(83 days)
The Arthro-Surgimat is a high flow arthroscopic pump classified under 21 C.F.R. § 888.1100 intended to distend joint cavities during arthroscopic procedures.
The Arthro-Surgimat is a high flow arthroscopic pump designed to react very quickly to various influences, thereby maintaining constant intraarticular pressure. It has pressure measurement through multiple sensors at the pump head, 3 optional preselectable pressure levels (to be programmed by end-user), a max. flow rate of 1500 ml/min, and a foot pedal for temporary increase of preselected flow level for rinsing of joint after/during shaver use.
The provided text does not contain information about acceptance criteria for a medical device or a study detailing its performance against such criteria. Instead, it describes a 510(k) Summary for the Arthro-Surgimat, a high-flow arthroscopic pump.
The document discusses:
- Device Description: The Arthro-Surgimat is an arthroscopic pump for distending joint cavities.
- Substantial Equivalence: It claims substantial equivalence to two predicate devices: Linvatec Apex Universal Irrigation System (K933873) and Smith & Nephew InteliJET Fluid Management System (K912453).
- Key Differences from Predicate Devices: These include pressure measurement points, preselectable pressure levels, max flow rate, and foot pedal features.
- Safety and Utility References: It cites two books (Hempfling, 1995 and McGinty, 1995) to generally discuss the utility and safety of arthroscopic techniques and high-flow pumps, mentioning the importance of effective instrumentation.
Therefore, I cannot populate the requested table and answer the specific questions about acceptance criteria and a study proving device performance because this information is not present in the provided text.
The text focuses on establishing substantial equivalence for a 510(k) submission, which typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study results against specific acceptance criteria.
§ 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.