(124 days)
The Gyrus Endourology System is a radio frequency bipolar electrosurgical device system intended for use in urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required. The specific urological indications where the system can be used are in transurethral prostatectomy (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.
The Gyrus Endourology System is comprised of four key components: the Electrode, the Connector Cable, an Axipolar Resectoscope and an electrosurgical generator called the Controller. The Connector Cable connects the Controller to the Electrode. The Electrode is provided in a variety of models, ranging in size from 5 Fr. to 24 Fr. A system specific Resectoscope is provided for use with one of the Electrode models. Other Electrode models are available for use with available cystoscopes with a 5Fr or larger operating channel. The Electrode is supplied sterile and intended for single patient use. The Connector Cable is designed for a number of sterilizations and the Resectoscope for repeat sterilizations using steam autoclaving methods. The Controller is an electronic radio frequency generator. The Gyrus Endourology System is bipolar, incorporating a return electrode as a part of the electrode tip. This means that a return pad is not required for system operation. The return energy in a bipolar device with an integral return electrode does not penetrate the tissue as in a monopolar device. In a monopolar device, the energy passes through the patient's body to reach the return pad.
The provided document is a 510(k) Premarket Notification for the Gyrus Endourology System. This type of FDA submission aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials with acceptance criteria.
Therefore, the document does not contain the following information typically associated with a study proving a device meets specific acceptance criteria:
- A table of acceptance criteria and the reported device performance: This document focuses on demonstrating equivalence to predicate devices, not meeting pre-defined performance thresholds.
- Sample size used for the test set and the data provenance: No new performance data specific to the Gyrus Endourology System is presented from a test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment is not relevant to a substantial equivalence demonstration for this type of device.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an electrosurgical device, not an AI/algorithm-based system.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
Instead, the document focuses on demonstrating substantial equivalence to existing predicate devices based on:
- Identical intended use: The Gyrus Endourology System's indications for use are described and implicitly compared to those of the predicate devices.
- Similar technological characteristics: The document explicitly states, "The technological characteristics of the Gyrus Endourology System are the same as those of the Scuba (Gynecare Versapoint™) Electrosurgery System, Electrodes (K962482, K982738) and its dedicated Resectoscope and accessories (K982771). The devices are substantially equivalent in terms of design, materials, principle of operation, product specifications and sterilization."
- Safety and effectiveness demonstrated by predicate devices: The submission asserts that "Equivalent monopolar and bipolar electrosurgery devices have been cleared via 510(k), such as those manufactured by Erbe (K933002) and COMEG (K971881). These devices have been demonstrated to be safe and effective in removing tissue during urological surgery." By demonstrating equivalence to these devices, the Gyrus system is presumed to also be safe and effective.
The provided text does not contain any information about specific acceptance criteria or performance studies in the way you've outlined for an AI/algorithm-based device. It is a regulatory submission focused on comparing the new device to existing, legally marketed devices.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).