(78 days)
The Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode is intended for use in the coagulation of tissues in the head and neck by qualified medical personnel trained in the use of electrosurgery. Indications for use for the Gyrus ENT Model 2420 Tissue Coagulating Electrode include the coagulation and reduction of enlarged tonsils for patients 13 years of age and older.
The Model 2420 Tissue Coagulating Electrode is used to deliver RF energy for selective thermal coagulation of tissue. The electrode is provided as a dual needle that is deployed from a guide sleeve. The angle of deployment is fixed at approximately 45°. The needle is covered proximally by insulation to protect the mucosa during coagulation. A beveled penetrator plate is located at the tip of the guide sleeve and serves to penetrate the tonsil mucosal surface prior to electrode deployment. Temperature sensors located at the tip of the needle and the tip of the insulation monitor lesion temperature.
Like the previously cleared Model 1420 electrode, the Model 2420 provides a slide actuator on the handle used to extend or retract the needle electrodes through attached dual guide lumens. The proximal end of the handle accepts the detachable and reusable power cable. The distal end of the handle is attached to the guide lumens containing the needle electrodes. The entire device is disposable.
This document is a 510(k) Summary for a medical device (Gyrus ENT Somnoplasty® Model 2420 Tissue Coagulating Electrode) seeking market clearance. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in terms of performance metrics.
Therefore, much of the requested information regarding acceptance criteria and performance evaluation through a study is not available in the provided text. The document is an FDA submission for market clearance, which relies on demonstrating equivalence to existing products rather than a novel clinical effectiveness study with defined acceptance criteria and performance outcomes.
Here is an attempt to address your request based only on the provided text, highlighting what is missing or not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not available in the provided 510(k) summary. Acceptance criteria for device performance (e.g., success rates, percentage reduction in tonsil size, complication rates) and corresponding reported performance metrics from a study are not included. The document emphasizes substantial equivalence to a predicate device, not a new performance evaluation against predefined criteria.
2. Sample Size Used for the Test Set and Data Provenance
This information is not available. The document does not describe a new clinical study with a defined test set for performance evaluation. It references previously cleared devices and states the current device "is substantially the same."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available, as no new clinical study with a test set requiring expert ground truth establishment is described.
4. Adjudication Method
This information is not available, as no new clinical study with a test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not available. No MRMC comparative effectiveness study is mentioned, nor is any human-in-the-loop performance evaluation or an effect size for human readers improving with/without AI assistance. The device is a surgical electrode, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance
This information is not available. The device is a physical electrosurgical electrode and does not involve an algorithm for standalone performance evaluation.
7. Type of Ground Truth Used
This information is not available, as no new clinical study requiring ground truth establishment is described.
8. Sample Size for the Training Set
This information is not available. The device is an electrosurgical electrode, not an AI model, and therefore does not have a "training set" in the context of machine learning. The submission relies on the established safety and effectiveness of predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not available (see point 8).
Summary of Device and its Basis for Clearance (Extracted Information):
- Intended Use/Indications: Coagulation and reduction of enlarged tonsils for patients 13 years and older in the head and neck by qualified medical personnel trained in electrosurgery.
- Device Description: The Somnoplasty® Model 2420 Tissue Coagulating Electrode is part of the Somnoplasty® System. It's a dual-needle electrode that deploys at approximately 45°, with insulation to protect mucosa and temperature sensors to monitor lesion temperature. It has a slide actuator on the handle and is disposable.
- Basis for Clearance: Substantial Equivalence to previously cleared devices:
- Previous Somnoplasty® Systems cleared for uvula/soft palate coagulation (K971450), chronic turbinate hypertrophy (K973618), and UARS/OSAS airway obstruction reduction (K982717).
- Current Model S2 Generator cleared in K001438.
- RC-20 Cable cleared in K000720.
- Model 2420 Tissue Coagulating Electrode is "substantially the same" as the Model 1420 Electrode cleared in K000720.
- Conclusion of FDA: The FDA determined the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
The 510(k) process is primarily a regulatory pathway to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not to prove clinical efficacy and safety through new, extensive clinical trials with defined acceptance criteria for performance (unless the device is significantly different or intended for a new use not covered by predicates).
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.