(169 days)
The A.S.D. Surgical Trocar is intended for use during vascular and gynecological laparoscopy and other abdominal procedures, to create an entry point for laporascopic instruments into the abdominal cavity. Surgical instruments of the appropriate size can be safely quided and entered into the abdominal cavity through the cannula.
The A.S.D. Surgical Trocar is a single-use, sterile, temporary, disposable device intended for use during laparoscopy, to create an entry point for laporascopic into the abdominal cavity. Surgical instruments of the appropriate size can be safely guided and entered into the abdominal cavity through the cannula. The Trocar consists of: 1) an obturator with a pointed pyramidal tip, 2) a spring-baded safety shield to of the obturator after lissue penetration. 3) a radiolucent cannula (sleeve) with a gasket system to prevent leakage of gas during i setion and withdrawal of instruments 4) an accessory stability thread to help secure the cannula in the body during use. An collional accessory, an obturator adapter is available to be used as a reducer with the 1011mm system. When the adapter is used, 5 mm instruments are accepted into the 10/11mm trocar. The A.S.D. Trocar is available in the 10/11mm and 5mm sizes. The size of the size of the size of the instrument that can be entered in the trocar. The sleeve lengths available for the 1011mm and 150mm; and for the 5mm trocar are 70 mm and 100mm. The stability threads are available in 38 mm and 51 mm lengths. The A.S.D. Trocar is made of aluminum, stainless steel, polycarbonate and silicone rubber.
This document is a 510(k) summary for a surgical device (A.S.D. Safety Trocar) and not an AI/ML device. Therefore, the requested information about acceptance criteria, study design, and ground truth in the context of AI/ML performance is not applicable to this submission.
The document describes a physical surgical instrument and focuses on its description, intended use, contraindications, and substantial equivalence to existing devices, as required for FDA 510(k) clearance for conventional medical devices.
§ 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.