(269 days)
The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease.
During gait, the stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
The MyGait® Stimulation System is a battery-operated two-channel stimulator and was developed exclusively for everyday use during walking in an everyday environment.
The patient wears a wireless heel switch in a special sock. If the user is not able to put sufficient weight on the affected leg, he or she can wear the heel switch on the other foot. The heel switch registers heel lift and ground contact and thus the swing and stance phase. It transmits the information to the stimulator wirelessly.
The stimulator is located in a cuff that holds the electrodes. It is easy to put on, even with only one hand. The correct placement of the electrodes is achieved by the cuff. The stimulator delivers the electrical stimulation to the common peroneal nerve. The nerve stimulates for controlled dorsiflexion of the foot during the swing phase.
The second channel can be used independently of the first channel to provide stimulation to the knee flexors or knee extensors in patients with thigh muscle weakness.
Using the wireless remote control, the patient can control and adjust the stimulator settings. When the patient sits for an extended period, the sleep mode helps save energy.
The adjustment tool enables qualified personnel to adjust the stimulation parameters to the patient's individual needs. Stimulation parameters are used to affect movements in the foot. Examples of stimulation parameters are current, pulse width and shape, frequency, stimulation timing,
The "MyGait Soft" PC software is used to manage and analyze gait analysis data and stimulation parameters. The data is loaded from the stimulator to the adjustment tool. The stimulation parameters can be restored to the stimulator from the PC.
The Otto Bock Healthcare Products GmbH MyGait Stimulation System, referenced in K141812, did not report a clinical study on human subjects to determine device performance against acceptance criteria. Instead, substantial equivalence was established by comparing the technical characteristics and indications for use of the MyGait Stimulation System to three legally marketed predicate devices: WalkAide (K123972), Empi 300pv (K021100), and NESS L300 Plus System (K103343). The document primarily focuses on demonstrating that the new device's specifications fall within the range or are similar to those of the predicate devices, and that it complies with relevant electrical safety and electromagnetic compatibility standards.
Therefore, the following information cannot be fully provided as a traditional performance study was not conducted or reported in this 510(k) summary:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- Multi reader multi case (MRMC) comparative effectiveness study findings
- Standalone (i.e. algorithm only without human-in-the loop performance) findings
- Type of ground truth used
- Sample size for the training set
- How the ground truth for the training set was established
However, based on the provided document, here's a summary of the technical specifications and how they align with the substantial equivalence claim:
1. Table of Acceptance Criteria and the Reported Device Performance
Since this is a 510(k) for substantial equivalence based on technical comparison, there isn't a direct "acceptance criteria" table from a performance study. Instead, the "acceptance criteria" are implied by the ranges and characteristics of the predicate devices. The "reported device performance" are the MyGait's technical specifications.
| Feature / Criterion (Implied by Predicate Devices) | MyGait Stimulation System Reported Performance |
|---|---|
| Indications for Use | Ankle dorsiflexion or extension; thigh muscle weakness; upper motor neuron injury/disease; improve gait; prevent/retard atrophy; facilitate muscle reeducation; maintain/improve range of motion; promote local blood circulation. |
| Power Source | Built-in Lilon battery (3.7V, 1100mAh) |
| Patient Leakage Current (normal condition) | < 1 µA (tested per IEC 60601-1) |
| Patient Leakage Current (single fault condition) | < 1 µA (tested per IEC 60601-1) |
| Number of Output Channels | 2 |
| Output Modes | Synchronous or alternating |
| Control Basis | Microprocessor controlled, constant current |
| Automatic Overload Trip | Yes |
| Automatic No-Load Trip | Yes |
| Patient Override Control | ON/OFF Button |
| Indicator Display (On/Off Status) | Yes (LED) |
| Indicator Display (Low Battery) | Yes (LED) |
| Indicator Display (Current Level) | Displayed on remote control |
| Timer Range | 5 to 120 minutes (in 5-min steps) |
| Accessories | Wireless foot switch (with failsafe), wireless remote control |
| Stimulation Parameter Setup | Wireless via MyGait Adjustment Tool |
| Waveform | Biphasic symmetrical or asymmetrical |
| Waveform Shape | Rectangular |
| Max Output Voltage (@ 500Ω) | 45V +/- 10% |
| Max Output Voltage (@ 1kΩ) | 90V +/- 10% |
| Max Output Voltage (@ 2kΩ) | 120V +/- 10% |
| Max Output Current (@ 500Ω) | 90mA (+/- 10%) |
| Max Output Current (@ 1kΩ) | 90mA (+/- 10%) |
| Max Output Current (@ 2kΩ) | 60mA (+/- 10%) |
| Pulse Width (Symmetrical) | 50 to 400µs (in 50µs steps) |
| Pulse Width (Asymmetrical, positive) | 50 to 400µs (in 50µs steps) |
| Pulse Width (Asymmetrical, negative) | 200 to 1600µs (in 100µs steps) |
| Frequency | 10 to 80Hz (in 1Hz steps) |
| Net Charge | 0µC (balanced pulses) |
| Max Pulse Charge (@ 500Ω) | 36µC |
| Max RMS Current Density (@ 500Ω) | 1.51 mA/cm² |
| Max Power Density (@ 500Ω) | 0.024 W/cm² |
| On Time (training mode) | 1 to 4 sec (in 0.1sec steps) |
| Off Time (training mode) | 1 to 30 sec (in 1 sec steps) |
2. Sample size used for the test set and the data provenance
No clinical test set of human subjects was reported for performance evaluation against acceptance criteria. The evaluation was based on a comparison of technical specifications to predicate devices and compliance with international standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no human subject test set requiring ground truth establishment by experts was reported.
4. Adjudication method for the test set
Not applicable.
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
Not applicable. This is a functional electrical stimulator, not an AI-assisted diagnostic or imaging device for which MRMC studies would typically be conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical stimulator used on a patient. Its functionality involves direct interaction with the human body and is not an "algorithm only" device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The ground truth for this submission is based on engineering specifications and compliance with recognized international safety and performance standards (e.g., IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10, IEC 60601-1-2).
8. The sample size for the training set
Not applicable, as this is not a machine learning/AI device requiring a training set in that context. The device's operation is based on established electrical stimulation principles, not learned from data.
9. How the ground truth for the training set was established
Not applicable.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. The profiles are arranged in a way that suggests unity and forward movement. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 2, 2015
Otto Bock Healthcare Products GmbH Rene Urtz Regulatory Affairs Specialist Brehmstrabe 16 1110 Vienna AUSTRIA
Re: K141812
Trade/Device Name: MyGait Stimulation System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: February 23, 2015 Received: February 27, 2015
Dear Mr. Urtz:
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. Isting 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
{1}------------------------------------------------
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 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" (21CFR 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 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 yours.
Felipe Aquel -S
Carlos L. Peña, PhD, MS for 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) K141812
Device Name MyGait Stimulation System
Indications for Use (Describe)
The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease.
During gait, the stimulation system sends electric stimuli to muscles in the affected leg, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY
1 Submitter Information
| Manufacturer: | Otto Bock Healthcare Products GmbH |
|---|---|
| Establishment Registration: | 9615892 |
| Adress: | Brehmstraße 161110 ViennaAustria |
| Contact Person: | Rene UrtzRegulatory Affairs Specialistrene.urtz@ottobock.com |
| Telephone: | +43 1 523 37 86 707 |
| Fax Number: | +43 1 523 22 64 |
| Date Prepared: | March 31, 2015 |
2 Device Information
| Trade Name: | MyGait® Stimulation System |
|---|---|
| Common or Usual Name: | Stimulator, Neuromuscular, External |
| Classification Name: | External functional neuromuscular stimulator |
| (21 CFR 882.5810) | |
| Classification Product Code: | GZI (stimulator, neuromuscular, external functional) |
| Subsequent Product Code: | IPF (stimulator, muscle, powered) |
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3 Identification of Legally Marketed Predicate Devices
| Name: | Walkaide |
|---|---|
| Manufacturer: | Innovative Neurotronics, Inc. |
| 510k Number: | K123972 |
| Date Cleared: | April 4th, 2013 |
| Name: | Empi 300pv |
|---|---|
| Manufacturer: | Empi, Inc |
| 510k Number: | K021100 |
| Date Cleared: | June 18th, 2002 |
| Name: | NESS L300 Plus System* |
|---|---|
| Manufacturer: | Bioness Neuromodulation Ltd |
| 510k Number: | K103343 |
| Date Cleared: | April 29th, 2011 |
- Primary predicate
{5}------------------------------------------------
4 Indications for Use
The stimulation system is intended to provide ankle dorsiflexion or extension in individuals with foot drop and thigh muscle weakness following an upper motor neuron injury or disease. During gait, the stimulation system sends electric stimuli to muscles in the affected leq, initiating dorsiflexion of the foot and knee extension or flexion and may thus improve the individual's gait. The stimulation system may also prevent or retard atrophy caused by inactivity, facilitate muscle reeducation, maintain or improve the range of motion in the joints and promote local blood circulation.
5 Device Description
The MyGait® Stimulation System is a battery-operated two-channel stimulator and was developed exclusively for everyday use during walking in an everyday environment.
The patient wears a wireless heel switch in a special sock. If the user is not able to put sufficient weight on the affected leg, he or she can wear the heel switch on the other foot. The heel switch registers heel lift and ground contact and thus the swing and stance phase. It transmits the information to the stimulator wirelessly.
The stimulator is located in a cuff that holds the electrodes. It is easy to put on, even with only one hand. The correct placement of the electrodes is achieved by the cuff. The stimulator delivers the electrical stimulation to the common peroneal nerve. The nerve stimulates for controlled dorsiflexion of the foot during the swing phase.
The second channel can be used independently of the first channel to provide stimulation to the knee flexors or knee extensors in patients with thigh muscle weakness.
Using the wireless remote control, the patient can control and adjust the stimulator settings. When the patient sits for an extended period, the sleep mode helps save energy.
The adjustment tool enables qualified personnel to adjust the stimulation parameters to the patient's individual needs. Stimulation parameters are used to affect movements in the foot. Examples of stimulation parameters are current, pulse width and shape, frequency, stimulation timing,
The "MyGait Soft" PC software is used to manage and analyze gait analysis data and stimulation parameters. The data is loaded from the stimulator to the adjustment tool. The stimulation parameters can be restored to the stimulator from the PC.
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6 Substantial Equivalence Discussion
6.1 Indications for Use
| New Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510k Number | K141812 | K123972 | K021100 | K103343 |
| DeviceName, Model | MyGait | WalkAide | Empi 300pv | NESS L300 Plus System |
| Manufacturer | Otto Bock HealthcareProducts GmbH | Innovative Neurotronics, Inc. | Empi, Inc | Bioness NeuromodulationLtd. |
| Indicationsfor Use | The stimulation system isintended to provide ankledorsiflexion and knee flexion orextension in individuals with footdrop and thigh muscleweakness following an uppermotor neuron injury or disease.During gait, the stimulationsystem sends electric stimuli tomuscles in the affected leg,initiating dorsiflexion of the footand knee extension or flexionand may thus improve theindividual's gait. The stimulationsystem may also prevent orretard atrophy caused byinactivity, facilitate musclereeducation, maintain orimprove the range of motion inthe joints and promote localblood circulation. | Summary StatementThe Innovative NeurotronicsWalkAide External FunctionalNeuromuscular Stimulator(WalkAide System) is intendedto address the lack of ankledorsiflexion in patients who havesustained damage to uppermotor neurons or pathways tothe spinal cord. During theswing phase of gait, theWalkAide System electricallystimulates the appropriatemuscles that cause ankledorsiflexion and may thusimprove the patient's gait.Medical benefits of FunctionalElectrical Stimulation (FES) mayinclude prevention, retardationof disuse atrophy, increasedlocal blood flow, muscle re-education, and maintained orincreased joint range of motion. | Summary StatementThe 300 PV is a multifunctionelectrotherapy device withvarious treatment modes thatallow for neuromuscularelectrical stimulation (NMES),transcutaneous electrical nervestimulation (TENS),interferential current stimulation(IFS) and functional electricalstimulation (FES).As a NMES device, the 300 PVis indicated for the followingconditions:Re-educating musclesRelaxation of muscle spasmIncreasing local blood circulationRetarding or preventing disuseatrophyMaintaining or increasing rangeof motion. Prevention of venousthrombosis of the calf musclesimmediately after surgery.As a TENS device, the 300 PVis indicated for the followingconditions:Symptomatic relief andmanagement of chronic,intractable pain.Adjunctive treatment for post-surgical and post-trauma acutepain. As an IFS device, the 300PV is indicated for the followingconditions:Symptomatic relief of acute painSymptomatic relief andmanagement of chronic pain.As a FES device, the 300 PV isindicated for the followingcondition:Stimulation of the muscles inthe leg and ankle of partiallyparalyzedpatients to provide flexion of thefoot and thus improve thepatient's gait. | Summary StatementThe NESS L300 Plus System isintended to provide ankledorsiflexion and knee flexion orextension in individuals with footdrop and thigh muscleweakness, following an uppermotor neuron injury or disease.During gait, the L300 PlusSystem electrically stimulatesmuscles in the affected leg toprovide dorsiflexion of the footand knee flexion or extension,thus it may improve theindividual's gait. The L300 PlusSystem may also:* Facilitate Muscle re-education* Prevent/retard disuse atrophy* Maintain or increase jointrange of motion* Increase local blood flow |
| New Device | Predicate Device | Predicate Device | Predicate Device | |
| 510k Number | K141812 | K123972 | K021100 | K103343 |
| Device Name, Model | MyGait | WalkAide | Empi 300pv | NESS L300 Plus System |
| Manufacturer | Otto Bock HealthcareProducts GmbH | Innovative Neurotronics,Inc. | Empi, Inc | Bioness NeuromodulationLtd. |
| Power Sources | ||||
| Battery | built in | replaceable | replaceable | built in |
| # of batteries | 1 | 1 | 2 | 1 |
| type | Lilon | Alkaline | Alkaline | Lilon |
| size | 3.7V, 1100mAh | AA, LR6 | AA, LR6 | 3.7 V, 750mAh |
| Method of Line CurrentIsolation | Medical Class II PowerAdapter | n/a | n/a | Unknown |
| Patient LeakageCurrent | ||||
| normal condition | <1 μA | Unknown | Unknown | Unknown |
| Single Fault condition | <1μA | Unknown | Unknown | Unknown |
| Number of OutputModes | 2 | 1 | 5 | 2 |
| Number of OutputChannels | 2 | 1 | 2 | 2 |
| Synchronous orAlternating | Synchronous or alternating | n/a | Unknown | Unknown |
| Method of ChannelIsolation | n/a | n/a | Unknown | Unknown |
| Regulated Current or | Regulated | |||
| regulated voltageSoftware/Firmware/ | Regulated Current | Constant Voltage | Current/Voltage | Regulated Current |
| MicroprocessorControl | yes | yes | yes | yes |
| Automatic OverloadTrip | yes | no | unknown | yes |
| Automatic No-LoadTrip | yes | no | unknown | no |
| Automatic Shut Off | no | no | unknown | no |
| Patient OverrideControl | ON/OFF Button | Amplitude Control Knob | ON/OFF Button | Intensity adjustmentbuttons and ON/OFFButtons |
| Indicator Display | ||||
| On/Off Status | yes | yes | yes | yes |
| Low Battery | yes | yes | yes | yes |
| Voltage/Current Level | no | Control Knob | yes | no |
| Timer Range (min) | 5 to 120min in steps of 5min | 1 to 30min steps of 1 min | 5-60 or unlimited | 1-60 |
| Compliance withVoluntary Standards | IEC 60601-1:2005+A1:2012IEC 60601-1-11:2010IEC 60601-2-10:2012IEC 60601-1-2:2007 | IEC 60601-1 3rd EdIEC60601-1-2:2007IEC 60601-2-10:1987+A1 | Unknown | Unknown |
Table 1 - Comparison Table of Indications for Use
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6.2 Technological Characteristics
6.2.1 Basic Unit Characteristics
Qualitätsmanagement Otto Bock Healthcare Products GmbH Bez. FO-019_GB [hoch] Version: V5A
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| ottobock. | 510(k) SummaryMyGait® Stimulation System | Project Report No.PD-PP00128451A-403 | Page6 of 13 |
|---|---|---|---|
| ----------- | ---------------------------------------------- | ------------------------------------------ | ----------------- |
| Compliance with 21CFR 898 | ||||
|---|---|---|---|---|
| Yes | Yes | Unknown | Unknown | |
| Weight | 78g | 87,6 | 226g | 45 g |
| Dimensions (in.)(WxHxD) | 3.26 x 2.08 x 0.71 | 2.4 x 3.25 x 0.81 | 1.26 x 3.3 x 4.5 | 3 x 1.7 x 0.57 |
| Housing Material | ABS | ABS | unknown | Unknown |
| Accessories | Wireless foot switch (withfailsafe mode), wirelessremote control | Wired foot switch | Wired external trigger | Wireless foot switch (withfailsafe mode), wirelessremote control |
| Procedure for settingup stimulationparameters | Wireless via MyGaitAdjustment Tool | Wireless via PC Software,Bluetooth adapter andWalklink unit | Via stimulation device | Wireless via PDA |
| Description of PC-Software | Download and display ofgait evaluation data,up/download ofstimulation parameters | Download and display ofgait evaluation data,up/download ofstimulation parameters,setting up stimulationparameters | n/a | Download and display ofgait evaluation data,up/download ofstimulation parameters,setting up stimulationparameters |
Table 2 - Comparison Table of Basic Unit Characteristics
6.2.2 Output Specifications
| New Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| 510k Number | K141812 | K123972 | K021100 | K103343 |
| Device Name, Model | MyGait | WalkAide | Empi 300pv | NESS L300 Plus System |
| Manufacturer | Otto Bock HealthcareProducts GmbH | Innovative Neurotronics,Inc. | Empi, Inc | Bioness NeuromodulationLtd. |
| Waveform | ||||
| Monophasic or biphasic | Biphasic | Biphasic | Biphasic | Biphasic |
| Symmetrical orAsymmetrical | Symmetrical orasymmetrical | Asymmetrical | Asymmetrical | Symmetrical orasymmetrical |
| Shape | Rectangular | Unknown | Unknown | Rectangular |
| Maximum outputvoltage,+/-% | ||||
| @ 500 | 45V +-10% | Unknown | Unknown | Unknown |
| @ 1k | 90V +-10% | 121V +-10% | 140V +/-10% | 80V (tolerance unknown) |
| @ 2k | 120V +-10% | Unknown | Unknown | Unknown |
| @ 10k | n/a(no stimulation possible at10k) | Unknown | Unknown | Unknown |
Qualitätsmanagement Otto Bock Healthcare Products GmbH Bez. FO-019_GB [hoch] Version: V5A
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| Maximum outputcurrent,+/-% | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| @ 500 | 90mA (+/- 10%) | 206,8mA peak (+/- 5%) | 100mA (+/- 20%) | 80mA (tolerance unknown) | |||||
| @ 1k | 90mA (+/- 10%) | 121mA | Unknown | Unknown | |||||
| @ 2k | 60mA (+/- 10%) | Unknown | 100mA (+/- 20%) | 60mA (tolerance unknown) | |||||
| @ 10k | n/a(no stimulation possible at 10k) | Unknown | Unknown | Unknown | |||||
| Pulse width,all possible discretesettings | Symmetrical:50 to 400µs in steps of 50µsAsymmetrical:pos.: 50 to 400µs in steps of 50µsNeg.: 200 to 1600µs in steps of 100µs | 25, 50, 100, 150, 200, 250, 300µs | 50-400µs(± 10% ≥ 100 µsec, ± 10 µsec < 100µsec) | Symmetrical:100,200,300µsAsymmetrical:pos: 100,200,300µsneg.: 400,800,1200µs | |||||
| Frequency,all possible discretesettings | 10 to 80Hz in 1Hz steps | 16.7, 20, 25, 33.3 Hz | 2-150 Hz | 20, 25, 30, 35, 40, 45 | |||||
| For interferentialmodes only:Beat Frequency (Hz) | n/a(no interferential mode) | n/a | n/a | n/a | |||||
| For multiphasicwaveforms only | n/a(no multiphasic waveforms) | n/a | n/a | n/a | |||||
| Symmetrical phases | n/a(no multiphasic waveforms) | n/a | n/a | n/a | |||||
| Phase Duration (includeunits) | n/a(no multiphasic waveforms) | n/a | n/a | n/a | |||||
| Net Charge (µC perpulse)if zero, state methodof achieving zero netcharge @500 | 0µCBalanced pulses | Unknown | Unknown | 0µCBalanced pulses | |||||
| max. pulse charge@500 | 36µC | 41,2µC | 40µC | 24µC | |||||
| max. RMS currentdensity (mA/cm2)@500 | 1,51 | 2,62 | 6,79 | 0,83 | |||||
| max. power density(W/cm2) @500 | 0,024 | 0,027 | 0,17 | 0,00536 | |||||
| BurstMode | |||||||||
| Pulses per burst | Burst length and ppsdependent | Burst length and ppsdependent | Burst length and ppsdependent | Burst length and ppsdependent | |||||
| Bursts per second | Depends on ON and OFFtimes | Depends on ON and OFFtimes | Depends on ON and OFFtimes | Depends on ON and OFFtimes | |||||
| Burst Duration (sec) | 1 to 4 sec in 0.1sec steps | 1 to 5 sec in 1 sec steps | Unknown | 4 to 20 sec in 1sec steps | |||||
| Duty Cycle | Duty Cycle | Depends on ON and OFFtimes | times | Depends on ON and OFFtimes | times | Depends on ON and OFFtimes | times | Depends on ON and OFFtimes | times |
| On Time | 1 to 4 sec in 0.1 sec steps | 1 to 5 sec in 1 sec steps | Unknown | 4 to 20 sec in 1 sec steps | |||||
| Off Time | 1 to 30 sec in 1 sec steps | 1 to 10 sec in 1 sec steps | Unknown | 4 to 60 sec in 1 sec steps | |||||
| AdditionalFrequencies (ifapplicable) | n/a(no additional frequencies) | n/a | n/a | n/a |
Table 3 - Comparison Table of Output Specifications
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6.3 Substantial Equivalence Discussion
6.3.1 Discussion on basic unit characteristics
Power sources
The MyGait stimulator has one built-in Lilon battery (3.7 V, 1100mAh), the same technology as the predicate device NESS L300 Plus (3.7V, 750mAh). An external medical class II power adaptor is used to charge the battery and to isolate the user from AC line current.
Patient Leakage current
The patient leakage is <1uA in normal condition and single fault condition was successfully tested according to IEC 60601-1.
Output channels
The MyGait stimulator can be used in one-channel operation or two-channel operation as well the predicate devices Empi 300pv and NESS L300 Plus can be used. It is possible to adjust the timing parameters of both channels. So therefore, a synchronous or an alternating stimulation related to the two channels is possible.
Output characteristics
The pulse generation is controlled by a microprocessor constant current based. All of the predicate devices are microprocessor controlled. In addition, NESS L300 Plus and Empi 300pv are constant current based too.
Automatic no-load trip
The MyGait has an automatic no-load trip in contrast to the predicate devices. An automatic no-load trip takes place via impedance measuring. It is a common feature of stimulation devices which improves the usability because stimulation is only possible, if an output load is connected.
Patient override control
The Override control is controlled by an ON/OFF button like the NESS L300 Plus and the Empi 300pv devices.
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Image /page/11/Picture/0 description: The image shows a document header with the Ottobock logo on the left. The header includes the text "510(k) Summary" and "MyGait® Stimulation System" in the center. On the right, it displays the "Project Report No. PD-PP00128451A-403" and "Page 9 of 13".
Indicator Display
The MyGait stimulator indicates the On/Off state and a low battery by a LED. The current level is displayed on the MyGait remote control. In principle, it is the same procedure as the NESS L300 Plus and the WalkAide offers.
Timer range
MyGait's training programme timer range is adjustable from 5 to 120 minutes in steps of 5 minutes. It is within the range of the predicate devices. The timer range goes from WalkAide's 5 to 30 minutes to Empi 300pv's 5 to 60 minutes or unlimited.
Accessories
The heel switch transmits its data wirelessly to the stimulator. Loss of communication will be detected and will trigger a failsafe mode. This technology is similar to the predicate device NESS L300 Plus.
Procedure for setting up stimulation parameters
The MyGait adjustment tool is for setting up the stimulation parameters of the My Gait stimulator. The predicate devices NESS L300 Plus and WalkAide have the same wireless principle.
Conclusion
The basic unit characteristics are equivalent to the predicate devices as can be seen in the comparison table in chapter 6.2.1.
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6.3.2 Discussion on output specifications
Waveform
The waveform of the MyGait is biphasic symmetrical or biphasic asymmetrical equal to the NESS L300 Plus. Innovative Neurotronics' WalkAide and Empi Inc.'s Empi 300pv have biphasic asymmetrical pulses.
Maximum output voltage
The maximum output voltage rating of the MyGait is 45V at 500 Ohm and 120V at an output load of 2 KOhm. In general, the maximum output peak is 120 V regardless of the load. There are no parameters provided at an output load of 500 Ohm and 2 kOhm by the predicate devices. WalkAide provides a maximum output voltage of 121 V and NESS L300 Plus of 120 V. Empi has an output value of 140 V without load. Based on this information is that the maximum output voltage of the MyGait is within the range of the predicate devices at 500 Ohm and 2 kOhm.
Maximum output current
The maximum output current of the MyGait is 90 mA at 500 Ohm and 60mA at a load of 2 kOhm. WalkAide's maximum output peak current is listed with 206.8 mA at 500 Ohm. In addition, the NESS L300 Plus is listed with 90 mA at 500 Ohm and the Empi 300pv with 100 mA at a load of 2 kOhm, the NESS L300 Plus is rated at 60 mA and the Empi 300pv at 100 mA. Based on this information the conclusion is that the maximum output current of the MyGait is within the range of the WalkAide and Empi 300pv devices.
Pulse width
The MyGait has the same positive pulse range width as the predicate Empi 300v. In asymmetrical mode, the negative pulse width range of the MyGait is from 200us to 1600us. The NESS L300 Plus has a negative pulse width range from 400us to 1200us. The MyGait and the NESS L300 Plus have both a ratio of 1:4 between the positive and the negative pulse. The MyGait's positive pulse width range is from 50 us to 400us compared to the 100us to 300μs of the NESS L300 Plus. Therefore the MyGait's negative pulse range is from 200us to 1600us compared to the 400us to 1200us of the NESS L300 Plus. All of these pulse widths are similar and common stimulation parameters.
Frequency
The adjustable frequency range of the MyGait is from 10 to 80 Hz and within Empi 300pv´s range from 2 to 150 Hz. The WalkAide is selectable between 16.7, 20, 25 and 33.3 Hz and the NESS L300 Plus is selectable from 20 to 45 Hz in steps of 5 Hz. Net charge
There is no net charge. Balanced pulses are used to achieve zero net charge. This is similar to the NESS L300 Plus.
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| ottobock. | 510(k) Summary | Project Report No. | Page |
|---|---|---|---|
| MyGait® Stimulation System | PD-PP00128451A-403 | 11 of 13 |
Maximum pulse charge
The maximum pulse charge at 500 Ohm load is 36 µC compared to the 41.2 µC, 24 µC and 40 µC of the predicate devices. The value is within the range of the predicate devices and therefore equivalent.
Maximum RMS current density
The maximum RMS current at 500 Ohm load is 1.51 mA/cm² compared to the 2.62 mA/cm², 0.83 mA/cm² and 6.79 mA/cm² of the predicate devices. The value is within the range of the predicate devices and therefore equivalent.
Maximum power density
The maximum power density at 500 Ohm load is 0.024 W/cm² compared to the 0.027 W/cm², 0.00536 W/cm² and 0.17 W/cm² of the predicate devices. The value is within the range of the predicate devices and therefore equivalent.
On time
The on time of the MyGait in training mode is adjustable from 1 to 4 seconds in steps of 0.1 seconds. The on time of the WalkAide is selectable from 1 to 5 seconds in steps of 1 second and the NESS L300 Plus from 4 to 20 seconds in steps of 1 second. The adjustment of the MyGait is more precisely but within the range of the compared devices.
Off time
The off time in training mode of the MyGait is adjustable from 1 to 30 seconds in steps of 1 second. The off time of the WalkAide is selectable from 1 to 10 seconds in steps of 1 second and the NESS L300 Plus from 4 to 60 seconds in steps of 1 second. The values of MyGait are within the range of the compared devices.
The output specifications are equivalent to the predicate devices as can be seen in the comparison table in chapter 6.2.2.
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6.3.3 Conclusion
The MyGait Stimulation System has the same indications for use and the same principle of operation as the WalkAide from Innovative Neurotronics Inc. cleared under 510(k) no. K123972, the NESS L300 Plus System from Bioness Neuromodulation Ltd. cleared under 510(k) no. K103343 and the Empi 300pv from Empi Inc. cleared under 510(k) no. K021100.
The MyGait Stimulation System was successfully tested for electrical safety according to IEC 60601-1 "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance", IEC 60601-1-11 "Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment", IEC 60601-2-10 "Medical electrical equipment – Part 2-10: Particular requirements for the safety of nerve and muscle stimulators" and for electromagnetic compatibility according to IEC 60601-1-2 "Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests".
The evaluation of the MyGait stimulation system does not raise any additional concerns regarding safety and effectiveness. Based on the equivalent indications for use and similar technological characteristics, Otto Bock Healthcare GmbH considers its MyGait Stimulation System to be substantially equivalent to the predicate devices.
The MyGait Stimulation System is safe and effective for its intended use.
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7 Summary of Performance Testing
| No. | Title | Version | Comments |
|---|---|---|---|
| IEC 60601-1 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance | 2005 +A1:2012 | Electrical Safety |
| IEC 60601-1-11 | Medical electrical equipment - Part 1-11: Generalrequirements for basic safety and essential performance -Collateral Standard: Requirements for medical electricalequipment and medical electrical systems used in thehome healthcare environment | 2010 | |
| IEC 60601-2-10 | Medical electrical equipment - Part 2-10: Particularrequirements for the safety of nerve and musclestimulators | 2012 | |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility -Requirements and tests | 2007 | ElectromagneticCompatibility |
| IEC 60529 | Degrees of protection provided by enclosures (IP Code) | 1999 | Enclosure |
| ISO 10993-1 | Biological evaluation of medical devicesPart 1: Evaluation and testing within a risk managementprocess | 2009 | Biocompatibility |
| ISO 10993-5 | Biological evaluation of medical devices Part 5: Tests forin vitro cytotoxicity | 2009 | |
| ISO 10993-10 | Biological evaluation of medical devicesPart 10: Tests for irritation and skin sensitization | 2009 | |
| EN 980 | Symbols for use in the labeling of medical devices | 2008 | LabelingSymbols |
| IEC 60721-3-2 | Classification of environmental conditions Part 3:Classification of groups of environmental parameters andtheir severities - Section 2: Transport | 1997 | Shipping test |
| IEC 60068-2-1 | Environmental testing Part 2-1: Tests - Test A: Cold | 2007 | |
| IEC 60068-2-2 | Environmental testing Part 2-2: Tests - Test B: Dry heat | 2007 | |
| IEC 60068-2-30 | Environmental testing Part 2-30: Tests – Test Db: Dampheat, cyclic (12 + 12-hour cycle) | 2005 | |
| IEC 60068-2-78 | Environmental testing Part 2-78: Tests – Test Cab: Dampheat, steady state | 2001 | |
| IEC 60068-2-14 | Environmental testing Part 2: Tests - Test N: Change oftemperature | 1986 | |
| IEC 68-2-64(EN 60068-2-64) | Environmental testing Part 2-64: Test methods – Test Fh:Vibration, broad-band random (digital control) andguidance | 1993 | |
| IEC 68-2-27(EN 60068-2-27) | Environmental testing Part 2-27: Tests - Test Ea andguidance: Shock | 1987 | |
| IEC 68-2-32(EN 60068-2-32) | Basic environmental testing procedures Part 2: Tests -Test Ed: Free fall | 1990 |
§ 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).