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510(k) Data Aggregation

    K Number
    K233006
    Manufacturer
    Date Cleared
    2024-06-25

    (277 days)

    Product Code
    Regulation Number
    882.5810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MyndMove, MyndMove 2.0

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    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.

    Device Description

    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.

    AI/ML Overview

    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 PredicateSimilar (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 PredicateIdentical
    Where Used: MyndMove: clinical setting only. MyndMove 2.0: clinical setting and home use by qualified user.Identical to PredicateIdentical
    Regulated current or regulated voltage? Current RegulatedCurrent RegulatedIdentical
    Software/firmware/microprocessor control? YesYesIdentical
    Automatic overload trip? YesYesIdentical
    Automatic no-load trip? YesYesIdentical
    Automatic shut off? YesYesIdentical
    User override control? YesYesIdentical
    Indicator display: Yes (On/off status, Low battery, Voltage/current level)YesIdentical
    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 PredicateIdentical
    Compliance with 21 CFR 898? YesYesIdentical
    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 PredicateIdentical
    Method of line current isolation: Galvanic Isolation (transformer) 4000 VACGalvanic Isolation (transformer) 4000 VACIdentical
    Normal condition (uA) (Leakage): Earth Leakage:
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    K Number
    K212149
    Device Name
    MyndMove 2.0
    Manufacturer
    Date Cleared
    2022-03-03

    (237 days)

    Product Code
    Regulation Number
    882.5810
    Reference & Predicate Devices
    Why did this record match?
    Device Name :

    MyndMove 2.0

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MYNDMOVE is an electrical stimulation device indicated for the following uses:

    Functional Electrical Stimulation (FES)

    Improvement of ann and hand functions 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)

    · Maintenance and/or increase of arm and hand range of motion

    • · Prevention and/or retardation of disuse atrophy
    • · Increase in local blood circulation
    • · Reduction of muscle spasm
      · Re-education of muscles.

    Myddlove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by Mynd Tec on the use of the MyndMove System.

    Device Description

    The MyndMove 2.0 System is a neuromodulation device that delivers short electrical pulses to stimulate muscle contractions and enhance motor recovery following Stroke or Spinal Cord Injury. The MyndMove system comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. The MyndMove 2.0 Functional Electrical Stimulator is an eight-channel device 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 Stimulator is connected, via an IEEE 802.11 a/b/q/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 ecosystem including but not limited to patient unique IDs and prescriptions, therapist profiles and stimulation protocols. MyndMove 2.0 Therapy can only be administered by trained MyndMove Therapy professionals (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove system.

    MyndMove 2.0 uses 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 2.0 is 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 2.0 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove 2.0 therapy, the patient executes functional tasks with assistance from the therapist and the 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 move and as the arm and/or hand is moved into the instructed position. Non-damaged pathways can be activated and non-damaged areas of the central nervous system can be trained to substitute for injured areas.

    AI/ML Overview

    The provided text is an FDA 510(k) summary for the MyndMove 2.0 device, which is an electrical stimulation device. The document primarily focuses on demonstrating substantial equivalence to a predicate device (MyndMove K170564) rather than providing a detailed study proving the device meets general acceptance criteria in a clinical performance context.

    Therefore, many of the requested details about acceptance criteria for clinical performance and specific study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone algorithm performance, and training set details) are not present in this type of regulatory submission document. This 510(k) summary focuses on technical equivalence and safety standards compliance due to minor modifications to an already cleared device.

    However, I can extract information related to technical performance and safety compliance acceptance criteria, and the study (testing) that proves the device meets these criteria, based on the provided text.

    Here is a breakdown of the available information:


    Acceptance Criteria and Device Performance (primarily technical and safety-related):

    Acceptance Criterion (Category)Reported Device Performance (MyndMove 2.0)
    Indications for UseIdentical to predicate device (MyndMove): Functional Electrical Stimulation (FES) for improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury. NeuroMuscular Electrical Stimulation (NMES) for maintenance/increase of arm/hand ROM, prevention/retardation of disuse atrophy, increase in local blood circulation, reduction of muscle spasm, and re-education of muscles.
    Output CharacteristicsBiphasic Asymmetrical Output Mode:
    • Waveform Shape: Rectangular
    • Max Output Voltage (+/- 10%): Positive: 160V @ 500Ω, 2kΩ, 10kΩ; Negative: 40V @ 500Ω, 2kΩ, 10kΩ (Identical to predicate)
    • Max Output Current (+/- 10%): Positive: 20mA @ 500Ω, 2kΩ, 16mA @ 10kΩ; Negative: 5mA @ 500Ω, 2kΩ, 4mA @ 10kΩ (Identical to predicate)
    • Pulse Width: Positive: 150-400 µs; Negative: 600-1600 µs (Identical to predicate)
    • Frequency: 1Hz or 40Hz (Identical to predicate)
    • Symmetrical phases: No (Identical to predicate)
    • Net Charge (per pulse): 1.85µC (Identical to predicate)
    • Maximum Phase Charge: 9.02µC (Equivalent to predicate)
    • Maximum Current Density (RMS) using smallest electrode: 0.93 mA/cm2 (for 1x3 cm electrode). (Meets criteria
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