Search Results

Ask a specific question about this device

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.

Ask a specific question about this device

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:

1. 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.
2. 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.
3. 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.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. 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.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable, as there's no mention of a training set for an algorithm.
9. 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.

Ask a specific question about this device