(118 days)
The device is an interferential stimulator with TENS indications used for symptomatic relief and management of chronic intractable pain. It is intended for use on the order of a physician only.
The Everyway IF-908 Interferential stimulator is the device which generates the small ture-sine pulses of electrical current. The generated current may be delivered to the patient skin and/or underlying nerves through the cable and electrode placed on skin. Through the current stimulation the chronic and/or acute pain is to be relieved
The Everyway IF-809 interferential stimulator consists mainly of two parts: the stimulus generator, and electrode. The stimulus generator generates the output current specified as the input of controller. The output port transmits the output current to the electrode, which is attached to the patient's skin so as to transmit this stimulus current to the patient for pain relief
The stimulation current is generated in such a way that the frequency in channel 1 is fixed, but frequency in channel 2 is adjustable. Also the output amplitude is also adjustable. Those adjustable parameters could provide user some stimulation output change depending upon the condition of patients according to the prescription of physician. In general IF-908 is the prescribtion device, which needs the physician instruction for stimulation treatment.
IF-908 provides two different alternative power supply system. 9V internal battery, 9V rechargeable battery pack charged by adaptor. The operator may recharge 9V battery pack for long term use via the power rechargeable battery system of IF-908. The battery pack can not be charged during operation via using 9V battery pack power.
The provided document is a 510(k) summary for the Everyway Interferential Stimulator, model IF-908. It indicates that no clinical studies were conducted to prove the device meets acceptance criteria. Instead, the device's safety and effectiveness were demonstrated through substantial equivalence to a predicate device and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since no clinical studies were performed, there are no specific performance-based acceptance criteria or reported device performance metrics from such studies. The acceptance criteria for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to the predicate device and compliance with relevant non-clinical standards.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Theratech IF series True sine interferential stimulator, model WL-2206A (K050847)) | Determined to be substantially equivalent |
| Performance Compliance Test according to ANSI/AAMI NS4 | Compliance achieved (conducted by manufacturer) |
| Electrical Compliance Test according to IEC 60601-1 | Compliance achieved (conducted by accredited laboratory) |
| EMC Compliance Test according to IEC 60601-1-2 | Compliance achieved (conducted by accredited laboratory) |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. No clinical test set was used. The substantial equivalence determination relies on comparisons of technical characteristics and non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No clinical test set with a ground truth established by experts was used.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No particular Clinical Test was conducted for Everyway Interferential Stimulator, model IF-908."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is an interferential stimulator, not an algorithm-based diagnostic or therapeutic tool that would typically undergo standalone algorithm performance testing.
7. The Type of Ground Truth Used
Not applicable. No clinical ground truth was established as no clinical studies were performed. The "truth" for this submission is based on fulfilling the requirements for substantial equivalence to a predicate device through non-clinical testing and technical specification comparison.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is not an AI/ML algorithm that requires a training set with established ground truth.
§ 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).