(18 days)
The Gyrus Endourology System, when used with a Gyrus Axipolar Resectoscope Electrode, 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 prostatectorny (TURP) for benign prostatic hypertrophy, transurethral incision of the prostate (TUIP) or bladder neck, resection of bladder tumors and in cystodiathermy.
The Axipolar Resectoscope Electrode devices described in this 510(k) are sterile, disposable electrodes designed for use with the Gyrus Endourology System.
The provided document, K994166 "Gyrus Axipolar Resectoscope Electrode (ARE) Special 510(k) Premarket Notification: Device Modification," describes a device modification and asserts substantial equivalence to a predicate device. It does not present a study with specific acceptance criteria and reported device performance metrics in the way one would expect for a new diagnostic or AI-driven device.
This submission is a Special 510(k): Device Modification for an electrosurgical electrode. The focus of such a submission is to demonstrate that a modified device is still substantially equivalent to its original predicate device, often by showing continued compliance with design control requirements and risk analysis procedures, rather than conducting a new, extensive performance study with detailed acceptance criteria.
Therefore, many of the requested elements for describing an acceptance criteria study are not directly applicable or available in this document.
Here's a breakdown based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document as a formal table of acceptance criteria and performance metrics from a study. As a Special 510(k) for a device modification, the submission likely relies on demonstrating that the modified device continues to meet the safety and effectiveness profile of the original predicate device through design controls and risk analysis, rather than new, quantitative performance testing with explicit acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided. The document makes no mention of a "test set" in the context of performance evaluation as it would for a new diagnostic device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable/provided. No "test set" and corresponding "ground truth establishment" by experts is described in this regulatory submission for a device modification.
4. Adjudication Method for the Test Set
This information is not applicable/provided. There is no described "test set" requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not mentioned or conducted. This type of study is more relevant for diagnostic devices (especially those involving image interpretation) to assess the impact of AI on human reader performance. This document concerns an electrosurgical system electrode.
6. Standalone (Algorithm Only) Performance Study
No, a standalone performance study was not conducted or described. This document describes a physical medical device (an electrosurgical electrode), not an algorithm or AI system.
7. Type of Ground Truth Used
This information is not applicable/provided. No "ground truth" in the context of diagnostic performance evaluation is mentioned. The "ground truth" for an electrosurgical device's safety and effectiveness would implicitly be adherence to engineering specifications, material biocompatibility, and functional performance (e.g., cutting, coagulation efficiency) which are typically assessed through bench testing and animal/cadaver studies, but specifics are not detailed in this summary.
8. Sample Size for the Training Set
This information is not applicable/provided. The device is an electrosurgical electrode, not an AI or machine learning model that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable/provided. As explained above, there is no "training set."
Summary of Device in the Context of the Request:
The provided document details a Special 510(k) Premarket Notification for a modification to the Gyrus Axipolar Resectoscope Electrode. The core of this type of submission is to demonstrate substantial equivalence to an existing, legally marketed predicate device (K990628 in this case) despite a modification. This is typically achieved by:
- Certification of compliance to 21 CFR 820.30 Design Control requirements: Showing that the design changes were controlled and documented to ensure the device still meets its intended use.
- Risk Analysis procedures: Demonstrating that the modifications do not introduce new or increased risks.
- Comparison to predicate: Arguing that the modified device maintains the same safety and effectiveness profile as the predicate.
The document explicitly states: "This submission is a Special 510(k): Device Modification as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Gyrus has provided certification of compliance to 21 CFR 820.30 design Control requirements, and Risk Analysis procedures."
Therefore, the "study" demonstrating the device meets "acceptance criteria" here is primarily the design control and risk analysis process that concludes the modified device remains substantially equivalent and performs as safely and effectively as its predicate. This is a qualitative and process-oriented demonstration rather than a quantitative, performance study with specific metrics and thresholds akin to those expected for a new diagnostic device or AI algorithm.
§ 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).