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

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 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.
1. 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").
1. Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required.
1. Adhesive, electrically conductive and replaceable electrode pads.
1. Electrode cover sheets.
1. 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.

AI/ML Overview

The provided FDA 510(k) summary for the Cionic Neural Sleeve NS-100 (K213622) does not include a detailed study proving the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, accuracy, or effect size for human readers with AI assistance.

The document focuses on demonstrating substantial equivalence to a predicate device (Bioness L300 Go System, K190285) rather than providing a standalone performance study with quantified acceptance criteria for diagnostic or assistive accuracy. The performance data presented is limited to non-clinical testing for safety and technical specifications, not clinical effectiveness in terms of how well it improves patient outcomes or how it performs against a measurable clinical metric.

Therefore, many of the requested items cannot be extracted directly from this document. However, I can provide what is available and clarify what is missing.

Acceptance Criteria and Device Performance (Based on Technical and Safety Testing)

While the document doesn't list quantitative clinical performance criteria, it outlines the non-clinical tests conducted to demonstrate the device performs as "intended" and is "substantially equivalent." The "reported device performance" in this context refers to its adherence to these technical and safety standards.

Acceptance Criteria (Implied by non-clinical tests)	Reported Device Performance
Safety and Electrical Performance:	Demonstrated Compliance:
Compliance with IEC 60601-1 (Electrical Safety)	Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards")
Compliance with IEC 60601-1-11 (Electrical Safety in Home Healthcare)	Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards")
Compliance with IEC 60601-2-10 (Muscle and Nerve Stimulators)	Compliant (Implied by "successfully verified/validated," "adhere to recognized/consensus electrical safety standards")
Compliance with IEC 60601-1-2 (Electromagnetic Compatibility)	Compliant
Battery Safety (IEC 62133-2)	Compliant
Stimulation Output Waveforms meet specifications	Performed as intended
Stimulation Output Channels and Isolation meet specifications	Performed as intended
Hybrid Stimulation functions as intended	Performed as intended
Stimulation Electrodes Short and/or Open detection functions as intended	Performed as intended
Biocompatibility:
Biological evaluation of medical devices according to ISO 10993-1	Compliant
Usability and Software:
Usability according to IEC 62366; IEC 60601-1-6	Compliant ("successfully verified/validated")
Software validation according to IEC 62304	Compliant ("successfully verified/validated")
Functional/Technological Equivalence (to Predicate):
Provide ankle dorsiflexion and/or plantarflexion, assist knee flexion or extension	Yes, similar indications, with additional plantarflexion capability compared to predicate.
Facilitate muscle re-education, prevent/retard disuse atrophy, maintain/increase ROM, increase local blood flow	Yes, similar to predicate.
Other technological characteristics (e.g., output current, power density, control methods)	Found "Substantially equivalent," with differences considered minor and having no impact on safety and effectiveness.

Detailed Information Regarding Study (Based on Document Analysis):

Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided in this summary. The document describes non-clinical bench testing and verification/validation processes, not a clinical study on a patient test set with performance metrics.
- Data Provenance: Not applicable, as it's not a clinical data set. It refers to non-clinical testing performed by the manufacturer, Cionic, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically defined for clinical or diagnostic performance studies is not established in this document, as it outlines technical and safety testing.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a human-reviewed test set or adjudication process for clinical performance.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an MRMC comparative effectiveness study involving human readers or AI assistance in a diagnostic context. The device is a functional neuromuscular stimulator, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies extensive standalone engineering verification and validation of the device's electrical, mechanical, software, and biocompatibility aspects. However, this is not a clinical "standalone performance" in the sense of an algorithm making a clinical decision without human intervention. The device's function is to directly stimulate muscles based on detected limb movement.
- The software was validated according to IEC 62304, and the overall system was "verified and validated successfully for its intended use through a combination of original bench testing and verification and validation of all software and firmware."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" was compliance with established engineering standards (e.g., IEC standards for electrical safety, biocompatibility, usability, software validation) and the device's design specifications. There is no clinical outcomes data or pathology-based ground truth presented in this summary for the purpose of demonstrating substantial equivalence.
The sample size for the training set:
- Not applicable. This document does not describe an AI/machine learning model that would require a "training set" in the traditional sense for diagnostic or predictive performance. The device uses embedded sensors and a control unit to generate stimulation for functional assistance, implying a rule-based or control-loop system rather than a trained AI classification model.
How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/machine learning model.

Summary of Conclusions from the Document:

The Cionic Neural Sleeve NS-100 underwent comprehensive non-clinical testing, including electrical safety, biocompatibility, usability, and software validation. Based on the results, Cionic Inc. concluded that the device is substantially equivalent to the predicate Bioness L300 Go System. The differences noted, such as the ability to provide plantarflexion and variations in technological characteristics (e.g., number of output modes, power sources, stimulation channels, clinician/user control interfaces, and trigger sources), were deemed "minor with no impact to safety and effectiveness" because they either represented a subset of the predicate's capabilities, adhered to recognized safety standards, or achieved similar functional outcomes through different but validated technological means.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 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)

☑ Remediation Use (Ref 21 CFR 201.Subpart D)	☐ 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 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.
1. 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").
1. Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required.
1. Adhesive, electrically conductive and replaceable electrode pads.
1. Electrode cover sheets.
1. 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.

> INDICATIONS FOR USE

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	PREDICATEDEVICE	REFERENCEDEVICE	SUBSTANTIALQUIVALENCE
510(k) Number	K213622	K190285	K080950
Device Name,Model	NS-100	L300 Go System	Stiwell MED4
Manufacturer	Cionic Inc.	Bioness Inc.	Otto Bock HealthcareProduct GmbH
Product code	IPF, GZI	GZI & IPF	IPF, GZI, GZJ, HCC,KPI	Same as predicate, and asubset of the referencedevice.
IntendedUse /Indicationsfor Use	The Cionic Neural SleeveNS-100 is intended toprovide ankledorsiflexion and/orplantarflexion in adultindividuals with foot dropand/or to assist kneeflexion or extension inadult individuals withmuscle weakness relatedto upper motor neurondisease/injury (e.g.stroke, damage topathways to the spinalcord). The Cionic NeuralSleeve NS-100electrically stimulatesmuscles in the affectedleg to provide ankledorsiflexion and/orplantarflexion of the footand/or knee flexion orextension; thus, it alsomay improve theindividual's gait.	The L300 Go Systemis intended toprovide ankledorsiflexion in adultand pediatricindividuals with footdrop and/or to assistknee flexion orextension in adultindividuals withmuscle weaknessrelated to uppermotor neurondisease/injury (e.g.stroke, damage topathways to thespinal cord).The L300 Go Systemelectricallystimulates musclesin the affected leg toprovide ankledorsiflexion of thefoot and/or kneeflexion or extension;	The STIWELL MED4is a neuromuscularelectrical stimulatorindicated for useunder medicalsupervision foradjunctive therapy inthe treatment ofmedical diseases andconditions.As a powered musclestimulator STIWELLMED4 is indicated forthefollowing conditions:• Relaxation ofmuscle spasm• Prevention ofretardation ofdisuse atrophy• Increasinglocal bloodcirculation	Same as predicate, and asubset of the referencedevice.

VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

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CIC C

The Cionic Neural SleeveNS-100 may also:	thus, it also mayimprove theindividual's gait.The L300 Go Systemmay 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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			Helpsrelearnvoluntarymotorfunctionsoftheextremities
Number ofOutput Modes	1 mode: Monophasicwith hybrid stimulation	2 modes: BiphasicAsymmetric andSymmetric	One	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sincemode number of subjectdevice is subset of predicatedevice.
Number ofProgram Modes	Gait Assist Training/Exercise	Gait Training/Exercise Cycle Training Mode Clinician mode	Multiple	Same as predicate deviceand a subset of referencedevice.
RegulatedCurrent orRegulatedVoltage	Regulated Current	Regulated Current	Regulated Current	Same
PowerSource(s)	Lithium Polymer (LiPo)rechargeable 7.4V1900mAh	Control Unit: Li CoinCell, CR2032, 3 V,240 mAh EPG:Rechargeable,Li-Ion, Prismatic, 3.7V, 1000 mAh FootSensor: Li Coin Cell,CR2032, 3 V, 240mAh	Battery Pack Li-Ion 11.1V	Substantially equivalent. Allthree devices meetelectrical safety standards.The battery of the proposeddevice meets IEC 62133-2,Edition 1.0, 2017-02 (alsoan FDA recognizedstandard). Differences areconsidered minor with noimpact to safety andeffectiveness since all threedevices adhere torecognized/consensuselectrical/battery safetystandards.
Microprocessor- Controlled	Yes	Yes	Yes	Same
MaximumOutputCurrent(+/- 10%)[mA]	Lower leg and thigh:100 mA @ 500 Ω60 mA @ 2 kΩ13 mA @ 10 kΩIrms=24.6 mAcomputed based on 500Ω 100mA (+/- 10%)400 [µs] 125 Hz	Lower leg: 100mA@ 500 Ω65mA @ 2 kΩ13mA @ 10 kΩThigh:100mA @ 500 Ω65mA @ 2 kΩ13mA @ 10 kΩ	NMES/TENS/FES 100 mA @500 Ω58 mA @ 2 kΩN/A mA @ 10kΩ	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sinceall three devices adhere torecognized/consensuselectrical safety standardsand all devices are similarwithin range.
MaximumCurrent(RMS)Density[mA/cm2]	0.98 mA/cm²Irms=24.6 mAcomputed based on 500Ω 100mA (+/- 10%)400 [μs] 125 Hzelectrode area of 25cm²	Thigh EPG:0.18 mArms/cm2(500 Ω, Irms=13.0mA, electrode areaof 74 cm2)Lower Leg EPG:	12.5 mA/cm2	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sinceall three devices adhere torecognized/consensus
		small cuff, gelelectrodes 1.27mArms/cm2 (500Ω, Irms=13.0 mA,electrode area of10.2 cm2)		electrical safety standardsand all devices are similarwithin range.
MaximumPowerDensity[mW/cm2]	12mW/cm2(500 Ω, Irms=24.6mA, electrode areaof 25 cm2)	Thigh EPG:1.1 mW/cm2(500 Ω,Irms=13.0 mA,electrode area of74 cm2)Lower Leg EPG:small cuff, gelelectrodes 8.3mW/cm2 (500 Ω,Irms=13.0 mA,electrode area of10.2 cm2)regular cuff, gelelectrodes 5.3mW/cm2 (500 Ω,Irms=13.0 mA,electrode area of15.9 cm2)	7.9mW/cm2	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sinceall three devices adhere torecognized/consensuselectrical safety standardsand all devices are similarwithin range.
StimulationChannels	1 stimulator channel with8 virtual Positive outputchannels and 15 virtualNegative output channels	Lower leg smallcuff – 1 channelLower leg regularcuff - 1 or 2channels (in 2channelconfiguration, bothchannels functionas a single channelwith separatelyadjustable medial /lateralstimulationintensity)Thigh cuff – 1channel	3 for FESprograms1 forIncontinenceprograms4 for TENSprograms1 forBiofeedback	Substantially equivalent.The proposed devicecontains a subset of thenumber of channelsavailable on the predicateand reference devices.Differences are consideredminor with no impact tosafety and effectivenesssince proposed devicestimulation channels are asubset of predicate andreference devices.
Connection ofdeviceelectrodes	24 Hydrogel electrodepads adhesivelyconnected to non-tissue contactingelectrode bases.	Lower Leg FSC:• 2 Hydro-Gelelectrodesassembled onelectrode bases,or• 2 non-woven clothelectrodesassembled onelectrode bases, or	Not PubliclyAvailable	Substantially equivalent.Electrode pads used in theproposed and predicatedevices attach using similarmethods, and both devicesembed the electrode wires.The reference device usesstandard electrode padsand leads. Differences areconsidered minor with no

		• 2 non-woven clothelectrodes attachedwith snaps (alsocalled "QuickFit"electrodes), or• 3 non-woven clothelectrodes attachedwith snaps(segmentedelectrodes [alsocalled "steering"electrodes], usingcommon anode toallow separateadjustment ofmedial and lateralstimulation)Thigh FSC:• 2 single, non-woven clothelectrodes attachedwith snaps		impact to safety andeffectiveness sinceproposed device connectionof electrodes is similar topredicate and referencedevices.
ClinicianControl/Programming	No separate clinicianprogramming mode.	Clinician uses theClinicianProgrammer (CAPP)to set stimulationenergy and temporalparameters relatedto the functionalstimulationperformance fordorsiflexion controland/or kneeweakness control.	Not Publicly Available	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sincethe proposed device stillprovides clinician control as inthe predicate and referencedevice, just not in the samespecific technological manner.Proposed device enablesclinician control through aweb/internet interface whichwas successfullyverified/validated duringdevelopment.
User Control	Using the Cionic mobileapp, the user can:• Start/Stopstimulation• Modulatestimulationbetween 0 and100%• Fine tunestimulationintensityaround theworking pointset by Cionictechnician.• SelectAssist/Exerciseprogram	Using hand-heldControl Unit, themobile application(MAPP), or the EPG-based interface, theuser can:• Turn systemOn/Off (viaEPG only) andStart/Stopstimulation• SelectGait/Trainingprogram• Fine-tunestimulationintensityaround	Not PubliclyAvailable	Substantially equivalent.Differences are consideredminor with no impact tosafety and effectiveness sincethe proposed device stillprovides user control as inthe predicate and referencedevice, just not in the samespecific technological manner.Proposed device enables usercontrol through a mobile appinterface which wassuccessfully verified/validatedduring 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.In EMG exercise mode, stimulation is triggered by the EMG sensors embedded in the SL-100.	In gait mode, stimulation is triggered by:(1) the motion sensor embedded in the EPG (two-dimension tilt); or(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 connectorMobile Application - Control Unit: wireless Bluetooth (Low Energy) communication protocolPortal - Control Unit (as needed for firmware updates or data transfer): USB-C connector	Control Unit - Lower Leg/Thigh EPG: wireless Bluetooth (Low Energy) communication protocolGait sensor-Lower Leg/Thigh EPG: Wireless Bluetooth (Low Energy) Communication protocolClinician Programmer - EPG: wireless Bluetooth (Low Energy)	Not publicly available	Same as predicate.
		communication protocolMAPP- Lower Leg/ThighEPG: wireless Bluetooth (Low Energy) communication protocol
Number ofEMG (input)Channels	8	N/A	2	Substantially equivalent to reference device.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(Bipolar/Monopolar)	Bipolar	N/A	Bipolar	Same as reference device
Weight	Control Unit DC-100145 gSleeve SL-100Medium L/R 240 gSleeve SL-100 SmallL/R 230 g	Not PubliclyAvailable	440 g	Substantially equivalent.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[W x H x D]	DC-100 137 x 53 x 24mmSL-100 Medium613 x 602 mmSL-100 Small 596 x560 mm	Not PubliclyAvailable	Device: 175 x 95 x30 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.

Regulation Number and Section

§ 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).

Indications for Use

Indications for Use (Describe)

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510(K) Summary

l SUBMITTER

PROPOSED DEVICE ll

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REFERENCE DEVICE

IV DEVICE DESCRIPTION

> INDICATIONS FOR USE

VI COMPARISON OF INDICATIONS FOR USE

Clonic

VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

CIC C

Clonic

cionic

PERFORMANCE DATA VIII

Summary of Nonclinical performance testing

clonic

IX CONCLUSION

§ 882.5810 External functional neuromuscular stimulator.

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