(269 days)
Not Found
No
The device description focuses on electrical stimulation triggered by a heel switch and adjustable parameters, with no mention of adaptive algorithms, learning, or data-driven decision-making that would indicate AI/ML.
Yes
The device is intended to treat foot drop and thigh muscle weakness by improving gait, preventing atrophy, facilitating muscle reeducation, maintaining range of motion, and promoting blood circulation, all of which are therapeutic effects.
No
Explanation: The device is described as a "stimulation system" intended to provide electrical stimulation to muscles to improve gait and related conditions. Its function is therapeutic rather than diagnostic, as it does not gather or analyze data to identify a disease, condition, or its severity.
No
The device description clearly outlines multiple hardware components including a battery-operated stimulator, a wireless heel switch, electrodes, a cuff, and a wireless remote control. While there is PC software mentioned ("MyGait Soft"), it is used for managing data and parameters, not as the primary functional component of the medical device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MyGait® Stimulation System is a therapeutic device that provides electrical stimulation to muscles to improve gait and address muscle weakness. It interacts directly with the patient's body through electrodes and a heel switch.
- Intended Use: The intended use clearly describes a therapeutic application for individuals with foot drop and thigh muscle weakness, not the analysis of biological specimens.
The device's function and intended use fall under the category of a therapeutic or rehabilitation device, not an in vitro diagnostic device.
N/A
Intended Use / 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 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.
Product codes
GZI, IPF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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". Additional tests conducted included: IEC 60529 (Degrees of protection provided by enclosures (IP Code)), ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process), ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity), ISO 10993-10 (Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization), EN 980 (Symbols for use in the labeling of medical devices), IEC 60721-3-2 (Classification of environmental conditions Part 3: Classification of groups of environmental parameters and their severities - Section 2: Transport), IEC 60068-2-1 (Environmental testing Part 2-1: Tests - Test A: Cold), IEC 60068-2-2 (Environmental testing Part 2-2: Tests - Test B: Dry heat), IEC 60068-2-30 (Environmental testing Part 2-30: Tests – Test Db: Damp heat, cyclic (12 + 12-hour cycle)), IEC 60068-2-78 (Environmental testing Part 2-78: Tests – Test Cab: Damp heat, steady state), IEC 60068-2-14 (Environmental testing Part 2: Tests - Test N: Change of temperature), IEC 68-2-64 (EN 60068-2-64) (Environmental testing Part 2-64: Test methods – Test Fh: Vibration, broad-band random (digital control) and guidance), IEC 68-2-27 (EN 60068-2-27) (Environmental testing Part 2-27: Tests - Test Ea and guidance: Shock), IEC 68-2-32 (EN 60068-2-32) (Basic environmental testing procedures Part 2: Tests - Test Ed: Free fall).
The evaluation of the MyGait stimulation system does not raise any additional concerns regarding safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5810 External functional neuromuscular stimulator.
(a)
Identification. An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.(b)
Classification. Class II (performance standards).
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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
2
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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3
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510(K) SUMMARY
1 Submitter Information
| Manufacturer: | Otto Bock Healthcare Products GmbH |
|---|---|
| Establishment Registration: | 9615892 |
| Adress: | Brehmstraße 16 |
| 1110 Vienna | |
| Austria | |
| Contact Person: | Rene Urtz |
| Regulatory Affairs Specialist | |
| rene.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) |
4
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.
6
6 Substantial Equivalence Discussion
6.1 Indications for Use
| 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 Healthcare | |||
| Products GmbH | Innovative Neurotronics, Inc. | Empi, Inc | Bioness Neuromodulation | |
| Ltd. | ||||
| Indications | ||||
| for Use | The stimulation system is | |||
| intended to provide ankle | ||||
| dorsiflexion and knee flexion 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. | Summary Statement | |||
| The Innovative Neurotronics | ||||
| WalkAide External Functional | ||||
| Neuromuscular Stimulator | ||||
| (WalkAide System) is intended | ||||
| to address the lack of ankle | ||||
| dorsiflexion in patients who have | ||||
| sustained damage to upper | ||||
| motor neurons or pathways to | ||||
| the spinal cord. During the | ||||
| swing phase of gait, the | ||||
| WalkAide System electrically | ||||
| stimulates the appropriate | ||||
| muscles that cause ankle | ||||
| dorsiflexion and may thus | ||||
| improve the patient's gait. | ||||
| Medical benefits of Functional | ||||
| Electrical Stimulation (FES) may | ||||
| include prevention, retardation | ||||
| of disuse atrophy, increased | ||||
| local blood flow, muscle re- | ||||
| education, and maintained or | ||||
| increased joint range of motion. | Summary Statement | |||
| The 300 PV is a multifunction | ||||
| electrotherapy device with | ||||
| various treatment modes that | ||||
| allow for neuromuscular | ||||
| electrical stimulation (NMES), | ||||
| transcutaneous electrical nerve | ||||
| stimulation (TENS), | ||||
| interferential current stimulation | ||||
| (IFS) and functional electrical | ||||
| stimulation (FES). | ||||
| As a NMES device, the 300 PV | ||||
| is indicated for the following | ||||
| conditions: | ||||
| Re-educating muscles | ||||
| Relaxation of muscle spasm | ||||
| Increasing local blood circulation | ||||
| Retarding or preventing disuse | ||||
| atrophy | ||||
| Maintaining or increasing range | ||||
| of motion. Prevention of venous | ||||
| thrombosis of the calf muscles | ||||
| immediately after surgery. | ||||
| As a TENS device, the 300 PV | ||||
| is indicated for the following | ||||
| conditions: | ||||
| Symptomatic relief and | ||||
| management of chronic, | ||||
| intractable pain. | ||||
| Adjunctive treatment for post- | ||||
| surgical and post-trauma acute | ||||
| pain. As an IFS device, the 300 | ||||
| PV is indicated for the following | ||||
| conditions: | ||||
| Symptomatic relief of acute pain | ||||
| Symptomatic relief and | ||||
| management of chronic pain. | ||||
| As a FES device, the 300 PV is | ||||
| indicated for the following | ||||
| condition: | ||||
| Stimulation of the muscles in | ||||
| the leg and ankle of partially | ||||
| paralyzed | ||||
| patients to provide flexion of the | ||||
| foot and thus improve the | ||||
| patient's gait. | Summary Statement | |||
| The NESS L300 Plus System is | ||||
| intended to provide ankle | ||||
| dorsiflexion and knee flexion or | ||||
| extension in individuals with foot | ||||
| drop and thigh muscle | ||||
| weakness, following an upper | ||||
| motor neuron injury or disease. | ||||
| During gait, the L300 Plus | ||||
| System electrically stimulates | ||||
| muscles in the affected leg to | ||||
| provide dorsiflexion of the foot | ||||
| and knee flexion or extension, | ||||
| thus it may improve the | ||||
| individual's gait. The L300 Plus | ||||
| System may also: |
- Facilitate Muscle re-education
- Prevent/retard disuse atrophy
- Maintain or increase joint
range 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 Healthcare
Products GmbH | Innovative Neurotronics,
Inc. | Empi, Inc | Bioness Neuromodulation
Ltd. |
| 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 Current
Isolation | Medical Class II Power
Adapter | n/a | n/a | Unknown |
| Patient Leakage
Current | | | | |
| normal condition |