(307 days)
Indications for FES waveform:
- Stimulation of the muscles in the leg and ankle of partially paralyzed patients to provide flexion of the foot and thus improve the patient's gait.
Indications for TENS waveform:
- Symptomatic relief of chronic (long term) intractable pain
- Symptomatic relief of post-traumatic acute pain and post surgical pain
Indications for Russian waveform:
- Temporary relaxation of muscle spasms
- Prevention or retardation of disuse atrophy in post-injury type conditions
- Increase local blood circulation
- Muscle re-education
- Maintaining or increasing range of motion
The device NEURODYN II is a four output channel stimulator, operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
The device NEURODYN COMPACT is a two output channel stimulator. operated in power supply 100 to 240 V, 50-60 Hz, with independent controls, graphic display backlit blue, mechanical contact keyboard and ABS cabinet with acrylic cover.
Used in the following electrical current therapies: TENS (Transcutaneous Electrical Nerve Stimulation) FES (Functional Electrical Stimulation) RUSSIAN CURRENT (Burst Modulated Medium Frequency)
Characteristics:
TENS: four 120mA peak to peak channels FES: four 120mA peak to peak channels RUSSIAN: four 120mA peak to peak channels Electrical Feed: 100 a 240V (50/60Hz) Input Power: 85VA Temperature Range During Transport and Storage: 41 to 122°F Environment Operating Temperature Range: 41 to 113°F
The provided submission for the NEURODYN Compact and NEURODYN II devices does not include a detailed study proving the devices meet specific quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices (K121369 Neurodyn/Aussie Powered Muscle Stimulator by Ibramed and K021100 300 PV Complete Electrotherapy System by EMPI) based on similar indications for use, operating principles, hardware configuration, and compliance with recognized electrical safety and performance standards.
The acceptance criteria are implicitly defined by compliance with these standards and the established performance characteristics of the predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | NEURODYN Compact / NEURODYN II Performance |
|---|---|
| Safety Standards | IEC 60601-1 (General requirements for basic safety and essential performance) |
| IEC 60601-1-2 (Electromagnetic compatibility) | |
| IEC 60601-1-4 (Programmable electrical medical systems) | |
| IEC 60601-2-10 (Nerve and muscle stimulators) | |
| Material | Biocompatibility (FDA cleared electrodes) |
| Electrical Output Parameters | |
| (Demonstrated to be "similar" or "identical" to predicate devices) | TENS: 0-120mA peak to peak |
| FES: 0-120mA peak to peak | |
| Russian: 0-120mA peak to peak | Reported as identical to K121369 for FES and Russian, and similar to K021100 for TENS (K021100 TENS is 0-50mA peak to peak, K121369 TENS is 0-120mA peak to peak). Given the new devices also have TENS 0-120mA, they are aligned with K121369. |
| Frequency | 0.5-250 Hz |
| Phase Duration | 50-500μs |
| Current Output (at various loads) | 124 mA @ 500Ω, 110mA @ 2KΩ, 39.2mA @ 10KΩ (for Compact/II) |
| Charge per Phase | 58μC |
| Max. avg. power density | 0.038W/cm² |
| Patient Leakage Control | Normal Condition: 0.0347 mA |
| Single Fault Condition: 0.0162 mA | Reported values are within acceptable limits per safety standards and comparable to predicate devices. (K121369: 0.0508mA normal, 0.0252mA single fault; K021100: 0.0502mA normal, 0.0248mA single fault). The new devices show lower leakage, indicating better safety performance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission does not describe a test set involving patient data or clinical trials. The "testing results" mentioned are non-clinical and relate to engineering and electrical safety compliance. Therefore, there is no sample size for a test set or information on data provenance in the context of clinical performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The submission focuses on non-clinical engineering and safety standard compliance, not clinical interpretation or ground truth established by medical experts for a diagnostic or treatment outcome.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a powered muscle stimulator, not an AI-assisted diagnostic or imaging device. No MRMC study was performed or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm, and its performance inherently involves human-in-the-loop (e.g., a therapist or patient operating the device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is adherence to recognized international electrical safety and performance standards (IEC 60601 series). These standards define acceptable electrical characteristics, safety mechanisms, and electromagnetic compatibility. The device's performance is measured against the specifications of these standards and comparison to predicate devices, rather than clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable, as there is no training set.
§ 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).