(184 days)
Not Found
No
The description focuses on pre-programmed stimulation protocols and therapist control, with no mention of adaptive algorithms or learning capabilities.
Yes
The intended use and device description explicitly state that MYNDMOVE is an electrical stimulation device indicated for improving arm and hand function, range of motion, preventing atrophy, increasing blood circulation, reducing muscle spasm, and re-educating muscles in patients with hemiplegia due to stroke or upper limb paralysis. These are all therapeutic applications.
No
This device is an electrical stimulation device intended for therapeutic purposes like improving movement, preventing atrophy, and re-educating muscles. It does not perform any diagnostic functions.
No
The device description explicitly states that the MyndMove System comprises the Stimulator device, stimulation electrodes and cables, hand and foot switches, and integrated software. This indicates the presence of significant hardware components beyond just software.
Based on the provided information, the MyndMove device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of the MyndMove device clearly states it is an electrical stimulation device that delivers pulses to stimulate muscle contractions. It works by applying electrodes to the surface of the skin to directly interact with the patient's muscles and nervous system. It does not involve the analysis of biological samples like blood, urine, or tissue.
- The intended use is therapeutic, not diagnostic. The indications for use are focused on improving arm and hand function, maintaining range of motion, preventing atrophy, increasing blood circulation, reducing muscle spasm, and re-educating muscles. These are all therapeutic goals aimed at treating a condition (hemiplegia or paralysis) rather than diagnosing one.
The MyndMove device falls under the category of a neuromodulation device or electrical stimulator used for rehabilitation.
N/A
Intended Use / Indications for Use
MYNDMOVE is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
o Improvement of arm and hand function 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)
o Maintenance and/or increase of arm and hand range of motion.
o Prevention and/or retardation of disuse atrophy.
o Increase in local blood circulation.
o Reduction of muscle spasm.
o Re-education of muscles.
MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove System.
Product codes (comma separated list FDA assigned to the subject device)
GZI, IPF
Device Description
The MyndMove 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 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 Therapy can only be administered by Trained MyndMove Therapists (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove system.
MyndMove 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 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 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 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-damaqed areas of the central nervous system can be trained to substitute for injured areas.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The MyndMove System stimulates the following muscles:
- Extensor Digitorum, Extensor Carpi Radialis & Extensor Carpi Ulnaris
- Thenar Eminence (Opponens Pollicis Brevis, Flexor Pollicis Brevis & Abductor Pollicis Brevis)
- Flexor Digitorum Superficialis and Flexor Digitorum Profundus
- Biceps
- Triceps
- Posterior Deltoid, Middle Deltoid, and Anterior Deltoid
- Pectoralis Major
- 1st, 2nd and 3rd Lumbricals
- 2nd Dorsal Interosseous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
MyndMove Therapy can only be administered by Trained MyndMove Therapists (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove system.
Used for therapy sessions in a clinical setting only.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
The MyndMove System has been evaluated for electrical safety and has been found to conform with applicable medical device safety standards. The MyndMove System successfully passed all testing in accordance with the defined requirements and the following international standards:
- IEC 60601-2-10 Medical Electrical Equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
- ANSI/AAMI ES60601-1:2005/A1:2012 Medical electrical equipment - part 1: general requirements for basic safety and essential performance (iec 60601-1:2005, mod).
- IEC 60601-1-6:2010 A1-2015 Medical electrical equipment - part 1-6: general requirements for basic safety and essential performance - collateral standard: usability.
- 62304:2006 Medical device software - software life cycle processes.
- IEC 62366-1 Edition 1.0 2015-02, medical devices - part 1: application of usability engineering to medical devices [including corrigendum 1 (2016)]
- AAMI/ANSI/IEC 60601-1-2:2007/(R) 2012, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests (Edition 3)
Testing was completed in accordance with FDA's guidance/draft guidance listed below:
- Guidance for Industry, FDA Reviewers/Staff and Compliance Guidance Document for Powered Muscle Stimulator 510(k)s issued on June 9, 1999
- Guidance for Industry and FDA Staff - Applying Human Factors and Usability Engineering to Medical Devices issued on February 3, 2016
- Guidance for Industry and FDA Staff - Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005
- Guidance for Industry and FDA Staff - Radio Frequency Wireless Technology in Medical Devices issued on August 14, 2013
The electrode cables included in the system comply with the U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables.
The patient contacting accessories included in the system (the electrodes and security tape) comply with the requirements for biocompatibility (ISO 10993-1).
Summary of Clinical Testing:
This submission referenced the following clinical studies in both stroke and spinal cord injured populations using FES therapy:
- Popovic MR et al. Functional electrical therapy: Retraining grasping in spinal cord injury, Spinal Cord, 2006;44(3):143-151.
- Popovic MR et al. Neuroprosthesis for restoring and grasping functions in severe hemiplegic patients Neuromodulation 2005;8(1):60-74.
- Thrasher TA, Zivanovic V, McIlroy W, et al. Rehabilitation of reaching and grasping function in severe hemiplegic patients using functional electrical stimulation therapy. Neurorehabil Neural Repair.2008;22(6):706-14.
- Popovic MR, Kapadia N, Zivanovic V, et al. Functional electrical stimulation therapy of voluntary grasping versus only conventional Rehabilitation for patients with subacute incomplete tetraplegia: a randomized clinical trial. Neurorehabil Neural Repair. 2011.
- Desai N. et al. Influence of different rehabilitation therapy models on patient outcomes: Hand function therapy in individuals with incomplete SCI. Journal of Spinal Cord Medicine, 2014;37(6):734-743.
The MyndMove System incorporates the stimulation protocols used in the FES therapy for the above mentioned clinical studies and couples it with new hardware and software. The stimulation protocols with the MyndMove System are substantially equivalent to the protocols delivered in the studies completed with a Compex electrical stimulation device.
Clinical Experience with MyndMove:
- MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke:
- Study Type: Open label clinical study
- Participants: People with stroke and low levels of arm and hand function (Chedoke-McMaster Stages of Motor Recovery 1 and 2, and Upper Extremity Fugl-Meyer Score (UE-FM) of ≤ 19).
- Design: Designed to investigate the efficacy of 20 one-hour sessions of MyndMove therapy in 3 cohorts: (1) early sub-acute ( 6 months) periods of recovery.
- Sample Size: Recruitment of 25 participants within each cohort is planned.
- Key Results:
- The enrolment of the chronic cohort is complete and results were reported by Hebert et al.
- Twenty-four of 25 individuals completed 19 of 20 sessions. One study participant was withdrawn for medical reasons unrelated to MyndMove therapy.
- After only twenty (20) 1-hour sessions of MyndMove therapy, 14 out of 24 (58%) people with chronic stroke realized clinically meaningful improvements in upper extremity voluntary mobility as measured by a gain in UE-FM of more than 5 points.
- Lead-In Usability Evaluation of MyndMove Prototype November 20, 2013:
- Study Type: Lead-In Usability Testing
- Participants: 5 end user volunteers administering treatment to 5 healthy volunteers.
- Protocol: End User Participants received three hours of training on the use of the device before the evaluation portion.
- MyndMove Human Factors Formative Evaluation April 4, 2014:
- Study Type: Second round of Usability Testing
- Participants: 5 end user-healthy volunteer pairs.
- Protocol: End User Participants received three hours of training on the use of the device before the evaluation portion.
- MyndMove Human Factors Validation Testing February 24, 2017:
- Study Type: Validation testing using simulated-use scenarios
- Participants: 15 end user participants delivered therapy to 15 health volunteer participants.
- Protocol: The testing sessions consisted of participant orientation, eight use scenarios corresponding to tasks that are critical to the safe and effective device use, and debrief interviews. After completing the scenarios, participants were asked to provide subjective feedback regarding any usability issues they encountered. Each end user was trained on the use of MyndMove before the start of the testing session.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
August 30, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Myndtec Inc Alexa Granger Manager, Ouality Assurance 2233 Argentia Road Suite 307 Mississauga, L5N 2X7 CA
Re: K170564
Trade/Device Name: MyndMove System, MyndMove Functional Electrical Stimulator Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: July 28, 2017 Received: July 31, 2017
Dear Alexa Granger:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Hoffmann -S
for
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170564
Device Name
MyndMove System and MyndMove Functional Electrical Stimulator
Indications for Use (Describe) MYNDMOVE is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
o Improvement of arm and hand function 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)
o Maintenance and/or increase of arm and hand range of motion.
- o Prevention and/or retardation of disuse atrophy.
- o Increase in local blood circulation.
- o Reduction of muscle spasm.
- o Re-education of muscles.
MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove System.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the logo for MyndTec. The word "Mynd" is in a dark gray color, while the word "Tec" is in a teal color. There is a teal dot above the "i" in "Mynd".
510(k) Summary
Submitter/Owner Information
MyndTec Inc. 2233 Argentia Road, Suite 307 Mississauga, Ontario Canada, L5N 2X7
Contact Person
Alexa Granger Manager Quality Assurance MyndTec Inc. 2233 Argentia Road, Suite 307 Mississauga, Ontario Canada, L5N 2X7
Phone: 1-905.363.0564 ext.222 Fax: 1-877-796-4624 alexa@myndtec.com
Date Prepared
August 21, 2017
Device Identification
| A. Name of Device | MyndMove System and MyndMove Functional
Electrical Stimulator |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| B. Classification Name | External Functional Neuromuscular Stimulator and
Powered Muscle Stimulator |
| C. Proprietary Name | MyndMove |
| D. Device Classification | Class II |
| E. Panel | Neurology |
| F. Device Product Code | GZI and IPF |
| G. Regulation Number | 882.5810 External functional neuromuscular
stimulators, and
890.5850 Powered Muscle stimulators |
| H. Previous FDA Status | no prior FDA Status |
| I. Basis for Submission | New Device |
I dentification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| NESS H200 Wireless Hand | |||
| Rehabilitation System | Bioness Inc. | K123636 | May 1, 2013 |
4
Device Description
The MyndMove 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 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 Therapy can only be administered by Trained MyndMove Therapists (TMMT) with assigned Therapist Log-In IDs. TMMTs are Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove system.
MyndMove 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 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 protocols achieve a wide range of reaching and grasping functions. During the delivery of MyndMove therapy, the patient executes functional tasks with assistance from the therapist and the MyndMove device. The patient attempts to perform the movement and is then assisted to complete the movement when the therapist activates the MyndMove 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-damaqed areas of the central nervous system can be trained to substitute for injured areas.
5
Image /page/5/Picture/0 description: The image shows the logo for MyndTec. The word "Mynd" is in a dark gray color, and there is a blue dot above the "i" in "Mynd". The word "Tec" is in a light blue color. The logo is simple and modern.
Indications for Use
MYNDMOVE is an electrical stimulation device indicated for the following uses:
- Functional Electrical Stimulation (FES) ●
- Improvement of arm and hand function and active range of motion in o patients with hemiplegia 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 O
- o Prevention and/or retardation of disuse atrophy.
- Increase in local blood circulation. o
- Reduction of muscle spasm. O
- Re-education of muscles. O
MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec on the use of the MyndMove Svstem.
There are three differences in the indications for use of the two devices.
The first difference is the addition of "arm and" before describing the treatment area. MyndMove can stimulate muscles in the whole arm, specifically, muscles of the pectoral girdle and shoulder, arm, forearm and hand complex. MyndMove stimulates 14 different muscles and muscle groups of the entire arm, whereas the NESS H200 Wireless is only stimulating muscles in the forearm and thumb (5 different muscle groups) treating only the hand. With 8 channels the MyndMove device can stimulate combinations of 3 to 8 of the 14 different muscle groups in one treatment protocol. As a result the MyndMove is able to deliver over 25 different reaching and grasping treatment protocols. The NESS H200 is limited to 3 channels and 5 electrodes due to the orthosis used to house the stimulation electrodes it can only stimulate the same 5 muscles groups, delivering two treatment protocols, namely palmar qrasps and lateral pinch grasp.
The second difference in the indication is the specified spinal cord injury level of C3 to T1 for MyndMove, and only C5 for the NESS H200 Wireless. This change is similar to the first, as it relates to the area being treated. MyndMove treats areas of the arm that are both more proximal and more distal to the areas treated by the NESS H200 Wireless, as a result the spinal cord injury patient population that can benefit from MyndMove is larger.
Lastly, the NESS H200 Wireless includes an optional accessory the Intelli-Connect Earpiece triggering Device. This accessory is specified in the NESS H200 Wireless indications for use. MyndMove uses switches (hand or foot controlled) to trigger stimulation, the earpiece triggering device and statement in the NESS H200 Wireless indications for use is not applicable to MyndMove.
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Image /page/6/Picture/0 description: The image shows the logo for MyndTec. The text "Mynd" is in a dark gray color, while "Tec" is in a light blue color. There is a small blue dot above the "i" in "Mynd".
Comparison of Technological Characteristics with the Predicate Device The below Table 1 compares the technological characteristics of the NESS H200 Wireless and the MyndMove System.
| | MyndMove
K170564 | NESS H200 Wireless
K123636 | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| K No. | | | Similar? |
| Indications for
Use | MYNDMOVE is an
electrical stimulation
device indicated for the
following uses:
- Functional Electrical
Stimulation (FES)
o Improvement of
arm and hand
function 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)
o Maintenance
and/or increase of
arm and hand
range of motion
o Prevention and/or
retardation of
disuse atrophy
o Increase in local
blood circulation
o Reduction of
muscle spasm
o Re-education of
muscles
MyndMove Therapy can
only be administered by
Occupational or Physical
Therapists that have
completed MyndMove
training by MyndTec on
the use of the
MyndMove System. | The NESS H200 Wireless
System is an electrical
stimulation device
indicated for the following
uses: - Functional Electrical
Stimulation (FES)
o Improvement of
hand function and
active range of
motion in patients
with hemiplegia due
to stroke or upper
limb paralysis due
to C5 spinal cord
injury. - NeuroMuscular Electrical
Stimulation (NMES)
o Maintenance and/or
increase of arm and
hand range of
motion
o Prevention and/or
retardation of disuse
atrophy
o Increase in local
blood circulation
o Reduction of muscle
spasm
o Re-education of
muscles
The Intelli-Connect is an
optional accessory device
used exclusively with the
H200 Wireless Orthosis
through simple jaw
movements. | Similar |
| K No. | MyndMove
K170564 | NESS H200 Wireless
K123636 | Similar? |
| a. Basic Unit Characteristics | | | |
| i. Power Sources | Mains OR Rechargeable
Li-Ion Battery.
Rechargeable Li-Ion:
14.8 V DC, 2000 mAh
Power Supply Input:
100-240 V AC, 1.2A, 50-60 Hz
Power Supply Output:
24 V DC, 4.16 A, 100W | Controller: Rechargeable
AAA NiMH 1.2V, 900-1100 mAh
Orthosis: Rechargeable
Li-Ion 3.7 V, 280-350 mAh
Charger Power Supply Input: 100-240 V AC,
400mA, 50-60 Hz
Charger Power Supply Output: 5V +/- 5%, 2400 mA | Different |
| - Method of line
current isolation | Galvanic Isolation
(transformer) 4000 VAC | Not Applicable - Battery
Operated | Different |
| Patient Leakage Current: | | | |
| a) Normal
condition
(uA) | Earth Leakage: 6 months) periods of recovery.
Recruitment of 25 participants within each cohort is planned. The
enrolment of the chronic cohort is complete and the results were
reported by Hebert et a/ ¹. Twenty-four of 25 individuals completed
19 of 20 sessions. One study participant was withdrawn from the
study for medical reasons unrelated to MyndMove therapy. After
only twenty (20) 1-hour sessions of MyndMove therapy, 14 out of 24
(58%) people with chronic stroke realized clinically meaningful
improvements in upper extremity voluntary mobility as measured by
a gain in UE-FM of more than 5 points |
| Lead-In
Usability
Evaluation of
MyndMove
Prototype
November 20,
2013 | Lead-In Usability Testing was also completed on an early prototype
version of MyndMove. The Lead-In Testing evaluated the use of the
MyndMove System with 5 end user volunteers administering
treatment to 5 healthy volunteers. End User Participants received
three hours of training on the use of the device before the evaluation
portion. |
| MyndMove
Human Factors
Formative
Evaluation
April 4, 2014 | A second round of Usability Testing with 5 end user-healthy volunteer
pairs. End User Participants received three hours of training on the
use of the device before the evaluation portion. |
| MyndMove
Human Factors
Validation
Testing
February 24,
2017 | The validation testing using simulated-use scenarios where 15 end
user participants delivered therapy to 15 health volunteer
participants. The testing sessions consisted of participant
orientation, eight use scenarios corresponding to tasks that are
critical to the safe and effective device use, and debrief interviews.
After completing the scenarios, participants were asked to provide
subjective feedback regarding any usability issues they encountered.
Each end user was trained on the use of MyndMove before the start
of the testing session. |
Conclusion
The MyndMove System is substantially equivalent to the NESS H200 Wireless because it has the same intended use as the predicate device. Non-Clinical and Clinical testing data supports that the MyndMove System is as safe and effective as the NESS H200 Wireless.
1 Hebert et al. Can severe upper extremity hemiplegia improve with functional electrical stimulation? Ontario Society of Occupational Therapists Conference, Kingston, Canada Sept 26, 2015.