(52 days)
The VEROSCOPE is used percutaneously for penetrating the abdominal cavity under endoscopic control to safely reach a defined body region. It therefore also serves to create a pneumoperitoneum under visual control in the abdomen.
The Dilation Tube System and standard Dilation System is used for dilating surgically created passages in body cavities.
Indications and field of use: The Veroscope and dilation tube systems are used for diagnosis and therapy in conjunction with endoscopic accessories in various disciplines such as surgery, gynecology and urology.
The 'Veroscope' consists of an outer trocar sleeve with insufflation stopcock, a veress cannula rice + erosopo consisted brotection tube with a transparent blunt tip and an endoscope.
The 'Veroscope' is similar to a spring-loaded, blunt Veress needle that is used for penetrating tissue layers under endoscopic view.
The Standard Dilation System consists of metal dilation sleeves and a guide rod.
The Dilation Tube System 4760 consists of a plastic dilation tube and trocars with sleeves of various dimensions.
The provided document is a 510(k) Summary for a medical device (VEROSCOPE, Optical Veress Cannula and Dilation Tube System). It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document explicitly states:
- "No performance standards are known." (Section 5.0 Performance Data)
- "No clinical tests performed." (Section 6.0 Clinical Tests)
Therefore, based solely on the provided text, I cannot complete the requested table or provide information about a study proving acceptance criteria. The submission focuses on demonstrating substantial equivalence to predicate devices, not on presenting new performance data or clinical trial results 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.