(74 days)
The KSEA Plastic Trocars are intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic procedures.
The Karl Storz Plastic Trocars are manually operated surgical devices. The body contact portions of the KSEA Plastic Trocars are composed of surgical grade stainless steel and PEEK which are commonly used in medical devices for a wide range of applications and have a long history of biocompatibility for human use.
I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. The document is a 510(k) summary for two medical devices:
These summaries focus on demonstrating substantial equivalence to predicate devices, which is the regulatory pathway for 510(k) notifications. They describe the device's indications for use, device description, and state that the device is substantially equivalent to a predicate device, implying that no new issues of safety or effectiveness are raised. They do not include specific performance metrics, acceptance criteria, or detailed study results that would typically be required to fill out the requested table and answer the study-related questions.
Therefore, I cannot provide the requested information based on the given input.
§ 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.