(176 days)
The Karl Storz Arthropump Plus system is designed to provide irrigation and aspiration of the surgical site during arthroscopic surgical procedures.
These instruments are intended for use by qualified surgeons and provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures.
The Karl Storz Arthropump Plus and accessories is a roller type irrigation/aspiration pump with user adjustable irrigation flow rate, irrigation pressure, and aspiration suction underpressure.
This 510(k) summary for the Karl Storz Arthropump Plus system states that it is substantially equivalent to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a regulatory approval and not a detailed performance study.
Therefore, I cannot provide the requested information based on the input text. The input does not describe a study or acceptance criteria for device performance.
§ 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.