(305 days)
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
This device is intended for use by licensed physicians. Physicians using this device are well trained in the use of EMG electrodes, their placement, and proper use of related EMG instruments.
The fine wire electrodes are designed to record electrical activity in muscle tissue. As recording electrodes, there is no risk of damage to the tissue from electrical current.
Fine wire electrodes allow for multiple tests without additional needle sticks.
Fine wire electrodes are supplied preloaded into a needle assembly. The needle is inserted into human muscle tissue and then removed, leaving the fine wires implanted for a short term. An adaptor cable is attached to the fine wires and then connected to an EMG instrument for electromyographic (EMG) diagnostic tests.
This document is a 510(k) clearance letter from the FDA for a device called "FINE WIRE ELECTRODE". This letter indicates that the device has been found substantially equivalent to a predicate device and can be marketed. However, it does not contain the detailed study information typically found in a clinical study report or a 510(k) submission summary that would describe acceptance criteria and the study proving it meets those criteria.
The provided text from the FDA 510(k) clearance letter does not describe the specific acceptance criteria for the device's performance nor does it detail a study proving the device meets those criteria. Such information is usually contained in the 510(k) submission itself, not in the clearance letter.
Therefore, I cannot provide the requested information from the given text. The letter only confirms that the FDA reviewed the submission and determined that the device is substantially equivalent to a previously marketed device.
To answer your request, I would need access to the original 510(k) submission, specifically the sections detailing the performance data and predicate comparison.
§ 890.1385 Diagnostic electromyograph needle electrode.
(a)
Identification. A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).(b)
Classification. Class II (performance standards).