(184 days)
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 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.
Here's an analysis of the acceptance criteria and supporting studies for the MyndMove System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided does not explicitly list "acceptance criteria" in the typical quantitative sense for device performance. Instead, it details the technological characteristics of the MyndMove System and compares them to a predicate device (NESS H200 Wireless). The "acceptance" for this submission is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical and clinical data indicating comparable safety and effectiveness.
However, the document highlights some performance aspects, particularly in the clinical summary. For the purpose of structuring a response consistent with your request, I will infer the "performance" as the clinical outcomes described in the referenced studies, specifically the MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke study.
| Acceptance Criteria (Inferred from Substantial Equivalence and Clinical Goal) | Reported Device Performance (from MyndMove clinical study) |
|---|---|
| Safety: Device operates without new questions of safety. | MyndMove System passed all electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, ANSI/AAMI ES60601-1, IEC 60601-1-6, IEC 62304, IEC 62366-1). Electrode cables comply with 21 CFR 898. Patient-contacting accessories (electrodes, tape) comply with biocompatibility (ISO 10993-1). Human Factors evaluations (Lead-In, Formative, Validation) found the device safe and effective for use. |
| Effectiveness - Stroke (Arm and Hand Function Improvement): Demonstrates improvement in arm and hand function and active range of motion in patients with hemiplegia due to stroke. | In the "MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke" study (chronic cohort): 14 out of 24 (58%) people with chronic stroke realized clinically meaningful improvements in upper extremity voluntary mobility as measured by a gain of more than 5 points in the Upper Extremity Fugl-Meyer Score (UE-FM) after 20 one-hour sessions of MyndMove therapy. |
| Effectiveness - Spinal Cord Injury (Arm and Hand Function Improvement): Demonstrates improvement of arm and hand function and active range of motion in patients with upper limb paralysis due to C3-T1 spinal cord injury. | While the indications for use cover SCI, the provided clinical summary specifically highlights outcomes for stroke patients. The summary states that "This submission referenced the following clinical studies in both stroke and spinal cord injured populations using FES therapy," however, the details of a specific MyndMove study on SCI patients with performance metrics are not explicitly provided in the same format as the stroke study. It refers to previously published studies using FES therapy. |
2. Sample Size for the Test Set and Data Provenance
The primary clinical "test set" and its findings specifically for the MyndMove System is described for stroke patients:
- Study: "MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke" (chronic cohort).
- Sample Size (Chronic Cohort):
- Planned recruitment: 25 participants.
- Completed sessions: 24 of 25 individuals.
- Withdrawn for unrelated medical reasons: 1 participant.
- Effective Sample Size for results: 24 participants.
- Data Provenance: The document does not explicitly state the country of origin for this specific MyndMove clinical study. However, MyndTec Inc. is based in Mississauga, Ontario, Canada, suggesting Canadian origin is plausible. The study is described as "ongoing" and its results (for the chronic cohort) were reported by Hebert et al. at an Ontario Society of Occupational Therapists Conference in Kingston, Canada. This indicates it is a prospective clinical study.
Additional usability testing (also considered "clinical testing" in a broader sense for safety and effectiveness) was conducted:
- Lead-In Usability Evaluation: 5 end-user volunteers administering treatment to 5 healthy volunteers.
- Human Factors Formative Evaluation: 5 end-user/healthy volunteer pairs.
- Human Factors Validation Testing: 15 end-user participants delivered therapy to 15 healthy volunteer participants.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
For the MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke study, the ground truth for "clinically meaningful improvements" was measured by a "gain in UE-FM of more than 5 points." The UE-FM (Upper Extremity Fugl-Meyer Score) is a standardized, clinician-administered, objective assessment tool. The document implies that qualified clinicians (likely Occupational or Physical Therapists, given the context of MyndMove administration) administered this scoring. It does not specify the number of individual experts or their years of experience for the scoring itself within this specific study, but it does state that "MyndMove therapy can only be administered by Occupational or Physical Therapists that have completed MyndMove training by MyndTec." This suggests the evaluators would be similarly qualified.
Regarding the usability/human factors studies, the "ground truth" was established by observing "end-user volunteers" (Occupational or Physical Therapists) interact with the device and identifying usability issues.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (like 2+1, 3+1 consensus) for the clinical outcomes measured by the UE-FM score. Standardized clinical assessments like the UE-FM are typically administered by a single trained assessor, with inter-rater reliability often established for the tool itself in broader literature, rather than requiring case-by-case adjudication.
For the usability/human factors evaluations, the adjudication method essentially involved observing participant interactions and gathering subjective feedback, which would then be analyzed by the study coordinators.
5. 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
The provided document describes a medical device, the MyndMove System, which is an electrical stimulation device for rehabilitation. It is not an AI/imaging device, and therefore, an MRMC comparative effectiveness study involving "human readers" and "AI assistance" is not applicable to this submission. The device directly delivers therapy rather than providing diagnostic information to human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Again, this is not an AI/imaging device. The MyndMove System is a hardware and software system that controls electrical stimulation. Its performance is tied to its output specifications and its clinical efficacy when administered to patients by trained therapists. There isn't a "standalone algorithm" performance in the sense of an AI performing a task independently. The device is the algorithm in terms of delivering stimulation protocols, but it explicitly requires human-in-the-loop (a trained therapist) for administration.
7. The Type of Ground Truth Used
For the clinical efficacy study on stroke patients ("MyndMove Therapy for Severe Hemiparesis of the Upper Limb Following Stroke"), the ground truth was clinical assessment scores, specifically the Upper Extremity Fugl-Meyer Score (UE-FM). This is an objective, quantitative measure of motor impairment and function.
For the non-clinical testing (electrical safety, biocompatibility, usability), the ground truth was established by adherence to recognized international standards and FDA guidance documents, as well as observed user performance in simulated environments.
8. The Sample Size for the Training Set
The provided document does not indicate a "training set" in the context of machine learning. The device is a direct therapeutic electrical stimulator, not an AI model that learns from data.
However, if "training set" is broadly interpreted as any data used during development to refine the device or its protocols:
- The document states, "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." It then references several published clinical studies (e.g., Popovic MR et al., Thrasher TA et al.) that used FES therapy with a "Compex electrical stimulation device." These studies would have informed the development and selection of the MyndMove's pre-programmed stimulation protocols. The sample sizes from these referenced studies vary, for example, Popovic et al. (2006) had 15 subjects, Popovic et al. (2005) had 14 subjects, Thrasher et al. (2008) had 15 patients, Popovic et al. (2011) and Desai et al. (2014) are also referenced, but specific sample sizes are not given in the 510(k) summary for these.
9. How the Ground Truth for the Training Set Was Established
As noted, there isn't a machine learning "training set" in the traditional sense. However, for the historical clinical studies that established the efficacy of FES protocols (which MyndMove then incorporates), the "ground truth" would have been established through clinical outcome measures (similar to the UE-FM used in the MyndMove-specific study), often compared against control groups or baseline measurements. These studies would have used objective assessments of motor function, range of motion, and other relevant clinical metrics to determine the effectiveness of the FES therapy.
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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 (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
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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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: 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 FunctionalElectrical Stimulator |
|---|---|
| B. Classification Name | External Functional Neuromuscular Stimulator andPowered 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 neuromuscularstimulators, and890.5850 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 HandRehabilitation 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.
| MyndMoveK170564 | NESS H200 WirelessK123636 | ||
|---|---|---|---|
| K No. | Similar? | ||
| Indications forUse | MYNDMOVE is anelectrical stimulationdevice indicated for thefollowing uses:- Functional ElectricalStimulation (FES)o Improvement ofarm and handfunction and activerange of motion inpatients withhemiplegia due tostroke or upperlimb paralysis dueto C3-T1 spinalcord injury.- NeuroMuscularElectrical Stimulation(NMES)o Maintenanceand/or increase ofarm and handrange of motiono Prevention and/orretardation ofdisuse atrophyo Increase in localblood circulationo Reduction ofmuscle spasmo Re-education ofmusclesMyndMove Therapy canonly be administered byOccupational or PhysicalTherapists that havecompleted MyndMovetraining by MyndTec onthe use of theMyndMove System. | The NESS H200 WirelessSystem is an electricalstimulation deviceindicated for the followinguses:- Functional ElectricalStimulation (FES)o Improvement ofhand function andactive range ofmotion in patientswith hemiplegia dueto stroke or upperlimb paralysis dueto C5 spinal cordinjury.- NeuroMuscular ElectricalStimulation (NMES)o Maintenance and/orincrease of arm andhand range ofmotiono Prevention and/orretardation of disuseatrophyo Increase in localblood circulationo Reduction of musclespasmo Re-education ofmusclesThe Intelli-Connect is anoptional accessory deviceused exclusively with theH200 Wireless Orthosisthrough simple jawmovements. | Similar |
| K No. | MyndMoveK170564 | NESS H200 WirelessK123636 | Similar? |
| a. Basic Unit Characteristics | |||
| i. Power Sources | Mains OR RechargeableLi-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 | Controller: RechargeableAAA NiMH 1.2V, 900-1100 mAhOrthosis: RechargeableLi-Ion 3.7 V, 280-350 mAhCharger Power Supply Input: 100-240 V AC,400mA, 50-60 HzCharger Power Supply Output: 5V +/- 5%, 2400 mA | Different |
| - Method of linecurrent isolation | Galvanic Isolation(transformer) 4000 VAC | Not Applicable - BatteryOperated | Different |
| Patient Leakage Current: | |||
| a) Normalcondition(uA) | Earth Leakage: < 500 uALead to Ground: < 100 uA | Not Available in 510k | Not Known |
| b) Singlefaultcondition(uA) | Earth Leakage: < 1000 uALead to Ground: < 500 uAPatient on Mains: < 5000 uA | Not Available in 510k | Not Known |
| ii. Average DCcurrent throughelectrodes whendevice is on butno pulses arebeing applied (uA) | Patient auxiliary current:Normal condition: < 100 uASingle fault condition: < 500 uA | Not Available in 510k | Not Known |
| iii. Number ofoutput modes (ie.Number ofstimulationprotocols) | Two Modes (applicableto all 33 stimulationprotocols):BiphasicSymmetricBiphasicAsymmetric | One Mode (applicable toall 7 stimulationprotocols):BiphasicSymmetric | Similar |
| iv. Number ofoutput channels | 8 | 3 | Different |
| Synchronous orAlternating? | Asynchronous (channelsare staggered) | Not Available in 510k | Not Known |
| - Method ofchannel isolation | Galvanic isolation(transformer):1500VAC/3kV DC | Not Available in 510k | Not Known |
| v. Regulatedcurrent orregulated voltage? | Current Regulated | Not Available in 510k | Not Known |
| vi. Software/firmware/microprocessorcontrol? (yes/no) | Yes | Yes | Same |
| MyndMove | NESS H200 Wireless | ||
| K No. | K170564 | K123636 | Similar? |
| vii. Automaticoverload trip?(yes/no) | Yes | Yes | Same |
| viii. Automatic no-load trip? (yes/no) | Yes | Yes | Same |
| ix. Automatic shutoff? (yes/no) | Yes | Yes | Same |
| x. User overridecontrol? (yes/no) | Yes | Yes | Same |
| xi. Indicatordisplay: | Yes | Yes | Same |
| - On/off status?(yes/no) | Yes | Yes | Same |
| - Low battery?(yes/no) | Yes | Yes | Same |
| - Voltage/currentlevel? (yes/no) | Yes | Yes | Same |
| xii. Timer range(minutes) | Stimulation timecontrolled by user.Max duration ofstimulation program =120 minutes(configurable in thebackend) | Max duration ofstimulation program =245 minutes | Similar |
| xiii. Compliancewith voluntarystandards? (if yes,specify) | IEC 60601-1IEC 60601-1-2IEC 60601-2-10 | IEC 60601-1IEC 60601-1-2 | Similar |
| xiv. Compliancewith 21 CFR 898?(yes/no) | Yes | Not Available in 510k | Same |
| xv. Weight (lbs.,oz.) | 14lbs 6oz. | Controller: 1.5 oz.Orthosis: 10.6 oz. | Different |
| xvi. Dimensions(in.) [W x H x D](includingaccessories) | Stimulator: 9.0 in x 4.3in x 9.8 in | Controller Dimensions:1.8 in x 0.7 in x 2.9 inOrthosis (Small):4.33 in x 10.63 in x 3.54inOrthosis (Medium):4.33 in x 10.63 in x 3.54inOrthosis (Large):5.11 in x 11.81 in x 5.11in | Different |
| MyndMove | NESS H200 Wireless | ||
| K No. | K170564 | K123636 | Similar? |
| xvii. Housingmaterials andconstruction(includingaccessories) | Stimulator HousingMaterials:- Enclosure = LexanPCB HPX4R- Plastic Bezel = ABSPlastic- Rubber Membrane =Silicone | Orthotic Materials:- Main body = RislanBZM 30 OTL- Wing Cover = TEREZABS 5010- Wrist Insert = flexiblefoam, two componentsurethane nonintegralskin, Purtec GMBH- Thenar = Dow CorningSilicone Rubber NPC 40 | Different |
| xv. AdditionalFeatures (specify,if applicable) | - Timing of stimulationcontrolled by user(therapist) throughthe use of a hand orfoot switch | - Orthotic- Controller- Intelli-Connect EarpieceTrigger Device | Different |
| xvi. Clinical and Human Factors Characteristics: | a) TargetPopulation | ||
| - Patients withhemiplegia due tostroke or upper limbparalysis due to C3-T1 spinal cord injury. | - Patients withhemiplegia due tostroke or upper limbparalysis due to C5spinal cord injury. | Similar | |
| b) AnatomicalSite | The MyndMove Systemstimulates the followingmuscles:- Extensor Digitorum,Extensor CarpiRadialis & ExtensorCarpi Ulnaris- Thenar Eminence(Opponens PollicisBrevis, Flexor PollicisBrevis & AbductorPollicis Brevis)- Flexor DigitorumSuperficialis andFlexor DigitorumProfundus- Biceps- Triceps- Posterior Deltoid,Middle Deltoid, andAnterior Deltoid- Pectoralis Major- 1st, 2nd and 3rdLumbricals- 2nd DorsalInterosseous | The NESS H200 Wirelessstimulates the followingmuscles:- Extensor Digitorum,Extensor Pollicis Brevisand Longus- Thenar Muscle Group- Flexor DigitorumSuperficialis, FlexorPollicis Longus | Similar |
| c) WhereUsed | - Used for therapysessions in a clinicalsetting only. | - Used both for therapysession in a clinicalsetting and for patientto take home | Similar |
| K No. | MyndMoveK170564 | NESS H200 WirelessK123636 | Similar? |
| d) DesignandHumanFactors | - Functional ElectricalStimulator.- Single Use GelElectrodes- 8 stimulationchannels, up to 16electrodes.- Controlled by anembedded touchscreen graphical userinterface and handand foot switches.- Preprogrammed withstimulation protocols.- No fitting required,instruction forelectrode placementfor each stimulationprotocol included inuser interface.- Used by ClinicianOnly. | - Orthotic with electricalstimulation.- Reusable ClothElectrodes- 3 stimulation channels,up to 5 electrodes.- Controlled by a wirelesscontrol unit.- Orthotic must be fittedby clinician for eachpatient.- Must be programmedby Clinical using the HPiPAQ ClinicianProgrammer.- Used by Clinician andPatient. | Different |
| b. Output specifications for each output mode (ie. Stimulation protocol) | |||
| Biphasic Symmetrical Output Mode | |||
| i. Waveform (eg.Pulsedmonophasic,biphasic) | Balanced BiphasicSymmetrical | Balanced BiphasicSymmetrical | Same |
| ii. Shape (eg.Rectangular,spike, rectifiedsinusoidal) | Rectangular | Not Available in 510k | Not Known |
| iii. MaximumOutput Voltage(volts) (+/-%) at500ohms, 2kohmsand 10kohms | (+/- 10%)@ 500ohms = 160V@ 2kohms = 160V@ 10kohms = 160V | 120VResistance and accuracyfor maximum outputvoltage not available in510k. | Different |
| iv. MaximumOutput Current(specify units)(+/- %) at500 ohms,2kohms and10kohms | (+/- 10%)@ 500ohms = 20mA@ 2kohms = 20mA@ 10kohms = 16mA | 80mAMaximum CurrentIntensity by electrode:Electrodes 1, 2, 3 and 5 =13.1mA rmsElectrode 4 = 18.6ma rmsResistance and accuracyfor maximum outputcurrent not available in510k. | Different |
| K No. | MyndMoveK170564 | NESS H200 WirelessK123636 | Similar? |
| v. Pulse width(specify units) | Positive: 150-400 usNegative: 150-400 us | Positive: 100, 200, 300 usNegative: 100, 200, 300 usInterphase period: 50usMax Total Pulse Duration:250, 450, 650 us | Similar |
| vi. Frequency (Hz) | 1Hz or 40Hz | 20-45Hz, 5 Hz Resolution | Similar |
| vii. For multiphase waveforms only: | |||
| - Symmetricalphases?(yes/no) | Yes | Yes | Same |
| - Phase Duration(include units),(state range, ifapplicable),(both phases, ifasymmetrical) | Positive: 150-400 usNegative: 150-400 us | 250, 450, 650 us | Different |
| viii. Net Charge(uC per pulse) (Ifzero, statemethod ofachieving zero netcharge) | 2.00 uC | Not Available in 510k | Not Known |
| ix. MaximumPhase Charge(uC) | 9.02 uC | Not Available in 510k | Not Known |
| x. MaximumCurrent Density(RMS) (mA/cm2) | 1.36 mA/cm2 (for 1cm x3cm electrode) | Not Available in 510k | Not Known |
| xi. MaximumPower Density,(W/cm2), (usingsmallest electrodeconductivesurface area) | 0.044W/cm2 | Not Available in 510k | Not Known |
| xii. Burst Mode(ie. Pulse trains): | Not Applicable, No BurstMode | Details Not Available in510k | Different |
| - Pulses per burst | Not Applicable, No BurstMode | Details Not Available in510k | Different |
| - Bursts persecond | Not Applicable, No BurstMode | Details Not Available in510k | Different |
| - Burst duration(seconds) | Not Applicable, No BurstMode | Details Not Available in510k | Different |
| - Duty Cycle: Line(b) x Line (c) | Not Applicable, No BurstMode | Details Not Available in510k | Different |
| xiii. ON Time(seconds) | Not Fixed - UserControlled | Not Available in 510k | Not Known |
| xiv. OFF Time(seconds) | Not Fixed - UserControlled | Not Available in 510k | Not Known |
| Biphasic Asymmetrical Output Mode | |||
| i. Waveform (eg.Pulsedmonophasic,biphasic) | Balanced BiphasicAsymmetrical | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| K No. | MyndMoveK170564 | NESS H200 WirelessK123636 | Similar? |
| ii. Shape (eg.Rectangular,spike, rectifiedsinusoidal) | Rectangular | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| iii. MaximumOutput Voltage(volts) (+/-%) at500ohms, 2kohmsand 10kohms | (+/- 10%)Positive:@ 500ohms = 160V@ 2kohms = 160V@ 10kohms = 160VNegative:@ 500ohms = 40V@ 2kohms = 40V@ 10kohms = 40V | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| iv. MaximumOutput Current(specify units)(+/- %) at500 ohms,2kohms and10kohms | (+/- 10%)Positive:@ 500ohms = 20mA@ 2kohms = 20mA@ 10kohms = 16mANegative:@ 500ohms = 5mA@ 2kohms = 5mA@ 10kohms = 4mA | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| v. Pulse width(specify units) | Positive: 150-400 usNegative: 600-1600 us | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| vi. Frequency (Hz) | 1Hz or 40Hz | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| vii. For multiphase waveforms only: | |||
| - Symmetricalphases?(yes/no) | No | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| - Phase Duration(include units),(state range, ifapplicable),(both phases, ifasymmetrical) | Positive: 150-400 usNegative: 600-1600 us | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| viii. Net Charge(uC per pulse) (Ifzero, statemethod ofachieving zero netcharge) | 1.85uC | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| ix. MaximumPhase Charge(uC) | Positive: 9.02 uCNegative: 8.86 uC | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| x. MaximumCurrent Density(RMS) (mA/cm2) | 1.07 mA/cm2 (for 1 cmx 3 cm electrodes) | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| K No. | MyndMoveK170564 | NESS H200 WirelessK123636 | Similar? |
| xi. MaximumPower Density,(W/cm2), (usingsmallest electrodeconductivesurface area) | 0.044W/cm2 | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| xii. Burst Mode(ie. Pulse trains): | Not Applicable, No BurstMode | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| - Pulses per burst | Not Applicable, No BurstMode | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| - Bursts persecond | Not Applicable, No BurstMode | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| - Burst duration(seconds) | Not Applicable, No BurstMode | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| - Duty Cycle: Line(b) x Line (c) | Not Applicable, No BurstMode | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| xiii. ON Time(seconds) | Not Fixed - UserControlled | Not Applicable, BiphasicSymmetrical Mode Only | Different |
| xiv. OFF Time(seconds) | Not Fixed - UserControlled | Not Applicable, BiphasicSymmetrical Mode Only | Different |
Table 1: Characteristic Comparison of MyndMove ad NESS H200 Wireless
MyndTec Inc, Traditional 510(k) – K170564 MyndMove System
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MyndTec Inc, Traditional 510(k) – K170564 MyndMove System
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MyndTec Inc, Traditional 510(k) – K170564 MyndMove System
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The MyndMove System is intended to be used by battery or mains power, the NESS H200 Wireless is designed to be used by battery power only. As a result, the power sources for the two devices are not the same and line current isolation is not applicable for the NESS H200 device. The MyndMove system requires a larger battery compared to the NESS H200 device due to the increased number of channels and the built-in touch screen user interface.
The MyndMove System and the NESS H200 Wireless differ in the number of output channels each device has. The NESS H200 Wireless has 3 channels, where as the MyndMove System has 8. The increased number of channels the MyndMove System has compared to the NESS H200 Wireless allows for stimulation of more muscles groups.
The maximum duration of stimulation for the two devices is also different, the NESS H200 has a maximum of 245 minutes whereas the MyndMove System's maximum is 120 minutes, within the range of the predicate's maximum.
The NESS H200 Wireless has one mode, Biphasic Symmetric. The MyndMove System has two modes a Biphasic Symmetric Mode, similar to the NESS H200, and a Biphasic Asymmetric mode.
When comparing the Symmetric modes of the two devices the maximum output voltage of the MyndMove System is higher than the NESS H200 but the maximum current output is lower and within range. The maximum output of the NESS H200 Wireless at 500 ohms, 2 kohms and 10 kohms is not provided in the 510k and a more detailed comparison cannot be completed. The pulse width of the output mode for both positive and neqative pulses for the two devices are substantially equivalent, the NESS H200 is between 100 and 300 us and the MyndMove System is between 150 to 400 us, the MyndMove pulse width is within range of other legally marketed NMES devices (for example K153696 has a pulse width of 300 to 400 us). The output
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frequency of the MyndMove system of 1-40 Hz is substantially equivalent to the NESS H200 Wireless output frequency.
The MyndMove System is compliant with requirements of IEC 60601-1, 60601-1-2 and 60601-2-10. Though there are differences for some of the technical and output characteristics of MyndMove compared to the NESS H200 Wireless no new questions of safety are raised by these differences.
Differences between the NESS H200 Wireless and the MyndMove System lie in the physical design of the two medical devices. The NESS H200 Wireless is an orthosis with built in electrodes and the MyndMove System is a Stimulator Unit with a built-in touch screen user interface that connects to electrodes by use of traditional cables. As a result, the weight, dimensions and power requirements for the two devices are different. These differences do not raise new questions of safety or effectiveness of the MyndMove System.
The difference in design of the two devices does not adversely affect safety and effectiveness of the MyndMove System. The MyndMove System is substantially equivalent to the NESS H200 Wireless predicate device.
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:
| FDA StandardsDatabase No. | Standard Title | Version |
|---|---|---|
| 17-11 | IEC 60601-2-10 Medical Electrical Equipment - Part2-10: Particular requirements for the basic safety andessential performance of nerve and musclestimulators | 2.0 |
| 19-4 | ANSI/AAMI ES60601-1:2005/A1:2012 Medicalelectrical equipment - part 1: general requirementsfor basic safety and essential performance (iec60601-1:2005, mod). | 3.0 |
| 5-89 | IEC 60601-1-6:2010 A1-2015 Medical electricalequipment - part 1-6: general requirements for basicsafety and essential performance - collateralstandard: usability. | 3.1 |
| 13-32 | 62304:2006 Medical device software - software lifecycle processes. | 1.0 |
| 5-114 | IEC 62366-1 Edition 1.0 2015-02, medical devices -part 1: application of usability engineering to medicaldevices [including corrigendum 1 (2016)] | 1.0 |
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| 19-2 | AAMI/ANSI/IEC 60601-1-2:2007/(R) 2012, MedicalElectrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticCompatibility - Requirements And Tests (Edition 3) | 3.0 |
|---|---|---|
| ------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----- |
Testing was completed in accordance with FDA's quidance/draft quidance 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. The below Table 2 summarizes the Clinical experience with the MyndMove System.
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| Table 2: Summary of Clinical Experience with MyndMove | ||
|---|---|---|
| Study | Study Summary |
|---|---|
| MyndMoveTherapy forSevereHemiparesis ofthe Upper LimbFollowingStroke | Open label clinical study on people with stroke and low levels of armand hand function as characterized by Chedoke-McMaster Stages ofMotor Recovery 1 and 2, and Upper Extremity Fugl-Meyer Score (UE-FM) of ≤ 19. This ongoing study is designed to investigate theefficacy of 20 one-hour sessions of MyndMove therapy in 3 cohorts ofparticipants: (1) early sub-acute (< 2 months), (2) late sub-acute (2- 6 months) and (3) chronic (> 6 months) periods of recovery.Recruitment of 25 participants within each cohort is planned. Theenrolment of the chronic cohort is complete and the results werereported by Hebert et a/ ¹. Twenty-four of 25 individuals completed19 of 20 sessions. One study participant was withdrawn from thestudy for medical reasons unrelated to MyndMove therapy. Afteronly twenty (20) 1-hour sessions of MyndMove therapy, 14 out of 24(58%) people with chronic stroke realized clinically meaningfulimprovements in upper extremity voluntary mobility as measured bya gain in UE-FM of more than 5 points |
| Lead-InUsabilityEvaluation ofMyndMovePrototypeNovember 20,2013 | Lead-In Usability Testing was also completed on an early prototypeversion of MyndMove. The Lead-In Testing evaluated the use of theMyndMove System with 5 end user volunteers administeringtreatment to 5 healthy volunteers. End User Participants receivedthree hours of training on the use of the device before the evaluationportion. |
| MyndMoveHuman FactorsFormativeEvaluationApril 4, 2014 | A second round of Usability Testing with 5 end user-healthy volunteerpairs. End User Participants received three hours of training on theuse of the device before the evaluation portion. |
| MyndMoveHuman FactorsValidationTestingFebruary 24,2017 | The validation testing using simulated-use scenarios where 15 enduser participants delivered therapy to 15 health volunteerparticipants. The testing sessions consisted of participantorientation, eight use scenarios corresponding to tasks that arecritical to the safe and effective device use, and debrief interviews.After completing the scenarios, participants were asked to providesubjective feedback regarding any usability issues they encountered.Each end user was trained on the use of MyndMove before the startof 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.
§ 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).