Cionic Neural Sleeve NS-100

K213622 · Cionic · GZI · Feb 14, 2022 · Neurology

Device Facts

• Record ID: K213622
• Device Name: Cionic Neural Sleeve NS-100
• Applicant: Cionic
• Product Code: GZI · Neurology
• Decision Date: Feb 14, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion 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 Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The Cionic Neural Sleeve NS-100 may also: Facilitate muscle re-education; Prevent/retard disuse atrophy; Maintain or increase joint range of motion; Increase local blood flow.

Device Story

Platform for measurement and augmentation of lower limb mobility; consists of fabric sleeve (SL-100) with embedded IMUs and EMG sensors, battery-powered control unit (DC-100), and mobile app. Device measures limb movement and muscle activity; control unit processes data to generate electrical stimulation via skin-contacting hydrogel electrodes. Used by adults with foot drop or upper motor neuron-related muscle weakness to assist gait, facilitate muscle re-education, prevent disuse atrophy, maintain range of motion, and increase local blood flow. User operates system via mobile app to start/stop stimulation, modulate intensity, and select programs. Clinician control enabled via web interface. Benefits include improved gait and functional mobility through targeted neuromuscular stimulation.

Clinical Evidence

Bench testing only. Evidence includes stimulation output waveform analysis, biological evaluation (ISO 10993-1), wireless coexistence, electrical safety (IEC 60601-1, IEC 60601-1-11, IEC 60601-2-10), EMC (IEC 60601-1-2), usability (IEC 62366, IEC 60601-1-6), and software validation (IEC 62304).

Technological Characteristics

External functional neuromuscular stimulator; fabric sleeve with embedded IMUs and 8 EMG input channels. Uses 24 hydrogel electrode pads. Power: 7.4V 1900mAh LiPo battery. Connectivity: Bluetooth Low Energy (app), USB-C (firmware/charging). Regulated current output (max 100mA @ 500Ω). Microprocessor-controlled. Sterilization: Not specified (components are body-worn).

Indications for Use

Indicated for adult individuals with foot drop and/or muscle weakness related to upper motor neuron disease/injury (e.g., stroke, spinal cord damage) to provide ankle dorsiflexion/plantarflexion and/or knee flexion/extension assistance.

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)

Reference Devices

• Stiwell MED4 (K080950)

Submission Summary (Full Text)

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February 14, 2022

Cionic Mihai Ionescu Head of Hardware Development 1606 Stockton St. Suite #1 San Francisco, California 94133

Re: K213622

Trade/Device Name: Cionic Neural Sleeve NS-100 Regulation Number: 21 CFR 882.5810 Regulation Name: External functional neuromuscular stimulator Regulatory Class: Class II Product Code: GZI, IPF Dated: November 15, 2021 Received: November 16, 2021

Dear Mihai Ionescu:

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

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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 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 (QS) 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 medical devices and radiation-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,

Amber Ballard, PhD Assistant 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) K213622

Device Name Cionic Neural Sleeve NS-100

### Indications for Use (Describe)

The Cionic Neural Sleeve NS-100 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 the spinal cord). The Cionic Neural Sleeve NS-100 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 Cionic Neural Sleeve NS-100 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)

| <span style="font-family: DejaVu Sans, sans-serif">☑</span> Remediation Use (Ref 21 CFR 201.Subpart D) | <span style="font-family: DejaVu Sans, sans-serif">☐</span> Over-The-Counter Use (21 CFR 201.Subpart C) |
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
|--------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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### 510(K) Summary

### l SUBMITTER

Cionic, Inc. 1606 Stockton St. Suite #1 San Francisco, CA 94133

Contact Person: Mihai Ionescu Date Prepared: February 11, 2021

#### PROPOSED DEVICE ll

Trade / Device Name: Cionic Neural Sleeve NS-100 Manufacturer: Cionic Inc. Regulation Number: 21 CFR 882.5810 Regulation Name: External Functional Neuromuscular Stimulator Regulatory Class: Class II Product Code: GZI, IPF 510(k) Number: K213622

### ��� PREDICATE DEVICE

Device Name: L300 Go System Manufacturer: Bioness Inc. 510(k) Number: K190285

### REFERENCE DEVICE

Device Name: Stiwell MED4 Manufacturer: Otto Bock Healthcare Product GmbH 510(k) Number: K080950

#### IV DEVICE DESCRIPTION

The Cionic Neural Sleeve NS-100 is a platform for the measurement and augmentation of lower limb mobility composed of a body-worn legging, a battery-powered electronic controller and a mobile application. The Cionic Neural Sleeve NS-100 has embedded sensors to measure limb movement and muscle activity. These data are used by the control unit to generate stimulation intended to activate muscles for exercise or functional assistance.

The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion in adult individuals with foot drop and/or to assist knee flexion or extension in adult individuals

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with muscle weakness related to upper motor neuron disease/injury (e.g. stroke, damage to pathways to the spinal cord). The Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The Cionic Neural Sleeve NS-100 system sales carton consists of the following components:

- 1) SL-100 a fabric sleeve covering the upper and lower leg containing embedded motion sensors and skin-contacting electrodes. Left and right leg sleeves are available in two sizes: small, and medium.
- 2) DC-100 a portable battery-powered Control and Stimulation Unit that connects to, and is worn within the SL-100. The DC-100 communicates over Bluetooth™Low Energy protocol to the Cionic mobile application ("Cionic app").
- 3) Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required.
- 4) Adhesive, electrically conductive and replaceable electrode pads.
- 5) Electrode cover sheets.
- 6) Instructions for Use documents.

Components are available as accessories to the Cionic Neural Sleeve NS-100 system:

- Replacement electrode pads.
The Cionic Neural Sleeve NS-100 requires a password-protected Cionic mobile application that is exclusively available to Cionic Neural Sleeve NS-100 users.

The Cionic Neural Sleeve NS-100 system consists of a software and hardware architecture that enables users to access a library exercise and augmentation programs. Programs can be added and removed from the user's mobile app. All exercise and assistance programs utilize a standard calibration and stimulation user interface that is extendible to future exercise and augmentation programs.

#### > INDICATIONS FOR USE

The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or plantarflexion 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 Cionic Neural Sleeve NS-100 electrically stimulates muscles in the affected leg to provide ankle dorsiflexion and/or plantarflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait.

The Cionic Neural Sleeve NS-100 may also:

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

#### VI COMPARISON OF INDICATIONS FOR USE

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## Clonic

The Cionic Neural Sleeve NS-100 Indications for use differs from the Bioness L300 Go System in that the Neural Sleeve can provide plantar flexion of the foot in addition to dorsiflexion of the foot. Adult individuals with muscle weakness related to upper motor neuron disease/injury may have mobility that is limited by insufficient foot plantarflexion, which is unaddressed by the Bioness L300 Go System. Stimulation of the muscles responsible for foot plantarflexion under the same technological characteristics of the predicate device does not pose new issues of safety and effectiveness under the intended use.

Like the Bioness L300 Go, the Neural Sleeve System is intended for adult individuals. Unlike the Bioness L300 Go, the Neural Sleeve System is not intended for pediatric individuals.

| Characteristic | SUBJECT DEVICE | PREDICATE<br>DEVICE | REFERENCE<br>DEVICE | SUBSTANTIAL<br>QUIVALENCE |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 510(k) Number | K213622 | K190285 | K080950 | |
| Device Name,<br>Model | NS-100 | L300 Go System | Stiwell MED4 | |
| Manufacturer | Cionic Inc. | Bioness Inc. | Otto Bock Healthcare<br>Product GmbH | |
| Product code | IPF, GZI | GZI & IPF | IPF, GZI, GZJ, HCC,<br>KPI | Same as predicate, and a<br>subset of the reference<br>device. |
| Intended<br>Use /<br>Indications<br>for Use | The Cionic Neural Sleeve<br>NS-100 is intended to<br>provide ankle<br>dorsiflexion and/or<br>plantarflexion in adult<br>individuals with foot drop<br>and/or to assist knee<br>flexion or extension in<br>adult individuals with<br>muscle weakness related<br>to upper motor neuron<br>disease/injury (e.g.<br>stroke, damage to<br>pathways to the spinal<br>cord). The Cionic Neural<br>Sleeve NS-100<br>electrically stimulates<br>muscles in the affected<br>leg to provide ankle<br>dorsiflexion and/or<br>plantarflexion of the foot<br>and/or knee flexion or<br>extension; thus, it also<br>may improve the<br>individual's gait. | The L300 Go System<br>is intended to<br>provide ankle<br>dorsiflexion in adult<br>and pediatric<br>individuals with foot<br>drop and/or to assist<br>knee flexion or<br>extension in adult<br>individuals with<br>muscle weakness<br>related to upper<br>motor neuron<br>disease/injury (e.g.<br>stroke, damage to<br>pathways to the<br>spinal cord).<br>The L300 Go System<br>electrically<br>stimulates muscles<br>in the affected leg to<br>provide ankle<br>dorsiflexion of the<br>foot and/or knee<br>flexion or extension; | The STIWELL MED4<br>is a neuromuscular<br>electrical stimulator<br>indicated for use<br>under medical<br>supervision for<br>adjunctive therapy in<br>the treatment of<br>medical diseases and<br>conditions.<br>As a powered muscle<br>stimulator STIWELL<br>MED4 is indicated for<br>the<br>following conditions:<br>• Relaxation of<br>muscle spasm<br>• Prevention of<br>retardation of<br>disuse atrophy<br>• Increasing<br>local blood<br>circulation<br> | Same as predicate, and a<br>subset of the reference<br>device. |

### VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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## CIC C

| The Cionic Neural Sleeve<br>NS-100 may also: | thus, it also may<br>improve the<br>individual's gait.<br>The L300 Go System<br>may also: | Muscle re-education |
|----------------------------------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| • Facilitate muscle re-education | • Facilitate muscle re-education | • Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis |
| • Precent/retard disuse atrophy | • Precent/retard disuse atrophy | • Maintaining or increasing range of motion |
| • Maintain or increase joint range of motion | • Maintain or increase joint range of motion | As a transcutaneous electrical nerve stimulator for pain relief the STIWELL MED4 is indicated for the following conditions: |
| • Increase local blood flow | • Increase local blood flow | • Symptomatic relief and management of chronic (long-term) intractable pain |
| | | • Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain |
| | | As a biofeedback device the STIWELL MED4 is indicated for the following conditions: |
| | | • Biofeedback, relaxation and muscle re-education purposes |
| | | As an external functional neuromuscular stimulator the STIWELL MED4 is indicated for the following conditions: |

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| | | | Helps<br>relearn<br>voluntary<br>motor<br>functions<br>of<br>the<br>extremities | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of<br>Output Modes | 1 mode: Monophasic<br>with hybrid stimulation | 2 modes: Biphasic<br>Asymmetric and<br>Symmetric | One | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>mode number of subject<br>device is subset of predicate<br>device. |
| Number of<br>Program Modes | Gait Assist Training/Exercise | Gait Training/Exercise Cycle Training Mode Clinician mode | Multiple | Same as predicate device<br>and a subset of reference<br>device. |
| Regulated<br>Current or<br>Regulated<br>Voltage | Regulated Current | Regulated Current | Regulated Current | Same |
| Power<br>Source(s) | Lithium Polymer (LiPo)<br>rechargeable 7.4V<br>1900mAh | Control Unit: Li Coin<br>Cell, CR2032, 3 V,<br>240 mAh EPG:<br>Rechargeable,<br>Li-Ion, Prismatic, 3.7<br>V, 1000 mAh Foot<br>Sensor: Li Coin Cell,<br>CR2032, 3 V, 240<br>mAh | Battery Pack Li-<br>Ion 11.1V | Substantially equivalent. All<br>three devices meet<br>electrical safety standards.<br>The battery of the proposed<br>device meets IEC 62133-2,<br>Edition 1.0, 2017-02 (also<br>an FDA recognized<br>standard). Differences are<br>considered minor with no<br>impact to safety and<br>effectiveness since all three<br>devices adhere to<br>recognized/consensus<br>electrical/battery safety<br>standards. |
| Microprocessor<br>- Controlled | Yes | Yes | Yes | Same |
| Maximum<br>Output<br>Current<br>(+/- 10%)<br>[mA] | Lower leg and thigh:<br>100 mA @ 500 Ω<br>60 mA @ 2 kΩ<br>13 mA @ 10 kΩ<br><br>Irms=24.6 mA<br>computed based on 500<br>Ω 100mA (+/- 10%)<br>400 [µs] 125 Hz | Lower leg: 100mA<br>@ 500 Ω<br>65mA @ 2 kΩ<br>13mA @ 10 kΩ<br><br>Thigh:<br>100mA @ 500 Ω<br>65mA @ 2 kΩ<br>13mA @ 10 kΩ | NMES/TENS/FE<br>S 100 mA @<br>500 Ω<br>58 mA @ 2 kΩ<br>N/A mA @ 10<br>kΩ | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>all three devices adhere to<br>recognized/consensus<br>electrical safety standards<br>and all devices are similar<br>within range. |
| Maximum<br>Current<br>(RMS)<br>Density<br>[mA/cm2] | 0.98 mA/cm²<br>Irms=24.6 mA<br>computed based on 500<br>Ω 100mA (+/- 10%)<br>400 [μs] 125 Hz<br>electrode area of 25cm² | Thigh EPG:<br>0.18 mArms/cm2<br>(500 Ω, Irms=13.0<br>mA, electrode area<br>of 74 cm2)<br>Lower Leg EPG: | 12.5 mA/cm2 | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>all three devices adhere to<br>recognized/consensus |
| | | small cuff, gel<br>electrodes 1.27<br>mArms/cm2 (500<br>Ω, Irms=13.0 mA,<br>electrode area of<br>10.2 cm2) | | electrical safety standards<br>and all devices are similar<br>within range. |
| Maximum<br>Power<br>Density<br>[mW/cm2] | 12mW/cm2<br>(500 Ω, Irms=24.6<br>mA, electrode area<br>of 25 cm2) | Thigh EPG:<br>1.1 mW/cm2<br>(500 Ω,<br>Irms=13.0 mA,<br>electrode area of<br>74 cm2)<br>Lower Leg EPG:<br>small cuff, gel<br>electrodes 8.3<br>mW/cm2 (500 Ω,<br>Irms=13.0 mA,<br>electrode area of<br>10.2 cm2)<br>regular cuff, gel<br>electrodes 5.3<br>mW/cm2 (500 Ω,<br>Irms=13.0 mA,<br>electrode area of<br>15.9 cm2) | 7.9mW/cm2 | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>all three devices adhere to<br>recognized/consensus<br>electrical safety standards<br>and all devices are similar<br>within range. |
| Stimulation<br>Channels | 1 stimulator channel with<br>8 virtual Positive output<br>channels and 15 virtual<br>Negative output channels | Lower leg small<br>cuff – 1 channel<br>Lower leg regular<br>cuff - 1 or 2<br>channels (in 2<br>channel<br>configuration, both<br>channels function<br>as a single channel<br>with separately<br>adjustable medial /<br>lateral<br>stimulation<br>intensity)<br>Thigh cuff – 1<br>channel | 3 for FES<br>programs<br>1 for<br>Incontinence<br>programs<br>4 for TENS<br>programs<br>1 for<br>Biofeedback | Substantially equivalent.<br>The proposed device<br>contains a subset of the<br>number of channels<br>available on the predicate<br>and reference devices.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness<br>since proposed device<br>stimulation channels are a<br>subset of predicate and<br>reference devices. |
| Connection of<br>device<br>electrodes | 24 Hydrogel electrode<br>pads adhesively<br>connected to non-<br>tissue contacting<br>electrode bases. | Lower Leg FSC:<br>• 2 Hydro-Gel<br>electrodes<br>assembled on<br>electrode bases,<br>or<br>• 2 non-woven cloth<br>electrodes<br>assembled on<br>electrode bases, or | Not Publicly<br>Available | Substantially equivalent.<br>Electrode pads used in the<br>proposed and predicate<br>devices attach using similar<br>methods, and both devices<br>embed the electrode wires.<br>The reference device uses<br>standard electrode pads<br>and leads. Differences are<br>considered minor with no |
| | | | | |
| | | • 2 non-woven cloth<br>electrodes attached<br>with snaps (also<br>called "QuickFit"<br>electrodes), or<br>• 3 non-woven cloth<br>electrodes attached<br>with snaps<br>(segmented<br>electrodes [also<br>called "steering"<br>electrodes], using<br>common anode to<br>allow separate<br>adjustment of<br>medial and lateral<br>stimulation)<br>Thigh FSC:<br>• 2 single, non-<br>woven cloth<br>electrodes attached<br>with snaps | | impact to safety and<br>effectiveness since<br>proposed device connection<br>of electrodes is similar to<br>predicate and reference<br>devices. |
| Clinician<br>Control/<br>Programming | No separate clinician<br>programming mode. | Clinician uses the<br>Clinician<br>Programmer (CAPP)<br>to set stimulation<br>energy and temporal<br>parameters related<br>to the functional<br>stimulation<br>performance for<br>dorsiflexion control<br>and/or knee<br>weakness control. | Not Publicly Available | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>the proposed device still<br>provides clinician control as in<br>the predicate and reference<br>device, just not in the same<br>specific technological manner.<br>Proposed device enables<br>clinician control through a<br>web/internet interface which<br>was successfully<br>verified/validated during<br>development. |
| User Control | Using the Cionic mobile<br>app, the user can:<br>• Start/Stop<br>stimulation<br>• Modulate<br>stimulation<br>between 0 and<br>100%<br>• Fine tune<br>stimulation<br>intensity<br>around the<br>working point<br>set by Cionic<br>technician.<br>• Select<br>Assist/Exercise<br>program | Using hand-held<br>Control Unit, the<br>mobile application<br>(MAPP), or the EPG-<br>based interface, the<br>user can:<br>• Turn system<br>On/Off (via<br>EPG only) and<br>Start/Stop<br>stimulation<br>• Select<br>Gait/Training<br>program<br>• Fine-tune<br>stimulation<br>intensity<br>around | Not Publicly<br>Available | Substantially equivalent.<br>Differences are considered<br>minor with no impact to<br>safety and effectiveness since<br>the proposed device still<br>provides user control as in<br>the predicate and reference<br>device, just not in the same<br>specific technological manner.<br>Proposed device enables user<br>control through a mobile app<br>interface which was<br>successfully verified/validated<br>during development. |
| | Test stimulation before starting an Assist/Exercise program Using the hand-held Control Unit worn within the Neural Sleeve, the user can: Turn Control Unit On/Off Reset Control Unit to factory settings Pause and unpause stimulation | working point set by the clinician Test L300 Lower Leg EPG & Thigh EPG stimulation before starting to ambulate | | |
| Stimulation Trigger Source for Gait Assist | In gait mode, stimulation is triggered by the two IMUs (Inertial Measurement Unit) embedded in the SL-100, one on the shank and the other on the thigh.<br>In EMG exercise mode, stimulation is triggered by the EMG sensors embedded in the SL-100. | In gait mode, stimulation is triggered by:<br>(1) the motion sensor embedded in the EPG (two-dimension tilt); or<br>(2) Foot Sensor that detects Heel On & Heel Contact events during gait and transmits them wirelessly to the lower and thigh EPGs. | N/A | Substantially equivalent to the predicate device. The manner in which both devices enable stimulation are different, however the difference is considered minor (therefore no impact to safety/effectiveness) due to the fact that both methods of enabling stimulation are based on detecting limb motion through motion sensors (Bioness) and IMUs (Cionic). Motion sensors and IMUs are very similar technologies used to measure motion. |
| Communication Method | DC-100 to SL-100 using a 40-pin connector<br>Mobile Application - Control Unit: wireless Bluetooth (Low Energy) communication protocol<br>Portal - Control Unit (as needed for firmware updates or data transfer): USB-C connector | Control Unit - Lower Leg/Thigh EPG: wireless Bluetooth (Low Energy) communication protocol<br>Gait sensor-Lower Leg/Thigh EPG: Wireless Bluetooth (Low Energy) Communication protocol<br>Clinician Programmer - EPG: wireless Bluetooth (Low Energy) | Not publicly available | Same as predicate. |
| | | communication protocol<br>MAPP- Lower Leg/Thigh<br>EPG: wireless Bluetooth (Low Energy) communication protocol | | |
| Number of<br>EMG (input)<br>Channels | 8 | N/A | 2 | Substantially equivalent to reference device.<br>Differences considered minor (therefore no impact to safety and effectiveness) since both devices measure muscle activity via EMG by detecting the electrical signal during activity. |
| EMG detection<br>(Bipolar/Monop<br>olar) | Bipolar | N/A | Bipolar | Same as reference device |
| Weight | Control Unit DC-100<br>145 g<br>Sleeve SL-100<br>Medium L/R 240 g<br>Sleeve SL-100 Small<br>L/R 230 g | Not Publicly<br>Available | 440 g | Substantially equivalent.<br>Although the appearance, weight and dimensions are different between the proposed, predicate, and reference devices, these differences are insignificant and do not raise any issues related to safety and effectiveness. |
| Dimensions<br>[W x H x D] | DC-100 137 x 53 x 24<br>mm<br>SL-100 Medium<br>613 x 602 mm<br>SL-100 Small 596 x<br>560 mm | Not Publicly<br>Available | Device: 175 x 95 x<br>30 mm | |

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## Clonic

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## cionic

### PERFORMANCE DATA VIII

### Summary of Nonclinical performance testing

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# clonic

The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve performs as intended and is substantially equivalent to the predicate device.

- Stimulation Output Waveforms ●
- Biological evaluation of medical devices according to ISO 10993-1 ●
- . Stimulation Output Specifications
- Stimulation Virtual Output Channels ●
- Stimulation Output Channel Isolation
- Hybrid Stimulation
- Stimulation Electrodes Short and/or Open detection ●
- Wireless Coexistence
- 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
- Usability according to IEC 62366; IEC 60601-1-6 ●
- . Software validation according to IEC 62304

#### IX CONCLUSION

The Cionic Neural Sleeve NS-100 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, Cionic concludes that the device is substantially equivalent to the predicate Bioness L300 Go System.