(218 days)
Intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in surgical procedures such as but not limited to orthopedic, arthroscopic, and spinal procedures.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted on the Arthro Kinetics Vesalius MR Generator. The document is a 510(k) premarket notification letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters such as classification, general controls, and compliance, but it does not detail any technical performance criteria or study results.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.