(28 days)
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
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 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.
This 510(k) submission (K221823) from Cionic, Inc. is a Special 510(k) submission to add compatibility of the Cionic Neural Sleeve to support the Android operating system and minor software updates to improve overall stability and performance. As such, the submission primarily focuses on software verification and validation, along with wireless coexistence testing. The claim of substantial equivalence is made with respect to the predicate device, also the Cionic Neural Sleeve NS-100 (K213622).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| New tests performed for this submission: | |
| 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) | Performed to ensure no loss of original functionality. (Specific results not detailed in this summary, but implies successful completion) |
| Software Validation (according to IEC 62304) | Performed to ensure no loss of original functionality. (Specific results not detailed in this summary, but implies successful completion) |
| Leveraged from predicate device (K213622) as modifications did not affect these areas: | |
| Stimulation Output Waveforms | (Assumed to meet criteria from predicate) |
| Biological evaluation of medical devices (according to ISO 10993-1) | (Assumed to meet criteria from predicate) |
| Stimulation Output Specifications | (Assumed to meet criteria from predicate) |
| Stimulation Virtual Output Channels | (Assumed to meet criteria from predicate) |
| Stimulation Output Channel Isolation | (Assumed to meet criteria from predicate) |
| Hybrid Stimulation | (Assumed to meet criteria from predicate) |
| Stimulation Electrodes Short and/or Open detection | (Assumed to meet criteria from predicate) |
| Electrical Safety (according to IEC 60601-1; IEC 60601-1-11) | (Assumed to meet criteria from predicate) |
| Muscle and Nerve Stimulators (according to IEC 60601-2-10) | (Assumed to meet criteria from predicate) |
| Electromagnetic compatibility (according to IEC 60601-1-2) | (Assumed to meet criteria from predicate) |
| Usability (according to IEC 62366; IEC 60601-1-6) | (Assumed to meet criteria from predicate) |
| Mobile Application OS Compatibility (specifically, addition of Android compatibility, risk analysis and testing) | Risk analysis and testing demonstrate substantial equivalence. (Implies successful testing for Android OS) |
2. Sample Size Used for the Test Set and Data Provenance:
The provided 510(k) summary does not detail specific sample sizes for the test sets. For software validation and wireless coexistence, these typically involve testing on the device itself and against relevant communication standards. No patient data or clinical study details are provided in this summary. Therefore, there's no information on the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. This submission is for a software/OS compatibility update and does not involve clinical performance assessment requiring expert opinion for ground truth establishment.
4. Adjudication Method for the Test Set:
Not applicable. The tests performed are primarily engineering and software validation tests (wireless coexistence, software validation) and do not involve subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC comparative effectiveness study was not done. This submission is for a software and OS compatibility update, not for establishing clinical effectiveness or comparing human reader performance with and without AI assistance.
6. If a Standalone (i.e., algorithm-only without human-in-the-loop performance) was done:
Not explicitly stated in terms of "standalone performance" in the context of an algorithm assessing medical images or data without human input. However, the software validation and wireless coexistence tests verify the system's technical functionality, which is an evaluation of the system's independent operation (without direct human user intervention during the specific test runs, although the device is designed for human interaction). There's no separate mention of an algorithm's standalone performance in a diagnostic or clinical decision-making capacity.
7. The Type of Ground Truth Used:
For the software and wireless coexistence tests, the ground truth would be defined by the technical specifications and standards (e.g., IEC 62304 for software, FDA guidance for wireless coexistence, Bluetooth Low Energy specifications for communication). The purpose of the tests is to verify that the device's software and communication capabilities adhere to these established technical requirements.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device submission in the sense of a new algorithm being trained. The submission refers to "minor software updates" and "stability and performance" improvements. Therefore, there's no mention of a training set or machine learning model training in this context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm mentioned in this submission.
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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
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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.
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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
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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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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.
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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:
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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) | SUBSTANTIALEQUIVALENCE |
|---|---|---|---|
| 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-100is intended to provide ankledorsiflexion and/or plantarflexion inadult individuals with foot dropand/or to assist knee flexion orextension in adult individuals withmuscle weakness related to uppermotor neuron disease/injury (e.g.,stroke, damage to pathways to thespinal cord). The Cionic NeuralSleeve NS-100 electricallystimulates muscles in the affectedleg to provide ankle dorsiflexionand/or plantarflexion of the footand/or knee flexion or extension;thus, it also may improve theindividual's gait.The Cionic Neural Sleeve NS-100may also:• Facilitate muscle re-education• Precent/retard disuse atrophy• Maintain or increase joint rangeof motion• Increase local blood flow | The Cionic Neural Sleeve NS-100 isintended to provide ankledorsiflexion and/or plantarflexion inadult individuals with foot dropand/or to assist knee flexion orextension in adult individuals withmuscle weakness related to uppermotor neuron disease/injury (e.g.,stroke, damage to pathways to thespinal cord). The Cionic NeuralSleeve NS-100 electricallystimulates muscles in the affectedleg to provide ankle dorsiflexionand/or plantarflexion of the footand/or knee flexion or extension;thus, it also may improve theindividual's gait.The Cionic Neural Sleeve NS-100may also:• Facilitate muscle re-education• Precent/retard disuse atrophy• Maintain or increase joint range ofmotion• Increase local blood flow | Same |
| Number of OutputModes | 1 mode: Monophasic with hybridstimulation | 1 mode: Monophasic with hybridstimulation | Same |
| Number of ProgramModes | • Gait Assist• Training/Exercise | • Gait Assist• Training/Exercise | Same |
| Regulated Currentor RegulatedVoltage | 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 OutputCurrent (+/- 10%)[mA] | Lower leg and thigh:100 mA @ 500 Ω60 mA @ 2 kΩ13 mA @ 10 kΩ | Lower leg and thigh:100 mA @ 500 Ω60 mA @ 2 kΩ13 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 PowerDensity [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 |
| StimulationChannels | 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 ofdevice 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 programUsing 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 programUsing 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 | ||
| StimulationTrigger Sourcefor Gait Assist | In gait mode, stimulation istriggered by the two IMUs(Inertial Measurement Unit)embedded in the SL-100, one onthe shank and the other on thethigh.In EMG exercise mode, stimulationis triggered by the EMG sensorsembedded in the SL- 100 | In gait mode, stimulation istriggered by the two IMUs (InertialMeasurement Unit) embedded inthe SL-100, one on the shank andthe other on the thigh.In EMG exercise mode, stimulationis triggered by the EMG sensorsembedded in the SL- 100 | Same |
| Communication Method | DC-100 to SL-100 using a 40-pinconnectorMobile Application - Control Unit:wireless Bluetooth (Low Energy)communication protocolPortal - Control Unit (as needed forfirmware updates or data transfer):USB-C connector | DC-100 to SL-100 using a 40-pinconnectorMobile Application - Control Unit:wireless Bluetooth (Low Energy)communication protocolPortal - Control Unit (as needed forfirmware 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 gSleeve SL-100 Small L/R 230 g | Sleeve SL-100 Medium L/R 240 gSleeve SL-100 Small L/R 230 g | |
| Dimensions[W x H x D] | DC-100 137 x 53 x 24 mmSL-100 Medium 613 x 602 mmSL-100 Small 596 x 560 mm | DC-100 137 x 53 x 24 mmSL-100 Medium 613 x 602 mmSL-100 Small 596 x 560 mm | Same |
| Mobile ApplicationOS Compatibility | Android, iOS | iOS | Different -added Androidcompatibility;risk analysisand testingdemonstrate SE |
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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
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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.
§ 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).