(140 days)
The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:
- Symptomatic relief of acute pain .
- . Symptomatic relief and management of chronic intractable pain
- . Symptomatic treatment for post-surgical and post-trauma acute pain
The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features:
- . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF)
- . Each channel has a dedicated intensity control
- . Maximum stimulation of 50 mA/500 V from each channel
- . Timed therapy sessions
- . Continuous stimulation
- . Adjustable pulse rates
- Balanced asymmetrical and symmetrical biphasic waveforms
- . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation
- . Lock option for clinician to control treatment regimens and stimulus intensity
- . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero
The provided text is a 510(k) Summary for the Infinity Electrotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment cannot be extracted from the provided text. The document does not describe any specific studies conducted to establish performance metrics for the Infinity Electrotherapy System against defined acceptance criteria.
The 510(k) submission process for this type of device (a Class II or unclassified device) generally relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, materials, intended use, and performance characteristics to the predicate, rather than conducting new clinical trials with acceptance criteria.
Information that can be extracted related to the device and its regulatory status:
- Device Name: Infinity Electrotherapy System
- Intended Use/Indications for Use:
- Symptomatic relief of acute pain.
- Symptomatic relief and management of chronic intractable pain.
- Symptomatic relief for post-surgical and post-trauma acute pain.
- Predicate Devices:
- Basis for Substantial Equivalence: The Infinity is described as an extension of the 300 PV and similar in design and functions, offering multiple treatment programs. Differences noted are that Infinity is a two-channel system (300 PV is four-channel) and Infinity is not indicated for NMES, FES, or TENS.
- Regulatory Decision: A substantial equivalence determination was made by the FDA on December 17, 2004, allowing the device to be marketed.
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).