(15 days)
Muscle Stimulation, Interferential and Non-Interferential Modality
- Relax muscle spasms
- Prevent or retard disuse atrophy
- Maintain or increase range of motion
- Increase local blood circulation
- Re-educate muscle
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Pain Relief, Interferential Current Modality - Relieve acute pain
- Relieve and manage chronic pain
The RS-4i device family consists of a hardware/software system that is identical to its predicate device (the RS-4M+ device family K100114). The RS-4i device family manufacturing process has been changed to a Surface Mount process and components. The RS-4i device family includes a 'Pattern Stimulation' modality that allows sequential 'pattern' output of the standard muscle stimulation pulses.
The RS-4i device family incorporates traditional muscle stimulation and interferential current stimulation modalities into one unit. Only one modality may be operated at a time. The RS-4i is housed in a plastic enclosure. The front of the enclosure houses the LCD patient display and the operator keypad. The accessories provided with the RS-4i include the output cables, the electrode pads, and the AC Charging Adapter.
The RS-4i pulse mode muscle stimulation modality operates at a specified 57.5 volts peak (+/-10% into a 500 ohm load) and 115 mA peak (+/-10% into a 500 ohm load) with a maximum pulse width of 415 uSec. (+/-10%) and a cycle frequency of 71 Hz (+/-5%). The pulses are bi-phasic. Intensity levels are controlled via pulse width while maintaining the pulse voltage within the specified peak. The waveform includes an on/off ramp, which slowly increases the pulse width to the desired setting.
The RS-4i interferential modality operates at a specified maximum of 100 mA peak (+/-10% into a 500 ohm load). The carrier and interferential signals are simulated sine wave symmetric, balanced outputs with zero net charge. The interferential modality can operate in a true interferential mode (4 pad mode) or the signals can be pre-mixed and only the pre-mixed signals sent to the patient (2 pad mode). The interference signal frequency can be fixed (Continuous) or varied based on three selections (Variable).
The provided document is a 510(k) summary for the RS-4i Muscle Stimulator family. It describes the device, its indications for use, and declares substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. This type of premarket notification for a Class II device primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel clinical study with detailed performance metrics against pre-defined acceptance criteria.
The key points from the provided text are:
- Predicate Device: The RS-4i family is substantially equivalent to its legally marketed predecessor, the RS-4M+ (K000114) muscle stimulator.
- Device Changes: The primary changes are a manufacturing process change to Surface Mount technology and components, and the addition of a 'Pattern Stimulation' modality.
- Performance Specifications: The document lists technical specifications (e.g., peak voltage, mA, pulse width, frequency for muscle stimulation; mA peak for interferential modality) but these are device specifications, not acceptance criteria for a clinical outcome study.
Therefore, based on the provided text, I cannot complete the requested tables and information. A 510(k) submission for a device like this typically relies on bench testing and comparisons to the predicate's technical specifications and safety profile, rather than extensive clinical efficacy trials with predefined acceptance criteria and human expert evaluation in the way you've described.
A 510(k) submission is generally intended to demonstrate that a new device is as safe and effective as a legally marketed predicate device. It does not typically require a new clinical study to establish "acceptance criteria" for clinical performance in the way a PMA (Pre-Market Approval) or a de novo classification might.
If this were a PMA or a de novo application, or if the FDA had required specific clinical data beyond substantial equivalence, then the document would contain the type of information you're asking for.
In summary, the provided document does not contain the information required to populate your requested table and study details.
§ 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).