(90 days)
No
The summary describes the device using embedded sensors to measure limb movement and muscle activity, which are then used by a control unit to generate stimulation. While this involves data processing and control logic, there is no explicit mention of AI, ML, or related terms like neural networks, deep learning, or training/test sets for such algorithms. The description focuses on standard functional electrical stimulation based on sensor input.
Yes
The device is intended to provide ankle dorsiflexion, assist knee flexion or extension, facilitate muscle re-education, prevent/retard disuse atrophy, increase joint range of motion, and increase local blood flow, all of which are therapeutic effects.
No
The device is intended to provide ankle dorsiflexion, assist knee flexion/extension, facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow. These are all therapeutic and restorative functions, not diagnostic ones. While it has embedded sensors to measure limb movement and muscle activity, this data is used by the control unit to generate stimulation for functional assistance, not for diagnosing a condition.
No
The device description explicitly lists multiple hardware components including a fabric sleeve with embedded sensors and electrodes, a battery-powered electronic controller, and a power supply. While it includes a mobile application (software), it is part of a larger system that relies on physical hardware for its function.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Cionic Neural Sleeve Function: The Cionic Neural Sleeve NS-100 is a therapeutic and assistive device. It works by applying electrical stimulation to muscles in the leg to improve movement and gait. It does not analyze any biological samples from the user.
The description clearly states its purpose is to provide physical assistance and facilitate muscle function through electrical stimulation, which falls outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
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
Product codes
GZI, IPF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (lower limb)
Indicated Patient Age Range
Adult individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical performance testing
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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
1
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
2
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)
| ☑ 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
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
4
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:
-
- 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.
-
- 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").
-
- Power supply and cable to recharge the DC-100 and connect the DC-100 to a user's computer when required.
-
- Adhesive, electrically conductive and replaceable electrode pads.
-
- Electrode cover sheets.
-
- 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
5
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
DEVICE | REFERENCE
DEVICE | SUBSTANTIAL
QUIVALENCE |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| 510(k) Number | K213622 | K190285 | K080950 | |
| Device Name,
Model | NS-100 | L300 Go System | Stiwell MED4 | |
| Manufacturer | Cionic Inc. | Bioness Inc. | Otto Bock Healthcare
Product GmbH | |
| Product code | IPF, GZI | GZI & IPF | IPF, GZI, GZJ, HCC,
KPI | Same as predicate, and a
subset of the reference
device. |
| Intended
Use /
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 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; | The STIWELL MED4
is a neuromuscular
electrical stimulator
indicated for use
under medical
supervision for
adjunctive therapy in
the treatment of
medical diseases and
conditions.
As a powered muscle
stimulator STIWELL
MED4 is indicated for
the
following conditions:
• Relaxation of
muscle spasm
• Prevention of
retardation of
disuse atrophy
• Increasing
local blood
circulation
| Same as predicate, and a
subset of the reference
device. |
VII COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
6
CIC C
| The Cionic Neural Sleeve
NS-100 may also: | thus, it also may
improve the
individual's gait.
The L300 Go System
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: |
7
| | | | Helps
relearn
voluntary
motor
functions
of
the
extremities | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Number of
Output Modes | 1 mode: Monophasic
with hybrid stimulation | 2 modes: Biphasic
Asymmetric and
Symmetric | One | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
mode number of subject
device is subset of predicate
device. |
| Number of
Program Modes | Gait Assist Training/Exercise | Gait Training/Exercise Cycle Training Mode Clinician mode | Multiple | Same as predicate device
and a subset of reference
device. |
| Regulated
Current or
Regulated
Voltage | Regulated Current | Regulated Current | Regulated Current | Same |
| Power
Source(s) | Lithium Polymer (LiPo)
rechargeable 7.4V
1900mAh | 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 | Battery Pack Li-
Ion 11.1V | Substantially equivalent. All
three devices meet
electrical safety standards.
The battery of the proposed
device meets IEC 62133-2,
Edition 1.0, 2017-02 (also
an FDA recognized
standard). Differences are
considered minor with no
impact to safety and
effectiveness since all three
devices adhere to
recognized/consensus
electrical/battery safety
standards. |
| Microprocessor
- Controlled | Yes | Yes | Yes | Same |
| Maximum
Output
Current
(+/- 10%)
[mA] | Lower leg and thigh:
100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ
Irms=24.6 mA
computed based on 500
Ω 100mA (+/- 10%)
400 [µs] 125 Hz | Lower leg: 100mA
@ 500 Ω
65mA @ 2 kΩ
13mA @ 10 kΩ
Thigh:
100mA @ 500 Ω
65mA @ 2 kΩ
13mA @ 10 kΩ | NMES/TENS/FE
S 100 mA @
500 Ω
58 mA @ 2 kΩ
N/A mA @ 10
kΩ | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
all three devices adhere to
recognized/consensus
electrical safety standards
and all devices are similar
within range. |
| Maximum
Current
(RMS)
Density
[mA/cm2] | 0.98 mA/cm²
Irms=24.6 mA
computed based on 500
Ω 100mA (+/- 10%)
400 [μs] 125 Hz
electrode area of 25cm² | Thigh EPG:
0.18 mArms/cm2
(500 Ω, Irms=13.0
mA, electrode area
of 74 cm2)
Lower Leg EPG: | 12.5 mA/cm2 | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
all three devices adhere to
recognized/consensus |
| | | small cuff, gel
electrodes 1.27
mArms/cm2 (500
Ω, Irms=13.0 mA,
electrode area of
10.2 cm2) | | electrical safety standards
and all devices are similar
within range. |
| Maximum
Power
Density
[mW/cm2] | 12mW/cm2
(500 Ω, Irms=24.6
mA, electrode area
of 25 cm2) | 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) | 7.9mW/cm2 | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
all three devices adhere to
recognized/consensus
electrical safety standards
and all devices are similar
within range. |
| Stimulation
Channels | 1 stimulator channel with
8 virtual Positive output
channels and 15 virtual
Negative output channels | Lower leg small
cuff – 1 channel
Lower leg regular
cuff - 1 or 2
channels (in 2
channel
configuration, both
channels function
as a single channel
with separately
adjustable medial /
lateral
stimulation
intensity)
Thigh cuff – 1
channel | 3 for FES
programs
1 for
Incontinence
programs
4 for TENS
programs
1 for
Biofeedback | Substantially equivalent.
The proposed device
contains a subset of the
number of channels
available on the predicate
and reference devices.
Differences are considered
minor with no impact to
safety and effectiveness
since proposed device
stimulation channels are a
subset of predicate and
reference devices. |
| Connection of
device
electrodes | 24 Hydrogel electrode
pads adhesively
connected to non-
tissue contacting
electrode bases. | Lower Leg FSC:
• 2 Hydro-Gel
electrodes
assembled on
electrode bases,
or
• 2 non-woven cloth
electrodes
assembled on
electrode bases, or | Not Publicly
Available | Substantially equivalent.
Electrode pads used in the
proposed and predicate
devices attach using similar
methods, and both devices
embed the electrode wires.
The reference device uses
standard electrode pads
and leads. Differences are
considered minor with no |
| | | | | |
| | | • 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 | | impact to safety and
effectiveness since
proposed device connection
of electrodes is similar to
predicate and reference
devices. |
| Clinician
Control/
Programming | No separate clinician
programming mode. | 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. | Not Publicly Available | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
the proposed device still
provides clinician control as in
the predicate and reference
device, just not in the same
specific technological manner.
Proposed device enables
clinician control through a
web/internet interface which
was successfully
verified/validated during
development. |
| User Control | Using the Cionic mobile
app, the user can:
• Start/Stop
stimulation
• Modulate
stimulation
between 0 and
100%
• Fine tune
stimulation
intensity
around the
working point
set by Cionic
technician.
• Select
Assist/Exercise
program | 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 | Not Publicly
Available | Substantially equivalent.
Differences are considered
minor with no impact to
safety and effectiveness since
the proposed device still
provides user control as in
the predicate and reference
device, just not in the same
specific technological manner.
Proposed device enables user
control through a mobile app
interface which was
successfully verified/validated
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.
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 connector
Mobile Application - Control Unit: wireless Bluetooth (Low Energy) communication protocol
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
Gait sensor-Lower Leg/Thigh EPG: Wireless Bluetooth (Low Energy) Communication protocol
Clinician Programmer - EPG: wireless Bluetooth (Low Energy) | Not publicly available | Same as predicate. |
| | | communication protocol
MAPP- Lower Leg/Thigh
EPG: wireless Bluetooth (Low Energy) communication protocol | | |
| Number of
EMG (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/Monop
olar) | Bipolar | N/A | Bipolar | Same as reference device |
| Weight | Control Unit DC-100
145 g
Sleeve SL-100
Medium L/R 240 g
Sleeve SL-100 Small
L/R 230 g | Not Publicly
Available | 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 24
mm
SL-100 Medium
613 x 602 mm
SL-100 Small 596 x
560 mm | Not Publicly
Available | Device: 175 x 95 x
30 mm | |
8
9
10
Clonic
11
12
cionic
PERFORMANCE DATA VIII
Summary of Nonclinical performance testing
13
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.