(66 days)
The Neuro20 PRO System is intended to stimulate muscles in order to improve or facilitate muscle performance.
Other indications for use include:
- · Re-educating muscles
- · Increasing local blood circulation
- · Maintaining or increasing range of motion
- · Relaxation of muscle spasm
- · Retarding or preventing disuse atrophy
The Neuro20 PRO System is a powered muscle stimulator designed for individual or group rehabilitation and recovery. The Neuro20 PRO System is a transcutaneous electrical muscle stimulation (EMS) device which stimulates motor nerves by means of electrical impulses transmitted by electrodes. The system utilizes electrical stimulation to create an involuntary contractions of motor neurons are transmitted to the muscle fibers where they stimulate a muscular response.
Depending on the parameters of the electrical impulses (pulse intensity, pulse duration, pulse width, pulse rise, pause time, total session duration), different types of muscle work can be imposed on the stimulated muscles. The involuntary muscle activation can be voluntarily over-ridden through intentional exercise. Individual intensity levels can be modulated for each muscle group. One to ten patients may be treated within a session.
The Neuro20 PRO System is comprised of three major components: the Control Box with battery (the muscle stimulator), Smart Suit (the wearable suit with electrodes covering the muscles), and Operating Tablet with software which allows the medical professional to adjust the parameters for the patient. Users may be actively engaged within a variety of training modes while the clinician/operator controls the software. The Neuro20 PRO System accessories are a battery charger, protective case, and Smart Suit packaging.
The Neuro20 Control Box connects to the suit and is powered by a battery. It is controlled by the medical practitioner operating the software. The Smart Suit applies the electrodes to the upper body, arms, legs, and buttocks. The Control Unit is connected to the Operating Tablet wirelessly.
The Neuro20 PRO System is a powered muscle stimulator intended to improve or facilitate muscle performance, re-educate muscles, increase local blood circulation, maintain or increase range of motion, relax muscle spasm, and retard or prevent disuse atrophy.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standard) | Reported Device Performance (Test Results) |
|---|---|
| IEC60601-2-10:2012+AMD1:2016 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators | Passed IEC60601-2-10 Standard Testing. |
| IEC 60601-1-2:Edition 4.1, 2020-09; Consolidated Version: Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests; FCC/CFR 47:Part 15B | Passed IEC 60601-1-2 Standard Testing. |
| IEC60601-1:2005+A1:2012 – Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | Passed IEC 60601-1 Standard Testing. |
| IEC 60601-1-11:Edition 2.1, 2020-07, Consolidated Edition:Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment | Passed IEC 60601-1-11 Testing. |
| IEC 62304:2006+AMD1:2015 Medical Device Software - Software life-cycle processes | Checklist of Compliance IEC 62304 accepted. |
| EN ISO 14971:2019 Medical devices - Application of risk management to medical devices | Risk Management per ISO 14971 performed. |
| IEC 62366-1:2015+AMD1:2020 Medical Devices – Part 1: Application of usability engineering to medical devices | Passed IEC 62366-1 Standard Testing. |
| ISO10993-1:2018 – Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process | ISO 10993-1 Evaluation Performed. |
| ISO 10993-5:2009 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Biological Evaluation 10993-5 performed. |
| ISO10993-10:2010 - Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Passed ISO-10993-10 Standard Testing. |
| IEC60601-1-6:2010+AMD2:2020 – Medical electrical equipment – Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | Passed IEC 60601-6 Standard Testing. (Also listed as Passed IEC 62366-1 Standard Testing.) |
| IEC 62133-2:2017 – Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | Passed IEC 62133-2 Standard Testing. |
Study Proving Device Meets Acceptance Criteria:
The device's compliance with the acceptance criteria is demonstrated through a series of non-clinical performance tests evaluating its safety, essential performance, and functionality according to recognized international and national standards.
2. Sample Size for the Test Set and Data Provenance:
The provided document does not specify a "test set" in the context of clinical data for performance evaluation. All performance data is based on non-clinical testing against relevant standards. Therefore, information regarding sample size and data provenance (e.g., country of origin, retrospective/prospective) for a test set of data is not applicable for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable, as no clinical test set requiring expert-established ground truth was used for this submission. The evaluation was based on non-clinical engineering and safety standards.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was conducted or referenced in the provided document. The submission explicitly states: "The determination of substantial equivalence using clinical performance data is not applicable because such data is not required to determine the substantial equivalence of the Neuro20 PRO System to the cited predicate devices." Therefore, no effect size of human readers improving with or without AI assistance is provided.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The Neuro20 PRO System is an electrical muscle stimulator, not an AI or algorithm-based diagnostic/therapeutic device that would typically undergo standalone algorithm performance studies. The compliance is demonstrated via adherence to safety and performance standards for muscle stimulators.
7. Type of Ground Truth Used:
The "ground truth" for demonstrating the device meets its acceptance criteria is based on adherence to established international and national performance and safety standards for medical electrical equipment, particularly for nerve and muscle stimulators. This includes standards related to electrical safety, electromagnetic compatibility, software lifecycle processes, risk management, usability engineering, and biological evaluation of medical devices.
8. Sample Size for the Training Set:
Not applicable, as this is related to clinical data for algorithm training, which was not part of this 510(k) submission for a powered muscle stimulator.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set requiring ground truth establishment for an algorithm was used.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).