(392 days)
The iRelieve Microcurrent Pain Relief System is intended to be used by physicians or licensed practitioners for symptomatic relief of chronic intractable pain.
The iRelieve Microcurrent Pain Relief System is a microcurrent TENS device that operates by sending electrical impulses through the skin to the nerves lying directly beneath the skin surface. These impulses help block the body's ability to send a pain message to the brain, thereby reducing the pain sensation. The iRelieve Microcurrent Pain Relief System is a single channel device that produces microampere currents with the selected envelopes, waveforms, frequencies, and polarity, with a maximum voltage of 3.0 volts. It is controlled by analogue electrical parts (voltage regulator, frequency oscillator, multiple resistors, etc.) and a digital microprocessor chip that contains embedded programmed software (firmware) that generates a sequence of current flows and frequencies during the course of a single treatment session. The iRelieve Microcurrent Pain Relief System performs this sequence of current flows without user manipulation or device controls other than switching the device on after application of the device to the electrodes.
The provided text is a 510(k) Summary for the iRelieve Microcurrent Pain Relief System. It describes the device, its intended use, and states that it has been determined to be substantially equivalent to a predicate device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria related to clinical performance or efficacy.
Instead, the performance testing for the iRelieve Microcurrent Pain Relief System focuses on:
- Output Performance: Micro Current Stimulator Measurements, Validation of Electrodes, Output sequence with Oscilloscope captures.
- Device Integrity/Safety: Shelf-life testing, Packaging testing (ASTM D4169-16), Battery use life testing, Biocompatibility testing (leveraged from predicate), Electromagnetic compatibility (EMC) and electrical safety (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 standards).
- Software Validation: Software verification and validation per FDA guidance for Class B level of concern (IEC 62304).
The document explicitly states that the determination of substantial equivalence is based on the device having the "same intended use and similar technical characteristics, performance and applications" as the predicate device (Model 7500 Microcurrent TENS Device, Version MCT-F50, K013167), and that it "does not pose any new question of safety or effectiveness."
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets clinical acceptance criteria because this information is not present in the provided document. The document details technical performance and safety testing to demonstrate substantial equivalence to a predicate device, not a new clinical efficacy study with acceptance criteria.
§ 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).