(28 days)
Not Found
Unknown
The description mentions using sensor data to "generate stimulation intended to activate muscles for exercise or functional assistance" and a "control unit" that uses this data. While this implies some level of processing and decision-making based on real-time data, the summary does not explicitly mention AI, ML, or any specific algorithms that would definitively classify it as such. The focus is on electrical stimulation based on sensor input, which could be achieved through traditional control systems.
Yes
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, all of which are therapeutic indications for individuals with foot drop or muscle weakness.
No
The Cionic Neural Sleeve NS-100 is intended to provide ankle dorsiflexion and/or assist knee movement through electrical stimulation of muscles, and to facilitate muscle re-education, prevent disuse atrophy, maintain/increase joint range of motion, and increase local blood flow. Its primary function is therapeutic and assistive, not diagnostic. While it has embedded sensors to measure limb movement and muscle activity, these data are used by the control unit to generate stimulation for exercise or functional assistance, not for diagnosing a condition.
No
The device description explicitly states that the Cionic Neural Sleeve NS-100 is composed of a body-worn legging, a battery-powered electronic controller, and a mobile application, indicating it includes significant hardware components beyond just software.
Based on the provided information, the Cionic Neural Sleeve NS-100 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Cionic Neural Sleeve Function: The Cionic Neural Sleeve NS-100 is a body-worn device that uses electrical stimulation to directly interact with the human body (muscles and nerves) to improve gait and provide functional assistance. It measures limb movement and muscle activity in vivo (within the living body), not in vitro (outside the living body).
- Intended Use: The intended use clearly describes a therapeutic and assistive function related to physical movement and muscle function, not the analysis of biological specimens.
- Device Description: The components and description focus on hardware for electrical stimulation, sensors for movement and muscle activity, and a mobile application for control and programs. There is no mention of components or processes related to handling or analyzing biological samples.
Therefore, the Cionic Neural Sleeve NS-100 falls under the category of a therapeutic or assistive medical device, not an In Vitro Diagnostic device.
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 pathways 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 (comma separated list FDA assigned to the subject device)
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.
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:
-
- 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:
- o 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 iOS and Android 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Affected leg (lower limb - ankle, knee, calf, thigh)
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)
Software and Firmware changes were subject to verification testing to ensure no loss of original functionality. The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve performs as intended and is substantially equivalent to the predicate device.
- Wireless Coexistence according to FDA Guidance Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: August 14, 2013.
- Software validation according to IEC 62304
The following non-clinical performance tests were leveraged from the predicate device submission because the addition of the Android operating system and the minor software modifications did not affect the following testing areas for the subject 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
- 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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized caduceus. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2022
Cionic Mihai Ionescu Head of Hardware Development 1606 Stockton St, Suite #1 San Francisco, California 94133
Re: K221823
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
Dear Mihai Ionescu:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 21, 2022. Specifically, FDA is updating this SE Letter to include a secondary product code, IPF, in addition to the primary product code, GZI, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Amber Ballard, PhD, OHT5: Office of Neurological and Physical Medicine Devices, Assistant Director, Amber.Ballard(@)fda.hhs.gov.
Sincerely,
Lauren E. Woodard -S
for 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2022
Cionic Mihai Ionescu Head of Hardware Development 1606 Stockton St. Suite #1 San Francisco, California 94133
Re: K221823
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 Dated: June 22, 2022 Received: June 23, 2022
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.
2
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lauren E. Woodard -S
for Amber Ballard, PhD Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K221823
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 pathways 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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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4
510(K) Summary
l SUBMITTER
Cionic, Inc. 1606 Stockton St. Suite #1 San Francisco, CA 94133
Contact Person: Mihai Ionescu Date Prepared: July 19, 2022
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 Requlatory Class: Class II Product Code: GZI, IPF 510(k) Number: K221823
���� REASON FOR SUBMISSION
The reason for this submission is to add compatibility of the Cionic Neural Sleeve to support the Android operating system. Other design changes which are considered minor have been implemented to the subject device since the original K213622 clearance. These changes are minor software updates which were implemented to improve the application's overall stability and performance.
IV TYPE OF SUBMISSION
Special 510(k)
V PREDICATE DEVICE
Device Name: Cionic Neural Sleeve NS-100 Manufacturer: Cionic, Inc. 510(k) Number: K213622
VI PURPOSE OF THIS SPECIAL 510(k)
This Special 510(k) is submitted to add an Android version Mobile Application to the Cionic Neural Sleeve NS-100 as well as to include minor modifications made to the device software since the clearance of the last 510(k), K213622. None of these changes affect the intended use of the device nor do they alter the fundamental scientific technology of the device.
5
DEVICE DESCRIPTION VII
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:
-
- 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:
- o 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 iOS and Android 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.
VIII 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:
6
Clonic
- 0 Facilitate muscle re-education
- Prevent/retard disuse atrophy o
- o Maintain or increase joint range of motion
- o Increase local blood flow
MODIFICATIONS ADDRESSED IN THIS SPECIAL 510(k) IX
This Special 510(k) addresses the following modifications:
- Changes to the Mobile Application iOS software ●
- . Changes to the Device software and firmware
- 0 Changes to the Technician Web Portal
- Changes to the Cionic Cloud APIs .
- · Labeling Changes
- Addition of an Android version Mobile Application .
X COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| CHARACTERISTIC | SUBJECT DEVICE | PREDICATE DEVICE (K213622) | SUBSTANTIAL
EQUIVALENCE |
|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| 510(k) Number | K221823 | K213622 | Same |
| Device Name, Model | NS-100 | NS-100 | Same |
| Manufacturer | Cionic Inc. | Cionic Inc. | Same |
| Product code | IPF, GZI | IPF, GZI | Same |
| 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 Cionic Neural Sleeve NS-100
may also:
• Facilitate muscle re-education
• Precent/retard disuse atrophy
• Maintain or increase joint range
of motion
• Increase local blood flow | 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
• Precent/retard disuse atrophy
• Maintain or increase joint range of
motion
• Increase local blood flow | Same |
| Number of Output
Modes | 1 mode: Monophasic with hybrid
stimulation | 1 mode: Monophasic with hybrid
stimulation | Same |
| Number of Program
Modes | • Gait Assist
• Training/Exercise | • Gait Assist
• Training/Exercise | Same |
| Regulated Current
or Regulated
Voltage | Regulated Current | Regulated Current | Same |
| Power Source(s) | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Lithium Polymer (LiPo) rechargeable 7.4V 1900mAh | Same |
| Microprocessor-
Controlled | Yes | Yes | Same |
| Maximum Output
Current (+/- 10%)
[mA] | Lower leg and thigh:
100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ | Lower leg and thigh:
100 mA @ 500 Ω
60 mA @ 2 kΩ
13 mA @ 10 kΩ | Same |
| Maximum Current
(RMS)
Density [mA/cm2] | Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 µs 125 Hz | Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 µs 125 Hz | |
| | 0.98 mA/cm² Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 [µs] 125 Hz electrode area of 25cm² | 0.98 mA/cm² Irms=24.6 mA computed based on 500 Ω 100mA (+/- 10%) 400 [µs] 125 Hz electrode area of 25cm² | Same |
| Maximum Power
Density [mW/cm2] | 12mW/cm2
(500 Ω, Irms=24.6mA, electrode area of 25 cm2) | 12mW/cm2
(500 Ω, Irms=24.6mA, electrode area of 25 cm2) | Same |
| Stimulation
Channels | 1 stimulator channel with 8 virtual Positive output channels and 15 virtual Negative output channels | 1 stimulator channel with 8 virtual Positive output channels and 15 virtual Negative output channels | Same |
| Connection of
device electrodes | 24 Hydrogel electrode pads adhesively connected to non- tissue contacting electrode bases | 24 Hydrogel electrode pads adhesively connected to non- tissue contacting electrode bases | Same |
| Clinician Control/
Programming | No separate clinician programming mode | No separate clinician programming mode | Same |
| 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
• 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 | 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
• 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 | Same |
| | | | |
| | • Pause and unpause stimulation | • Pause and unpause stimulation | |
| 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 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 | Same |
| Communicatio
n 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 | 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 | Same |
| EMG detection
(Bipolar/Monopolar) | Bipolar | Bipolar | Same |
| | Control Unit DC-100 145 g | Control Unit DC-100 145 g | Same |
| Weight | Sleeve SL-100 Medium L/R 240 g
Sleeve SL-100 Small L/R 230 g | Sleeve SL-100 Medium L/R 240 g
Sleeve SL-100 Small L/R 230 g | |
| 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 | DC-100 137 x 53 x 24 mm
SL-100 Medium 613 x 602 mm
SL-100 Small 596 x 560 mm | Same |
| Mobile Application
OS Compatibility | Android, iOS | iOS | Different -
added Android
compatibility;
risk analysis
and testing
demonstrate SE |
7
Clonic
8
PERFORMANCE DATA XI
Software and Firmware changes were subject to verification testing to ensure no loss of original functionality. The tests listed have been conducted to demonstrate that the Cionic Neural Sleeve performs as intended and is substantially equivalent to the predicate device.
- Wireless Coexistence according to FDA Guidance Radio Frequency Wireless Technology in ● Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: August 14, 2013.
- Software validation according to IEC 62304 0
9
Clonic
The following non-clinical performance tests were leveraged from the predicate device submission because the addition of the Android operating system and the minor software modifications did not affect the following testing areas for the subject 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
- · 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
CONCLUSION XII
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 Cionic Neural Sleeve.