(235 days)
This decice is restricted to use by authorized expert personnel / physicians!
The WISAP THERME-PNEU Computer 7070C/7070CM/7070CM/7070CMF may only be used for building up a pneumoperitoneum with CO .- Gas for diagnostic or operative Pelviscopy/Laparoscopy. The Flow-Therme integrated in the appliance preheats the insufflation gas to body temperature.
Not Found
The provided FDA document is a 510(k) clearance letter for the WISAP Therme Pneu Computer. It primarily focuses on regulatory approval based on substantial equivalence to a predicate device. This type of document does not contain the detailed information required to answer your questions about acceptance criteria and performance studies.
The letter states: "We have reviewed your Section 510k) notification of intent to market the device and we have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."
This means that the device's clearance was likely based on a comparison to an existing device, rather than a new clinical performance study with specific acceptance criteria as you've outlined.
Therefore, I cannot provide the requested information because it is not present in the given text.
To answer your questions, one would need access to the full 510(k) submission document, which would detail any performance testing conducted, if applicable to this type of device and regulatory pathway. For many Class I and Class II devices cleared via the 510(k) pathway, extensive "acceptance criteria" and "study data" as you've described for AI/diagnostic devices are not typically required beyond demonstrating functional equivalence and safety to a predicate device.
§ 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.