(57 days)
The Karl Storz Multidrive Mini Shaver and blades are designed to provide controlled shaving, abrading and cutting of bone and tissue during arthroscopic surgical procedures of the ankle, wrist, elbow and TMJ.
The Karl Storz Multidrive Mini Shaver and blades are motorized surgical devices and include reusable and sterile, single use instruments are long enough to gain access to the surgical area and are designed to be used as accessories to arthroscopes. The body contact materials of the blades are surgical grade stainless steel.
This document is a 510(k) summary for a medical device (Karl Storz Multidrive Mini Shaver and blades). It describes the device's intended use and design but does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in performance studies for AI/machine learning devices or software.
This document is from 1997 and pertains to traditional surgical equipment, not AI/ML-driven medical devices. Therefore, the questions regarding acceptance criteria, study design, sample sizes, ground truth, expert consensus, MRMC studies, or standalone performance are not applicable to the information provided in this 510(k) summary.
The summary states that the device is "substantially equivalent" to predicate devices, meaning its safety and effectiveness are established by demonstrating similarity to already legally marketed devices, rather than through a new clinical performance study as would be required for novel AI-based devices.
§ 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.