MyndMove System, MyndMove Functional Electrical Stimulator

K170564 · Myndtec, Inc. · GZI · Aug 30, 2017 · Neurology

Device Facts

• Record ID: K170564
• Device Name: MyndMove System, MyndMove Functional Electrical Stimulator
• Applicant: Myndtec, Inc.
• Product Code: GZI · Neurology
• Decision Date: Aug 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MyndMove is an 8-channel functional electrical stimulation (FES) and neuromuscular electrical stimulation (NMES) system; used in clinical settings by trained occupational or physical therapists. Device inputs include therapist-selected stimulation protocols via touch screen UI and patient-triggered hand/foot switches. Device delivers short electrical pulses through surface electrodes to specific arm/hand muscle groups to produce coordinated reaching and grasping movements. Operation influences efferent/afferent pathways to promote neuroplasticity; patient actively attempts movement while device provides stimulation assistance. Output consists of muscle contractions; therapist monitors treatment via UI. System includes cloud-based backend for managing patient IDs, prescriptions, and therapist profiles. Benefits include improved motor recovery, increased ROM, and reduced muscle atrophy/spasm for stroke or spinal cord injury patients.

Clinical Evidence

Evidence includes literature on FES therapy for stroke/SCI and an ongoing open-label study. In the chronic stroke cohort (n=24), 58% (14/24) achieved clinically meaningful improvements in upper extremity mobility (UE-FM gain > 5 points) after 20 one-hour sessions. Usability/Human Factors validation testing (n=15) confirmed safe operation by trained clinicians across critical use scenarios. Referenced literature supports the efficacy of the stimulation protocols used.

Technological Characteristics

8-channel FES/NMES stimulator; mains or Li-Ion battery powered. Materials: Lexan PCB HPX4R enclosure, ABS plastic bezel, silicone rubber membrane. Connectivity: IEEE 802.11 a/b/g/n wireless to cloud backend. Waveforms: Biphasic symmetric and asymmetric; 1Hz or 40Hz frequency; 150-400us pulse width. Safety: Galvanic isolation (4000 VAC), automatic overload/no-load/shut-off. Standards: IEC 60601-1, 60601-1-2, 60601-2-10, IEC 62304, ISO 10993-1.

Indications for Use

Indicated for patients with hemiplegia due to stroke or upper limb paralysis due to C3-T1 spinal cord injury requiring FES for improved arm/hand function/ROM, or NMES for maintenance/increase of ROM, prevention/retardation of disuse atrophy, increased local blood circulation, reduction of muscle spasm, or muscle re-education.

Regulatory Classification

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.

Predicate Devices

• NESS H200 Wireless Hand Rehabilitation System (K123636)

Submission Summary (Full Text)

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Public Health Service

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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# 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) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="border: 1px solid black;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="border: 1px solid black;"> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] ext.222 Fax: [phone] [e-mail]

Date Prepared

August 21, 2017

### Device Identification

| A. Name of Device | MyndMove System and MyndMove Functional<br>Electrical Stimulator |
|--------------------------|-------------------------------------------------------------------------------------------------------|
| B. Classification Name | External Functional Neuromuscular Stimulator and<br>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<br>stimulators, and<br>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<br>Rehabilitation System | Bioness Inc. | K123636 | May 1, 2013 |

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# 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.

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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<br>K170564 | NESS H200 Wireless<br>K123636 | |
|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| K No. | | | Similar? |
| Indications for<br>Use | MYNDMOVE is an<br>electrical stimulation<br>device indicated for the<br>following uses:<br>- Functional Electrical<br>Stimulation (FES)<br>o Improvement of<br>arm and hand<br>function and active<br>range of motion in<br>patients with<br>hemiplegia due to<br>stroke or upper<br>limb paralysis due<br>to C3-T1 spinal<br>cord injury.<br>- NeuroMuscular<br>Electrical Stimulation<br>(NMES)<br>o Maintenance<br>and/or increase of<br>arm and hand<br>range of motion<br>o Prevention and/or<br>retardation of<br>disuse atrophy<br>o Increase in local<br>blood circulation<br>o Reduction of<br>muscle spasm<br>o Re-education of<br>muscles<br>MyndMove Therapy can<br>only be administered by<br>Occupational or Physical<br>Therapists that have<br>completed MyndMove<br>training by MyndTec on<br>the use of the<br>MyndMove System. | The NESS H200 Wireless<br>System is an electrical<br>stimulation device<br>indicated for the following<br>uses:<br>- Functional Electrical<br>Stimulation (FES)<br>o Improvement of<br>hand function and<br>active range of<br>motion in patients<br>with hemiplegia due<br>to stroke or upper<br>limb paralysis due<br>to C5 spinal cord<br>injury.<br>- NeuroMuscular Electrical<br>Stimulation (NMES)<br>o Maintenance and/or<br>increase of arm and<br>hand range of<br>motion<br>o Prevention and/or<br>retardation of disuse<br>atrophy<br>o Increase in local<br>blood circulation<br>o Reduction of muscle<br>spasm<br>o Re-education of<br>muscles<br>The Intelli-Connect is an<br>optional accessory device<br>used exclusively with the<br>H200 Wireless Orthosis<br>through simple jaw<br>movements. | Similar |
| K No. | MyndMove<br>K170564 | NESS H200 Wireless<br>K123636 | Similar? |
| a. Basic Unit Characteristics | | | |
| i. Power Sources | Mains OR Rechargeable<br>Li-Ion Battery.<br><br>Rechargeable Li-Ion:<br>14.8 V DC, 2000 mAh<br><br>Power Supply Input:<br>100-240 V AC, 1.2A, 50-60 Hz<br>Power Supply Output:<br>24 V DC, 4.16 A, 100W | Controller: Rechargeable<br>AAA NiMH 1.2V, 900-1100 mAh<br><br>Orthosis: Rechargeable<br>Li-Ion 3.7 V, 280-350 mAh<br><br>Charger Power Supply Input: 100-240 V AC,<br>400mA, 50-60 Hz<br>Charger Power Supply Output: 5V +/- 5%, 2400 mA | Different |
| - Method of line<br>current isolation | Galvanic Isolation<br>(transformer) 4000 VAC | Not Applicable - Battery<br>Operated | Different |
| Patient Leakage Current: | | | |
| a) Normal<br>condition<br>(uA) | Earth Leakage: < 500 uA<br>Lead to Ground: < 100 uA | Not Available in 510k | Not Known |
| b) Single<br>fault<br>condition<br>(uA) | Earth Leakage: < 1000 uA<br>Lead to Ground: < 500 uA<br>Patient on Mains: < 5000 uA | Not Available in 510k | Not Known |
| ii. Average DC<br>current through<br>electrodes when<br>device is on but<br>no pulses are<br>being applied (uA) | Patient auxiliary current:<br>Normal condition: < 100 uA<br>Single fault condition: < 500 uA | Not Available in 510k | Not Known |
| iii. Number of<br>output modes (ie.<br>Number of<br>stimulation<br>protocols) | Two Modes (applicable<br>to all 33 stimulation<br>protocols):<br>Biphasic<br>Symmetric<br>Biphasic<br>Asymmetric | One Mode (applicable to<br>all 7 stimulation<br>protocols):<br>Biphasic<br>Symmetric | Similar |
| iv. Number of<br>output channels | 8 | 3 | Different |
| Synchronous or<br>Alternating? | Asynchronous (channels<br>are staggered) | Not Available in 510k | Not Known |
| - Method of<br>channel isolation | Galvanic isolation<br>(transformer):<br>1500VAC/3kV DC | Not Available in 510k | Not Known |
| v. Regulated<br>current or<br>regulated voltage? | Current Regulated | Not Available in 510k | Not Known |
| vi. Software/<br>firmware/<br>microprocessor<br>control? (yes/no) | Yes | Yes | Same |
| | MyndMove | NESS H200 Wireless | |
| K No. | K170564 | K123636 | Similar? |
| vii. Automatic<br>overload trip?<br>(yes/no) | Yes | Yes | Same |
| viii. Automatic no-<br>load trip? (yes/no) | Yes | Yes | Same |
| ix. Automatic shut<br>off? (yes/no) | Yes | Yes | Same |
| x. User override<br>control? (yes/no) | Yes | Yes | Same |
| xi. Indicator<br>display: | Yes | Yes | Same |
| - On/off status?<br>(yes/no) | Yes | Yes | Same |
| - Low battery?<br>(yes/no) | Yes | Yes | Same |
| - Voltage/current<br>level? (yes/no) | Yes | Yes | Same |
| xii. Timer range<br>(minutes) | Stimulation time<br>controlled by user.<br>Max duration of<br>stimulation program =<br>120 minutes<br>(configurable in the<br>backend) | Max duration of<br>stimulation program =<br>245 minutes | Similar |
| xiii. Compliance<br>with voluntary<br>standards? (if yes,<br>specify) | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10 | IEC 60601-1<br>IEC 60601-1-2 | Similar |
| xiv. Compliance<br>with 21 CFR 898?<br>(yes/no) | Yes | Not Available in 510k | Same |
| xv. Weight (lbs.,<br>oz.) | 14lbs 6oz. | Controller: 1.5 oz.<br>Orthosis: 10.6 oz. | Different |
| xvi. Dimensions<br>(in.) [W x H x D]<br>(including<br>accessories) | Stimulator: 9.0 in x 4.3<br>in x 9.8 in | Controller Dimensions:<br>1.8 in x 0.7 in x 2.9 in<br>Orthosis (Small):<br>4.33 in x 10.63 in x 3.54<br>in<br>Orthosis (Medium):<br>4.33 in x 10.63 in x 3.54<br>in<br>Orthosis (Large):<br>5.11 in x 11.81 in x 5.11<br>in | Different |
| | MyndMove | NESS H200 Wireless | |
| K No. | K170564 | K123636 | Similar? |
| xvii. Housing<br>materials and<br>construction<br>(including<br>accessories) | Stimulator Housing<br>Materials:<br>- Enclosure = Lexan<br>PCB HPX4R<br>- Plastic Bezel = ABS<br>Plastic<br>- Rubber Membrane =<br>Silicone | Orthotic Materials:<br>- Main body = Rislan<br>BZM 30 OTL<br>- Wing Cover = TEREZ<br>ABS 5010<br>- Wrist Insert = flexible<br>foam, two components<br>urethane nonintegral<br>skin, Purtec GMBH<br>- Thenar = Dow Corning<br>Silicone Rubber NPC 40 | Different |
| xv. Additional<br>Features (specify,<br>if applicable) | - Timing of stimulation<br>controlled by user<br>(therapist) through<br>the use of a hand or<br>foot switch | - Orthotic<br>- Controller<br>- Intelli-Connect Earpiece<br>Trigger Device | Different |
| xvi. Clinical and Human Factors Characteristics: | a) Target<br>Population…