(60 days)
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
- Temporary relaxation of muscle spasm
- Prevention of post-surgical phlebo-thrombosis through immediate stimulation of calf muscles
- Increase of blood flow in the treatment area.
- Prevention or retardation of disuse atrophy in post-injury type conditions.
- Muscle re-education.
- Maintaining or increasing range of motion.
SysStim 208, Model ME 208: The microprocessor controlled SysStim 208 produces low volt current through one channel. The unit produces an asymmetrical electrically balanced waveform. There are three modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz and Surge-80 Hz, On/Off times variable. The SysStim 208 is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the SysStim 208 is the Patient Termination Switch, which is connected to the jack located on back of the unit.
SysStim 208A, Model ME 208A: The microprocessor controlled SysStim 208A produces low volt current through two channels. The unit produces an asymmetrical electrically balanced waveform. There are four modes of operation: Pulse-1 to 80 Hz, Tetanize-Continuous Output, 80 Hz, Surge-80 Hz, On/Off times variable and Recip-80 Hz, output alternates between the two channels. The Sys*Stim 208A is portable and beautifully designed. Up and down buttons control the timer while easy-to-use knobs allow you to select treatment parameters and adjust intensity. An optional accessory for the Sys+Stim 208A is the Patient Termination Switch, which is connected to the jack located on back of the unit.
The provided 510(k) summary for the Sys*Stim® 208/208A, Model ME 208/208A does not describe acceptance criteria or a study to prove the device meets acceptance criteria.
The document is a "510(k) Summary" which serves to demonstrate substantial equivalence to previously cleared predicate devices. It provides a detailed comparison of the technological characteristics of the Sys*Stim® 208/208A with its predicate devices (Chattanooga's Intelect LV110/LV120 and AMREX' MS322/MS324). This comparison serves as the basis for the FDA's determination of substantial equivalence, meaning that the new device is as safe and effective as the predicate device(s) and does not raise new questions of safety or effectiveness.
Therefore, I cannot populate the requested table or answer most of the questions, as the information is not present in the provided text.
Here's a breakdown of what can be inferred or directly stated from the document, and what is explicitly missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail criteria for a study. Instead, the document presents the specifications of the new device and compares them to predicate devices, implying that matching or being within acceptable ranges of the predicate device specifications is the "acceptance" for substantial equivalence.
- Reported Device Performance: The document lists the technical specifications and operational parameters of the Sys*Stim® 208/208A. These are not "reported performance" from a study but rather the design specifications of the device.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Sys*Stim® 208/208A) |
|---|---|---|
| Power Source | Similar to predicate devices (110-120V AC, 50/60 Hz) | 110 V AC, 60 Hz ±10% |
| Number Of Output Modes | Similar to predicate devices (3 for 208, 4 for 208A) | SysStim 208: 3; SysStim 208A: 4 |
| Channels | Similar to predicate devices (1 for 208, 2 for 208A) | SysStim 208: 1; SysStim 208A: 2 |
| Waveform & Channels | Asymmetrical biphasic with zero net DC | Asymmetrical biphasic with zero net DC |
| Max Output Current (mA) | Not explicitly stated for predicates, but implied similar operating range | 184 mA peak ±20% into 500 Ω; 72 mA peak ±20% into 2 KΩ; 17 mA peak ±20% into 10 KΩ |
| Max Output Voltage (V) | Similar to predicate devices (e.g., 110 V peak into 1K ohm load) | 92 V peak ±20% into 500 Ω; 144 V peak ±20% into 2 KΩ; 166 peak ±20% into 10 KΩ (Sys*Stim 208/208A) |
| Max Leakage Current (µA) | Normal |
§ 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).