(269 days)
The devices are intended to be used for stimulation of peripheral nerves for diagnostic purposes.
MagPro R30 incl. MagOption, MagPro X100 and MagPro X100 incl. MagOption are Magnetic stimulators used for Magnetic stimulation. These three devices are, together with the predicate device MagPro R30, called "MagPro Family". Hereafter we name the three devices in this submission "the new devices". Magnetic stimulation is a non-invasive technique for stimulating neural tissue. Application areas of magnetic stimulation are a sub-set of the application areas for current stimulation. The new devices are connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. All Standard coils as well as the Fluid and Cool coils can be used with the MagPro devices, (K926516, K061645, K071821). The new devices are magnetic stimulators, featuring Biphasic, Monophasic, Halfsine, Biphasic Burst waveform, stimulation rates up to 100 pulses per second (pps), stimulus sequences and protocols controlled via a built-in computer and 8,4" display.
This 510(k) premarket notification is for magnetic stimulators (MagPro R30, X100, and variants) and does not contain information typically associated with AI/ML device studies. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through technological comparison and compliance with existing medical device standards rather than clinical performance metrics in the context of an algorithmic decision.
Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not applicable to this specific 510(k) submission.
The document indicates that the devices are for "stimulation of peripheral nerves for diagnostic purposes" and that "The difference in performance between the new devices and the predicate devices are thoroughly compared and discussed in the 'Substantial Equivalence' section." However, this section (not fully provided in the input) would likely focus on electrical and magnetic output characteristics, safety, and functional equivalence, not diagnostic accuracy in the way an AI/ML device would be assessed.
The submission concludes that "The new devices do not raise new issues of safety and effectiveness and are substantially equivalent to the predicate devices." This is the primary "acceptance criterion" for a 510(k) of this nature.
§ 882.1870 Evoked response electrical stimulator.
(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).