(364 days)
The STIWELL med4 is a neuromuscular electronic stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.
As a powered muscle stimulator the STIWELL med4 is indicated for the following conditions:
- Relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a transcutaneous electrical nerve stimulator for pain relief the STIWELL med4 is indicated for the following conditions:
- Symptomatic relief and management of chronic (long-term), intractable pain
- Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
As a biofeedback device the STIWELL med4 is indicated for the following conditions:
- Biofeedback, relaxation and muscle re-education purposes
As an external functional neuromuscular stimulator the STIWELL med4 is indicated for the following conditions:
- Helps to relearn voluntary motor functions of the extremities
As a nonimplanted electrical continence device the STIWELL med4 is indicated for the following conditions:
- Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detruser muscles through reflexive mechanisms and strengthening of pelvic floor muscles
- Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles such as the abdominal and the gluteus muscles
The STIWELL med4 is powered by rechargeable batteries. It has four stimulation channels and two EMG measurement channels.
The STIWELL med4 is intended for stationary use in a hospital as well as home use by the patient. The physician/therapist has the flexibility to adjust the programs and monitors the progress of the therapy. Statistics regarding the completed treatments can be retrieved from the STIWELL med4 and from the PC.
The provided document is a 510(k) premarket notification for the STIWELL med4, a neuromuscular electronic stimulator. It focuses on establishing substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information regarding clinical study design, performance metrics, and expert adjudication is not present in this type of submission.
Here's an analysis based on the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to legally marketed predicate devices, meaning the new device has the same intended use and the same technological characteristics as the predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.
The document provides extensive tables comparing the STIWELL med4's technical characteristics across various stimulation programs (Functional Electrical Stimulation, Incontinence, TENS, Biofeedback) with its predicate devices. The "performance" in this context is the successful demonstration that these characteristics are similar enough to existing devices to not introduce new safety or effectiveness concerns.
Summary Table of Equivalence (Acceptance Criteria are inferred from predicate device characteristics):
| Characteristic/Program Type | Acceptance Criteria (inferred by predicate) | STIWELL med4 Performance (Reported) | Notes |
|---|---|---|---|
| General Unit Characteristics | |||
| Power Source | Battery Pack (NiMH or Alkaline) | Battery Pack Li-Ion 11,1V | Different battery chemistry, but the submission implicitly argues it does not raise new safety/effectiveness concerns. |
| Method of Line Current Isolation | Medical Class II Power Adapter/N/A | Medical Class II Power Adapter | Consistent. |
| Patient Leakage Current | N/A (Battery) | N/A (Battery) | Consistent. |
| Number of Output Modes | 1 | 1 | Consistent. |
| Number of Output Channels | 2 or 4 | 4 | Consistent with some predicates, exceeds others (e.g., Elpha II3000 has 2). |
| Number of EMG (input) Channels | 1 or 2 (or N/A) | 2 | Consistent with predicates that have EMG (e.g., Myotrac Infinity, Mentamove). |
| EMG Sensitivity |
§ 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).