(224 days)
The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.
Micro-France trocars are manually operated surgical instruments. They consist of a stainless steel mandrel used to establish surgical access to the abdominal or thoracic cavity, and a sleeve the maintain access for surgical and laparoscopic instruments. The trocars may include an automatic valve feature and a port with stopcock for insufflation. Trocar accessories include threaded and smooth sleeves, reduction sleeves, and parietal elevators.
The provided 510(k) summary for the Micro-France trocars and accessories does not contain specific information regarding acceptance criteria for device performance or a study proving it meets such criteria. This type of submission, often for Class II devices, typically relies on demonstrating substantial equivalence to legally marketed predicate devices rather than requiring de novo clinical performance studies with acceptance criteria.
Therefore, the following information is not available in the provided document:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not applicable as a performance study is not detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable (no software algorithm).
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
- Intended Use: The trocars and accessories are used to establish and maintain surgical access to the abdominal or thoracic cavity, access for surgical and laparoscopic instruments, and may provide a port with stopcock for insufflation.
- Substantial Equivalence: The device is deemed substantially equivalent to predicate devices marketed by Richard Wolf (K960299), Pilling Weck (K964450), and Ethicon Endo-Surgery (K965045). This is the primary basis for its clearance, implying that its safety and effectiveness are comparable to these established devices without requiring a new performance study with specific acceptance criteria.
§ 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.