(237 days)
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.
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.
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 Use | Identical 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 Characteristics | Biphasic 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 < 2mA/cm2 limit identified in IEC 60601-2-10).- Maximum Power Density: 0.044W/cm2 (Identical to predicate).Note: Biphasic Symmetrical Output Mode removed in MyndMove 2.0, deemed "Equivalent" based on overall safety and performance. |
| Electrical Safety Standards Compliance | Complies with:- IEC 60601-2-10 Ed 2.1 2016-04 (nerve & muscle stimulators)- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (basic safety & essential performance)- IEC 60601-1-2 Ed 4.0 2014-02 (EMC)- IEC 60601-1-11 Ed 2.0 2015-01 (home healthcare environment)- IEC 62304:2006 (software life cycle)- 60601-1-6:2010 + A1:2013 (usability).Reported performance: Earth Leakage (< 500 uA normal, < 1000 uA single fault); Lead to Ground (< 100 uA normal, < 500 uA single fault); Patient on Mains (< 5000 uA single fault); Patient auxiliary current (< 100 uA normal, < 500 uA single fault). All meet specified limits. |
| Mechanical/Physical Changes | - Change of stimulator tablet material (due to availability)- Removal of internal battery- Addition of IP22 rated ingress protection- Addition of an optional cart- Max 20mA output current for all electrode sizes (was varied by size in predicate)- Addition of scapula protocols |
| Usability | No additional usability testing required as no change to hardware or software design affecting usability. |
| Maximum net charge per pulse & phase charge | Net charge per pulse: 1.85 µC (Identical to cleared device)Maximum phase charge: 9.02 µC (Identical to cleared device) |
| Peak current density | In all cases, peak current density does not exceed 2mA/cm2 (limit identified in IEC 60601-2-10). |
Study (Testing) Proving Device Meets Acceptance Criteria:
-
Sample size used for the test set and the data provenance:
- For the technical performance and safety standard compliance, no specific sample size for a "test set" in a clinical trial sense is mentioned. Compliance was verified through Third Party testing for the relevant IEC standards and internal performance testing.
- For the scapula anatomical site addition: "Testing was performed... on 3 healthy volunteers."
- Data Provenance: Not explicitly stated for all testing. For the scapula protocol validation, it was performed at "a clinical site called Lyndhurst and the Toronto Rehabilitation Institute of the University Health Network of the University of Toronto" (Canada). This implies prospective testing for this specific modification. General IEC compliance testing is typically laboratory-based.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document as it's not a clinical performance study involving expert reads for ground truth.
- For the scapula protocol validation, the "objective was to test each protocol on each subject to ensure that the induced motions achieve the desired motions per the described use cases." This likely involved observation by a qualified professional (e.g., physiotherapist), but no specific "expert" panel or "ground truth" establishment in a traditional clinical validation sense is described.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided as it's not a clinical performance study with subjective assessments requiring adjudication.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study was done or reported. The device is an electrical stimulator, not an AI imaging or diagnostic tool where MRMC studies are typically performed.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The device is a medical device, not an AI algorithm intended for standalone diagnostic performance. Therefore, no such standalone algorithmic performance study was done or reported.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For technical and safety performance: Compliance with recognized international standards (e.g., IEC 60601 series) serves as the "ground truth" or benchmark. This is verified through objective testing (oscilloscope tracings, leakage current measurements, etc.).
- For the scapula protocol addition: The "ground truth" was whether the "induced motions achieve the desired motions per the described use cases." This appears to be a functional verification, likely observed by therapists, rather than a diagnostic ground truth.
-
The sample size for the training set:
- This information is not applicable as the device is not an AI or machine learning model that requires a training set in the conventional sense.
-
How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above.
Summary of the Study/Testing:
The "study" or testing described in this 510(k) summary is primarily focused on demonstrating technical and safety compliance of the modified MyndMove 2.0 device with relevant medical device standards, and confirming that the modifications (e.g., removed battery, new tablet material, home-use capability, new anatomical protocols, altered current for electrodes) do not negatively impact its safety or essential performance compared to the predicate device.
- Main tests: Third-party testing for compliance with IEC 60601-2-10, ES60601-1, 60601-1-2, 60601-1-11, 62304, and 60601-1-6. Internal performance testing.
- Specific validation for new protocols: For the addition of scapula protocols, there was "planned validation testing on 3 healthy volunteers" to ensure "induced motions achieve the desired motions." This was done at a clinical site, with "All verification and validation... successfully performed per the design and development plans and under REB decision."
The document concludes that the MyndMove 2.0 device is "substantially equivalent" to its predicate based on these technical and functional assessments, not on clinical performance metrics typically associated with diagnostic AI or imaging devices.
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March 03, 2022
MyndTec Inc. Yesmil Pena Quality Assurance Manager 1900 Minnesota Court Suite 122 Mississauga, Ontario Canada
Re: K212149
Trade/Device Name: MyndMove 2.0 Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: January 18, 2022 Received: January 20, 2022
Dear Yesmil Pena:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2023 See PRA Statement below.
Indications for Use
510(k) Number (if known) K212149
Device Name
MyndMove 2.0
Indications for Use (Describe)
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.
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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510(k) Summary
Submitter / Owner Information
MyndTec Inc. 1900 Minnesota Court, Suite 122 Mississauga, Ontario Canada, L5N 3C9
Contact Person
Yesmil Pena Telephone:: 905-363-0564 ext. 225 Toll Free: 1-888-363-0581 Fax: 1-877-796-4624 yesmil.pena@myndtec.com
Date Prepared:
March 02, 2022
Device Identification
| A. Name of Device | MyndMove System and MyndMove FunctionalElectrical Stimulator |
|---|---|
| B. Classification Name | External Functional Neuromuscular Stimulator andPowered Muscle Stimulator |
| C. Proprietary Name | MyndMove 2.0 |
| D. Device Classification | Class II |
| E. Panel | Neurology |
| F. Device Product Code | GZI and IPF |
| G. Regulation Number | 882.5810 External functional neuromuscularstimulators, and890.5850 Powered Muscle stimulators |
| H. Previous FDA Status | no prior FDA Status |
| I. Basis for Submission | Modified Device |
Identification of Predicate Device
| Device | Applicant | 510(k) No. | Date Cleared |
|---|---|---|---|
| MyndMove | MyndTec Inc. | K170564 | August 30, 2017 |
Device Description
The purpose of this Traditional 510(k) is to obtain clearance for MyndMove 2.0, a modified version of the MyndMove device (K170564) functional electrical and neuromuscular
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stimulation device. The MyndMove device (K170564) has undergone minor modifications resulting in the MyndMove 2.0 version. The modifications are a change of the stimulator tablet material due to availability, the removal of the internal battery from the design of the MyndMove 2.0, the addition of IP22 rated ingress protection and the addition of an optional cart to facilitate mobility in the clinical environment. A slight change in the final paragraph after the indications for use to add Physiotherapist Assistants (PTAs) and Occupational Therapy Assistants (OTAs) in addition to Physiotherapists (PTs) and Occupational Therapists (OTs) as authorized users of the MyndMove 2.0 upon training and licensing by State Law, in alignment with Medicare and TRICARE policies.
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.
Indications for Use
MYNDMOVE 2.0 is an electrical stimulation device indicated for the following uses:
Functional Electrical Stimulation (FES)
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Improvement of arm and hand functions and active range of motion in patients with hemiplegia due to stroke or upperlimb 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.
MyndMove therapy can only be administered by Occupational or Physical Therapy professionals that have completed MyndMove training by MyndTec on the use of the MyndMove System.
Type of Use
Prescription Use (Rx)
Performance Standards
MyndMove 2.0 complies with the current medical electrical equipment electromagnetic compatibility basic safety and performance, and software standards listed below, as verified upon Third Party testing for compliance with 60601-2-10 Edition 2.1 2016-04, ( basic safety and essential performance of nerve and muscle stimulators), ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (basic safety and essential performance); 60601-1-2 Edition 4.0 2014-02 ( basic safety and essential performance for Electromagnetic disturbances); 60601-1-11 Edition 2.0 2015-01( basic safety and essential performance requirements for medical electrical equipment a used in the home healthcare environment). MyndMove also complies with IEC 62304:2006 Medical device software - Software life cycle processes and 60601-1-6:2010 Third Edition + A1:2013 (basic safety and essential performance for usability). No additional usability testing to the original cleared device was required. There was no change to the hardware or
software design. Performance testing was performed also internally against the same specifications of the cleared device.
As part of performance testing, six oscilloscope tracings were generated for 500 ohm, 2k ohm and 10k ohms and include output mode, amplitude baseline, load resistance, pulse width, and electrode surface area with the corresponding maximum power density and average current density per surface area. The maximum net charge per pulse and phase charge for the modified device MyndMove 2.0 are identical to those of the cleared device MyndMove. The net charge per pulse for both the modified and cleared devices is 1.85 µC, and the maximum phase charge is 9.02 uC.
| FDA Recognition No. | Standard Title |
|---|---|
| 17-16 | IEC 60601-2-10 Edition 2.1 2016-04. Medical electrical equipment - Part 2-10:Particular requirements for the basic safety and essential performance of nerveand muscle stimulators. |
| 19-4 | ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text): Medical electrical equipment - Part 1:General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). |
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| 19-8 | IEC 60601-1-2 Edition 4.0 2014-02: Medical electrical equipment - Part 1-2:General requirements for basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements and tests. |
|---|---|
| 19-14 | IEC 60601-1-11 Edition 2.0 2015-01: Medical electrical equipment - Part 1-11:General requirements for basic safety and essential performance - CollateralStandard: Requirements for medical electrical equipment and medical electricasystems used in the home healthcare environment. |
Basis for Substantial Equivalence
MyndTec Inc.'s MyndMove and MyndMove 2.0 are similar in design, function and technical specifications. Both devices have the same intended use and deliver functional electrical and neuromuscular stimulation using coded therapeutic algorithmic protocols using an eightchannel stimulator with a maximum 20 mA output current for all 9cm x 5cm, 5cm, 2.5cm diameter and 1cm x 3cm sinqle use electrodes. Both the cleared and modified device have almost identical technical specifications as illustrated in the table below.
MyndMove 2.0 is the result of the removal of the battery, an upgrade of the tablet PC and other modifications to meet home use requirements, maximum current equal to all electrodes, the addition of scapula protocols, and the addition of an optional cart. The predicate device MyndMove has maximum outputs for electrodes depending on size, ranging from 5mA for a 3cm2 electrode, the smallest size, to 20mA for a 45cm2 electrode, the largest size. The modified MyndMove 2.0 applies a maximum 20 mA output current for all electrodes regardless of electrode size to enable the therapist to select the peak currents to generate full muscle recruitment with any electrode size, particularly with denervated muscles. In both the predicate and modified devices, peak current values for all electrode sizes fall under the 2mA/cm maximum allowed by IEC 60601-2-10. Scapula protocols were added to the existing deltoid anatomical sites to optimize patient objectives. An analysis of the performance testing results and all similarities and differences listed in the table below
leads to determine that the modified MyndMove 2.0 has the same technical characteristics the cleared MyndMove. The differences do not raise any concerns regarding safety and effectiveness. Therefore, MyndMove 2.0 is substantially equivalent to the predicate device, the cleared MyndMove.
| Substantial Equivalence discussion for subject device MyndMove 2.0 and predicate device MyndMove. | |||
|---|---|---|---|
| Cleared Device MyndMove | Modified Device MyndMove 2.0 | SE Comparison | |
| 510(k) Number | K170564 | (To Be Assigned) | |
| Indications for Use | MyndMove is an electrical stimulation deviceindicated for the following uses: | MyndMove is an electrical stimulation deviceindicated for the following uses: | Identical |
| Functional electrical stimulation (FES) | Functional electrical stimulation (FES) | ||
| Improvement of arm and hand function andactive range of motion in patients with hemiplegiadue to stroke or upper limb paralysis due toC3-T1 spinal cord injury.NeuroMuscular Electrical Stimulation (NMES)• maintenance and/or increase of arm and handrange of motion,• prevention and/or retardation of disuse atrophy,• increase in local blood circulation,• reduction in muscle spasm, and• re-education of muscles.MyndMove therapy can only be administered byOccupational or Physical Therapists that havecompleted MyndMove training by MyndTec on theuse of the MyndMove System. | Improvement of arm and hand function andactive range of motion in patients with hemiplegiadue to stroke or upper limb paralysis due toC3-T1 spinal cord injury.NeuroMuscular Electrical Stimulation (NMES)• maintenance and/or increase of arm and handrange of motion,• prevention and/or retardation of disuse atrophy,• increase in local blood circulation,• reduction in muscle spasm, and• re-education of muscles.MyndMove therapy can only be administered byOccupational or Physical Therapyprofessionals that have completed MyndMovetraining by MyndTec on the use of theMyndMove System. | (There was a minorchange on the laststatement from'Occupational orPhysical Therapists' to'Occupational orPhysical Therapyprofessionals' toenable Occupationalor Physical TherapyAssistants (OTAs orPTAs) to administerthe MyndMovetherapy with theappropriate trainingand per thecorrespondingjurisdiction laws andregulations).Thischange does not alterthe intended use. | |
| Anatomical Sitesfor Stimulation(Upper Limb) | The MyndMove System stimulates thefollowing Muscles:Extensor Digitorum, Extensor Carpi Radialis& Extensor Carpi UlnarisThenar Eminence (Opponens Pollicis Brevis,Flexor Pollicis Brevis & Abductor PollicisBrevis)Flexor Digitorum Superficialis and Flexor | The MyndMove System stimulates thefollowing Muscles:Extensor Digitorum, Extensor Carpi Radialis& Extensor Carpi UlnarisThenar Eminence (Opponens Pollicis Brevis,Flexor Pollicis Brevis & Abductor PollicisBrevis)Flexor Digitorum Superficialis and Flexor | EquivalentPlease refer to theScapula protocoladdition discussion |
| Digitorum ProfundusBicepsTricepsPosterior Deltoid, Middle Deltoid, andAnterior DeltoidPectoralis Major1st, 2nd, and 3rd Lumbricals2nd Dorsal Interosseous | Digitorum ProfundusBicepsTricepsPosterior Deltoid, Middle Deltoid, andAnterior DeltoidPectoralis Major1st, 2nd, and 3rd Lumbricals2nd Dorsal InterosseousSerratus Anterior, Lower Trapezius, UpperTrapezius (Scapula). | below. | |
| Serratus Anterior, Lower Trapezius, UpperTrapezius (Scapula). | |||
| Where Used | Used for therapy sessions in a clinical settingonly. | Used for therapy sessions in a clinical settingand for home use by a qualified user. | EquivalentMyndMove 2.0 wasdesigned for andtested against60601-1-11 (homehealthcare) |
| Regulated currentor | Current Regulated | Current Regulated | Identical |
| regulated voltage?Software/firmware/microprocessorcontrol? (yes/no) | Yes | Yes | Identical |
| Automaticoverload trip?(yes/no) | Yes | Yes | Identical |
| Automatic no- loadtrip? (yes/no) | Yes | Yes | Identical |
| Automatic shutoff? (yes/no) | Yes | Yes | Identical |
| User overridecontrol? (yes/no) | Yes | Yes | Identical |
| Indicator display: | Yes | Yes | Identical |
| - On/off status?(yes/no) | Yes | Yes | Identical |
| - Low battery?(yes/no) | Yes | Yes | Identical |
| - Voltage/currentlevel? (yes/no) | Yes | Yes | Identical |
| Timer range( minutes ) | Stimulation time controlled by user. | Stimulation time controlled by user. | Identical |
| Max duration of stimulation program = 120minutes (configurable in the backend) | Max duration of stimulation program = 120minutes (configurable in the backend) | ||
| Compliance withvoluntarystandards? (if yes,specify) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | ANSI AAMI ES 60601-1IEC 60601-1-2IEC 60601-2-10 | Equivalent |
| Compliance with21 CFR 898?(yes/no) | Yes | Yes | Identical |
| Power Sources | Mains OR Rechargeable Li-Ion Battery.Rechargeable Li-Ion:14.8 V DC, 2000 mAhPower Supply Input: 100-240 V AC, 1.2A, 50-60 HzPower Supply Output: 24 V DC, 4.16 A, 100W | AHM100PS24C2-8 manufactured by XP-Power100-240 V AC, 1.2 A, 50-60 Hz24 V DC, 4.16 A, 100 WTripp Lite P012-006, 1-15P to C7 -10A, 120V, 18AWG, 6 ft., BlackSabic, Lexan Polycarbonate: Sabic, Lexan PolycarbonateSabic, Lexan Polycarbonate Covestro, Makrolon2805 Polycarbonate TPE E4001-40-J02 | Equivalent |
| Method of linecurrent isolation | Galvanic Isolation (transformer) 4000 VAC | Galvanic Isolation (transformer) 4000 VAC | Identical |
| Normalcondition (uA) | Earth Leakage: < 500 uALead to Ground: < 100 uA | Earth Leakage: < 500 uALead to Ground: < 100 uA | Identical |
| Singlefault condition(uA) | Earth Leakage: < 1000 uALead to Ground: < 500 uAPatient on Mains: < 5000 uA | Earth Leakage: < 1000 uALead to Ground: < 500 uAPatient on Mains: < 5000 uA | Identical |
| Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied (uA) | Patient auxiliary current: Normal condition: < 100uASingle fault condition: < 500 uA | Patient auxiliary current: Normal condition: < 100uASingle fault condition: < 500 uA | Identical |
| Number of outputmodes (ie.Number ofstimulationprotocols) | Two Modes (applicable to all 33 stimulationprotocols):- Biphasic Symmetric- Biphasic Asymmetric | Biphasic Asymmetric | Similar |
| Number of outputchannels | 8 | 8 | Identical |
| Synchronous orAlternating? | Asynchronous (channels are staggered) | Asynchronous (channels are staggered) | Identical |
| Method of channelisolation | Galvanic isolation (transformer): 1500VAC/3kV DC | Galvanic isolation (transformer): 1500VAC/3kV DC | Identical |
| Weight (lbs., oz.) | 14lbs 6oz. | 14lbs 6oz. | Identical |
| Dimensions (in.)[W x H x D](includingaccessories) | Stimulator: 9.0 in x 4.3 in x 9.8 in | Stimulator: L 33 cm x W 25 cm x H 13.5 cm | Similar |
| Housingmaterials andconstruction(includingaccessories) | Stimulator Housing Materials:- Enclosure = Lexan PCB HPX4R- Plastic Bezel = ABS Plastic- Rubber Membrane = Silicone | Stimulator Housing Materials:- Enclosure = Lexan PCB HPX4R- Plastic Bezel = ABS Plastic- Rubber Membrane = Silicone | Identical |
| AdditionalFeatures(specify,if applicable) | - Timing of stimulation controlled by user(therapist) through the use of a hand orfoot switch | - Timing of stimulation controlled by user(therapist) through the use of a hand orfoot switch | Identical |
| Design andHuman Factors | - Functional Electrical Stimulator.- Single Use Gel Electrodes- 8 stimulation channels, up to 16 electrodes.- Controlled by an embedded touch screen graphicaluser interface and hand and foot switches.- Preprogrammed with stimulation protocols.- No fitting required, instruction for electrodeplacement for each stimulation protocol included inuser interface.- Used by Clinician Only. | - Functional Electrical Stimulator.- Single Use Gel Electrodes- 8 stimulation channels, up to 16 electrodes.- Controlled by an embedded touch screengraphical user interface and hand and footswitches.- Preprogrammed with stimulation protocols.- No fitting required, instruction for electrodeplacement for each stimulation protocol included inuser interface.- Used by Clinician Only | Identical |
| Biphasic Symmetrical Output Mode | |||
| Waveform (eg.Pulsedmonophasic,biphasic) | Balanced Biphasic Symmetrical | Not Applicable, No Symmetrical Output Mode | Equivalent |
| Shape (eg. | Rectangular | Not Applicable, No Symmetrical Output Mode | Equivalent |
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| Rectangular,spike, rectifiedsinusoidal) | |||||||
|---|---|---|---|---|---|---|---|
| Maximum OutputVoltage (volts)(+/- %) at500ohms, 2kohmsand 10kohms | (+/- 10%) @ 500ohms = 160V @ 2kohms = 160V@ 10kohms = 160V | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Maximum OutputCurrent (specifyunits) (+/- %) at500 ohms, 2kohmsand 10kohms | (+/- 10%) @ 500ohms = 20mA @ 2kohms = 20mA@ 10kohms = 16mA | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Pulse width(specify units) | Positive: 150-400 usNegative: 150-400 us | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Frequency (Hz) | 1Hz or 40Hz | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| For multiphase waveforms only: | |||||||
| Symmetricalphases? (yes/no) | Yes | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Phase Duration(include units),(state range, ifapplicable), (bothphases, ifasymmetrical) | Positive: 150-400 usNegative: 150-400 us | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Net Charge (uCper pulse) (Ifzero, state methodof achieving zeronet charge) | 2.00 uC | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Maximum PhaseCharge (uC) | 9.02 uC | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Maximum CurrentDensity (RMS)(mA/cm2) | 1.36 mA/cm2 (for 1cm x 3cm electrode) | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Maximum PowerDensity, (W/cm2),(using smallestelectrodeconductive surfacearea) | 0.044W/cm2 | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Burst Mode (ie.Pulse trains): | Not Applicable, No Burst Mode | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Pulses per burst | Not Applicable, No Burst Mode | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Bursts per second | Not Applicable, No Burst Mode | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Burst duration(seconds) | Not Applicable, No Burst Mode | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Duty Cycle: Line(b) x Line (c) | Not Applicable, No Burst Mode | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| ON Time(seconds) | Not Fixed - User Controlled | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| OFF Time(seconds) | Not Fixed - User Controlled | Not Applicable, No Symmetrical Output Mode | Equivalent | ||||
| Biphasic Asymmetrical Output Mode | |||||||
| Waveform (eg.Pulsedmonophasic,biphasic) | Shape (eg.Rectangular,spike, rectifiedsinusoidal) | Balanced Biphasic Asymmetrical | Balanced Biphasic Asymmetrical | Identical | |||
| Maximum OutputVoltage (volts)(+/- %) at500ohms, 2kohmsand 10kohms | (+/- 10%)Positive:@ 500ohms = 160V @ 2kohms = 160V @ 10kohms= 160VNegative:@ 500ohms = 40V @ 2kohms = 40V @ 10kohms =40V | (+/- 10%)Positive:@ 500ohms = 160V @ 2kohms = 160V @10kohms = 160VNegative:@ 500ohms = 40V @ 2kohms = 40V @ 10kohms =40V | Identical | ||||
| Maximum OutputCurrent (specify | (+/- 10%)Positive: | (+/- 10%)Positive: | Identical | ||||
| Rectangular | Rectangular | Identical |
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| units) (+/- %) at500 ohms, 2kohmsand 10kohms | @ 500ohms = 20mA @ 2kohms = 20mA @10kohms = 16mANegative:@ 500ohms = 5mA @ 2kohms = 5mA@ 10kohms = 4mA | @ 500ohms = 20mA @ 2kohms = 20mA @10kohms = 16mANegative:@ 500ohms = 5mA @ 2kohms = 5mA@ 10kohms = 4mA | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pulse width(specify units) | Positive: 150-400 usNegative: 600-1600 us | Positive: 150-400 usNegative: 600-1600 us | Identical | |||||||||||||||
| Frequency (Hz) | 1Hz or 40Hz | 1Hz or 40Hz | Identical | |||||||||||||||
| For multiphase waveforms only: | ||||||||||||||||||
| Symmetricalphases? (yes/no) | No | No | Identical | |||||||||||||||
| Phase Duration(include units),(state range, ifapplicable), (bothphases, ifasymmetrical) | Positive: 150-400 usNegative: 600-1600 us | Positive: 150-400 usNegative: 600-1600 us | Identical | |||||||||||||||
| Net Charge (uCper pulse) (Ifzero, state methodof achieving zeronet charge) | 1.85uC | 1.85uC | Identical | |||||||||||||||
| Maximum PhaseCharge (uC) | Positive: 9.02 uCNegative: 8.86 uC | 9.02μC | Equivalent | |||||||||||||||
| Maximum CurrentDensity (RMS)(mA/cm2) | 1.07 mA/cm2 (for 1 cm x 3 cm electrodes) | Electrode Size:Peak Current/Imrs (Max):Current Density1 cm x 3 cm20 mA /2.83 mA0.93 mA/cm22.5 cm Ø20 mA / 2.83 mA0.57 mA/cm25 cm x 5 cm20 mA / 2.83 mA0.11 mA/cm29 cm x 5 cm20 mA / 2.83 mA0.06 mA/cm2 | EquivalentRefer toPeakcurrent valuediscussion below. | |||||||||||||||
| Maximum PowerDensity, (W/cm2),(using smallestelectrodeconductive surfacearea) | 0.044W/cm2 | 0.044W/cm2 | Identical | |||||||||||||||
| Burst Mode (ie.Pulse trains): | Not Applicable, No Burst Mode | Not Applicable, No Burst Mode | Identical | |||||||||||||||
| Pulses per burst | Not Applicable, No Burst Mode | Not Applicable, No Burst Mode | Identical | |||||||||||||||
| Bursts per second | Not Applicable, No Burst Mode | Not Applicable, No Burst Mode | Identical | |||||||||||||||
| Burst duration(seconds) | Not Applicable, No Burst Mode | Not Applicable, No Burst Mode | Identical | |||||||||||||||
| Duty Cycle: Line(b) x Line (c) | Not Applicable, No Burst Mode | Not Applicable, No Burst Mode | Identical | |||||||||||||||
| ON Time(seconds) | Not Fixed - User Controlled | Not Fixed - User Controlled | Identical | |||||||||||||||
| OFF Time(seconds) | Not Fixed - User Controlled | Not Fixed - User Controlled | Identical |
Scapula anatomical site addition discussion:
The addition of the scapula protocols is essential for the optimization and achievement of the objectives of patients using MyndMove without departing from the existing anatomical sites already connected to the scapula, such as the posterior and middle deltoid muscles, which connect to the upper part of the scapula (Cleveland clinic, 2021), although the deltoids alone were not enough to achieve the movements intended by adding the scapula protocol (sideways reach, sideways reach with Scapula and hand opening, Forward reach with Scapula muscle , Forward reach with Scapula muscle + hand opening/closing, hand to mouth with Scapula muscle plus hand closing, and hand to mouth with Scapula muscle + hand closing). Scapula protocols were subject to planned validation testing on 3 healthy volunteers. The objective was to test each protocol on each subject to ensure that the induced motions achieve
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the desired motions per the described use cases presented in section. Shoulder range of motion (flexion and abduction) under stimulation was collected using a goniometer.
Testing was performed at a clinical site called Lyndhurst and the Toronto Rehabilitation Institute of the University Health Network of the University of Toronto. All verification and validation was successfully performed per the design and development plans and under REB decision at the Toronto Rehabilitation Institute.
The addition of Scapula to the anatomical sites treated with MyndMove protocols fall within or at least are connected in movements of the same anatomical sites listed in the predicate device, the cleared MyndMove. In addition, these do not add new risk or change the existing risk profile.
References:
Cowan PT, Mudreac A, Varacallo M. Anatomy, Back, Scapula. [Updated 2021 Aug 11]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2021 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK531475/
Cleveland Clinic (2021). Deltoid Muscles. https://my.clevelandclinic.org/health/body/21875deltoid-muscles.
Peak current value discussion.
The peak current for the cleared MyndMove is a function of electrode size, ranging from 5mA for a 3cm2 electrode. to the peak current 20mA for a 45cm2 electrode. For MyndMove 2.0 the peak current is also 20mA for all electrode sizes. The purpose of this change is to enable the therapist to select the peak currents to generate full muscle recruitment if using the smallest electrode size. This is particularly needed when stimulating denervated muscles. In all cases the peak current density does not exceed 2mA/cm2, the limit identified in IEC 60601-2-10, therefore the level of stimulation is considered safe. The risks of stimulation are described in the risk analysis and the benefit of treatment outweighs the risk.
Conclusion:
MyndMove 2.0 has the same indications for use and output characteristics as the predicate device MyndMove. MyndMove 2.0 is fundamentally an upgraded MyndMove enabled for home environment use as a prescription device. The differences in some specifications do not raise safety and effectiveness questions. The safety and effectiveness of adding scapula protocols to the anatomical sites was demonstrated through validation testing with healthy volunteers in a clinical setting, in addition to internal testing. The average current density regardless of electrode size does not incorporate risks or safety concerns; the smallest electrode surface area average current density it falls under the allowed 2mA/cm2 limit established by IEC 60601-2-10 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators. Third party testing on the addition of features to meet home use requirements of 60601-1-11 concluded that MyndMove 2.0 is safefor home use within the same indications for use of the predicate device.
In conclusion, there are no fundamental differences between the MyndMove 2.0 and MyndMove device. The modifications made in MyndMove 2.0 did not raise different questions regarding safety and effectiveness. Both are prescription devices with the same indications for use and specifications except for slight technical differences. The modified MyndMove 2.0 is deemed substantially equivalent to the predicate, the cleared MyndMove.
§ 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).