(91 days)
The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation.
The InterX500 Flexible Array Electrode consists of stainless steel electrodes assembled in a biomedical grade silicone rubber. The electrodes are connected to each other by wiring through a connector cable. There is no power to the InterX500 Flexible Array Electrode unless it is connected to interactive electrostimulation device provided by Neuro Resource Group, Inc. The InterX500 Flexible Array Electrode is placed directly onto unbroken skin and does not use any conductive gels. The connector is medically recognized and cannot be plugged into an AC socket. The InterX500 Flexible Array Electrode is an optional external electrode accessory for an interactive electrostimulation device provided by Neuro Resource Group. The electrode serves as an extension to the device to allow the user to apply treatment in larger and less accessible areas by the electrodes on the interactive electrostimulation device. The InterX500 Flexible Array Electrode is intended to be used with a Neuro Resource Group, Inc. provided electrostimulation device and does not contain any active electrical components. The cable is a two conductor cable using two 24 AWG single wires tinned with copper. The cable is UL and CSA approved.
The provided text is a 510(k) summary for a medical device called the "InterX500 Flexible Array Electrode." It describes the device, its intended use, and its classification, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot provide the requested table and study details. This document is a regulatory submission for substantial equivalence, not a performance study report.
Here's what the document does contain or imply:
- Device Name: InterX500 Flexible Array Electrode
- Intended Use/Indications for Use: "The InterX500 Flexible Array Electrode is intended to be used with authorized InterX TENS and/or Powered Muscle Stimulator devices for the purpose of applying electrical stimulation."
- Predicate Device: K042912 - InterX 5000
- Classification Regulation: 21 CFR 882.1320 (Electroencephalograph – but this seems to be a misclassification as the device is for electrical stimulation, not EEG. The product code GXY is for "Electrode, Patient, Intracavitary, Therapeutic, Stimulating" so the regulation number might be a typo in the FDA letter.)
- Regulatory Class: II
The document focuses on establishing substantial equivalence to a predicate device, which primarily relies on demonstrating similar technological characteristics and intended use, and often includes safety testing (e.g., biocompatibility, electrical safety) but not necessarily advanced performance metrics in a clinical study context.
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).