(113 days)
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The FemRx™ Morcellator System is virtually identical to the currently marketed Karl Storz STEINER™ Morcellator in terms of its tissue cutting and extraction mechanism. Both devices utilize a separate motor drive box and flexible drive a rotating cutting blade, internal to a cylindrical housing, used to cut or core tissue as it is drawn up through the central lumen of the device by the use of standard forceps.
The principle difference between the FemRx™ Morcellator and the Storz device is that the FemRx device incorporates a fixed cylinder inside the rotating cutter (see figure below). The fixed (non rotating) cylinder located on the inside of the cutter is designed to reduce the torsional or rotational force applied to the cored tissue fragments as they are pulled up through the central lumen of the FemRx™ device.
The FemRx™ Morcellator System also differs from the Storz device in that it is disposable and utilizes the Motor Drive Unit (MDU) that has been previously cleared as part of the FemRx™ ores STARTM and TORSTAR™ Hysteroscopic and Urological Resectosocipic Systems [510(k) numbers K954648 and K962506].
All tissue contacting materials are standard medical grade and non-toxic.
Based on the provided text, it appears that the FemRx™ Morcellator is being compared to the Karl Storz STEINER™ Morcellator, highlighting the FemRx's design difference (fixed internal cylinder) and disposability, and its use of a previously cleared motor drive unit.
However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert involvement, or any of the other specific details requested for a comprehensive study description.
Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study that proves the device meets specific criteria, as this information is entirely absent from the provided "Input" text.
If you can provide a different input that includes such study details, I would be happy to process it accordingly.
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. 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 § 884.9.