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