lower Trapezius, Upper Trapezius (Scapula). | Identical to Predicate | Identical |
| Where Used: MyndMove: clinical setting only. MyndMove 2.0: clinical setting and home use by qualified user. | Identical to Predicate | Identical |
| Regulated current or regulated voltage? Current Regulated | Current Regulated | Identical |
| Software/firmware/microprocessor control? Yes | Yes | Identical |
| Automatic overload trip? Yes | Yes | Identical |
| Automatic no-load trip? Yes | Yes | Identical |
| Automatic shut off? Yes | Yes | Identical |
| User override control? Yes | Yes | Identical |
| Indicator display: Yes (On/off status, Low battery, Voltage/current level) | Yes | Identical |
| Timer range (minutes): Max duration of stimulation program = 120 minutes (configurable in the backend). | Max duration of stimulation program = 120 minutes (configurable in the backend). | Identical |
| Compliance with voluntary standards: MyndMove: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10. MyndMove 2.0: ANSI AAMI ES 60601-1, IEC 60601-1-2, IEC 60601-2-10. | Identical to Predicate | Identical |
| Compliance with 21 CFR 898? Yes | Yes | Identical |
| Power Sources: MyndMove: Mains OR Rechargeable Li-Ion Battery (specified specs). MyndMove 2.0: AHM100PS24C2-8 manufactured by XP-Power (specified specs), Tripp Lite P012-006. | Identical to Predicate | Identical |
| Method of line current isolation: Galvanic Isolation (transformer) 4000 VAC | Galvanic Isolation (transformer) 4000 VAC | Identical |
| Normal condition (uA) (Leakage): Earth Leakage: |
§ 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).