(265 days)
Not Found
No
The summary describes a functional electrical stimulation (FES) device that uses a gait event detection algorithm. While this involves processing data, there is no mention of AI, ML, or related terms, nor is there any description of training or test sets typically associated with ML models. The performance studies focus on standard electrical safety, compatibility, and software validation, not on the performance metrics common for AI/ML devices.
Yes.
The device description clearly states that it is intended to provide "treatment for foot drop" and assists with muscle weakness, which indicates a therapeutic purpose.
No
The device is described as a non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion and/or assist knee flexion/extension to improve gait in individuals with muscle weakness. It stimulates muscles for treatment, not to diagnose a condition.
No
The device description explicitly lists hardware components such as the EvoWalk device with a battery, charge cable, lead cables, and electrodes, in addition to the mobile application software.
No, the EvoWalk 1.0 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves testing blood, urine, tissue, or other bodily fluids or samples outside of the body to diagnose diseases, conditions, or monitor health.
- The EvoWalk 1.0 System is a functional electrical stimulation (FES) device. It works by applying electrical stimulation to the muscles of the affected leg to assist with movement and improve gait. This is a form of therapy or assistance, not a diagnostic test performed on a specimen.
The description clearly states the device's function is to "electrically stimulates muscles in the affected leg" and "provide ankle dorsiflexion... and/or to assist knee flexion or extension." This is a direct interaction with the body for therapeutic or assistive purposes, not an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.
Product codes
GZI
Device Description
The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.
The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
affected leg
Indicated Patient Age Range
adult individuals
Intended User / Care Setting
healthcare facility and home settings.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The EvoWalk 1.0 system has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware. Based on the result of the nonclinical testing, Evolution Devices, Inc. concludes that the device is substantially equivalent to the predicate Bioness L300 Go System. The tests listed have been conducted to demonstrate that the EvoWalk 1.0 system performs as intended and is substantially equivalent to the predicate device.
- Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms
- Motion analysis to validate the gait event detection algorithm
- Electrical Safety according to IEC 60601-1; IEC 60601-1-11
- Muscle and Nerve Stimulators according to IEC 60601-2-10
- Electromagnetic compatibility according to IEC 60601-1-2
- Software validation according to IEC 62304
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 28, 2023
Evolution Devices, Inc. Pierluigi Mantovani CEO 1111 Broadway FL 3. Oakland, California 94607
Re: K230997
Trade/Device Name: EvoWalk 1.0 System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI Dated: December 5, 2023 Received: December 18, 2023
Dear Pierluigi Mantovani:
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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Rehabilitation Devices
2
OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K230997
Device Name EvoWalk 1.0 System
Indications for Use (Describe)
The EvoWalk 1.0 System is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron disease/injury (e.g., stoke, damage to pathways to the spinal cord). The EvoWalk 1.0 System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the flexion or extension; thus, it also may improve the individual's gait.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | ☑ |
|---|---|
| ---------------------------------------------- | ----------------------------------------- |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
|---|---|
| --------------------------------------------- | ----------------------------------------- |
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4
510(k) Summary
Evolution Devices, Inc. EvoWalk 1.0 System
510(k) Summary: EvoWalk 1.0 System
Company Name: Evolution Devices, Inc.
Contact Person: Pierluigi Mantovani Chief Executive Officer Evolution Devices, Inc. 1111 Broadway FL 3, Oakland CA 94607 United States Phone Number: 6619930685 Email: pierluigi@evolutiondevices.com
Date Prepared: November 15, 2023
Trade Name: EvoWalk 1.0 System
Classification: Name: External functional neuromuscular stimulator Product Code: GZI Regulation Number: 21 CFR 882.5810 External functional neuromuscular stimulator Class: II Classification Panel: Neurology
Predicate devices: Company: Bioness Inc. Device: L300 Go System (K173682)
Purpose of the traditional 510(k): This Traditional 510(k) is submitted to clear a new device, the EvoWalk 1.0 System.
Device description:
The EvoWalk 1.0 system is a wearable non-invasive functional electrical stimulation (FES) device intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion in adult individuals with muscle weakness related to upper motor neuron diseaselinjury (e.g., stroke, damage to pathways in the spinal cord), thus providing treatment for foot drop. EvoWalk 1.0 can be used in a healthcare facility and home settings.
The EvoWalk 1.0 system consists of the EvoWalk device with an elastic band and built-in rechargeable lithium polymer battery, and the accessories including the EvoWalk mobile application, micro USB type charge cable with charge port, lead cables (one single channel and one dual channel), eight sets of electrodes for each channel, instructions for use (IFU), and a carrying case.
Indications for use:
The EvoWalk 1.0 system is intended to provide ankle dorsiflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals with muscle weakness related to upper motor neuron
5
disease/injury (e.g., stroke, damage to pathways to the spinal cord). The EvoWalk 1.0 system electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the floxion or extension; thus, it also may improve the individual's gait.
Substantial Equivalence:
Table 1. Predicate Comparison Chart
| Trade Name | EvoWalk 1.0 System
(K230997) | L300 Go System
(K173682) |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Evolution Devices Inc. | Bioness Inc. |
| 510(k) Number | K230997 | K173682 |
| Product Code | GZI | GZI & IPF |
| Indication for
Use | The EvoWalk 1.0 system is intended to
provide ankle dorsiflexion in adult individuals
with foot drop and/or to assist knee flexion or
extension in adult individuals with muscle
weakness related to upper motor neuron
disease/injury (e.g., stroke, damage to
pathways to the spinal cord). The EvoWalk
1.0 system electrically stimulates muscles in
the affected leg to provide ankle dorsiflexion
of the foot and/or knee flexion or extension;
thus, it also may improve the individual's gait. | The L300 Go System is intended to provide ankle
dorsiflexion in adult and pediatric individuals with
foot drop and/or to assist knee flexion or
extension in adult individuals with muscle
weakness related to upper motor neuron
disease/injury (e.g., stroke, damage to pathways
to the spinal cord). The L300 Go System
electrically stimulates muscles in the affected leg
to provide ankle dorsiflexion of the foot and/or
knee flexion or extension; thus, it also may
improve the individual's gait.
The L300 Go System may also:
• Facilitate muscle re-education
• Prevent/retard disuse atrophy
• Maintain or increase joint range of motion
• Increase local blood flow |
| Number of
Output Modes | Biphasic Symmetric Mode only | 2 modes: Biphasic Asymmetric and Symmetric |
| Number of
Programs | • Gait
• Tuning
• Standby | • Gait
• Training/Exercise
• Clinician mode |
| Regulated
Current or
Regulated
Voltage | Current | Current |
| Power Source | Rechargeable, Li-Ion, Prismatic, 3.7 V, 700
mAh | Control Unit: Li Coin Cell, CR2032, 3 V, 240 mAh
EPG: Rechargeable, Li-Ion, Prismatic, 3.7 V,
1000 mAh
Foot Sensor: Li Coin Cell, CR2032, 3 V, 240 mAh |
| Microprocessor
-Controlled | Yes | Yes |
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| Max Output
Current
(± 10%) | Thigh Channel:
102.4 mA @ 500
Ohm load | Lower Leg Channel:
102.4 mA @ 500 Ohm
load | Thigh FSC: 100
mA @ 500
Ohm load | L300 Lower Leg FSC: 100
mA @ 500 Ohm load |
|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Max Average
Current Density
[mARMS/cm²]
[Over smallest
electrode] | Thigh Channel:
rectangular
electrodes
0.26 mArms/cm²
(500 Ω, Irms=13.0
mA, electrode area
of 50 cm²) | Lower Leg Channel:
Square electrodes
0.56 mArms/cm²
(500 Ω, Irms=13.0 mA,
electrode area of 25
cm²)
round electrodes
1.37 mArms/cm²
(Area 10.2 cm²) | Thigh EPG:
0.18 mArms/cm²
(500 Ω, Irms=13.0
mA, electrode area of
74cm²) | Lower Leg EPG:
small cuff, gel electrodes
1.27 mArms/cm²
(500 Ω, Irms=13.0 mA,
electrode area of 10.2cm²) |
| Max Average
Power Density,
(mW/cm²) | Thigh Channel:
rectangular
electrodes
A = 10.1x5.0 cm =
50 cm²
1.7 mW/cm² @ 500
Ω | Lower Leg Channel:
square electrodes
A = 5x5 cm = 25 cm²
3.4 mW/cm² @ 500 Ω
round electrodes
A =10.2cm²
8.3 mW/cm² @ 500 Ω | Thigh EPG:
1.1 mW/cm²
(500 Ω, Irms=13.0
mA, electrode area of
74 cm²) | Lower Leg EPG: small cuff,
gel electrodes
8.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode area of 10.2
cm²)
regular cuff, gel electrodes
5.3 mW/cm²
(500 Ω, Irms=13.0
mA, electrode area of 15.9
cm²) |
| Stimulation
Channels | 2 channels | | Thigh EPG: 1 | Lower Leg EPG: 2
(functioning as a single
channel with separately-
adjustable medial / lateral
stimulation intensity) |
| Electrodes used
in the system | Hydrogel Electrodes:
Square Electrodes:
Male Snap connector;
Surface area 25.0 cm²
Rectangular Electrodes:
Male Snap connector;
Surface area 50.0 cm²
Round Electrode:
Male Snap connector;
Surface area: 10.2cm² | | Lower Leg FSC:
• 2 Hydro-Gel electrodes assembled on
electrode bases, or
• 2 non-woven cloth electrodes assembled
on electrode bases, or
• 2 non-woven cloth electrodes attached with
snaps (also called "QuickFit" electrodes), or
• 3 non-woven cloth electrodes attached with
snaps (segmented electrodes [also called
"steering" electrodes], using common anode
to allow separate adjustment of medial and
lateral stimulation)
Thigh FSC:
• 2 single, non-woven cloth electrodes
attached with snaps | |
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| Clinician
Control/
Programming | Clinician uses the EvoWalk 1.0 companion
application to set stimulation energy and
temporal parameters related to the functional
stimulation performance for dorsiflexion
control and/or knee weakness control | Clinician uses the Clinician Programmer (CAPP)
to set stimulation energy and temporal
parameters related to the functional stimulation
performance for dorsiflexion control and/or knee
weakness control |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Clinician
Programmer
(CAPP)
Platform | Mobile Application (iOS and Android) | Tablet PC |
| User Control | Wearable unit:
Users can press the button to power on,
power off, enter pairing mode and toggle
between standby mode (pause all stimulation)
and active mode.
Mobile application:
From the app the user can set stimulation
parameters, review usage data, toggle
between standby mode (pause all
stimulation), active mode, and tune the
stimulation intensity before and during
ambulation. | Using hand-held Control Unit, the mobile
application (MAPP), or the EPG-based interface,
the user can:
• Turn system On/Off (via EPG only) and
Start/Stop stimulation
• Select Gait/Training program
• Fine-tune stimulation intensity around
working point set by the clinician
• Test L300 Lower Leg EPG & Thigh EPG |
| Stimulation
trigger source
(when used for
gait) | In gait mode, stimulation is triggered by
the inertial measurement unit motion sensor
embedded in the stimulator printed circuit
board | In gait mode, stimulation is triggered by:
(1) the motion sensor embedded in the EPG;
or
(2) Foot Sensor that detects Heel On & Heel
Contact events during gait and transmits
them wirelessly to the lower and thigh
EPGs. |
| Communication
method | EvoWalk 1.0 system - mobile user interface
application:
wireless Bluetooth (Low Energy)
communication protocol | Control Unit – Lower Leg /Thigh EPG: wireless
Bluetooth (Low Energy) communication protocol
Gait Sensor - Lower Leg/Thigh EPG: wireless
Bluetooth (Low Energy) communication protocol
Clinician Programmer - EPG: wireless Bluetooth
(Low Energy) communication protocol
MAPP - Lower Leg /Thigh EPG: wireless
Bluetooth (Low Energy) communication
protocol |
| Maximum Phase
Charge, (µC)
@500 Ω | Lower leg:
$200μs * 102mA = 20μC$
Thigh:
$200μs * 102mA = 20μC$ | Not Reported |
The indication for use is the same for EvoWalk 1.0 System and Bioness L300 Go System except EvoWalk 1.0 system is for adults only and Bioness L300 Go System is for pediatrics and adults. Additionally, EvoWalk 1.0 System is not indicated for muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, or increase local blood flow. Both devices are worn on the user's leg, use hydrogel electrodes, have two channels of stimulation, use an embedded sensor to control stimulation, and both devices have a user interface through a mobile application. The EvoWalk 1.0 system eliminates some optional features of the Bioness L300 Go System including the separate thigh cuff, heel sensor, semi-rigid cuff, cloth electrode option, and dedicated remote control. Both systems control the stimulation in the gait program by reading the embedded motion sensor and applying algorithms and user-specified parameters such that the stimulation activates at a specific time within each gait cycle.
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Summary of Nonclinical Tests Submitted
The EvoWalk 1.0 system has been verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware. Based on the result of the nonclinical testing, Evolution Devices, Inc. concludes that the device is substantially equivalent to the predicate Bioness L300 Go System. The tests listed have been conducted to demonstrate that the EvoWalk 1.0 system performs as intended and is substantially equivalent to the predicate device.
- Technological Characteristics of Powered Muscle Stimulation Stimulation Output Waveforms ●
- Motion analysis to validate the gait event detection algorithm ●
- Electrical Safety according to IEC 60601-1; IEC 60601-1-11 ●
- Muscle and Nerve Stimulators according to IEC 60601-2-10 ●
- Electromagnetic compatibility according to IEC 60601-1-2 ●
- Software validation according to IEC 62304 ●
Conclusion:
Evolution Devices believes the EvoWalk 1.0 system is substantially equivalent to the Bioness L300 GO system (K173682), and does not raise any new issues or concerns of safety or effectiveness. The evidence presented in the bench testing and non-clinical testing is sufficient to support the safety and effectiveness of the device.
The testing ensures that the device is safe for the intended use and will not cause harm to the user or interfere with other medical equipment or electronic devices. The software verification and validation testing ensure that the software used in the device operates as intended and is free of defects or errors.
In conclusion, the non-clinical evidence and testing considered for the bench testing 510k FDA submission for the EvoWalk 1.0 system supports the safety and effectiveness of the device.