(510 days)
The Laparo-Tenser is intended for use as a laparoscopic retractor in gasless laparoscopic procedures. the Laparo-Tenser creates a gasless cavity to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Laparo-Tenser Laparoscopic Abdominal Retractor
This document is a 510(k) clearance letter from the FDA for a medical device called the "Laparo-Tenser Laparoscopic Abdominal Retractor." It is a regulatory approval document, not a study report or clinical trial summary.
Therefore, the input document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria. The document only confirms that the device is substantially equivalent to a predicate device already on the market, allowing it to be marketed.
Specifically, it lacks:
- A table of acceptance criteria and reported device performance.
- Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods.
- Information on MRMC comparative effectiveness studies or standalone algorithm performance.
- Details about ground truth establishment or training set sample sizes.
§ 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.