(384 days)
The Karl Storz Semi-Rigid Micro-Endoscopes and Accessories are designed to allow viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.
Karl Storz Semi-Rigid Micro-Endoscopes are straight-shafted, fiberoptic endoscopes. Accessories are available for use with the Micro-Endoscopes, including forceps, scissors, probes, trocars, cannulae, and needles. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.
This document describes an application for a 510(k) premarket notification for Karl Storz Semi-Rigid Micro-Endoscopes and Accessories. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study. Therefore, the information requested regarding acceptance criteria, study design, and performance metrics is generally not applicable in the context of this 510(k) summary.
Here's an explanation based on the provided text:
-
Table of acceptance criteria and the reported device performance:
Not applicable. This 510(k) summary does not define specific performance acceptance criteria or report device performance against such metrics. The core of a 510(k) is to demonstrate "substantial equivalence" to a legally marketed predicate device, meaning the new device is as safe and effective as the predicate. -
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
Not applicable. No specific test set or study data is presented to demonstrate performance. The submission relies on comparing design features, intended use, and materials to predicate devices. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable. No ground truth establishment process is described, as no specific performance study was conducted in the context of this 510(k) summary. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set or adjudication process is mentioned. -
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. This device is an endoscope and associated accessories, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI assistance is irrelevant. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device (endoscope), not a software algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. No ground truth is established or discussed in this submission. -
The sample size for the training set:
Not applicable. This type of submission does not involve training sets, as it's not a machine learning or AI-based product. -
How the ground truth for the training set was established:
Not applicable. As above, no training set or ground truth establishment is pertinent to this 510(k) summary.
Summary of the 510(k) Statement:
The document states that the Karl Storz Semi-Rigid Micro-Endoscopes and Accessories for endoscopic gynecological surgery are substantially equivalent to predicate devices. The justification for this equivalence is based on:
- Same basic features: Straight-shafted, fiberoptic endoscopes.
- Same design: Implies similar construction and function.
- Same intended uses: Allows viewing of, and access to, the surgical site during endoscopic gynecological surgical procedures.
- Minor differences: The document asserts that any minor differences between the new device and predicate devices "raise no new issues of safety and effectiveness" and "have no effect on the performance, function or intended use of the devices."
- Biocompatibility: The body contact materials are commonly used in medical devices and have a long history of biocompatibility.
In essence, this 510(k) summary is a declaration that the new device is so similar to existing, legally marketed devices that it performs similarly and presents no new risks, thus avoiding the need for extensive new clinical performance studies typical of premarket approval (PMA) applications.
§ 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.