(50 days)
The RIWO CUT-Morcellator is used in gynecologic and surgical laparoscopic procedures to shred large pieces of tissue and to remove myomata or other tissue by means of a manually operated tubular knife.
Severed tissue like myoma, uterus or cysts can be grasped by a forceps, morcella extracted.
The claw grasping forceps is used to grasp and hold organs and tissue (e.g. myomas) under laparoscopic view.
The RIWO CUT-Morcellator 8386.205 is a manually operated rotary knife with a sealed protective sleeve. Via the protective sleeve, a grasping forceps 8385.181 for grasping the tissue to be morcellated is introduced also under gas-tight conditions. In the case of proper use (operating instructions), the replaceable cutting knife can not be damaged. The preassembled unit (consisting of Cutting Sleeve, protection sleeve and grasping forceps) is inserted into the trocar sleeve 8943.011, which was previously inserted into the abdominal with the help of the dilator and guide sleeve 8943.911.
RIWO CUT-Morcellator. A harded knife with corrugated edge is screwed on the outer sleeve with 15 mm diameter. Via a handle provided with recessed grips, the cutting sleeve is made rotate by hand. The handle is fitted with a replaceable sealing system. The protective sleeve also provided with a sealing cap is introduced via the cutting sleeve. A claw grasping forceps (opening with both jaws) can be brought to the operation field via the protective sleeve. If the tissue to be morcellated is grasped with the grasping forceps, the forceps must be withdrawn into the protective sleeve until the marking is visible. This will ensure that the sharp cutting edges of the knife are not damaged by the forceps branches.
The claw grasping forceps is a tube shaft instrument with axial handle and spring-mechanism. The jaws have sharp hooks which enter into the tissue.
The trocar sleeve is a tube with a trumpet valve which can be opened, when the morcellator is inserted. The dilation and guide sleeve is a tube with a screw-in tip.
This document does not contain information on acceptance criteria or a study proving the device meets those criteria. In fact, it explicitly states:
"No clinical tests performed."
Therefore, the requested information cannot be extracted from the provided text.
Here is a breakdown of why this information is missing, based on your request:
- Table of acceptance criteria and reported device performance: Not present. The document describes the device's function and intended use but provides no quantitative performance metrics or acceptance criteria.
- Sample size used for the test set and data provenance: Not applicable, as no clinical tests were performed.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, as no clinical tests were performed.
- Adjudication method for the test set: Not applicable, as no clinical tests were performed.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, as no clinical tests were performed.
- Standalone (i.e. algorithm only without human-in-the loop performance) study: Not applicable, as this is a mechanical surgical instrument, not an AI algorithm.
- Type of ground truth used: Not applicable, as no clinical tests were performed.
- Sample size for the training set: Not applicable, as this is a mechanical surgical instrument, not an AI algorithm.
- How the ground truth for the training set was established: Not applicable, as this is a mechanical surgical instrument, not an AI algorithm.
The "Performance Data" section only mentions:
- "A 100% outgoing test ensures, that there is no permanently deformation of the forceps if normally used."
- "The steam stenlization tests performed by Richard Wolf shows, that the steam sterilization has no influence to the functional performance of the RIWO CUT-Morcellator or of the claw grasping forceps, when using the fractional method."
These are quality control and sterilization validation statements, not performance data from a clinical or even pre-clinical study measuring effectiveness against specific performance criteria. The document concludes that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual," but this is a general statement, not a report of a specific study proving it.
§ 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.