(79 days)
The Karl Storz Unimat Plus system is designed to provide irrigation and aspiration of the surgical site during general and endoscopic plastic, reconstructive and aesthetic surgical procedures.
The Karl Storz Unimat Plus and accessories is a membrane type irrigation/aspiration pump with fixed irrigation/aspiration flow rate of 3.5 liters/min. and a maximum irrigation pressure of 400 mm Hg.
The given text is a 510(k) summary for a medical device called the "Karl Storz Unimat Plus" system, which is a suction/irrigation pump. This document focuses on establishing the device's substantial equivalence to existing predicate devices based on its intended use and design, rather than proving its performance against specific clinical acceptance criteria through a study.
Therefore, the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set information.
The summary states:
- "The Karl Storz Unimat Plus system is substantially equivalent to the predicate devices since the basic features and intended uses are similar."
- "The minor differences between the Karl Storz Unimat Plus and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices."
This indicates that the regulatory clearance is based on comparison to legally marketed devices, implying that if the predicate devices are safe and effective, and the new device is substantially similar without raising new safety/effectiveness concerns, then the new device is also considered safe and effective for its stated use. It does not describe a performance study with specific quantitative acceptance criteria for the device itself.
§ 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.