(71 days)
Recording muscle activity for Electromyograph (RMG) applications . For single patient use only.
Rhythmlink Disposable Monopolar EMG Needle is a device intended for recording muscle activity during electromyography (EMG) procedures. The device consists of an insulated monopolar needle, needle hub, connector (solderless crimped connection), and plastic needle cover. The monopolar needle is made of medical grade stainless steel and is available in three lengths. The entire needle is coated with Teflon (PTFE), except for the recording tip, to insulate the needle and reduce friction upon insertion. The solderless crimped connection consists of a gold-plated brass tube 1mm in thickness, crimped onto the isolated needle. The connection is covered with a needle hub made of black polyethylene molding. The plastic needle cover is made of polyethylene. The device is available in seven different needle sizes. The needles are available in 0.32 to 0.57mm in diameter and are available in 15 to 75mm lengths. The needle is intended to record muscle activity during EMG procedures, and the needle hub is designed to be held by the user to secure the needle in the recording site. The solderless crimped connection secures the needle to the end of the leadwire. With the exception of the needle length, needle diameter, and leadwire length, the components and their dimensions are consistent throughout the product line, and these material and dimensional specifications are outlined in the product drawing under Device Description.
The provided text is for a 510(k) summary for the "Rhythmlink Disposable Monopolar EMG Needle". This document describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information on acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.
This type of 510(k) submission, particularly for Class II devices like this EMG needle, relies primarily on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, material compatibility, and performance characteristics (e.g., electrical impedance, mechanical strength, biocompatibility). It typically does not involve the kind of clinical performance studies with detailed acceptance criteria, expert ground truth, or MRMC analysis that would be expected for more complex diagnostic or AI-driven devices.
Therefore, I cannot extract the requested information from the provided text because it is not present in the document. The text mainly focuses on device description, indications for use, and a comparison to a predicate device to establish substantial equivalence.
§ 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).