L100 Go System

K200262 · Bioness, Inc. · GZI · Mar 4, 2020 · Neurology

Device Facts

• Record ID: K200262
• Device Name: L100 Go System
• Applicant: Bioness, Inc.
• Product Code: GZI · Neurology
• Decision Date: Mar 4, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait. The L100 Go System may also: Facilitate muscle re-education. Prevent/retard disuse atrophy. Maintain or increase joint range of motion. Increase local blood flow.

Device Story

L100 Go System is an external functional neuromuscular stimulator for foot drop. Input: motion sensor data (2D tilt) from External Pulse Generator (EPG) worn on lower leg. Operation: EPG delivers transcutaneous electrical stimulation to lower leg muscles to trigger ankle dorsiflexion during gait. Used in clinic (by clinician for configuration) and home (by patient for ambulation/training). Output: electrical stimulation pulses. Clinician uses tablet-based Clinician Application (CAPP) to configure stimulation parameters. Patient uses mobile app (MAPP) or EPG interface to control stimulation intensity, select modes (Gait, Training), and monitor activity. Benefits: improved gait, muscle re-education, atrophy prevention, increased blood flow, and joint mobility maintenance.

Clinical Evidence

Bench testing only. Verification and validation testing performed on the modified cuff design to ensure mechanical strength and functionality. No clinical data presented.

Technological Characteristics

External functional neuromuscular stimulator; battery-powered (3.7V Li-Ion EPG). Regulated current output (max 100mA @ 500 Ohm). Frequency 10-45 Hz; phase duration 100-900μs. Connectivity: Bluetooth Low Energy (BLE) for MAPP and CAPP. Standards: IEC 60601-1, IEC 60601-2-10, IEC 60950-1, IEC 60601-1-11, IEC 60601-1-2, FCC Part 15. Software-controlled with automatic overload/no-load trip and shut-off. Single-channel stimulation.

Indications for Use

Indicated for adults with foot drop or muscle weakness due to upper motor neuron disease/injury (e.g., stroke, spinal cord damage) to provide ankle dorsiflexion and improve gait; also for muscle re-education, atrophy prevention, joint range of motion maintenance, and increased local blood flow.

Regulatory Classification

Identification

An external functional neuromuscular stimulator is an electrical stimulator that uses external electrodes for stimulating muscles in the leg and ankle of partially paralyzed patients (e.g., after stroke) to provide flexion of the foot and thus improve the patient's gait.

Predicate Devices

• L300 Go System (K190285)

Submission Summary (Full Text)

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March 4, 2020

Bioness Inc. Shanna Hu Regulatory Affairs Manager, FES Technology 25103 Rye Canyon Loop Valencia, California 91355

Re: K200262

Trade/Device Name: L100 Go System Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: January 31, 2020 Received: February 3, 2020

Dear Shanna Hu:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Vivek Pinto, Ph.D. Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known)

Device Name L100 Go System

Indications for Use (Describe)

The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

- · Facilitate muscle re-education
- · Prevent/retard disuse atrophy
- · Maintain or increase joint range of motion
- · Increase local blood flow

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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Image /page/3/Picture/1 description: The image shows the logo for Bioness. The logo features an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller font below it. The logo is simple and modern, and the colors are bright and cheerful.

| 510(k) Summary: | L100 Go System |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Name: | Bioness Inc. |
| Contact Person(s): | Shanna Hu<br>Regulatory Affairs Manager, FES Technology<br>Bioness Inc.<br>25103 Rye Canyon Loop<br>Valencia, CA 91355, U.S.A<br>Office Number: [phone]<br>Email: [e-mail]<br>Mercedes Bayani<br>Global Vice-President, Clinical & Regulatory Affairs<br>Bioness Inc.<br>Office Number: [phone]<br>Fax Number: [phone]<br>Email: [e-mail] |
| Date Prepared: | March 4, 2020 |
| Trade Name: | L100 Go System |
| Classification: | Name: External functional neuromuscular stimulator<br>Product Code: GZI and IPF<br>Regulation No: 21 CFR § 882.5810, § 890.5850<br>Class: II<br>Classification Panel: Neurology |

Establishment Registration No.: 3004553866

Reason for Submission: Device Modifications

Type of Submission: Special 510(k)Type of Submission:Special 510(k)

# Predicate Device:

Company: Bioness, Inc. Device: L300 Go System, K190285

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Image /page/4/Picture/1 description: The image shows the logo for Bioness. The logo consists of an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and the words "LiveOn" in a smaller gray font below the word "Bioness". The sun-like symbol has eight orange rays, each made up of two lines that curve inward.

### Purpose of this Special 510(k):

This Special 510(k) is submitted for a system called L100 Go System which is the same device as the Lower Leg configuration of the predicate L300 Go System with modified cuff design. None of the modifications affect the intended use of the device nor do they alfer the fundamental scientific technology of the device.

### Device Description:

The L100 Go System is designed to improve gait in adults suffering from foot drop or muscle weakness. The L100 Go System can also deliver transcutaneous stimulation to the muscles in the lower leg to facilitate muscle re-education, prevent/retard disuse atrophy, maintain or increase joint range of motion, and/or increase local blood flow.

The L100 Go system consists of the following L300 Go components/accessories with the exception of a modified lower leg cuff:

- 1) External Pulse Generator (EPG), which can be plugged into Lower Leg Cuff. EPG contains user interface including control and indications. EPG also contains integrated motion sensors enabling detecting gait events.
- 2) Lower Leg Cuff, including cradle for the EPG. This is the only L300 Go component modified for the L100 Go.
- 3) Clinician Application (CAPP), installed on tablet PC. CAPP is used by a trained clinician during configuration of the system for optimal fitting to the patient.
- 4) Power supply (charger) with two USB ports and a proprietary cable to charge the EPG.
- 5) Tester, which is used for trouble shooting to confirm that stimulation is being delivered.
- 6) Optional Mobile Application (MAPP), based on the iOS and Android SmartPhone platform enabling the patients to wirelessly control the EPG(s) and retrieve and monitor their daily activity.
- 7) Electrode and electrode bases which are attached to the inner side of the lower leg cuff.

The L100 Go System can be operated in one of the following modes:

- Gait Mode
- Training Mode •
- . Clinician Mode

Gait Mode is used for walking, and it can be selected by the clinician and also by the patient. Training Mode is used to train muscles when patients are not walking (for example, sitting or lying down), and it can be selected by either the clinician or the patient. Clinician Mode allows the clinician to apply enhanced training and is only available to the clinicians.

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Image /page/5/Picture/1 description: The image shows the logo for Bioness LiveOn. The logo features an orange sun-like symbol on the left, followed by the word "Bioness" in gray, and "LiveOn" in a smaller font below it. The logo is simple and modern, with a focus on the company name.

### Indications for Use:

The L100 Go System is intended to provide ankle dorsiflexion in adults with foot drop or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, damage to pathways to the spinal cord). The L100 Go System electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot; thus, it also may improve the adult's gait.

The L100 Go System may also:

- Facilitate muscle re-education .
- Prevent/retard disuse atrophy .
- Maintain or increase joint range of motion ●
- Increase local blood flow ●

#### Modifications Addressed in this Special 510(k)

This Special 510(k) addresses the new L100 Go Cuff which is a modification of the predicate L300 Go lower leg cuffs. The L100 Go Cuff combines the design elements of both the L300 Go lower leg Reqular and Small cuffs.

#### Summary of Technological Characteristics

The Table below summarizes the technological characteristics of the subject device in comparison to those of the predicate device, specifically, the lower leg configuration of the predicate device.

| | L300 Go System<br>(K190285) | L100 Go System (this<br>submission) | Equivalency<br>Assessment |
|-------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Bioness Inc. | Bioness Inc. | Same |
| 510(k) number | K190285 | To be assigned | N/A |
| Product code | GZI & IPF | GZI & IPF | Same |
| | L300 Go System<br>(K190285) | L100 Go System (this<br>submission) | Equivalency<br>Assessment |
| Intended use | The L300 Go System is<br>intended to provide ankle<br>dorsiflexion in adult and<br>pediatric individuals with<br>foot drop and/or to assist<br>knee flexion or extension in<br>adult individuals with<br>muscle weakness related to<br>upper motor neuron<br>disease/injury (e.g., stroke,<br>damage to pathways to the<br>spinal cord). The L300 Go<br>System electrically<br>stimulates muscles in the<br>affected leg to provide<br>ankle dorsiflexion of the<br>foot and/or knee flexion or<br>extension; thus, it also may<br>improve the individual's<br>gait.<br>The L300 Go System may<br>also:<br>• Facilitate muscle re-<br>education<br>• Prevent/retard disuse<br>atrophy<br>• Maintain or increase joint<br>range of motion<br>• Increase local blood flow | The L100 Go System is<br>intended to provide ankle<br>dorsiflexion in adults with<br>foot drop or muscle<br>weakness related to upper<br>motor neuron disease/injury<br>(e.g., stroke, damage to<br>pathways to the spinal cord).<br>The L100 Go System<br>electrically stimulates<br>muscles in the affected leg<br>to provide ankle dorsiflexion<br>of the foot; thus, it also may<br>improve the adult's gait.<br>The L100 Go System may<br>also:<br>• Facilitate muscle re-<br>education<br>• Prevent/retard disuse<br>atrophy<br>• Maintain or increase joint<br>range of motion<br>• Increase local blood flow | Same<br>(The intended use of<br>L100 Go System is a<br>subset of the<br>predicate device.<br>The L100 Go System<br>is a lower leg cuff<br>only system,<br>therefore, it does not<br>assist knee flexion or<br>extension) |
| Number of<br>Output Modes | 2 modes: Biphasic<br>Asymmetric and Symmetric | 2 modes: Biphasic<br>Asymmetric and Symmetric | Same |
| Number of<br>Programs | • Gait<br>• Training/Exercise<br>• Cycle Training Mode<br>• Clinician mode | • Gait<br>• Training/Exercise<br>• Clinician mode | Different<br>(Cycle Training Mode<br>is disabled for the<br>L100 Go System) |
| Regulated<br>Current or<br>Regulated<br>Voltage | Current | Current | Same |
| | L300 Go System<br>(K190285) | L100 Go System (This<br>submission) | Equivalency<br>Assessment |
| Power Source | Control Unit: Li Coin Cell,<br>CR2032, 3 V, 240 mAh<br><br>EPG: Rechargeable, Li-Ion,<br>Prismatic, 3.7 V, 1000 mAh<br><br>Foot Sensor: Li Coin Cell,<br>CR2032, 3 V, 240 mAh | EPG: Rechargeable, Li-Ion,<br>Prismatic, 3.7 V, 1000 mAh | Same<br>(optional Control Unit<br>and Foot Sensor are<br>not offered with the<br>L100 Go System) |
| Method of Line<br>Current<br>Isolation | N/A (Battery operated) | N/A (Battery operated) | Same |
| Patient<br>Leakage<br>Current,<br>Normal<br>condition [μA] | Less than 1.0 (IEC 60601-<br>1) | Less than 1.0 (IEC 60601-1) | Same |
| Patient<br>Leakage<br>Current, Single<br>fault condition<br>[μA] | 3.0 (IEC 60601-1) | 3.0 (IEC 60601-1) | Same |
| Number of<br>Output Modes | Two: Symmetric &<br>Asymmetric | Two: Symmetric &<br>Asymmetric | Same |
| Number of<br>Output<br>Channels | Small lower leg cuff: 1<br>Regular lower leg cuff: 1 or<br>2<br>Thigh cuff: 1 | Lower leg cuff: 1 | Same<br>(The L100 Go lower<br>leg cuff has the same<br>output channel as<br>the L300 Go small<br>lower leg cuff) |
| Synchronous<br>or Alternating? | Alternating (at one time<br>only one channel is<br>activated) | N/A (only one channel will<br>be activated) | Same<br>(L100 Go cuff is<br>single channeled.<br>This is the same as<br>L300 Go small lower<br>leg cuff) |
| Method of<br>Channel<br>Isolation | Isolation between lower leg<br>and thigh cuff stimulators:<br>Thigh and Lower cuffs are<br>stimulated by different<br>battery operated EPG's<br>without galvanic connection<br>between them.<br><br>Isolation between channels<br>within the regular lower cuff | Isolation between channels<br>with the lower leg cuff<br>stimulator: N/A<br>(Only one channel will be<br>activated) | Same<br>(The isolation<br>between channels is<br>not applicable to<br>L100 Go lower leg<br>cuff stimulator, this is<br>the same as L300<br>Go small lower leg<br>cuff stimulator) |
| | L300 Go System<br>(K190285) | L100 Go System (This<br>submission) | Equivalency<br>Assessment |
| | same EPG are switched<br>using high voltage FET<br>switches. | | |
| | Isolation between channels<br>within the small lower cuff<br>stimulator: N/A (only one<br>channel will be activated) | | |
| | Isolation between channels<br>within the Thigh cuff<br>stimulator: N/A (only one<br>channel will be activated) | | |
| Regulated<br>Current or<br>Regulated<br>Voltage? | Current | Current | Same |
| Software/Firmw<br>are/Microproce<br>ssor-Controlled | Yes | Yes | Same |
| Automatic<br>Overload Trip? | Yes | Yes | Same |
| Automatic No-<br>Load Trip? | Yes | Yes | Same |
| Automatic Shut<br>Off? | Yes | Yes | Same |
| Patient<br>Override<br>Control? | Yes | Yes | Same |
| Indicator<br>Display:<br>• On/Off<br>Status?<br>• Low Battery?<br>•Voltage/Current Level? | Yes<br>Yes<br>Yes | Yes<br>Yes<br>Yes | Same |
| Timer Range<br>[minutes] | No | No | Same |
| | L300 Go System<br>(K190285) | L100 Go System (This<br>submission) | Equivalency<br>Assessment |
| Max Output<br>Current<br>(± 10%) | Lower leg cuffs:<br>100 mA @ 500 Ohm<br>Thigh cuff:<br>100 mA @ 500 Ohm | Lower leg cuff:<br>100 mA @ 500 Ohm | Same<br>(L100 Go lower leg<br>cuff has the same<br>maximum output<br>current as the L300<br>Go lower leg cuff.<br>Thigh cuff is not<br>available in the L100<br>Go System) |
| Max Average<br>Current Density<br>[mARMS/cm2]<br>[Over smallest<br>electrode] | Lower leg EPG:<br>small cuff, small round<br>electrodes (36mm)<br>$1.27 \text{ mA}_{\text{RMS}}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0 mA, electrode<br>area of 10.2 cm2)<br>Thigh EPG: $0.18 \text{mA}_{\text{RMS}}/\text{cm}^{2}$<br>(500 Ω, Irms=13.0 mA,<br>electrode area of 74 cm2) | Lower leg EPG:<br>Lower leg cuff, regular round<br>electrodes (45mm)<br>$0.82 \text{mA}_{\text{RMS}}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0 mA, electrode area<br>of 15.9 cm2) | Different<br>(since L100 Go cuff<br>only comes in the<br>size same as the<br>predicate regular<br>cuff, the calculation<br>is based on the<br>electrode of the<br>regular cuff. Thigh<br>cuff is not available<br>in the L100 Go<br>System) |
| Max Average<br>Power Density,<br>(mW/cm2) | Lower leg EPG:<br>small cuff, small round<br>electrodes (36mm)<br>$8.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0 mA, electrode<br>area of 10.2 cm2)<br>regular cuff, regular round<br>electrodes (45mm)<br>$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0 mA, electrode<br>area of 15.9 cm2)<br>Thigh EPG:<br>$1.1 \text{mW}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0mA, electrode area<br>of 74 cm2) | Lower Leg EPG:<br>Lower leg cuff, regular round<br>electrodes (45mm)<br>$5.3 \text{ mW}/\text{cm}^{2}$ (500 Ω,<br>Irms=13.0 mA, electrode area<br>of 15.9 cm2) | Same<br>(L100 Go cuff only<br>comes in regular<br>size) |
| | L300 Go System<br>(K190285) | L100 Go System (This<br>submission) | Equivalency<br>Assessment |
| Stimulation<br>Channels | Regular Cuff: 1 or 2 (In 2-<br>channel<br>mode, both function as a<br>single channel but with<br>separately<br>adjustable medial/ lateral<br>stimulation<br>intensity)<br>Small Cuff: 1<br>Thigh Cuff: 1 | Lower leg cuff: 1 | Same<br>(L100 Go has one<br>stimulation channel<br>which is identical to<br>channel #1 of L300<br>Go Regular Cuff) |
| Frequency/<br>Phase duration | Frequency: 10, 15, 20, 25,<br>30, 35, 40, 45 Hz<br>Symmetric and Asymmetric<br>positive: 100, 150, 200,<br>250, 300μs;<br>Asymmetric Negative: 300,<br>450, 600, 750, 900μs; | Frequency: 10, 15, 20, 25,<br>30, 35, 40, 45 Hz<br>Symmetric and Asymmetric<br>positive: 100, 150, 200, 250,<br>300μs;<br>Asymmetric Negative: 300,<br>450, 600, 750, 900μs; | Same |
| Electrodes<br>used in the<br>system | Lower Leg Cuffs:<br>• 2 Hydro-Gel electrodes<br>assembled on<br>electrode bases, or<br>• 2 non-woven cloth<br>electrodes assembled<br>on electrode bases, or<br>• 2 non-woven cloth<br>electrodes attached<br>with snaps (also called<br>"QuickFit" electrodes),<br>or<br>• 3 non-woven cloth<br>electrodes attached<br>with snaps (segmented<br>electrodes [also called<br>"steering" electrodes],<br>using common anode<br>to allow separate<br>adjustment of medial<br>and lateral stimulation.<br>This electrode is only<br>used for regular cuff)<br>Thigh Cuff:<br>• 2 single, non-woven<br>cloth electrodes<br>attached with snaps | Lower leg Cuff:<br>• 2 Hydro-Gel electrodes<br>assembled on electrode<br>bases, or<br>• 2 non-woven cloth<br>electrodes assembled<br>on electrode bases, or<br>• 2 non-woven cloth<br>electrodes attached<br>with snaps (also called<br>"QuickFit" electrodes) | Different<br>(L100 Go does not<br>use steering<br>electrodes)…